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Sample records for surgical adjuvant study

  1. Long term (five-year survival following radical surgical treatment plus adjuvant chemotherapy (FAM in advanced gastric cancer: a controlled study

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    Bresciani Cláudio

    2000-01-01

    Full Text Available Several drugs and their associations are being used for adjuvant or complementary chemotherapy with the aim of improving results of gastric cancer treatment. The objective of this study was to verify the impact of these drugs on nutrition and on survival rate after radical treatment of 53 patients with gastric cancer in stage III of the TNM classification. A control group including 28 patients who had only undergone radical resection was compared to a group of 25 patients who underwent the same operative technique followed by adjuvant polychemotherapy with FAM (5-fluorouracil, Adriamycin, and mitomycin C. In this latter group, chemotherapy toxicity in relation to hepatic, renal, cardiologic, neurological, hematologic, gastrointestinal, and dermatological functions was also studied. There was no significant difference on admission between both groups in relation to gender, race, macroscopic tumoral type of tumor according to the Borrmann classification, location of the tumor in the stomach, length of the gastric resection, or response to cutaneous tests on delayed sensitivity. Chemotherapy was started on average, 2.3 months following surgical treatment. Clinical and laboratory follow-up of all patients continued for 5 years. The following conclusions were reached: 1 The nutritional status and incidence of gastrointestinal manifestation were similar in both groups; 2 There was no occurrence of cardiac, renal, neurological, or hepatic toxicity or death due to the chemotherapeutic method per se; 3 Dermatological alterations and hematological toxicity occurred exclusively in patients who underwent polychemotherapy; 4 There was no significant difference between the rate and site of tumoral recurrence, the disease-free interval, or the survival rate of both study groups; 5 Therefore, we concluded, after a 5-year follow-up, chemotherapy with the FAM regimen did not increase the survival rate.

  2. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma.

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    Schmitt, Thomas; Lehner, Burkhard; Kasper, Bernd; Bischof, Marc; Roeder, Falk; Dietrich, Sascha; Dimitrakopoulou-Strauss, Antonia; Strauss, Ludwig G; Mechtersheimer, Gunhild; Wuchter, Patrick; Ho, Anthony D; Egerer, Gerlinde

    2011-12-07

    The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event, resulting in 5-year overall survival rates of only 50-60%. Neo-adjuvant and adjuvant chemotherapy (CTX) has been applied to achieve pre-operative cytoreduction, assess chemosensitivity, and to eliminate occult metastasis. Here we report on the results of our non-randomized phase II study on neo-adjuvant treatment for high-risk STS. Patients with potentially curative high-risk STS (size ≥ 5 cm, deep/extracompartimental localization, tumor grades II-III [FNCLCC]) were included. The protocol comprised 4 cycles of neo-adjuvant chemotherapy (EIA, etoposide 125 mg/m(2) iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m(2) day 1, pegfilgrastim 6 mg sc day 5), definitive surgery with intra-operative radiotherapy, adjuvant radiotherapy and 4 adjuvant cycles of EIA. Between 06/2005 and 03/2010 a total of 50 subjects (male = 33, female = 17, median age 50.1 years) were enrolled. Median follow-up was 30.5 months. The majority of primary tumors were located in the extremities or trunk (92%), 6% originated in the abdomen/retroperitoneum. Response by RECIST criteria to neo-adjuvant CTX was 6% CR (n = 3), 24% PR (n = 12), 62% SD (n = 31) and 8% PD (n = 4). Local recurrence occurred in 3 subjects (6%). Distant metastasis was observed in 12 patients (24%). Overall survival (OS) and disease-free survival (DFS) at 2 years was 83% and 68%, respectively. Multivariate analysis failed to prove influence of resection status or grade of histological necrosis on OS or DFS. Severe toxicities included neutropenic fever (4/50), cardiac toxicity (2/50), and CNS toxicity (4/50) leading to CTX dose reductions in 4 subjects. No cases of secondary leukemias were observed so far. The current protocol is feasible for achieving local control rates, as well as OS and DFS comparable to previously published

  3. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma

    Directory of Open Access Journals (Sweden)

    Schmitt Thomas

    2011-12-01

    Full Text Available Abstract Background The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event, resulting in 5-year overall survival rates of only 50-60%. Neo-adjuvant and adjuvant chemotherapy (CTX has been applied to achieve pre-operative cytoreduction, assess chemosensitivity, and to eliminate occult metastasis. Here we report on the results of our non-randomized phase II study on neo-adjuvant treatment for high-risk STS. Method Patients with potentially curative high-risk STS (size ≥ 5 cm, deep/extracompartimental localization, tumor grades II-III [FNCLCC] were included. The protocol comprised 4 cycles of neo-adjuvant chemotherapy (EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5, definitive surgery with intra-operative radiotherapy, adjuvant radiotherapy and 4 adjuvant cycles of EIA. Result Between 06/2005 and 03/2010 a total of 50 subjects (male = 33, female = 17, median age 50.1 years were enrolled. Median follow-up was 30.5 months. The majority of primary tumors were located in the extremities or trunk (92%, 6% originated in the abdomen/retroperitoneum. Response by RECIST criteria to neo-adjuvant CTX was 6% CR (n = 3, 24% PR (n = 12, 62% SD (n = 31 and 8% PD (n = 4. Local recurrence occurred in 3 subjects (6%. Distant metastasis was observed in 12 patients (24%. Overall survival (OS and disease-free survival (DFS at 2 years was 83% and 68%, respectively. Multivariate analysis failed to prove influence of resection status or grade of histological necrosis on OS or DFS. Severe toxicities included neutropenic fever (4/50, cardiac toxicity (2/50, and CNS toxicity (4/50 leading to CTX dose reductions in 4 subjects. No cases of secondary leukemias were observed so far. Conclusion The current protocol is feasible for achieving local control rates, as well as OS

  4. National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: advancing the science of recruitment and breast cancer risk assessment in minority communities.

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    McCaskill-Stevens, Worta; Wilson, John W; Cook, Elise D; Edwards, Cora L; Gibson, Regina V; McElwain, Diane L; Figueroa-Moseley, Colmar D; Paskett, Electra D; Roberson, Noma L; Wickerham, D Lawrence; Wolmark, Norman

    2013-04-01

    One of the first chemoprevention trials conducted in the western hemisphere, the National Surgical Adjuvant Breast and Bowel Project's (NSABP) Breast Cancer Prevention Trial (BCPT), demonstrated the need to evaluate all aspects of recruitment in real time and to implement strategies to enroll racial and ethnic minority women. The purpose of this report is to review various patient recruitment efforts the NSABP developed to enhance the participation of racial and ethnic minority women in the Study of Tamoxifen and Raloxifene (STAR) trial and to describe the role that the recruitment process played in the implementation and understanding of breast cancer risk assessment in minority communities. The NSABP STAR trial was a randomized, double-blinded study comparing the use of tamoxifen 20 mg/day to raloxifene 60 mg/day, for a 5-year period, to reduce the risk of developing invasive breast cancer. Eligible postmenopausal women were required to have a 5-year predicted breast cancer risk of 1.66% based on the modified Gail Model. For the current report, eligibility and enrollment data were tabulated by race/ethnicity for women who submitted STAR risk assessment forms (RAFs). A total of 184,460 RAFs were received, 145,550 (78.9%) from white women and 38,910 (21.1%) from minority women. Of the latter group, 21,444 (11.6%) were from African Americans/blacks, 7913 (4.5%) from Hispanics/Latinas, and 9553 (5.2%) from other racial or ethnic groups. The percentages of risk-eligible women among African Americans, Hispanics/Latinas, others, and whites were 14.2%, 23.3%, 13.7%, and 57.4%, respectively. Programs targeting minority enrollment submitted large numbers of RAFs, but the eligibility rates of the women referred from those groups tended to be lower than the rates among women referred outside of those programs. The average number of completed risk assessments increased among minority women over the course of the recruitment period compared to those from whites. We have not

  5. Primary renal angiosarcoma with progressive clinical course despite surgical and adjuvant treatment: A case report

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    CELEBI, FILIZ; PILANCI, KEZBAN NUR; SAGLAM, SEZER; BALCI, NUMAN CEM

    2015-01-01

    Angiosarcoma is an extremely rare, high-grade malignancy, which accounts for <2% of all soft-tissue sarcomas. Cases of primary renal angiosarcoma represent 1% of these. Angiosarcomas involving the kidney usually originate from metastatic skin lesions or primary visceral lesions and most often occur in the sixth and seventh decades of life. The present study describes a case of primary renal angiosarcoma that presented as a large right-sided renal mass with symptoms of flank pain. Despite surgical removal of the tumor, recurrent disease with associated lung metastases was identified at the surgical site following adjuvant chemotherapy. The patient succumbed to the disease 13 months after the diagnosis. PMID:25789072

  6. Longitudinal Assessments of Quality of Life in Endometrial Cancer Patients: Effect of Surgical Approach and Adjuvant Radiotherapy

    International Nuclear Information System (INIS)

    Le, Tien; Menard, Chantal; Samant, Rajiv; Choan, E.; Hopkins, Laura; Faught, Wylam; Fung-Kee-Fung, Michael

    2009-01-01

    Purpose: Adjuvant radiotherapy (RT) is often considered for endometrial cancer. We studied the effect of RT and surgical treatment on patients' quality of life (QOL). Methods and Materials: All patients referred to the gynecologic oncology clinics with biopsy findings showing endometrial cancer were recruited. QOL assessments were performed using the European Organization for Research and Treatment of Cancer QOL questionnaire-C30, version 3. Assessments were obtained at study entry and at regular 3-month intervals for a maximum of 2 years. Open-ended telephone interviews were done every 6 months. Linear mixed regression models were built using QOL domain scores as dependent variables, with the predictors of surgical treatment and adjuvant RT type. Results: A total of 40 patients were recruited; 80% of the surgeries were performed by laparotomy. Significant improvements were seen in most QOL domains with increased time from treatment. Adjuvant RT resulted in significantly more severe bowel symptoms and improvement in insomnia compared with conservative follow-up. No significant adverse effect from adjuvant RT was seen on the overall QOL. Bowel symptoms were significantly increased in patients treated with laparotomy compared with laparoscopy in the patients treated with whole pelvic RT. Qualitatively, about one-half of the patients noted improvements in their overall QOL during follow-up, with easy fatigability the most prevalent. Conclusion: No significant adverse effect was seen on patients' overall QOL with adjuvant pelvic RT after the recovery period. The acute adverse effects on patients' QOL significantly improved with an increasing interval from diagnosis.

  7. Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer

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    Beatty J David

    2011-03-01

    Full Text Available Abstract Background Accelerated partial breast irradiation (APBI may be used to deliver radiation to the tumor bed post-lumpectomy in eligible patients with breast cancer. Patient and tumor characteristics as well as the lumpectomy technique can influence patient eligibility for APBI. This report describes a lumpectomy procedure and examines patient, tumor, and surgical characteristics from a prospective, multicenter study of electronic brachytherapy. Methods The study enrolled 65 patients of age 45-84 years with ductal carcinoma or ductal carcinoma in situ, and 44 patients, who met the inclusion and exclusion criteria, were treated with APBI using the Axxent® electronic brachytherapy system following lumpectomy. The prescription dose was 34 Gy in 10 fractions over 5 days. Results The lumpectomy technique as described herein varied by site and patient characteristics. The balloon applicator was implanted by the surgeon (91% or a radiation oncologist (9% during or up to 61 days post-lumpectomy (mean 22 days. A lateral approach was most commonly used (59% for insertion of the applicator followed by an incision site approach in 27% of cases, a medial approach in 5%, and an inferior approach in 7%. A trocar was used during applicator insertion in 27% of cases. Local anesthetic, sedation, both or neither were administered in 45%, 2%, 41% and 11% of cases, respectively, during applicator placement. The prescription dose was delivered in 42 of 44 treated patients. Conclusions Early stage breast cancer can be treated with breast conserving surgery and APBI using electronic brachytherapy. Treatment was well tolerated, and these early outcomes were similar to the early outcomes with iridium-based balloon brachytherapy.

  8. Adjuvant Radiation Therapy Improves Local Control After Surgical Resection in Patients With Localized Adrenocortical Carcinoma

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    Sabolch, Aaron; Else, Tobias; Griffith, Kent A.; Ben-Josef, Edgar; Williams, Andrew; Miller, Barbra S.; Worden, Francis; Hammer, Gary D.; Jolly, Shruti

    2015-01-01

    Purpose: Adrenocortical carcinoma (ACC) is a rare malignancy known for high rates of local recurrence, though the benefit of postoperative radiation therapy (RT) has not been established. In this study of grossly resected ACC, we compare local control of patients treated with surgery followed by adjuvant RT to a matched cohort treated with surgery alone. Methods and Materials: We retrospectively identified patients with localized disease who underwent R0 or R1 resection followed by adjuvant RT. Only patients treated with RT at our institution were included. Matching to surgical controls was on the basis of stage, surgical margin status, tumor grade, and adjuvant mitotane. Results: From 1991 to 2011, 360 ACC patients were evaluated for ACC at the University of Michigan (Ann Arbor, MI). Twenty patients with localized disease received postoperative adjuvant RT. These were matched to 20 controls. There were no statistically significant differences between the groups with regard to stage, margins, grade, or mitotane. Median RT dose was 55 Gy (range, 45-60 Gy). Median follow-up was 34 months. Local recurrence occurred in 1 patient treated with RT, compared with 12 patients not treated with RT (P=.0005; hazard ratio [HR] 12.59; 95% confidence interval [CI] 1.62-97.88). However, recurrence-free survival was no different between the groups (P=.17; HR 1.52; 95% CI 0.67-3.45). Overall survival was also not significantly different (P=.13; HR 1.97; 95% CI 0.57-6.77), with 4 deaths in the RT group compared with 9 in the control group. Conclusions: Postoperative RT significantly improved local control compared with the use of surgery alone in this case-matched cohort analysis of grossly resected ACC patients. Although this retrospective series represents the largest study to date on adjuvant RT for ACC, its findings need to be prospectively confirmed

  9. Adjuvant Radiation Therapy Improves Local Control After Surgical Resection in Patients With Localized Adrenocortical Carcinoma

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    Sabolch, Aaron [Department of Radiation Oncology, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States); Else, Tobias [Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States); Griffith, Kent A. [Center for Cancer Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Mchigan (United States); Ben-Josef, Edgar [Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (United States); Williams, Andrew [University of Michigan Medical School, Ann Arbor, Mchigan (United States); Miller, Barbra S. [Division of Endocrine Surgery, Department of General Surgery, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States); Worden, Francis [Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States); Hammer, Gary D. [Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States); Jolly, Shruti, E-mail: shrutij@med.umich.edu [Department of Radiation Oncology, University of Michigan Hospital and Health Systems, Ann Arbor, Mchigan (United States)

    2015-06-01

    Purpose: Adrenocortical carcinoma (ACC) is a rare malignancy known for high rates of local recurrence, though the benefit of postoperative radiation therapy (RT) has not been established. In this study of grossly resected ACC, we compare local control of patients treated with surgery followed by adjuvant RT to a matched cohort treated with surgery alone. Methods and Materials: We retrospectively identified patients with localized disease who underwent R0 or R1 resection followed by adjuvant RT. Only patients treated with RT at our institution were included. Matching to surgical controls was on the basis of stage, surgical margin status, tumor grade, and adjuvant mitotane. Results: From 1991 to 2011, 360 ACC patients were evaluated for ACC at the University of Michigan (Ann Arbor, MI). Twenty patients with localized disease received postoperative adjuvant RT. These were matched to 20 controls. There were no statistically significant differences between the groups with regard to stage, margins, grade, or mitotane. Median RT dose was 55 Gy (range, 45-60 Gy). Median follow-up was 34 months. Local recurrence occurred in 1 patient treated with RT, compared with 12 patients not treated with RT (P=.0005; hazard ratio [HR] 12.59; 95% confidence interval [CI] 1.62-97.88). However, recurrence-free survival was no different between the groups (P=.17; HR 1.52; 95% CI 0.67-3.45). Overall survival was also not significantly different (P=.13; HR 1.97; 95% CI 0.57-6.77), with 4 deaths in the RT group compared with 9 in the control group. Conclusions: Postoperative RT significantly improved local control compared with the use of surgery alone in this case-matched cohort analysis of grossly resected ACC patients. Although this retrospective series represents the largest study to date on adjuvant RT for ACC, its findings need to be prospectively confirmed.

  10. Adjuvant whole brain radiotherapy: strong emotions decide but rational studies are needed.

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    Brown, Paul D; Asher, Anthony L; Farace, Elana

    2008-04-01

    Brain metastases are common in cancer patients and cause considerable morbidity and mortality. For patients with limited disease and good performance status, treatment typically involves a combination of focal measures (e.g., surgical resection or radiosurgery) for the radiographically apparent disease, followed by adjuvant whole brain radiotherapy (WBRT) to treat subclinical disease. Because of concerns regarding the toxicity of WBRT, especially neurocognitive deterioration, many have advocated withholding adjuvant WBRT. Recently published studies have shed more light on the efficacy of adjuvant WBRT and the neurocognitive effects of WBRT. However, the inclusion of neurocognitive and quality-of-life data in clinical trials are still required to better define the role of adjuvant WBRT. Currently, two Phase III trials are underway, one in Europe and one in North America, that will determine the effect of adjuvant WBRT on patients' quality of life, neurocognitive function, and survival.

  11. Adjuvant Whole Brain Radiotherapy: Strong Emotions Decide But Rational Studies Are Needed

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    Brown, Paul D. [Department of Radiation Oncology, Mayo Clinic, Rochester, MN (United States)], E-mail: brown.paul@mayo.edu; Asher, Anthony L [Brain and Spinal Cord Tumors Programs, Carolinas Medical Center and Presbyterian Hospital, Charlotte, NC (United States); Farace, Elana [Department of Neurosurgery, Pennsylvania State University, Penn State Milton S. Hershey Medical Center, Hershey, PA (United States)

    2008-04-01

    Brain metastases are common in cancer patients and cause considerable morbidity and mortality. For patients with limited disease and good performance status, treatment typically involves a combination of focal measures (e.g., surgical resection or radiosurgery) for the radiographically apparent disease, followed by adjuvant whole brain radiotherapy (WBRT) to treat subclinical disease. Because of concerns regarding the toxicity of WBRT, especially neurocognitive deterioration, many have advocated withholding adjuvant WBRT. Recently published studies have shed more light on the efficacy of adjuvant WBRT and the neurocognitive effects of WBRT. However, the inclusion of neurocognitive and quality-of-life data in clinical trials are still required to better define the role of adjuvant WBRT. Currently, two Phase III trials are underway, one in Europe and one in North America, that will determine the effect of adjuvant WBRT on patients' quality of life, neurocognitive function, and survival.

  12. Adjuvant Whole Brain Radiotherapy: Strong Emotions Decide But Rational Studies Are Needed

    International Nuclear Information System (INIS)

    Brown, Paul D.; Asher, Anthony L.; Farace, Elana

    2008-01-01

    Brain metastases are common in cancer patients and cause considerable morbidity and mortality. For patients with limited disease and good performance status, treatment typically involves a combination of focal measures (e.g., surgical resection or radiosurgery) for the radiographically apparent disease, followed by adjuvant whole brain radiotherapy (WBRT) to treat subclinical disease. Because of concerns regarding the toxicity of WBRT, especially neurocognitive deterioration, many have advocated withholding adjuvant WBRT. Recently published studies have shed more light on the efficacy of adjuvant WBRT and the neurocognitive effects of WBRT. However, the inclusion of neurocognitive and quality-of-life data in clinical trials are still required to better define the role of adjuvant WBRT. Currently, two Phase III trials are underway, one in Europe and one in North America, that will determine the effect of adjuvant WBRT on patients' quality of life, neurocognitive function, and survival

  13. Long-term outcomes of adjuvant radiotherapy after surgical resection of central neurocytoma

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    Chen, Yi-Dong; Li, Wen-Bin; Feng, Jin; Qiu, Xiao-Guang

    2014-01-01

    The role of adjuvant radiotherapy for central neurocytomas (CNs) is not clear. Therefore, we aimed to examine the clinical outcomes of treating histologically confirmed CNs with adjuvant RT after surgical resection. Sixty-three CN patients were retrospectively evaluated: 24 patients underwent gross total resection (GTR); 28, subtotal resection (STR); 9, partial resection (PR), and 2, biopsy (Bx). They underwent adjuvant RT after surgery (median dose, 54 Gy). The median follow-up was 69 months (15–129 months). The 5-year overall survival (OS) and 5-year progression-free survival (PFS) were 94.4% and 95% after GTR + RT, 96.4% and 100% after STR + RT, and 100% and 90.9% after PR + RT. Only three patients had tumor recurrence: at the primary site at 30 and 24 months in two GTR + PR patients, and dissemination to the spinal cord at 75 months in one STR + RT patient. Thirty-eight (63.3%) patients experienced late neurotoxicity (28, grade 1; 7, grade 2; 3, grade 3). Short-term memory impairment was the most common toxicity. RT after incomplete resection (IR) led to OS and PFS comparable to those for GTR. Considering the excellent outcomes and limited late toxicity, adjuvant RT maybe a good option for CN patients who undergo IR

  14. Use of adjuvant carboplatin for treatment of dogs with oral malignant melanoma following surgical excision.

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    Dank, G; Rassnick, K M; Sokolovsky, Y; Garrett, L D; Post, G S; Kitchell, B E; Sellon, R K; Kleiter, M; Northrup, N; Segev, G

    2014-03-01

    Melanoma is the most common oral malignancy in dogs. This retrospective study evaluated adjuvant carboplatin chemotherapy (with or without radiation therapy) in 17 dogs with malignant oral melanoma following surgical resection. The median dosage and number of doses of carboplatin administered to the 17 dogs was 300 mg m(-2) (range, 150-300 mg m(-2)) and 4 (range, 2-11), respectively. The overall median progression-free survival for all dogs was 259 days [95% confidence interval (CI95), 119-399 days]. The first progression-free survival event was local recurrence in seven dogs (41%) and metastases in seven dogs (41%). The median overall survival for all dogs was 440 days (CI95, 247-633 days). The tumour was the cause of death in 10 dogs (59%). On the basis of this study, systemic therapy with carboplatin may be an appropriate adjunct to local treatment for canine malignant melanoma, although future prospective controlled studies are needed to compare treatment modalities for this aggressive neoplasia. © 2012 John Wiley & Sons Ltd.

  15. Vaginal brachytherapy alone is sufficient adjuvant treatment of surgical stage I endometrial cancer

    International Nuclear Information System (INIS)

    Solhjem, Matthew C.; Petersen, Ivy A.; Haddock, Michael G.

    2005-01-01

    Purpose To determine the efficacy and complications of adjuvant vaginal high-dose-rate brachytherapy alone for patients with Stage I endometrial cancer in whom complete surgical staging had been performed. Methods and Materials Between April 1998 and March 2004, 100 patients with Stage I endometrial cancer underwent surgical staging (total abdominal hysterectomy and bilateral salpingo-oophorectomy with pelvic ± paraaortic nodal sampling) and postoperative vaginal high-dose-rate brachytherapy at our institution. The total dose was 2100 cGy in three fractions. Results With a median follow-up of 23 months (range 2-62), no pelvic or vaginal recurrences developed. All patients underwent pelvic dissection, and 42% underwent paraaortic nodal dissection. A median of 29.5 pelvic nodes (range 1-67) was removed (84% had >10 pelvic nodes removed). Most patients (73%) had endometrioid (or unspecified) adenocarcinoma, 16% had papillary serous carcinoma, and 11% had other histologic types. The International Federation of Gynecology and Obstetrics stage and grade was Stage IA, grade III in 5; Stage IB, grade I, II, or III in 6, 27, or 20, respectively; and Stage IC, grade I, II, or III in 13, 17, or 10, respectively. The Common Toxicity Criteria (version 2.0) complications were mild (Grade 1-2) and consisted primarily of vaginal mucosal changes, temporary urinary irritation, and temporary diarrhea. Conclusion Adjuvant vaginal high-dose-rate brachytherapy alone may be a safe and effective alternative to pelvic external beam radiotherapy for surgical Stage I endometrial cancer

  16. Skull base meningioma. Surgical and adjuvant treatment with clinical and PET evaluation

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    Gudjonsson, O.

    2001-01-01

    The treatment strategy for skull base meningiomas remains a controversial issue. Because of the proximity of these tumours to critical neurovascular structures, the risk for vascular damage and new cranial neuropathies postoperatively is significant. To avoid unacceptable neurological deficits the surgical treatment strategy includes different surgical approaches and a subtotal removal of these tumours in some cases. However, because the rate of recurrence and progression is significant in these patients, a demand for adjuvant treatment and better prognostic methods is called for so that treatment and follow-up can be tailored to each patient. Accordingly, we have chosen to evaluate general outcome and facial nerve function after translabyrinthine and transcochlear approaches for cerebellopontine angle (CPA) meningiomas. Furthermore, we have evaluated two adjuvant treatments, namely, irradiation by high-energy proton beams and medical treatment with interferon-alpha as well as evaluation of the treatment effect with 11 C-L-methionine PET. In addition, we have evaluated a new PET tracer ( 76 Br-BrdU) for 'in vivo' determination of the growth potential of intracranial tumours. Conclusion: The translabyrinthine and transcochlear approaches are apparently safe surgical procedures in the treatment of CPA meningiomas. Proton beam therapy is technically feasible as suggested by the fact that only minimal side effects were observed. Moreover, none of the meningiomas treated have shown progression during a 36-month follow-up. Our results indicate that IFN-alpha can be an effective oncostatic treatment for certain patients with meningiomas. The 11 C-L-methionine PET method might be used as a complement to CT or MRI in the evaluation of the effect of proton beam and IFN-alpha treatment in meningiomas. The present attempt failed to demonstrate that the PET tracer 76 Br-BrdU could be used for the non-invasive characterisation of growth potential in brain, tumours

  17. Skull base meningioma. Surgical and adjuvant treatment with clinical and PET evaluation

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    Gudjonsson, O

    2001-05-01

    The treatment strategy for skull base meningiomas remains a controversial issue. Because of the proximity of these tumours to critical neurovascular structures, the risk for vascular damage and new cranial neuropathies postoperatively is significant. To avoid unacceptable neurological deficits the surgical treatment strategy includes different surgical approaches and a subtotal removal of these tumours in some cases. However, because the rate of recurrence and progression is significant in these patients, a demand for adjuvant treatment and better prognostic methods is called for so that treatment and follow-up can be tailored to each patient. Accordingly, we have chosen to evaluate general outcome and facial nerve function after translabyrinthine and transcochlear approaches for cerebellopontine angle (CPA) meningiomas. Furthermore, we have evaluated two adjuvant treatments, namely, irradiation by high-energy proton beams and medical treatment with interferon-alpha as well as evaluation of the treatment effect with {sup 11}C-L-methionine PET. In addition, we have evaluated a new PET tracer ({sup 76}Br-BrdU) for 'in vivo' determination of the growth potential of intracranial tumours. Conclusion: The translabyrinthine and transcochlear approaches are apparently safe surgical procedures in the treatment of CPA meningiomas. Proton beam therapy is technically feasible as suggested by the fact that only minimal side effects were observed. Moreover, none of the meningiomas treated have shown progression during a 36-month follow-up. Our results indicate that IFN-alpha can be an effective oncostatic treatment for certain patients with meningiomas. The {sup 11}C-L-methionine PET method might be used as a complement to CT or MRI in the evaluation of the effect of proton beam and IFN-alpha treatment in meningiomas. The present attempt failed to demonstrate that the PET tracer {sup 76}Br-BrdU could be used for the non-invasive characterisation of growth potential in

  18. Pancreatic Neuroendocrine Tumors With Involved Surgical Margins: Prognostic Factors and the Role of Adjuvant Radiotherapy

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    Arvold, Nils D. [Harvard Radiation Oncology Program, Harvard Medical School, Boston, MA (United States); Willett, Christopher G. [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Fernandez-del Castillo, Carlos [Department of Surgery, Massachusetts General Hospital, Boston, MA (United States); Ryan, David P. [Department of Medicine, Massachusetts General Hospital, Boston, MA (United States); Ferrone, Cristina R. [Department of Surgery, Massachusetts General Hospital, Boston, MA (United States); Clark, Jeffrey W.; Blaszkowsky, Lawrence S. [Department of Medicine, Massachusetts General Hospital, Boston, MA (United States); Deshpande, Vikram [Department of Pathology, Massachusetts General Hospital, Boston, MA (United States); Niemierko, Andrzej [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Allen, Jill N.; Kwak, Eunice L.; Wadlow, Raymond C.; Zhu, Andrew X. [Department of Medicine, Massachusetts General Hospital, Boston, MA (United States); Warshaw, Andrew L. [Department of Surgery, Massachusetts General Hospital, Boston, MA (United States); Hong, Theodore S., E-mail: Tshong1@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States)

    2012-07-01

    Purpose: Pancreatic neuroendocrine tumors (pNET) are rare neoplasms associated with poor outcomes without resection, and involved surgical margins are associated with a worse prognosis. The role of adjuvant radiotherapy (RT) in these patients has not been characterized. Methods and Materials: We retrospectively evaluated 46 consecutive patients with positive or close (<1 mm) margins after pNET resection, treated from 1983 to 2010, 16 of whom received adjuvant RT. Median RT dose was 50.4 Gy in 1.8-Gy fractions; half the patients received concurrent chemotherapy with 5-fluorouracil or capecitabine. No patients received adjuvant chemotherapy. Cox multivariate analysis (MVA) was used to analyze factors associated with overall survival (OS). Results: Median age at diagnosis was 56 years, and 52% of patients were female. Median tumor size was 38 mm, 57% of patients were node-positive, and 11% had a resected solitary liver metastasis. Patients who received RT were more likely to have larger tumors (median, 54 mm vs. 30 mm, respectively, p = 0.002) and node positivity (81% vs. 33%, respectively, p = 0.002) than those not receiving RT. Median follow-up was 39 months. Actuarial 5-year OS was 62% (95% confidence interval [CI], 41%-77%). In the group that did not receive RT, 3 patients (10%) experienced local recurrence (LR) and 5 patients (18%) developed new distant metastases, while in the RT group, 1 patient (6%) experienced LR and 5 patients (38%) developed distant metastases. Of all recurrences, 29% were LR. On MVA, male gender (adjusted hazard ratio [AHR] = 3.81; 95% CI, 1.21-11.92; p = 0.02) and increasing tumor size (AHR = 1.02; 95% CI, 1.01-1.04; p = 0.007) were associated with decreased OS. Conclusions: Long-term survival is common among patients with involved-margin pNET. Despite significantly worse pathologic features among patients receiving adjuvant RT, rates of LR between groups were similar, suggesting that RT might aid local control, and merits further

  19. Patterns of intracranial glioblastoma recurrence after aggressive surgical resection and adjuvant management. Retrospective analysis of 43 cases

    International Nuclear Information System (INIS)

    Konishi, Yoshiyuki; Muragaki, Yoshihiro; Iseki, Hiroshi; Mitsuhashi, Norio; Okada, Yoshikazu

    2012-01-01

    The present retrospective study evaluated the recurrence patterns after aggressive surgical removal of intracranial glioblastomas in 43 consecutive adult patients. The resection rate of the enhanced lesion on magnetic resonance imaging was 100% and 95-99% in 22 and 21 cases, respectively. All patients received postoperative fractionated radiotherapy (60 Gy in 30 fractions) with additional chemotherapy (25 cases) or vaccine therapy (18 cases). During follow-up (median 17 months), tumor recurrence was identified in 33 patients, most frequently regional within the wall of the resection cavity (20 cases). No clinical factor differed significantly between the groups of patients with regional or marginal tumor progression (N=22) and patients with distant or multiple recurrences (N=8). Progression-free survival did not differ significantly between these two groups (p=0.27). However, overall survival was significantly longer (p=0.04) in patients with regional or marginal tumor progression, and constituted 90% and 54% at 1 and 2 years after surgery, respectively, compared to 75% and 0% in patients with distant or multiple recurrences. Aggressive surgical resection and adjuvant management of intracranial glioblastoma may change its recurrence pattern. Tumor progression appears in the wall of the resection cavity or within 2 cm from its margin in approximately half of patients. (author)

  20. The reasonable timing of the adjuvant radiotherapy in the treatment of uterine carcinosarcoma according to the surgical intent: suggestion based on progression patterns

    International Nuclear Information System (INIS)

    Yu, Jeong Il; Choi, Doo Ho; Huh, Seung Jae; Park, Won; Oh, Dong Ryul; Bae, Duk Soo

    2013-01-01

    We designed this study to identify and suggest the reasonable timing of adjuvant radiotherapy in the treatment of uterine carcinosarcoma according to the surgical intent and patterns of progression. We retrospectively analyzed a total of 50 carcinosarcoma patients diagnosed between 1995 and 2010. Among these 50 patients, 32 underwent curative surgery and 13 underwent maximal tumor debulking surgery. The remaining five patients underwent biopsy only. Twenty-six patients received chemotherapy, and 15 patients received adjuvant radiotherapy. The median follow-up period was 17.3 months. Curative resection (p < 0.001) and stage (p < 0.001) were statistically significant factors affecting survival. During follow-up, 30 patients showed progression. Among these, eight patients (16.0%) had loco-regional progression only. The patients who had received adjuvant radiotherapy did not show loco-regional progression, and radiotherapy was a significant negative risk factor for loco-regional progression (p = 0.01). The time to loco-regional progression was much earlier for non-curative than curative resection (range, 0.7 to 7.6 months vs. 7.5 to 39.0 months). Adjuvant radiotherapy in the treatment of carcinosarcoma might be related to a low loco-regional progression rate. Radiotherapy should be considered in non-curatively resected patients as soon as possible.

  1. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04.

    Science.gov (United States)

    O'Connell, Michael J; Colangelo, Linda H; Beart, Robert W; Petrelli, Nicholas J; Allegra, Carmen J; Sharif, Saima; Pitot, Henry C; Shields, Anthony F; Landry, Jerome C; Ryan, David P; Parda, David S; Mohiuddin, Mohammed; Arora, Amit; Evans, Lisa S; Bahary, Nathan; Soori, Gamini S; Eakle, Janice; Robertson, John M; Moore, Dennis F; Mullane, Michael R; Marchello, Benjamin T; Ward, Patrick J; Wozniak, Timothy F; Roh, Mark S; Yothers, Greg; Wolmark, Norman

    2014-06-20

    The optimal chemotherapy regimen administered concurrently with preoperative radiation therapy (RT) for patients with rectal cancer is unknown. National Surgical Adjuvant Breast and Bowel Project trial R-04 compared four chemotherapy regimens administered concomitantly with RT. Patients with clinical stage II or III rectal cancer who were undergoing preoperative RT (45 Gy in 25 fractions over 5 weeks plus a boost of 5.4 Gy to 10.8 Gy in three to six daily fractions) were randomly assigned to one of the following chemotherapy regimens: continuous intravenous infusional fluorouracil (CVI FU; 225 mg/m(2), 5 days per week), with or without intravenous oxaliplatin (50 mg/m(2) once per week for 5 weeks) or oral capecitabine (825 mg/m(2) twice per day, 5 days per week), with or without oxaliplatin (50 mg/m(2) once per week for 5 weeks). Before random assignment, the surgeon indicated whether the patient was eligible for sphincter-sparing surgery based on clinical staging. The surgical end points were complete pathologic response (pCR), sphincter-sparing surgery, and surgical downstaging (conversion to sphincter-sparing surgery). From September 2004 to August 2010, 1,608 patients were randomly assigned. No significant differences in the rates of pCR, sphincter-sparing surgery, or surgical downstaging were identified between the CVI FU and capecitabine regimens or between the two regimens with or without oxaliplatin. Patients treated with oxaliplatin experienced significantly more grade 3 or 4 diarrhea (P < .001). Administering capecitabine with preoperative RT achieved similar rates of pCR, sphincter-sparing surgery, and surgical downstaging compared with CVI FU. Adding oxaliplatin did not improve surgical outcomes but added significant toxicity. The definitive analysis of local tumor control, disease-free survival, and overall survival will be performed when the protocol-specified number of events has occurred. © 2014 by American Society of Clinical Oncology.

  2. Cytoplasmic Hu-Antigen R (HuR) Expression is Associated with Poor Survival in Patients with Surgically Resected Cholangiocarcinoma Treated with Adjuvant Gemcitabine-Based Chemotherapy.

    Science.gov (United States)

    Toyota, Kazuhiro; Murakami, Yoshiaki; Kondo, Naru; Uemura, Kenichiro; Nakagawa, Naoya; Takahashi, Shinya; Sueda, Taijiro

    2018-05-01

    Hu-antigen R (HuR) is an RNA-binding protein that regulates the stability, translation, and nucleus-to-cytoplasm translocation of messenger RNAs (mRNAs). The aim of this study was to investigate the prognostic significance of HuR in cholangiocarcinoma patients who received adjuvant gemcitabine-based chemotherapy (AGC) after surgical resection. Nuclear and cytoplasmic HuR expression was investigated immunohistochemically in 131 patients with resected cholangiocarcinoma, including 91 patients administered AGC and 40 patients who did not receive adjuvant chemotherapy. The correlation between HuR expression and survival was evaluated by statistical analysis. High nuclear and cytoplasmic HuR expression was observed in 67 (51%) and 45 (34%) patients, respectively. Cytoplasmic HuR expression was significantly associated with lymph node metastasis (p < 0.01), while high cytoplasmic HuR expression was significantly associated with poor disease-free survival [DFS] (p = 0.03) and overall survival [OS] (p = 0.001) in the 91 patients who received AGC, but not in the 40 patients who did not receive AGC (DFS p = 0.17; OS p = 0.07). In the multivariate analysis of patients who received AGC, high cytoplasmic HuR expression was an independent predictor of poor DFS (hazard ratio [HR] 1.77; p = 0.04) and OS (HR 2.09; p = 0.02). Nuclear HuR expression did not affect the survival of enrolled patients. High cytoplasmic HuR expression was closely associated with the efficacy of AGC in patients with cholangiocarcinoma. The current findings warrant further investigations to optimize adjuvant chemotherapy regimens for resectable cholangiocarcinoma.

  3. Ear-lobe keloids: treatment by a protocol of surgical excision and immediate postoperative adjuvant radiotherapy.

    Science.gov (United States)

    Ragoowansi, R; Cornes, P G; Glees, J P; Powell, B W; Moss, A L

    2001-09-01

    There is no universally agreed policy for treating keloid scars of the ear lobe following piercing. We treated 35 patients (34 women) for high-risk ear-lobe keloids; the average age was 24 years (range: 16-44 years). All had failed to respond to prior treatment with massage and silicone, and corticosteroid injection. The keloids were excised extralesionally and the defects were closed with interrupted prolene sutures. The operative scar was covered with topical 2% lignocaine-0.25% chlorhexidine sterile lubricant gel under a transparent adhesive dressing. Adjuvant postoperative radiotherapy of 10 Gy, applied as 100 kV photons (4 mm high-voltage therapy (HVT) Al), was given within 24 h of surgery. All keloid scars were controlled at 4 weeks' follow-up. At 1 year, three out of 34 cases followed up had relapsed (probability of control: 91.2%). At 5 years, a further four out of the remaining 31 patients had relapsed (cumulative probability of control at 5 years: 79.4%). There were no cases of serious toxicity. Copyright 2001 The British Association of Plastic Surgeons.

  4. Subconjunctival PRGF Fibrin Membrane as an Adjuvant to Nonpenetrating Deep Sclerectomy: A 2-Year Pilot Study.

    Science.gov (United States)

    Rodríguez-Agirretxe, Iñaki; Freire, Vanesa; Muruzabal, Francisco; Orive, Gorka; Anitua, Eduardo; Díez-Feijóo, Elio; Acera, Arantxa

    2018-01-01

    To evaluate the potential role of the autologous PRGF (plasma rich in growth factors) fibrin membrane in tissue regeneration after glaucoma filtering surgery. Ten patients with medically uncontrolled primary open-angle glaucoma underwent nonpenetrating deep sclerectomy and were treated with PRGF fibrin membrane as adjuvant. Intraocular pressure reduction was the primary outcome. This variable was measured preoperatively and also at each follow-up visit. Secondary outcomes included the number of antiglaucoma medications, anterior segment optical coherence tomography bleb examination, photographic bleb evaluation, and subjective clinical symptomatology evaluation. The surgical technique showed a significant reduction (p PRGF-Endoret treatment could promote ocular surface regeneration after glaucoma surgery, enhancing the surgery success rates and reducing the need for postoperative medications. It is important to highlight that this is a preliminary study and some large clinical studies are necessary to verify these results. © 2017 S. Karger AG, Basel.

  5. Conventional external irradiation alone as adjuvant treatment in resectable pancreatic cancer; Results of a prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Bosset, J.F.; Pavy, J.J.; Gillet, M.; Mantuon, G.; Pelissier, E.; Schraub, S. (Centre Hospitalier Universitaire, 25 - Besancon (France))

    1992-07-01

    Between 1/85 and 1/90, 14 consecutive patients were entered into a prospective study of conventional adjuvant post-operative external beam radiotherapy after complete resection for a pancreatic adeno-carcinoma. The surgical procedure was a Whipple resection in 9 patients, a distal pancrea-tectomy in 1 patient. There were 3 T[sub 1b], 8 T[sub 2] and 3 T[sub 3] tumors (UICC 1987); nodal involvement was present in 5 cases. The radiotherapy was delivered using a 4-field box technique with a 23 x MV photon beam. All patients received a total dose of 54 Gy to the tumor bed. The mean treated volume was 900 cm[sup 3]. Acute toxicities consisted mainly of weight loss (mean: 2 kg). Two patients had a grade 2 diarrhea and 2 patients a grade 2 gastritis. Late effects were minimal and only observed in 2 patients. The overall loco-regional recurrence (LR) rate was 50%. The median disease-free survival was 12 months, and the median survival was 23 months. This post-operative conventional radiotherapy treatment gives results that are comparable to the results of GITSG-adjuvant study using a combination of split-course radiotherapy and 5-fluorouracil (5-FU). (author). 46 refs.; 1 fig.; 1 tab.

  6. THE USE OF ADJUVANTS IN STUDIES ON INFLUENZA IMMUNIZATION

    Science.gov (United States)

    Salk, Jonas E.; Laurent, Angela M.

    1952-01-01

    Untoward reactions at the site of inoculation were not observed in monkeys vaccinated with influenza virus incorporated in a water-in-oil emulsion without acid-fast bacilli. Studies were then made to measure some of the dimensions of antigenicity of these emulsions to evaluate the extent of the immunologic adjuvant effect. This included measurements of height and persistence of the antibody response to inoculation and measurements of the extent to which the vaccine could be diluted and still induce antibody formation; i.e., antigenic extinction. In addition, comparisons were made of the rates of development of hemagglutination-inhibiting, virus-neutralizing, and complement-fixing antibody activities to determine the relationship among these three properties of the serum of immunized animals. It was found that levels of antibody many fold higher were induced by the virus-adjuvant mixtures as compared with virus in an aqueous menstruum, and that the level of antibody induced was related to the quantity of antigen incorporated in the emulsion. The stock vaccine when emulsified could be diluted 100,000-fold and was still active in antibody formation whereas a 100-fold dilution of the antigen without emulsification was essentially ineffective. Equivalent quantities of virus in 0.1 ml. or 1.0 ml. of emulsion induced antibody responses that were indistinguishable with respect to level or persistence. In comparing the course of antibody development it was found that hemagglutination-inhibiting, virus-neutralizing, and complement-fixing antibodies develop at different rates; careful analysis of the data derived from the present study together with other observations warrant the conclusion that these antibody activities are not present in constant proportion and are independent of one another. The implications of this observation and of the others mentioned above are discussed. PMID:14927797

  7. Surgical infections: a microbiological study

    Directory of Open Access Journals (Sweden)

    Santosh Saini

    Full Text Available Surgical infections are mostly polymicrobial, involving both aerobes and anaerobes. One hundred seventeen cases comprised of abscesses (n=51, secondary peritonitis (n=25, necrotizing fascitis (n=22 and wounds with devitalized tissues (n=19 were studied. The number of microorganisms isolated per lesion was highest in secondary peritonitis (2.32. The aerobe/ anaerobe ratio was 0.81 in secondary peritonitis and 1.8 in necrotizing fascitis. Most secondary peritonitis (80%, necrotizing fascitis (75% and wounds with devitalized tissues (66.7% were polymicrobial. Common microorganisms isolated in our study were E. coli, Staphylococcus aureus, Klebsiella spp., Pseudomonas aeruginosa, Bacteroides fragilis and Peptostreptococcus spp. The most effective antibiotics for S. aureus were clindamycin (79.1% and cefuroxime (70.8%. For Gram-negatives (Klebsiella spp., E. coli and Proteus spp., the most effective antibiotics were cefotaxime, ceftizoxime, amikacin and ciprofloxacin. Pseudomonas aeruginosa was maximally sensitive to amikacin (35.2% and ciprofloxacin (35.2%. The greatest degree of multidrug resistance to all the drugs was found in P. aeruginosa (52.9%, followed by Klebsiella spp. (33.3%, Proteus spp. (33.3%, E. coli (22.2%, and S. aureus (12.5%. All the anaerobes that we isolated were 100% sensitive to metronidazole and chloramphenicol, followed by clindamycin (95% to 100%. Apart from antibiotic therapy, non-antimicrobial methods, such as hyperbaric oxygen therapy and debridement also play an important role in the treatment of surgical infections.

  8. A Controlled Study Using Acupuncture as an Adjuvant to Treat Chemotherapy-Induced Nausea and Vomiting

    National Research Council Canada - National Science Library

    Lao, Lixing

    2001-01-01

    ...) on nausea and vomiting induced by chemotherapy in cancer patients. The primary aim of this study is to evaluate the usefulness of EA as an adjuvant on N/V in chemotherapy patients who do not respond to conventional antiemetics...

  9. Minimally invasive surgical approaches offer earlier time to adjuvant chemotherapy but not improved survival in resected pancreatic cancer.

    Science.gov (United States)

    Mirkin, Katelin A; Greenleaf, Erin K; Hollenbeak, Christopher S; Wong, Joyce

    2018-05-01

    Pancreatic surgery encompasses complex operations with significant potential morbidity. Greater experience in minimally invasive surgery (MIS) has allowed resections to be performed laparoscopically and robotically. This study evaluates the impact of surgical approach in resected pancreatic cancer. The National Cancer Data Base (2010-2012) was reviewed for patients with stages 1-3 resected pancreatic carcinoma. Open approaches were compared to MIS. A sub-analysis was then performed comparing robotic and laparoscopic approaches. Of the 9047 patients evaluated, surgical approach was open in 7511 (83%), laparoscopic in 992 (11%), and robotic in 131 (1%). The laparoscopic and robotic conversion rate to open was 28% (n = 387) and 17% (n = 26), respectively. Compared to open, MIS was associated with more distal resections (13.5, 24.3%, respectively, p offered significantly shorter LOS in all types. Multivariate analysis demonstrated no survival benefit for any MIS approach relative to open (all, p > 0.05). When adjusted for patient, disease, and treatment characteristics, TTC was not an independent prognostic factor (HR 1.09, p = 0.084). MIS appears to offer comparable surgical oncologic benefit with improved LOS and shorter TTC. This effect, however, was not associated with improved survival.

  10. Adjuvant chemotherapy for rectal cancer: Is it needed?

    Science.gov (United States)

    Milinis, Kristijonas; Thornton, Michael; Montazeri, Amir; Rooney, Paul S

    2015-01-01

    Adjuvant chemotherapy has become a standard treatment of advanced rectal cancer in the West. The benefits of adjuvant chemotherapy after surgery alone have been well established. However, controversy surrounds the use adjuvant chemotherapy in patients who received preoperative chemoradiotherapy, despite it being recommended by a number of international guidelines. Results of recent multicentre randomised control trials showed no benefit of adjuvant chemotherapy in terms of survival and rates of distant metastases. However, concerns exist regarding the quality of the studies including inadequate staging modalities, out-dated chemotherapeutic regimens and surgical approaches and small sample sizes. It has become evident that not all the patients respond to adjuvant chemotherapy and more personalised approach should be employed when considering the benefits of adjuvant chemotherapy. The present review discusses the strengths and weaknesses of the current evidence-base and suggests improvements for future studies. PMID:26677436

  11. Pilot study of postoperative adjuvant chemoradiation for advanced gastric cancer: Adjuvant 5-FU/cisplatin and chemoradiation with capecitabine

    Science.gov (United States)

    Lee, Hyung-Sik; Choi, Youngmin; Hur, Won-Joo; Kim, Hyo-Jin; Kwon, Hyuk-Chan; Kim, Sung-Hyun; Kim, Jae-Seok; Lee, Jong-Hoon; Jung, Ghap-Joong; Kim, Min-Chan

    2006-01-01

    AIM: To evaluate the efficacy and toxicity of postoperative chemoradiation using FP chemotherapy and oral capecitabine during radiation for advanced gastric cancer following curative resection. METHODS: Thirty-one patients who had underwent a potentially curative resection for Stage III and IV (M0) gastric cancer were enrolled. Therapy consists of one cycle of FP (continuous infusion of 5-FU 1000 mg/m2 on d 1 to 5 and cisplatin 60 mg/m2 on d 1) followed by 4500 cGy (180 cGy/d) with capecitabine (1650 mg/m2 daily throughout radiotherapy). Four wk after completion of the radiotherapy, patients received three additional cycles of FP every three wk. The median follow-up duration was 22.2 mo. RESULTS: The 3-year disease free and overall survival in this study were 82.7% and 83.4%, respectively. Four patients (12.9%) showed relapse during follow-up. Eight patients did not complete all planned adjuvant therapy. Grade 3/4 toxicities included neutropenia in 50.2%, anemia in 12.9%, thrombocytopenia in 3.2% and nausea/vomiting in 3.2%. Neither grade 3/4 hand foot syndrome nor treatment related febrile neutropenia or death were observed. CONCLUSION: These preliminary results suggest that this postoperative adjuvant chemoradiation regimen of FP before and after capecitabine and concurrent radiotherapy appears well tolerated and offers a comparable toxicity profile to the chemoradiation regimen utilized in INT-0116. This treatment modality allowed successful loco-regional control rate and 3-year overall survival. PMID:16489675

  12. [Critical analysis of reference studies on aluminium-based adjuvants toxicokinetics].

    Science.gov (United States)

    Masson, J-D; Crépeaux, G; Authier, F-J; Exley, C; Gherardi, R K

    2017-07-01

    We reviewed the three reference toxicokinetic studies commonly used to suggest innocuity of aluminum (Al)-based adjuvants. A single experimental study was carried out using isotopic 26 Al (Flarend et al., 1997). This study ignored adjuvant cell capture. It was conducted over a short period of time (28 days) and used only two rabbits per adjuvant. At the endpoint, Al retention was 78% for aluminum phosphate and 94% for aluminum hydroxide, both results being incompatible with quick elimination of vaccine-derived Al in urines. Tissue distribution analysis omitted three important retention sites: the injected muscle, the draining lymph node and bone. Two theoretical studies have evaluated the potential risk of vaccine Al in infants, by reference to the oral Minimal Risk Level (MRL) extrapolated from animal studies. Keith et al., 2002 used a too high MRL (2mg/kg/d), an erroneous model of 100% immediate absorption of vaccine Al, and did not consider renal and blood-brain barrier immaturity. Mitkus et al. (2011) only considered absorbed Al, with erroneous calculations of absorption duration. They ignored particulate Al captured by immune cells, which play a role in systemic diffusion and the neuro-inflammatory potential of the adjuvant. MRL they used was both inappropriate (oral Al vs injected adjuvant) and far too high (1mg/kg/d) with regard to experimental studies of Al-induced memory and behavioral changes. Both paucity and serious weaknesses of these studies strongly suggest that novel experimental studies of Al adjuvants toxicokinetics should be performed on the long-term, including post-natal and adult exposures, to ensure innocuity and restore population confidence in Al-containing vaccines. Copyright © 2017 Académie Nationale de Pharmacie. All rights reserved.

  13. Which prognostic factors influence the outcome of patients with surgically staged endometrial cancer treated with adjuvant radiation?

    International Nuclear Information System (INIS)

    Greven, Kathryn M.; Corn, Benjamin W.; Case, Douglas; Purser, Phillip; Lanciano, Rachelle M.

    1997-01-01

    Purpose: Despite the fact that retrospective reviews have documented pelvic failure rates ranging from 15-20% in patients with high-risk uterine-confined endometrial cancer who have received no or 'inadequate' RT, the role of RT has been questioned. We sought to analyze pelvic control and disease-free survival for a large data base of women with corpus cancers managed with initial surgery followed by adjuvant irradiation. Methods and Materials: Between 1983 and 1993, 294 patients received adjuvant postoperative RT from one of three academic radiation practices. RT consisted of vaginal brachytherapy alone in 28 patients, pelvic RT in 173 patients, pelvic RT with vaginal brachytherapy in 97 patients, and whole abdominal RT in 2 patients. Lymph nodes were evaluated in 49%. The median number of pelvic and periaortic LN in the pathology specimen were 6 and 4, respectively. Median follow up was 63 months. Results: 5-year disease-free survival (DFS) rate and pelvic control rates were 86 and 95%, respectively. Patient-related, treatment-related, and tumor-related characteristics were assessed for the effect on time to relapse. Unfavorable histology, older age, and capillary space invasion were univariately associated with decreased DFS and pelvic control. Pathologic Stage II patients had significantly worse DFS than Stage I patients. Multivariate analysis revealed that age, capillary space invasion, and histology were jointly predictive of disease free survival. Conclusion: The excellent pelvic control and disease-free survival of patients with uterine-confined disease in this series suggest that adjuvant RT should continue for patients with high risk disease. This analysis of a large group of postoperatively treated patients will provide a basis for determining alternative treatment strategies for patients who have an increased risk of disease recurrence despite RT

  14. p53 nuclear accumulation and multiploidy are adverse prognostic factors in surgically resected stage II colorectal cancers independent of fluorouracil-based adjuvant therapy.

    Science.gov (United States)

    Buglioni, S; D'Agnano, I; Vasselli, S; Perrone Donnorso, R; D'Angelo, C; Brenna, A; Benevolo, M; Cosimelli, M; Zupi, G; Mottolese, M

    2001-09-01

    To identify the prognostically highest risk patients, DNA content and p53 nuclear or cytoplasmic accumulation, evaluated by monoclonal antibody DO7 and polyclonal antibody CM1, were determined in 94 surgically resected stage II (Dukes B2) colorectal cancers, treated or not with adjuvant 5-fluorouracil-based chemotherapy. Sixty-one (65%) of the tumors were aneuploid, 16 (17%) of which had a multiploid DNA content; 50 (53%) displayed DO7 nuclear p53 accumulation, and 44 (47%) showed cytoplasmic CM1 positivity. In multivariate analysis, only multiploidy and p53 nuclear positivity emerged as independent prognostic indicators of a poorer outcome. Positivity for p53 was associated with shorter survival in 5-fluorouracil-treated and untreated patients. Therefore, in patients with Dukes B2 colorectal cancer, a biologic profile based on the combined evaluation of DNA multiploidy and p53 status can provide valuable prognostic information, identifying patients to be enrolled in alternative, more aggressive therapeutic trials.

  15. Influence of radiation treatment on pharmaceuticals and adjuvants: A literature study. Pt. 9. Supplement

    International Nuclear Information System (INIS)

    Lindemann, L.; Schuettler, C.; Boegl, K.W.

    1993-01-01

    Sterilization of medical aid articles (e.g. catheters, one-way syringes) with ionizing radiation is a successful practice in many countries. During recent years, the results from numerous experiments of radiosterillization of pharmaceuticals and adjuvants have likewise been published. Experience has shown that radiation treatment, in many cases, is leading to transformations of the irradiated substances. In the present part IX of the bibliographic study on the influence of radiation treatment on pharmaceuticals and adjuvants the results of experiments on ca. 80 substances from 36 different sources have been evaluated. In all parts of the study results of about 560 experiments on 360 substances from 176 different sources are present. (orig.)

  16. Pediatric surgical diseases. A radiological surgical case study approach

    International Nuclear Information System (INIS)

    Esposito, Ciro; Esposito, Giovanni

    2009-01-01

    Radiologic evaluation of an infant or child suspected of having a surgical disease can be a complex problem. With this volume, the editors have created a book focused on pediatric imaging written by pediatricians, pediatric surgeons and pediatric radiologists. This book is a collection of over 200 case reports. The concept is a case study approach: The reader is given radiologic images (plain radiography, computed tomography, magnetic resonance imaging, ultrasonography, etc.) and the clinical history of the patient. On the basis of this information, the reader is asked to identify a diagnostic and therapeutic strategy. Each case is complemented by information on the disease affecting the patient and the management of the case shown, including therapy and follow-up. This educational text is targeted at all medical professionals faced with a variety of diagnostic and therapeutic problems affecting infants and children. (orig.)

  17. Pediatric surgical diseases. A radiological surgical case study approach

    Energy Technology Data Exchange (ETDEWEB)

    Esposito, Ciro [Federico II Univ. of Naples (Italy). Chair of Pediatric Surgery; Esposito, Giovanni (eds.) [Federico II Univ. of Naples (Italy). School of Medicine

    2009-07-01

    Radiologic evaluation of an infant or child suspected of having a surgical disease can be a complex problem. With this volume, the editors have created a book focused on pediatric imaging written by pediatricians, pediatric surgeons and pediatric radiologists. This book is a collection of over 200 case reports. The concept is a case study approach: The reader is given radiologic images (plain radiography, computed tomography, magnetic resonance imaging, ultrasonography, etc.) and the clinical history of the patient. On the basis of this information, the reader is asked to identify a diagnostic and therapeutic strategy. Each case is complemented by information on the disease affecting the patient and the management of the case shown, including therapy and follow-up. This educational text is targeted at all medical professionals faced with a variety of diagnostic and therapeutic problems affecting infants and children. (orig.)

  18. A STUDY ON ADJUVANT HEAD CORING IN PATIENTS UNDERGOING LONGITUDINAL PANCREATICOJEJUNOSTOMY AND ITS AID IN PAIN REDUCTION IN CHRONIC PANCREATITIS

    Directory of Open Access Journals (Sweden)

    Sudhansu Sekhar Mohanty

    2016-07-01

    Full Text Available BACKGROUND The condition manifests as recurrent intractable abdominal pain. 1 This is the most important indication for surgical procedures. The pain is caused by increased pancreatic parenchymal and ductal pressure. Another cause is that chronic inflammation of the pancreas may lead to fibrosis of the peripancreatic capsule and perilobular parenchyma, which impairs local and regional blood flow, therefore causing pain through tissue ischaemia and acidosis. 2 This is the rationalisation behind adding the head coring to the decompression surgeries that had been classically in practice. METHODS This is a retrospective study. The study period spans over from January 2003 to December 2013, which is a 10-year period. Patients with intractable and non-relenting abdominal pain and a diagnosis of chronic pancreatitis with evidence of fibrosis of head of pancreas in imaging studies were included. 35 patients were randomly allocated for Head coring and LPJ by lottery method. The patients were analysed for duration of surgery, hospital stay, operative/postoperative complications and assessment of postoperative pain relief. Pain relief was assessed as complete (No analgesic required, satisfactory (Tolerable pain with normal daily activities and unsatisfactory (Hospitalisation and hampered daily activities. RESULTS Alcohol consumption (65.71% was the main cause of pancreatitis in the study group, followed by gallstones (14.28% and idiopathic (20% cause. Head coring (120 minutes takes a median operative time of 30 minutes more when done adjuvant to LPJ (90 minutes. Incidence of complications were comparable in both the surgeries. The common complications of prolonged ileus and wound infection are in the percentage of 12.5% in only LPJ and 15.78% in adjuvant head coring surgeries. Pain relief was good when the complete and satisfactory groups were compared. But there is not much of difference in unsatisfactory group comparison. CONCLUSION A 30 minutes

  19. A Controlled Study Using Acupuncture as an Adjuvant to Treat Chemotherpay-Induced Nausea and Vomiting

    National Research Council Canada - National Science Library

    Lao, Lixing

    2000-01-01

    ...) on nausea and vomiting induced by chemotherapy in breast cancer patients. The primary aim of this study is to evaluate the usefulness of HA as an adjuvant on N/v in chemotherapy patients who do not respond to conventional antiemetics...

  20. Adjuvant chemo- and radiotherapy in gastrointestinal tumors

    International Nuclear Information System (INIS)

    Sendler, A.; Feldmann, H.J.; Fink, U.; Molls, M.; Siewert, J.R.

    1995-01-01

    In modern surgical oncology, adjuvant therapies are important complementary strategies. In local advanced carcinomas of the gastrointestinal tract, 5-year survival data are still disappointing despite standardized surgery. In this context, it has to be differentiated between adjuvant therapy following complete tumor exstirpation (so-called UICC R 0 resection) and additive therapies following incomplete tumor resections (UICC R 1 or R 2 resection). Modalities in the adjuvant setting are chemotherapy, radiotherapy or the combined radio-/chemotherapy. In esophageal and gastric cancer there is up to now no benefit of postoperative adjuvant therapy. In pancreatic cancer, there are studies indicating a benefit of combined radio-/chemotherapy after complete tumor resection. A standard adjuvant chemotherapeutic treatment is proven in colon cancer stage III (Dukes C) with levamisole and 5-FU. Completely resected rectal carcinoma should be treated postoperatively with combined radio-/chemotherapy. In the common clinical or practical setting, adjuvant therapy is indicated only in locally advanced gastrointestinal tumors following R 0 resection. Postoperative therapy following incomplete tumor resection has its reason only in a palliative intention. (orig.) [de

  1. Evaluation of adjuvant chemoradiation therapy for ampullary adenocarcinoma: the Johns Hopkins Hospital - Mayo Clinic collaborative study

    International Nuclear Information System (INIS)

    Narang, Amol K; Haddock, Michael G; Donohue, John H; Schulick, Richard D; Wolfgang, Christopher L; Cameron, John L; Herman, Joseph M; Miller, Robert C; Hsu, Charles C; Bhatia, Sumita; Pawlik, Timothy M; Laheru, Dan; Hruban, Ralph H; Zhou, Jessica; Winter, Jordan M

    2011-01-01

    The role of adjuvant chemoradiation therapy for ampullary carcinoma is unknown. Previous literature suggests that certain populations with high risk factors for recurrence may benefit from adjuvant chemoradiation. We combined the experience of two institutions to better delineate which patients may benefit from adjuvant chemoradiation. Patients who underwent curative surgery for ampullary carcinoma at the Johns Hopkins Hospital (n = 290; 1992-2007) and at the Mayo Clinic (n = 130; 1977-2005) were reviewed. Patients with <60 days of follow-up, metastatic disease at surgery, or insufficient pathologic data were excluded. The final combined study consisted of 186 patients (n = 104 Johns Hopkins, n = 82 Mayo). Most patients received 5-FU based chemoradiation with conformal radiation. Cox proportional hazards models were used for survival analysis. Median overall-survival was 39.9 months with 2- and 5-year survival rates of 62.4% and 39.1%. On univariate analysis, adverse prognostic factors for overall survival included T3/T4 stage disease (RR = 1.86, p = 0.002), node positive status (RR = 3.18, p < 0.001), and poor histological grade (RR = 1.69, p = 0.011). Patients who received adjuvant chemoradiation (n = 66) vs. surgery alone (n = 120) showed a higher rate of T3/T4 stage disease (57.6% vs. 30.8%, P < 0.001), lymph node involvement (72.7% vs. 30.0%, P < 0.001), and close or positive margins (4.6% vs. 0.0%, P = 0.019). Five year survival rates among node negative and node positive patients were 58.7% and 18.4% respectively. When compared with surgery alone, use of adjuvant chemoradiation improved survival among node positive patients (mOS 32.1 vs. 15.7 mos, 5 yr OS: 27.5% vs. 5.9%; RR = 0.47, P = 0.004). After adjusting for adverse prognostic factors on multivariate analysis, patients treated with adjuvant chemoradiation demonstrated a significant survival benefit (RR = 0.40, P < 0.001). Disease relapse occurred in 37.1% of all patients, most commonly metastatic

  2. [Benefit of adjuvant 5-fluorouracil based chemotherapy for colon cancer: a retrospective cohort study].

    Science.gov (United States)

    Mondaca, Sebastián; Villalón, Constanza; Leal, José Luis; Zúñiga, Álvaro; Bellolio, Felipe; Padilla, Oslando; Palma, Silvia; Garrido, Marcelo; Nervi, Bruno

    2016-02-01

    Multiple clinical trials have demonstrated the benefits of adjuvant 5-fluorouracil-based chemotherapy for patients with resectable colon cancer (CC), especially in stage III. To describe the clinical characteristics of a cohort of CC patients treated at a single university hospital in Chile since 2002, and to investigate if chemotherapy had an effect on survival rates. Review of a tumor registry of the hospital. Medical records of patients with CC treated between 2002 and 2012 were reviewed. Death certificates from the National Identification Service were used to determine mortality. Overall survival was described using the Kaplan-Meier method. A multivariate Cox proportional hazard regression model was also used. A total of 370 patients were treated during the study period (202 in stage II and 168 in stage III). Adjuvant chemotherapy was administered to 22 and 70% of patients in stage II and III respectively. The median follow-up period was 4.6 years. The 5-year survival rate for stage II patients was 79% and there was no benefit observed with adjuvant chemotherapy. For stage III patients, the 5-year survival rate was 81% for patients who received adjuvant chemotherapy, compared to 56% for those who did not receive chemotherapy (hazard ratio (HR): 0.29; 95% confidence interval (CI): 0.15-0.56). The benefit of chemotherapy was found to persist after adjustment for other prognostic variables (HR: 0.47; 95% CI: 0.23-0.94). Patients with colon cancer in stage III who received adjuvant chemotherapy had a better overall survival.

  3. Impact of video game genre on surgical skills development: a feasibility study.

    Science.gov (United States)

    de Araujo, Thiago Bozzi; Silveira, Filipe Rodrigues; Souza, Dante Lucas Santos; Strey, Yuri Thomé Machado; Flores, Cecilia Dias; Webster, Ronaldo Scholze

    2016-03-01

    The playing of video games (VGs) was previously shown to improve surgical skills. This is the first randomized, controlled study to assess the impact of VG genre on the development of basic surgical skills. Twenty first-year, surgically inexperienced medical students attended a practical course on surgical knots, suturing, and skin-flap technique. Later, they were randomized into four groups: control and/or nongaming (ContG), first-person-shooter game (ShotG), racing game (RaceG), and surgery game (SurgG). All participants had 3 wk of Nintendo Wii training. Surgical and VG performances were assessed by two independent, blinded surgeons who evaluated basal performance (time 0) and performance after 1 wk (time 1) and 3 wk (time 2) of training. The training time of RaceG was longer than that of ShotG and SurgG (P = 0.045). Compared to SurgG and RaceG, VG scores for ShotG improved less between times 0 and 1 (P = 0.010) but more between times 1 and 2 (P = 0.004). Improvement in mean surgical performance scores versus time differed in each VG group (P = 0.011). At time 2, surgical performance scores were significantly higher in ShotG (P = 0.002) and SurgG (P = 0.022) than in ContG. The surgical performance scores of RaceG were not significantly different from the score achieved by ContG (P = 0.279). Different VG genres may differentially impact the development of surgical skills by medical students. More complex games seem to improve performance even if played less. Although further studies are needed, surgery-related VGs with sufficient complexity and playability could be a feasible adjuvant to improving surgical skills. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Prognostic impact of interhospital variation in adjuvant chemotherapy for patients with Stage II/III colorectal cancer: a nationwide study.

    Science.gov (United States)

    Arakawa, K; Kawai, K; Tanaka, T; Hata, K; Sugihara, K; Nozawa, H

    2018-05-12

    Clinical guidelines recommend adjuvant chemotherapy for high-risk patients with Stage II-III colorectal cancer. However, chemotherapeutic administration rates differ significantly between hospitals. We assessed the prognostic benefit of adjuvant chemotherapy in patients with Stage IIb/c colorectal cancer, and the prognostic impact of interhospital variations in the administration of adjuvant chemotherapy for Stage II-III colorectal cancer. We conducted a multicentre, retrospective study of 17 757 patients with Stage II-III colorectal cancer treated between 1997 and 2008 in 23 hospitals in Japan. Hospitals were classified as high-rate (rate > 42.8%) or low-rate (rate ≤ 42.8%), chemotherapy prescribing clinics. The 5-year overall survival (OS) of patients with Stage II-III colorectal cancer receiving adjuvant chemotherapy was significantly higher than for those not receiving adjuvant chemotherapy (85.7% vs 79.2%, P colorectal cancer (both P colorectal cancer who received adjuvant chemotherapy, with patients who were treated in hospitals with high adjuvant chemotherapy rates demonstrating better prognoses. Colorectal Disease © 2018 The Association of Coloproctology of Great Britain and Ireland.

  5. Thymoquinone as a Potential Adjuvant Therapy for Cancer Treatment: Evidence from Preclinical Studies

    Directory of Open Access Journals (Sweden)

    A.G.M. Mostofa

    2017-06-01

    Full Text Available Thymoquinone (TQ, the main bioactive component of Nigella sativa, has been found to exhibit anticancer effects in numerous preclinical studies. Due to its multitargeting nature, TQ interferes in a wide range of tumorigenic processes and counteracts carcinogenesis, malignant growth, invasion, migration, and angiogenesis. Moreover, TQ can specifically sensitize tumor cells toward conventional cancer treatments (e.g., radiotherapy, chemotherapy, and immunotherapy and simultaneously minimize therapy-associated toxic effects in normal cells. In this review, we summarized the adjuvant potential of TQ as observed in various in vitro and in vivo animal models and discussed the pharmacological properties of TQ to rationalize its supplementary role in potentiating the efficacy of standard therapeutic modalities namely surgery, radiotherapy, chemotherapy, and immunotherapy. Altogether, we suggest further comprehensive evaluation of TQ in preclinical and clinical levels to delineate its implied utility as a novel complementary adjuvant therapy for cancer treatment.

  6. Retrospective study of adjuvant icotinib in postoperative lung cancer patients harboring epidermal growth factor receptor mutations.

    Science.gov (United States)

    Yao, Shuyang; Zhi, Xiuyi; Wang, Ruotian; Qian, Kun; Hu, Mu; Zhang, Yi

    2016-09-01

    Epidermal growth factor receptor (EGFR) mutations occur in about 50% of Asian patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC and EGFR mutations derive clinical benefit from treatment with EGFR-tyrosine kinase inhibitors (TKIs). This study assessed the efficacy and safety of adjuvant icotinib without chemotherapy in EGFR-mutated NSCLC patients undergoing resection of stage IB-IIIA. Our retrospective study enrolled 20 patients treated with icotinib as adjuvant therapy. Survival factors were evaluated by univariate and Cox regression analysis. The median follow-up time was 30 months (range 24-41). At the data cut-off, five patients (25%) had recurrence or metastasis and one patient had died of the disease. The two-year disease-free survival (DFS) rate was 85%. No recurrence occurred in the high-risk stage IB subgroup during the follow-up period. In univariate analysis, the micropapillary pattern had a statistically significant effect on DFS ( P = 0.040). Multivariate logistic regression analysis showed that there was no independent predictor. Drug related adverse events (AEs) occurred in nine patients (45.0%). The most common AEs were skin-related events and diarrhea, but were relatively mild. No grade 3 AEs or occurrences of intolerable toxicity were observed. Icotinib as adjuvant therapy is effective in patients harboring EGFR mutations after complete resection, with an acceptable AE profile. Further trials with larger sample sizes might confirm the efficiency of adjuvant TKI in selected patients. © 2016 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

  7. Study of Serum Magnesium in Surgical Stress

    Directory of Open Access Journals (Sweden)

    Sandip D. Lambe

    2016-10-01

    Full Text Available Background: A deficiency of magnesium is of clinical importance in hospitalized patients. The prevalence of hypomagnesaemia is high in critically ill patients. Knowing the important role of magnesium in surgical cases, it is necessary to anticipate and diagnose magnesium deficiency prior to surgery and in the immediate postoperative period to correct it. Aims and Objectives: The aim of this study was to analyse serum magnesium levels in patients undergoing emergency surgical procedures, planned surgical procedures and normal healthy matched controls and to compare the serum magnesium levels in all the three groups. Materials and Methods: The study participants were divided into three groups: i Group I: patients undergoing emergency major surgery ii Group II: patients undergoing planned major surgery iii Group III: normal healthy controls. Serum Magnesium investigation was done by Xylidyl Blue Method using UV-1800/Shimadzu UV-Spectrophotometer. Results: The mean serum Magnesium in control group was found to be 2.16 ± 0.30 mg/dl. In patients undergoing planned surgery, pre-operative serum magnesium was normal (2.16 ± 0.22 mg/dl but decreased significantly on postoperative day 3 (1.63 ± 0.27 mg/dl and day 6 (1.97 ± 0.12 mg/dl and returned to normal level by post-operative day 9 (2.14 ± 0.14 mg/dl compared to controls. In patients undergoing emergency surgery, serum magnesium was decreased pre-operatively (1.90 ± 0.48 mg/dl.Further significant reduction was found at post-operative day 3 (1.38 ± 0.28 mg/dl, day 6 (1.59 ± 0.30 mg/dl and day 9 (1.88 ± 0.46 mg/dl compared to controls. Mean serum Magnesium overall in emergency surgery patients was reduced significantly compared to planned surgery patients. Conclusion: A transient fall in the serum Magnesium as compared to its pre-operative level was seen in every patient undergoing surgical procedure due to surgical stress. In patients undergoing emergency surgical procedure, the decrease was

  8. Endodontic treatment of teeth with periapical lesion in one session with photodynamic therapy as an adjuvant: study "in vivo"

    OpenAIRE

    Supercilio Barros Filho

    2012-01-01

    Hypothesis of the study: It is assumed that the use of photodynamic therapy (PDT) as an adjuvant in root canal therapy can promote the repair of teeth with periapical lesions treated in one session. Objectives: This in vivo study was to evaluate the effects of photodynamic therapy as an adjuvant in root canal therapy in one session for the repair of periapical lesions. Method: Fourteen human teeth with mortification pulp and periapical lesions were randomly divided into two groups (n=7): G1- ...

  9. Prolongation of survival of dogs with oral malignant melanoma treated by en bloc surgical resection and adjuvant CSPG4-antigen electrovaccination.

    Science.gov (United States)

    Piras, L A; Riccardo, F; Iussich, S; Maniscalco, L; Gattino, F; Martano, M; Morello, E; Lorda Mayayo, S; Rolih, V; Garavaglia, F; De Maria, R; Lardone, E; Collivignarelli, F; Mignacca, D; Giacobino, D; Ferrone, S; Cavallo, F; Buracco, P

    2017-09-01

    Reported post-surgery 1-year survival rate for oral canine malignant melanoma (cMM) is around 30%; novel treatments are needed as the role of adjuvant chemotherapy is unclear. This prospective study regards adjuvant electrovaccination with human chondroitin sulfate proteoglycan-4 (hCSPG4)-encoded plasmid in 23 dogs with resected II/III-staged CSPG4-positive oral cMM compared with 19 dogs with resected only II/III-staged CSPG4-positive oral cMM. Vaccination resulted in 6-, 12-, 18- and 24-month survival rate of 95.6, 73.9, 47.8 and 30.4%, respectively [median survival time (MST) 684 days, range 78-1694, 8 of 23 dogs alive] and 6-, 12-, 18- and 24-month disease-free interval (DFI) rate of 82.6, 47.8, 26.1 and 17.4%, respectively (DFI 477 days, range 50-1694). Non-vaccinated dogs showed 6-, 12-, 18- and 24-month survival rate of 63.2, 26.3, 15.8 and 5.3%, respectively (MST 200 days, range 75-1507, 1 of 19 dogs alive) and 6-, 12-, 18- and 24-month DFI rate of 52.6, 26.3, 10.5 and 5.3%, respectively (DFI 180 days, range 38-1250). Overall survival and DFI of vaccinated dogs was longer in those dogs local recurrence rate was 34.8 and 42%, respectively while lung metastatic rate was 39 and 79%, respectively. © 2016 John Wiley & Sons Ltd.

  10. Assessment of the densities of local anesthetics and their combination with adjuvants: an experimental study.

    Science.gov (United States)

    Imbelloni, Luiz Eduardo; Moreira, Adriano Dias; Gaspar, Flávia Cunha; Gouveia, Marildo A; Cordeiro, José Antônio

    2009-01-01

    The relative density of a local anesthetic in relation to that of the cerebrospinal fluid (CSF) at 37 degrees C is one of the most important physical properties that affect the level of analgesia obtained after the subarachnoid administration of the drug. The objective of this study was to determine the density of local anesthetic solutions, with and without glucose, and the combination of the local anesthetic with adjuvants at 20 degrees C, 25 degrees C, and 37 degrees C. The density (g.mL(-1)) was determined by using a DMA 450 densimeter with a sensitivity of +/- 0.00001 g.mL(-1). The densities, and variations, according to the temperature were obtained for all local anesthetics and their combination with opioids at 20 degrees C, 25 degrees C, and 37 degrees C. The solution is hyperbaric if its density exceeds 1.00099, hypobaric when its density is lower than 1.00019, and isobaric when its density is greater than 1.00019 and lower than 1.00099. The densities of both local anesthetics and adjuvants decrease with the increase in temperature. At 37 degrees C, all glucose-containing solutions are hyperbaric. In the absence of glucose, all solutions are hypobaric. At 37 degrees C, morphine, fentanyl, sufentanil, and clonidine are hypobaric. The densities of local anesthetics and adjuvants decrease with the increase in temperature and increase when glucose is added. The knowledge of the relative density helps select the most adequate local anesthetic to be administered in the subarachnoid space.

  11. COMPARATIVE STUDY OF DEXMEDETOMIDINE AND MAGNESIUM SULPHATE AS AN ADJUVANT TO BUPIVACAINE IN SPINAL ANESTHESIA

    Directory of Open Access Journals (Sweden)

    Rakesh Kumar

    2015-08-01

    Full Text Available INTRODUCTI ON: spinal anaesthesia is a widely used simple anaesthethetic technique providing adequate analgesia and muscle relaxation. Search for an adjuvant providing satisfactory intra and post - operative analgesia is still continuing. This study aims to compare the dexmedetomidine and magnesium sulphate as an adjuvant to spi nal anaesthesia. MATERIAL AND METHODS: After obtaining institutional ethical committee approval and written informed consent from patients 90 ASA grade I &II patients of either sex having height between 140 - 180 cm and weight between 40 - 90 kg were randomly divided in 3 groups of 30 patients each (n=30. Group C: Received 3.0 ml 0.5% bupivacaine heavy + 0.5 ml NS . Group M: Received 3.0 ml 0.5% bupivacaine heavy + 50 mg MgSO 4 diluted to 0.5 ml of NS . Group D: Received 3.0 ml 0.5% bupivacaine heavy 10 +dexmedet omidine 10μg diluted to 0.5 ml NS . RESULTS: onset of sensory and motor block was delayed in Group M as compared to group D and group C. Onset of sensory and motor block in group D was significantly faster as compared to group C and group M. Total duration of sensory anaesthesia, duration of sensory block and duration of motor block was significantly prolonged in group D as compared to group M and group C. Patients were hemodynamically stable in all the groups. There were no incidences of any significant adv erse effect in any group. CONCLUSION: intrathecal dexmedetomidine is a better adjuvant to intrathecal bupivacaine because of rapid onset of sensory and motor blockade and prolonged duration of sensory and motor blockade without any potential side effects

  12. Current adjuvant treatment modalities for gastric cancer: From history to the future

    Science.gov (United States)

    Kilic, Leyla; Ordu, Cetin; Yildiz, Ibrahim; Sen, Fatma; Keskin, Serkan; Ciftci, Rumeysa; Pilanci, Kezban Nur

    2016-01-01

    The discrepancy between the surgical technique and the type of adjuvant chemotherapy used in clinical trials and patient outcomes in terms of overall survival rates has led to the generation of different adjuvant treatment protocols in distinct parts of the world. The adjuvant treatment recommendation is generally chemoradiotherapy in the United States, perioperative chemotherapy in the United Kingdom and parts of Europe, and chemotherapy in Asia. These options mainly rely on the United States Intergroup-0116, United Kingdom British Medical Research Council Adjuvant Gastric Infusional Chemotherapy, and the Asian Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer and Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer trials. However, the benefits were evident for only certain patients, which were not very homogeneous regarding the type of surgery, chemotherapy regimens, and stage of disease. Whether the dissimilarities in survival are attributable to surgical technique or intrinsic biological differences is a subject of debate. Regardless of the extent of surgery, multimodal therapy may offer modest survival advantage at least for diseases with lymph node involvement. Moreover, in the era of individualized treatment for most of the other cancer types, identification of special subgroups comprising those who will derive more or no benefit from adjuvant therapy merits further investigation. The aim of this review is to reveal the historical evolution and future reflections of adjuvant treatment modalities for resected gastric cancer patients. PMID:27190583

  13. Comparative Study of Intrathecal Dexamethasone with Epinephrine as Adjuvants to Lidocaine in Cesarean Section

    Directory of Open Access Journals (Sweden)

    Fereshteh Naziri

    2013-09-01

    Full Text Available Background: Different additives have been used with local anesthetics to provide prolonged duration of sensory block in spinal anesthesia. The aim of present study was to evaluate the onset and duration of sensory block of intrathecal dexamethasone and epinephrine as adjuvants to lidocaine in patients who were candidate for cesarean section. Materials and Methods: This double-blind clinical trial research was conducted on 90 pregnant women candidate for cesarean section under spinal anesthesia. Patients were randomly allocated to receive intrathecally either 75 mg hyperbaric lidocaine plus 100 μg epinephrine or 75 mg hyperbaric lidocaine plus 4 mg dexamethasone or 75 mg hyperbaric lidocaine. The onset and duration of sensory block as well as postoperative analgesia were assessed. Results: The time to reach the peak sensory block in lidocaine group was shorter than that of other two groups (p<0.001. Duration of sensory block in the control group, dexamethasone group, and epinephrine group were 64.16±7.99 min, 74.79±12.78 min, and 99.30±10.93 min, respectively (p<0.001. Conclusion: The present research shows that intrathecal dexamethasone and intrathecal epinephrine as adjuvant to lidocaine increases sensory block duration in the women candidate for cesarean section.

  14. Use of adjuvant chemotherapy in patients with stage III colon cancer in Puerto Rico: A population-based study

    Science.gov (United States)

    Tortolero-Luna, Guillermo; Ríos-Motta, Ruth; Veintidós-Feliú, Alejandro; Hunter-Mellado, Robert; Torres-Cintrón, Carlos R.; Suárez-Ramos, Tonatiuh; Magno, Priscilla

    2018-01-01

    Objective This study aims to examine factors associated with the use of adjuvant chemotherapy and the use of oxaliplatin after curative resection in stage III colon cancer patients and assesses the effect of their use in three-year survival. Methods This retrospective cohort study was conducted using Puerto Rico Central Cancer Registry-Health Insurance Linkage Database. The study cohort consisted of stage III colon cancer patients with a curative surgery in the period 2008–2012. Multivariate logistic regression was used to estimate adjusted odds ratios. Kaplan-Meier methods and Cox proportional hazards models were used to assess the association between adjuvant chemotherapy and oxaliplatin use and overall survival and risk of death, respectively. Results Overall, 75% of the study population received adjuvant chemotherapy during the study period. Factors statistically associated with receiving adjuvant chemotherapy within four months after resection included being married (adjusted odds ratio [AOR] 1.64; 95% CI 1.18–2.28; p = 0.003), and being enrolled in Medicare (AOR 1.68; 95% CI: 1.03–2.75; p = 0.039) or Medicaid and Medicare dual eligible (AOR 1.66; 95% CI: 1.06–2.60; p = 0.028). However, patients aged ≥70 years were less likely to receive adjuvant chemotherapy (AOR 0.22; 95%CI 0.14–0.36; p<0.001). Discussion We observed a significant reduction in mortality in adjuvant chemotherapy treated patients. Similarly, patients <70 years treated with oxaliplatin had significantly lower risk of death than those who did not, although for patients ≥70 years no statistical significance was achieved. Future studies should assess effective interventions to reduce barriers to access guideline-based recommended colon cancer treatment. PMID:29584752

  15. Study of adjuvant effect of model surfactants from the groups of alkyl sulfates, alkylbenzene sulfonates, alcohol ethoxylates and soaps

    DEFF Research Database (Denmark)

    Clausen, S K; Sobhani, S; Poulsen, O M

    2000-01-01

    The sodium salts of representatives of anionic surfactants, dodecylbenzene sulfonate (SDBS), dodecyl sulfate (SDS) and coconut oil fatty acids, and a nonionic surfactant, dodecyl alcohol ethoxylate, were studied for adjuvant effect on the production of specific IgE antibodies in mice. The surfact......The sodium salts of representatives of anionic surfactants, dodecylbenzene sulfonate (SDBS), dodecyl sulfate (SDS) and coconut oil fatty acids, and a nonionic surfactant, dodecyl alcohol ethoxylate, were studied for adjuvant effect on the production of specific IgE antibodies in mice...

  16. Cerebral biochemical pathways in experimental autoimmune encephalomyelitis and adjuvant arthritis: a comparative metabolomic study.

    Directory of Open Access Journals (Sweden)

    Norbert W Lutz

    Full Text Available Many diseases, including brain disorders, are associated with perturbations of tissue metabolism. However, an often overlooked issue is the impact that inflammations outside the brain may have on brain metabolism. Our main goal was to study similarities and differences between brain metabolite profiles of animals suffering from experimental autoimmune encephalomyelitis (EAE and adjuvant arthritis (AA in Lewis rat models. Our principal objective was the determination of molecular protagonists involved in the metabolism underlying these diseases. EAE was induced by intraplantar injection of complete Freund's adjuvant (CFA and spinal-cord homogenate (SC-H, whereas AA was induced by CFA only. Naive rats served as controls (n = 9 for each group. Two weeks after inoculation, animals were sacrificed, and brains were removed and processed for metabolomic analysis by NMR spectroscopy or for immunohistochemistry. Interestingly, both inflammatory diseases caused similar, though not identical, changes in metabolites involved in regulation of brain cell size and membrane production: among the osmolytes, taurine and the neuronal marker, N-acetylaspartate, were decreased, and the astrocyte marker, myo-inositol, slightly increased in both inoculated groups compared with controls. Also ethanolamine-containing phospholipids, sources of inflammatory agents, and several glycolytic metabolites were increased in both inoculated groups. By contrast, the amino acids, aspartate and isoleucine, were less concentrated in CFA/SC-H and control vs. CFA rats. Our results suggest that inflammatory brain metabolite profiles may indicate the existence of either cerebral (EAE or extra-cerebral (AA inflammation. These inflammatory processes may act through distinct pathways that converge toward similar brain metabolic profiles. Our findings open new avenues for future studies aimed at demonstrating whether brain metabolic effects provoked by AA are pain/stress-mediated and

  17. Adjuvant treatment with the bacterial lysate (OM-85 improves management of atopic dermatitis: A randomized study.

    Directory of Open Access Journals (Sweden)

    Christine Bodemer

    Full Text Available Environmental factors play a major role on atopic dermatitis (AD which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend.This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®, in the treatment of established AD in children.Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF during the study period, evaluated by Hazard Ratio (HR derived from conditional Cox proportional hazard regression models accounting for repeated events.Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85% patients in the OM-85 group and 72 (88% in the placebo group. Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI: 0.67-0.96, also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98. No major side effect was reported, with comparable and good tolerability for OM-85 and placebo.Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.

  18. Cerebral biochemical pathways in experimental autoimmune encephalomyelitis and adjuvant arthritis: a comparative metabolomic study.

    Science.gov (United States)

    Lutz, Norbert W; Fernandez, Carla; Pellissier, Jean-François; Cozzone, Patrick J; Béraud, Evelyne

    2013-01-01

    Many diseases, including brain disorders, are associated with perturbations of tissue metabolism. However, an often overlooked issue is the impact that inflammations outside the brain may have on brain metabolism. Our main goal was to study similarities and differences between brain metabolite profiles of animals suffering from experimental autoimmune encephalomyelitis (EAE) and adjuvant arthritis (AA) in Lewis rat models. Our principal objective was the determination of molecular protagonists involved in the metabolism underlying these diseases. EAE was induced by intraplantar injection of complete Freund's adjuvant (CFA) and spinal-cord homogenate (SC-H), whereas AA was induced by CFA only. Naive rats served as controls (n = 9 for each group). Two weeks after inoculation, animals were sacrificed, and brains were removed and processed for metabolomic analysis by NMR spectroscopy or for immunohistochemistry. Interestingly, both inflammatory diseases caused similar, though not identical, changes in metabolites involved in regulation of brain cell size and membrane production: among the osmolytes, taurine and the neuronal marker, N-acetylaspartate, were decreased, and the astrocyte marker, myo-inositol, slightly increased in both inoculated groups compared with controls. Also ethanolamine-containing phospholipids, sources of inflammatory agents, and several glycolytic metabolites were increased in both inoculated groups. By contrast, the amino acids, aspartate and isoleucine, were less concentrated in CFA/SC-H and control vs. CFA rats. Our results suggest that inflammatory brain metabolite profiles may indicate the existence of either cerebral (EAE) or extra-cerebral (AA) inflammation. These inflammatory processes may act through distinct pathways that converge toward similar brain metabolic profiles. Our findings open new avenues for future studies aimed at demonstrating whether brain metabolic effects provoked by AA are pain/stress-mediated and/or due to the

  19. [Caprine arthritis-encephalitis: trial of an adjuvant vaccine preparation. I. Clinical and virological study].

    Science.gov (United States)

    Russo, P; Vitu, C; Fontaine, J J; Vignoni, M

    1993-04-01

    In purpose to protect goats against caprine arthritis encephalitis virus (CAEV), the first group of kids (I) was inoculated with purified, inactivated and adjuvant-treated virions, the second group (II) with adjuvant and the third one (III) with culture medium. 2-4 months later, the three groups were challenged with virulent CAEV by intraarticular route. On the clinical level, vaccinated and challenged kids show more early and severe arthritis than other groups. On the virological level, isolation of lentivirus from white blood cells and different organs is more important in group I than groups II and III. Therefore, vaccinations with inactivated and adjuvant-treated virions do not protect against a virulent challenge; there is an enhancement of lesions. We note that the adjuvant elicits a mild non-specific protection against virulent challenge.

  20. Study of surgical treatment on neovascular glaucoma

    Directory of Open Access Journals (Sweden)

    Xiao-Nü Liu

    2014-05-01

    Full Text Available AIM: To compare the effect of two surgical methods on neovascular glaucoma(NVG. METHODS: The clinical date of 46 cases(57 eyeswith NVG underwent surgical treatment were retrospectively analyzed and followed-up. Patients were divided into Ahmed glaucoma valve(AGVimplantation group(group A, 24 cases, 31 eyesand semiconductor diode laser transscleral ciliary body photocoagulation(TSCPCgroup(group B, 22cases, 26 eyesaccording to the surgical approach. The intraocular pressure, visual acuity and postoperative complications were compared before and after operation. RESULTS: The intraocular pressure postoperative in two groups were significantly lower than those preoperative(P P>0.05. The changes of visual acuity postoperative showed no statistical difference between the two groups(P>0.05. The postoperative complications of group A was significantly lower than that in group B, in which the incidence of eye pain, anterior chamber bleeding were significant differences between two groups(P CONCLUSION: AGV implantation treatment and TSCPC for NVG are both valid, but AGV implantation is filtration surgery, and TSCPC isciliary body destructive surgery, and the latter has higher rate of postoperative complications.

  1. [Changing surgical therapy because of clinical studies?].

    Science.gov (United States)

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine.

  2. Phase 2 Study of Erlotinib Combined With Adjuvant Chemoradiation and Chemotherapy in Patients With Resectable Pancreatic Cancer

    International Nuclear Information System (INIS)

    Herman, Joseph M.; Fan, Katherine Y.; Wild, Aaron T.; Hacker-Prietz, Amy; Wood, Laura D.; Blackford, Amanda L.; Ellsworth, Susannah; Zheng, Lei; Le, Dung T.; De Jesus-Acosta, Ana; Hidalgo, Manuel; Donehower, Ross C.; Schulick, Richard D.; Edil, Barish H.; Choti, Michael A.; Hruban, Ralph H.

    2013-01-01

    Purpose: Long-term survival rates for patients with resected pancreatic ductal adenocarcinoma (PDAC) have stagnated at 20% for more than a decade, demonstrating the need to develop novel adjuvant therapies. Gemcitabine-erlotinib therapy has demonstrated a survival benefit for patients with metastatic PDAC. Here we report the first phase 2 study of erlotinib in combination with adjuvant chemoradiation and chemotherapy for resected PDAC. Methods and Materials: Forty-eight patients with resected PDAC received adjuvant erlotinib (100 mg daily) and capecitabine (800 mg/m 2 twice daily Monday-Friday) concurrently with intensity modulated radiation therapy (IMRT), 50.4 Gy over 28 fractions followed by 4 cycles of gemcitabine (1000 mg/m 2 on days 1, 8, and 15 every 28 days) and erlotinib (100 mg daily). The primary endpoint was recurrence-free survival (RFS). Results: The median follow-up time was 18.2 months (interquartile range, 13.8-27.1). Lymph nodes were positive in 85% of patients, and margins were positive in 17%. The median RFS was 15.6 months (95% confidence interval [CI], 13.4-17.9), and the median overall survival (OS) was 24.4 months (95% CI, 18.9-29.7). Multivariate analysis with adjustment for known prognostic factors showed that tumor diameter >3 cm was predictive for inferior RFS (hazard ratio, 4.01; P=.001) and OS (HR, 4.98; P=.02), and the development of dermatitis was associated with improved RFS (HR, 0.27; P=.009). During CRT and post-CRT chemotherapy, the rates of grade 3/4 toxicity were 31%/2% and 35%/8%, respectively. Conclusion: Erlotinib can be safely administered with adjuvant IMRT-based CRT and chemotherapy. The efficacy of this regimen appears comparable to that of existing adjuvant regimens. Radiation Therapy Oncology Group 0848 will ultimately determine whether erlotinib produces a survival benefit in patients with resected pancreatic cancer

  3. Phase 2 Study of Erlotinib Combined With Adjuvant Chemoradiation and Chemotherapy in Patients With Resectable Pancreatic Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Herman, Joseph M., E-mail: jherma15@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Fan, Katherine Y.; Wild, Aaron T.; Hacker-Prietz, Amy [Department of Radiation Oncology and Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Wood, Laura D. [Department of Pathology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Blackford, Amanda L. [Department of Oncology Biostatistics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Ellsworth, Susannah [Department of Radiation Oncology and Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Zheng, Lei; Le, Dung T.; De Jesus-Acosta, Ana [Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Hidalgo, Manuel [Centro Nacional de Investigaciones Oncologicas, Madrid (Spain); Donehower, Ross C. [Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Schulick, Richard D.; Edil, Barish H. [Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, Colorado (United States); Choti, Michael A. [Department of Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Hruban, Ralph H. [Department of Pathology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland (United States); and others

    2013-07-15

    Purpose: Long-term survival rates for patients with resected pancreatic ductal adenocarcinoma (PDAC) have stagnated at 20% for more than a decade, demonstrating the need to develop novel adjuvant therapies. Gemcitabine-erlotinib therapy has demonstrated a survival benefit for patients with metastatic PDAC. Here we report the first phase 2 study of erlotinib in combination with adjuvant chemoradiation and chemotherapy for resected PDAC. Methods and Materials: Forty-eight patients with resected PDAC received adjuvant erlotinib (100 mg daily) and capecitabine (800 mg/m{sup 2} twice daily Monday-Friday) concurrently with intensity modulated radiation therapy (IMRT), 50.4 Gy over 28 fractions followed by 4 cycles of gemcitabine (1000 mg/m{sup 2} on days 1, 8, and 15 every 28 days) and erlotinib (100 mg daily). The primary endpoint was recurrence-free survival (RFS). Results: The median follow-up time was 18.2 months (interquartile range, 13.8-27.1). Lymph nodes were positive in 85% of patients, and margins were positive in 17%. The median RFS was 15.6 months (95% confidence interval [CI], 13.4-17.9), and the median overall survival (OS) was 24.4 months (95% CI, 18.9-29.7). Multivariate analysis with adjustment for known prognostic factors showed that tumor diameter >3 cm was predictive for inferior RFS (hazard ratio, 4.01; P=.001) and OS (HR, 4.98; P=.02), and the development of dermatitis was associated with improved RFS (HR, 0.27; P=.009). During CRT and post-CRT chemotherapy, the rates of grade 3/4 toxicity were 31%/2% and 35%/8%, respectively. Conclusion: Erlotinib can be safely administered with adjuvant IMRT-based CRT and chemotherapy. The efficacy of this regimen appears comparable to that of existing adjuvant regimens. Radiation Therapy Oncology Group 0848 will ultimately determine whether erlotinib produces a survival benefit in patients with resected pancreatic cancer.

  4. The Influence of Total Nodes Examined, Number of Positive Nodes, and Lymph Node Ratio on Survival After Surgical Resection and Adjuvant Chemoradiation for Pancreatic Cancer: A Secondary Analysis of RTOG 9704

    Energy Technology Data Exchange (ETDEWEB)

    Showalter, Timothy N. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Winter, Kathryn A. [Radiation Therapy Oncology Group, RTOG Statistical Center, Philadelphia, PA (United States); Berger, Adam C., E-mail: adam.berger@jefferson.edu [Department of Surgery, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Regine, William F. [Department of Radiation Oncology, University of Maryland Medical Center, Baltimore, MD (United States); Abrams, Ross A. [Department of Radiation Oncology, Rush University Medical Center, Chicago, IL (United States); Safran, Howard [Department of Medicine, Miriam Hospital, Brown University Oncology Group, Providence, RI (United States); Hoffman, John P. [Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA (United States); Benson, Al B. [Division of Hematology-Oncology, Northwestern University, Chicago, IL (United States); MacDonald, John S. [St. Vincent' s Cancer Care Center, New York, NY (United States); Willett, Christopher G. [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States)

    2011-12-01

    Purpose: Lymph node status is an important predictor of survival in pancreatic cancer. We performed a secondary analysis of Radiation Therapy Oncology Group (RTOG) 9704, an adjuvant chemotherapy and chemoradiation trial, to determine the influence of lymph node factors-number of positive nodes (NPN), total nodes examined (TNE), and lymph node ratio (LNR ratio of NPN to TNE)-on OS and disease-free survival (DFS). Patient and Methods: Eligible patients from RTOG 9704 form the basis of this secondary analysis of lymph node parameters. Actuarial estimates for OS and DFS were calculated using Kaplan-Meier methods. Cox proportional hazards models were performed to evaluate associations of NPN, TNE, and LNR with OS and DFS. Multivariate Cox proportional hazards models were also performed. Results: There were 538 patients enrolled in the RTOG 9704 trial. Of these, 445 patients were eligible with lymph nodes removed. Overall median NPN was 1 (min-max, 0-18). Increased NPN was associated with worse OS (HR = 1.06, p = 0.001) and DFS (HR = 1.05, p = 0.01). In multivariate analyses, both NPN and TNE were associated with OS and DFS. TNE > 12, and >15 were associated with increased OS for all patients, but not for node-negative patients (n = 142). Increased LNR was associated with worse OS (HR = 1.01, p < 0.0001) and DFS (HR = 1.006, p = 0.002). Conclusion: In patients who undergo surgical resection followed by adjuvant chemoradiation, TNE, NPN, and LNR are associated with OS and DFS. This secondary analysis of a prospective, cooperative group trial supports the influence of these lymph node parameters on outcomes after surgery and adjuvant therapy using contemporary techniques.

  5. Further studies on the H-2 linked dependence of the adjuvant action of Brucella abortus

    International Nuclear Information System (INIS)

    Oth, D.; Sabolovic, D.

    1978-01-01

    The B 19S strain of Brucella abortus has been found to act as an adjuvant to the anti-sheep red blood cell (SRBC) reaction in some congenic strains of mice but not in others. If the recipient was H-2sup(b), there was no adjuvant effect (B 19S); neither was there (thymus-dependent) anti-B 19S reaction as measured by thymocyte activation and change of electrophoretic mobility. In contrast, there was a thymus-independent anti-B 19S reaction (production of haemagglutinins) as good in the H-2sup(b) mice as in the others. Experiments with T cell deprived mice showed that the adjuvant action of B 19S was thymus-dependent. As the anti-SRBC reaction without adjuvant was also thymus-dependent, it was difficult to distinguish anti-SRBC and anti-B reactions from the adjuvant action of B 19S on the anti-SRBC reaction. Several explanations are possible, all involving H-2 (Isup(r)) controlled thymus dependent mechanisms. (author)

  6. Adjuvant therapy for gastric cancer: what have we learned since INT0116?

    Science.gov (United States)

    Jácome, Alexandre A; Sankarankutty, Ajith K; dos Santos, José Sebastião

    2015-04-07

    Gastric cancer is one of the main cancer-related causes of death worldwide. The curative treatment of gastric cancer consists of tumor resection and lymphadenectomy. However, surgical treatment alone is associated with high recurrence rates. Adjuvant treatment strategies have been studied over the last decades, but there have been controversial results from the initial studies. The pivotal INT0116 study demonstrated that the use of adjuvant chemoradiotherapy with 5-fluorouracil increases relapse-free and overall survival, and it has been adopted across the Western world. The high toxicity of radiochemotherapy and suboptimal surgical treatment employed, with fewer than 10% of the patients submitted to D2 lymphadenectomy, were the main study limitations. Since its publication, other adjuvant treatment modalities have been studied, and radiochemotherapy is being refined to improve its efficacy and safety. A multimodal approach has been demonstrated to significantly increase relapse-free and overall survival, and it can be offered in the form of perioperative chemotherapy, adjuvant chemoradiotherapy or adjuvant chemotherapy, regardless of the extent of lymphadenectomy. The objective of the present review is to report the major advances obtained in the last decades in the adjuvant treatment of gastric cancer as well as the perspectives of treatment based on recent knowledge of the molecular biology of the disease.

  7. Pilot study of sodium phenylbutyrate as adjuvant in cyclophosphamide-resistant endemic Burkitt's lymphoma.

    Science.gov (United States)

    Phillips, John A; Griffin, Beverly E

    2007-12-01

    Burkitt's lymphoma (BL) accounts for the majority of childhood malignancies seen in sub-Saharan Africa. In Malawi, cyclophosphamide (CPM), the mainstay of treatment for endemic BL, is effective in around 50% of cases. Evidence exists in support of an association between activation of replication of Epstein-Barr virus (EBV) in the tumour and response to this chemotheraupeutic agent. Phenylbutyrate (PB), approved for treatment of inborn errors of the urea cycle with minimal toxicity in children, induces EBV replication and cell lysis in BL-derived cell cultures. It has also shown some success as adjuvant in treatment of chronic leukaemia and lymphoma. We tested in African BL patients with CPM-resistant tumours, and thus unlikely to survive, the hypothesis that PB can reverse this resistance. A study of five patients showed PB before CPM to induce shrinkage of CPM-resistant tumours in two of them. Findings suggested that for this effect PB pre-treatment should be given for a week before CPM treatment. A larger study is indicated.

  8. Clinicopathological study of surgically treated osteoradionecrosis

    International Nuclear Information System (INIS)

    Ohishi, Shin-ichiro

    2001-01-01

    To evaluate prognostic factors affecting surgically treated osteoradionecrosis (ORN) of the mandible, 13 patients with mandibular bone necrosis caused by irradiation for head and neck cancer were examined chlinicopathologically. The subjects were included 12 men and 1 woman, with a mean age of 65.3 years at surgery. The mean total dose of irradiation was 61.6 Gy. The clinical stage according to Epstein et al. (1987) was IIB in 1 patient, IIIA in 4, and IIIB in 8. The mandible was resected 10 mm or more from the lesion. Delayed healing was found in two patients, and three had recurrence of necrosis of the remaining bone. Patients whose mandibular periosteum had been resected previously who received mandibular reconstruction had a poor outcome. Pathological changes, such as stenosis of the inferior alveolar artery, fibrosis of bone marrow, and low osteocyte density in cortical bone, were found in all resected mandibles. Among them, mandibles lacking sequestra and bone remodeling had poor viability. Therefore, the periosteal blood supply should be conserved and surgical interventions, particularly heat, must be minimized to avoid recurrence of ORN. (author)

  9. Factors Affecting Surgical Decision-making—A Qualitative Study

    Directory of Open Access Journals (Sweden)

    Caroline Gunaratnam

    2018-01-01

    Full Text Available Background Guidelines and Class 1 evidence are strong factors that help guide surgeons’ decision-making, but dilemmas exist in selecting the best surgical option, usually without the benefit of guidelines or Class 1 evidence. A few studies have discussed the variability of surgical treatment options that are currently available, but no study has examined surgeons’ views on the influential factors that encourage them to choose one surgical treatment over another. This study examines the influential factors and the thought process that encourage surgeons to make these decisions in such circumstances. Methods Semi-structured face-to-face interviews were conducted with 32 senior consultant surgeons, surgical fellows, and senior surgical residents at the University of Toronto teaching hospitals. An e-mail was sent out for volunteers, and interviews were audio-recorded, transcribed verbatim, and subjected to thematic analysis using open and axial coding. Results Broadly speaking there are five groups of factors affecting surgeons’ decision-making: medical condition, information, institutional, patient, and surgeon factors. When information factors such as guidelines and Class 1 evidence are lacking, the other four groups of factors—medical condition, institutional, patient, and surgeon factors (the last-mentioned likely being the most powerful—play a significant role in guiding surgical decision-making. Conclusions This study is the first qualitative study on surgeons’ perspectives on the influential factors that help them choose one surgical treatment option over another for their patients.

  10. Results of adjuvant chemo radiation after curative surgery for gastric cancer. A retrospective study

    International Nuclear Information System (INIS)

    Muller, Bettina; Balbontin, Paulina; Trujillo, Cristian; Becerra, Sergio; Sola, Antonio; Neveu, Rodrigo; Fernandez, Roberto; Buchholtz, Martin; Villanueva, Luis; Cerda, Berta

    2009-01-01

    Background: Survival rates after curative surgery for gastric cancer are disappointing. Therefore adjuvant therapeutic strategies are required. Aim: To analyze survival and side effects of treatment among gastric cancer patients treated with adjuvant chemoradiotherapy after curative resection of gastric adenocarcinoma. Material and methods: Retrospective review of medical records of 74 patients aged 20 to 74 years, treated with complete resection of gastric adenocarcinoma followed by adjuvant chemo radiation. Survival analysis was based on the records and information from the National Mortality Registry. Results: Five years survival fluctuated from 50% among patients in stage 1B to 25% among those is stage IV. Significant acute toxicity was observed in 23 patients (31%). No patients died due to acute toxicity. Eleven patients (16.4%) developed significant late toxicity, with two possible deaths related to treatment. Conclusions: Postoperative chemoradiotherapy is feasible in our experience. Continuos infusion of 5- fluoruracil is recommended to reduce toxicity

  11. Study on Application of Static Magnetic Field for Adjuvant Arthritis Rats

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    Norimasa Taniguchi

    2004-01-01

    Full Text Available In order to examine the effectiveness of the application of static magnetic field (SMF on pain relief, we performed a study on rats with adjuvant arthritis (AA. Sixty female Sprague–Dawley (SD rats (age: 6 weeks, body weight: approximately 160 g were divided into three groups [SMF-treated AA rats (Group I, non-SMF-treated AA rats (Group II and control rats (Group III]. The SD rats were injected in the left hind leg with 0.6 mg/0.05 ml Mycobacterium butyrium to induce AA. The rats were bred for 6 months as chronic pain model. Thereafter, the AA rats were or were not exposed to SMF for 12 weeks. We assessed the changes in the tail surface temperature, locomotor activity, serum inflammatory marker and bone mineral density (BMD using thermography, a metabolism measuring system and the dual-energy X-ray absorptiometry (DEXA method, respectively. The tail surface temperature, locomotor activity and femoral BMD of the SMF-exposed AA rats were significantly higher than those of the non-SMF-exposed AA rats, and the serum inflammatory marker was significantly lower. These findings suggest that the pain relief effects are primarily due to the increased blood circulation caused by the rise in the tail surface temperature. Moreover, the pain relief effects increased with activity and BMD of the AA rats.

  12. Vaccines, adjuvants and autoimmunity.

    Science.gov (United States)

    Guimarães, Luísa Eça; Baker, Britain; Perricone, Carlo; Shoenfeld, Yehuda

    2015-10-01

    Vaccines and autoimmunity are linked fields. Vaccine efficacy is based on whether host immune response against an antigen can elicit a memory T-cell response over time. Although the described side effects thus far have been mostly transient and acute, vaccines are able to elicit the immune system towards an autoimmune reaction. The diagnosis of a definite autoimmune disease and the occurrence of fatal outcome post-vaccination have been less frequently reported. Since vaccines are given to previously healthy hosts, who may have never developed the disease had they not been immunized, adverse events should be carefully accessed and evaluated even if they represent a limited number of occurrences. In this review of the literature, there is evidence of vaccine-induced autoimmunity and adjuvant-induced autoimmunity in both experimental models as well as human patients. Adjuvants and infectious agents may exert their immune-enhancing effects through various functional activities, encompassed by the adjuvant effect. These mechanisms are shared by different conditions triggered by adjuvants leading to the autoimmune/inflammatory syndrome induced by adjuvants (ASIA syndrome). In conclusion, there are several case reports of autoimmune diseases following vaccines, however, due to the limited number of cases, the different classifications of symptoms and the long latency period of the diseases, every attempt for an epidemiological study has so far failed to deliver a connection. Despite this, efforts to unveil the connection between the triggering of the immune system by adjuvants and the development of autoimmune conditions should be undertaken. Vaccinomics is a field that may bring to light novel customized, personalized treatment approaches in the future. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. The Duration of Immunity to an Inactivated Adjuvanted Canine Parvovirus Vaccine. A 52 and 64 Week Postvaccination Challenge Study

    OpenAIRE

    Povey, R. C.; Carman, P. S.; Ewert, E.

    1983-01-01

    Dogs were successfully isolated for a period of either 52 or 64 weeks following vaccination with an inactivated, adjuvanted canine parvovirus-2 vaccine. Antibody persisted in all ten vaccinated dogs, although in one case by 52 weeks postvaccination only virus neutralizing antibody, and not hemagglutination-inhibiting antibody, could be detected. Sentinel unvaccinated dogs housed alongside the vaccinated dogs throughout the study remained free of canine parvovirus-2 antibody until challenged. ...

  14. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy

    International Nuclear Information System (INIS)

    Biermann, M.; Pixberg, M.K.; Schober, O.; Schuck, A.; Willich, N.; Heinecke, A.; Koepke, W.; Schmid, K.W.; Dralle, H.

    2003-01-01

    Aim: The Multicenter Study Differentiated Thyroid Carcinoma (MSDS) is an ongoing study in Germany, Austria, and Switzerland on the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated thyroid carcinoma (DTC) in TNM stages pT4 pNO/1/xMO/x (5th ed. 1997). Methods: MSDS was designed as a prospective randomized trial. Patients receive thyroidectomy, radioiodine therapy (RIT) to ablate the thyroid remnant, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical iodine-131 uptake (http://msds-studie.uni-muenster.de). Results: 311 patients were enrolled between January 2000 and March 2003. 279 patients met the trial's inclusion criteria. 45 consented to randomization, of whom 17 were randomized into treatment arm A (RTx) and 18 into arm B (no RTx). Advised by the trial's independent Data Monitoring and Safety Committee, the MSDS steering committee decided to terminate randomization in April 2003 and continue MSDS as a prospective cohort study. 23 of the 234 patients in the observation arm of the trial were prescribed RTx by their physicians. Thus, 14% of the trial cohort were randomized or assigned to receive RTx (intention-to-treat analysis). In contrast, at least 44% of all patients with pT4 papillary DTC in Germany in the nationwide PCES study underwent RTx in 1996 (p 2 -test). Conclusions: Acceptance of external beam RTx as a treatment modality for DTC has receded to a degree that accrual of a sufficient number of patients for a randomized trial has been impossible. Observation of the trial cohort is continued in order to assess clinical event rates with and without RTx and chronic RTx toxicity. (orig.) [de

  15. Adjuvant chemotherapy for gastric cancer: Current evidence and future challenges

    Science.gov (United States)

    Miceli, Rosalba; Tomasello, Gianluca; Bregni, Giacomo; Di Bartolomeo, Maria; Pietrantonio, Filippo

    2014-01-01

    Gastric cancer still represents one of the major causes of cancer mortality worldwide. Patients survival is mainly related to stage, with a high proportion of patients with metastatic disease at presentation. Thus, the cure rate largely depend upon surgical resection. Despite the additional, albeit small, benefit of adjuvant chemotherapy has been clearly demonstrated, no general consensus has been reached on the best treatment option. Moreover, the narrow therapeutic index of adjuvant chemotherapy (i.e., limited survival benefit with considerable toxicity) requires a careful assessment of expected risks and benefits for individual patients. Treatment choices vary widely based on the different geographic areas, with chemotherapy alone more often preferred in Europe or Asia and chemoradiotherapy in the United States. In the present review we discuss the current evidence and future challenges regarding adjuvant chemotherapy in curatively resected gastric cancer with particular emphasis on the recently completed landmark studies and meta-analyses. The most recent patient-level meta-analysis demonstrated the benefit of adjuvant chemotherapy over curative surgery; the same Authors also showed that disease-free survival may be used as a surrogate end-point for overall survival. We finally discuss future research issues such as the need of economic evaluations, development of prognostic or predictive biomarkers, and the unmet clinical need of trials comparing perioperative chemotherapy with adjuvant treatment. PMID:24782604

  16. A COMPARATIVE STUDY OF INTRATHECAL DEXMEDETOMIDINE AND FENTANYL AS ADJUVANTS TO BUPIVACAINE FOR LOWER ABDOMINAL SURGERIES

    Directory of Open Access Journals (Sweden)

    Hari Kishore

    2015-01-01

    Full Text Available INTRODUCTION: Various adjuvants have been used with local anesthetics in spinal anesthesia to improve the quality of block and to provide prolonged postoperative analgesia. Dexmedetomidine, the new highly selective α2 - agonist drug, is now being used as a neuraxial adju vant. AIM: The aim of this study was to evaluate the onset and duration of sensory and motor block, hemodynamic effect, postoperative analgesia, and adverse effects of dexmedetomidine or fentanyl given intrathecally with hyperbaric 0.5% bupivacaine. METHOD OLOGY: Fifty patients classified in American Society of Anesthesiologists classes I and II scheduled for lower abdominal surgeries were included in this prospective cohort study at Amala Institute of Medical Sciences. Patients received either 15 mg hyperba ric bupivacaine plus 25 μg fentanyl (group 1, n = 25 or 15 mg hyperbaric bupivacaine plus 5 μg dexmedetomidine (group 2, n = 25 intrathecally . RESULTS : Patients in dexmedetomidine group (2 had a significantly longer duration of motor and sensory block t han patients in fentanyl group . (1 The mean time regression of motor block to reach Bromage 0 was 17 6 . 2± 5.71 min in d exmeditomid ine group and 16 6 . 36 ± 5.97 min in fentanyl group (P<0.05. Duration of analgesia was 2 39.52 ± 9.05 min in D exmed i tomidine gro up and 189.96 ± 5.35 min in fentanyl group ( p< 0.05. A significant decrease in heart rate was noted in dexmedetomidine group. CONCLUSION : Intrathecal dexmedetomidine is associated with prolonged duration of analgesia and motor block along with significant dec rease in heart rate.

  17. A COMPARATIVE STUDY OF INTRATHECAL DEXMEDETOMIDINE AND FENTANYL AS ADJUVANTS TO BUPIVACAINE

    Directory of Open Access Journals (Sweden)

    Gollapalli Hanumanth

    2016-02-01

    Full Text Available INTRODUCTION Uncontrolled postoperative pain may produce a range of detrimental acute and chronic effects. Spinal anaesthesia provided by bupivacaine may be too short for providing postoperative analgesia. This study is conducted to evaluate the efficacy of intrathecal fentanyl and intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine with regards to the onset and duration of sensory and motor blockade, as well as postoperative analgesia and adverse effects. Hundred patients aged 18-55 years were randomly divided into two groups, each group consisting of 50 patients of either sex belonging to ASA class I and II posted for elective lower abdominal surgeries were given spinal anaesthesia using bupivacaine 0.5%, heavy 2.5 ml with either fentanyl 25µg (group F or 5µg of preservative free dexmedetomidine (group D. Assessment of the sensory and motor blockade were done at the end of each minute till the maximum level achieved. Measurement of blood pressure, pulse rate, respiratory rate and arterial oxygen saturation were obtained. Postoperatively the patients were observed for the duration of analgesia, time taken for complete regression of sensory blockade to S1 and time taken for complete recovery of motor power. RESULTS Our results showed a statistically highly significant prolongation of sensory and motor blockade, and postoperative analgesia in the dexmedetomidine group compared to the fentanyl group. In dexmedetomidine group four out of fifty patients, and in fentanyl group two out of fifty patients developed hypotension. In dexmedetomidine group five out of fifty patients, and in fentanyl group two out of fifty patients developed bradycardia. Incidence of pruritis is significantly high in fentanyl group.

  18. Adjuvant treatment or primary topical monotherapy for ocular surface squamous neoplasia: a systematic review

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    Gustavo Arruda Viani

    Full Text Available ABSTRACT In this systematic review, we evaluated studies involving adjuvant and primary topical treatment for ocular surface squamous neoplasia (OSSN. The findings were: (i adjuvant 5-fluorouracil (5-FU reduces the risk of relapse after surgical excision with mild side effects [level Ib, grade of recommendation (GR A]. (ii Primary topical mitomycin (MMC produces a high rate of complete response, low recurrence rate, and mild side effects (level Ib, GR A. (iii Primary chemotherapy versus adjuvant chemotherapy produce similar rates of recurrence, with no significant difference (level IIb, GR B. (iv Adjuvant 5-FU versus MMC showed no significant differences, with mild side effects in both groups and a better toxicity profile for MMC (level III, GR C. (v Primary topical 5-FU versus MMC versus interferon (IFN showed similar rates of tumor recurrence, mild side effects for all drugs, and more severe side effects in the 5-FU arm, followed successively by MMC and IFN (level III, GR C.

  19. Effects of Frequent Glove Change on Outcomes of Orthopaedic Surgical Procedures - A Multicenter Study on Surgical Gloves

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    Nishit Palo

    2017-10-01

    Full Text Available Introduction: Intact surgical gloves are a barrier to microorganisms migration between surgical team members and the patient. The surgical gloves are changed at various junctures but the effects of changing gloves during surgical procedures on various surgical parameters or clinical outcomes are not established. Aim: To determine rationale of glove change during orthopaedic procedures, differences amongst surgical parameters with and without changing the surgical gloves and whether frequent glove change affected surgical parameters or clinical outcomes. Materials and Methods: A prospective multicenter study conducted at three centers from January 2014 to January 2016. A 250 patients were divided into 2 groups (n=125 each in Group 1, surgical team operated with regular changing of gloves. In Group 2, only 1 set of double gloves were worn throughout the procedure. Surgical parameters or clinical outcomes were assessed for both the groups. Statistical analyses included the median, mode, range, Interquartile Range (IQR and sample standard deviation (s and independent-samples t-test. Bacterial counts were expressed as median with (IQR. Results: Surgical Timing Difference was 10 (S.D.- 4.2 minutes more in Group-1 (<0.05, Surgical Cost was higher in Group-1 by Rs.150-450 (<0.05. Outer glove micro-perforation rate was 5.85% and 8.15% in group-1 and 2 respectively with no inner glove perforation or Surgical Site Infections. Outer glove micro perforations were proportional to duration of surgery; operations lasting 120-210 and 61-120 minutes had 66.6% and 37.2% micro perforation rates respectively (p<0.05. Conclusion: Under standard operating conditions, procedures performed without glove change are shorter and cost effective than procedures performed with regular glove change with similar surgical and functional results. Judicious use of surgical gloves is a patient and environment friendly option, thereby reducing the hospital’s biomedical waste load.

  20. Biological characterization and selection criteria of adjuvant chemotherapy for early breast cancer: experience from the Italian observational NEMESI study

    International Nuclear Information System (INIS)

    Clavarezza, Matteo; Marchetti, Paolo; Gori, Stefania; Carrozza, Francesco; Maiello, Evaristo; Giotta, Francesco; Dondi, Davide; Venturini, Marco; Mustacchi, Giorgio; Casadei Gardini, Andrea; Del Mastro, Lucia; De Matteis, Andrea; Riccardi, Ferdinando; Adamo, Vincenzo; Aitini, Enrico; Amoroso, Domenico

    2012-01-01

    International treatment guidelines recommend administration of adjuvant chemotherapy in early breast cancer based on clinical, prognostic and predictive parameters. An observational study (NEMESI) was conducted in 63 Italian oncology centres in patients with early breast cancer. Age, performance status, concomitant disease, menopausal status, histology, tumor dimension (pT), axillary lymph node status (pN), grading (G), estrogen and progesterone receptor (ER and PgR), proliferative index (ki67 or MIB-1), human epidermal growth factor receptor 2 (HER2) and type of adjuvant treatment were recorded. The primary objective of the study was to define parameters influencing the decision to prescribe adjuvant chemotherapy and the type of chemotherapy. Data for 1894 patients were available. 69.0% postmenopausal, 67.0% pT1, 22.3% pTmic/pT1a/pT1b, 61.0% pN0, 48.7% luminal A, 18.1% luminal B, 16.1% HER2 positive, 8.7% triple negative, 8.4% unknown. 57.8% received adjuvant chemotherapy: 38.1% of luminal A, 67.3% luminal B, 88.2% HER2-positive, 97.6% triple negative. Regimens administered: 9.1% CMF-like, 48.8% anthracyclines, 38.4% anthracyclines plus taxanes, 3.7% taxanes alone. Increasing pT/pN and, marginally, HER2-positive were associated with the prescription of anthracyclines plus taxanes. Suboptimal schedules (CMF-like or AC/EC or FEC-75) were prescribed in 37.3% receiving chemotherapy, even in HER2-positive and triple negative disease (36.5% and 34.0%, respectively). This study showed an overprescription of adjuvant chemotherapy for early breast cancer, particularly referred to luminal A. pT, pN and, marginally, HER2 were the principal determinants for the choice of chemotherapy type. Suboptimal chemotherapy regimens were adopted in at least one third of HER2-positve and triple negative

  1. Critical care admission of South African (SA surgical patients: Results of the SA Surgical Outcomes Study

    Directory of Open Access Journals (Sweden)

    David Lee Skinner

    2017-05-01

    Full Text Available Background. Appropriate critical care admissions are an important component of surgical care. However, there are few data describing postoperative critical care admission in resource-limited low- and middle-income countries. Objective. To describe the demographics, organ failures, organ support and outcomes of non-cardiac surgical patients admitted to critical care units in South Africa (SA. Methods. The SA Surgical Outcomes Study (SASOS was a 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient non-cardiac surgery between 19 and 26 May 2014 at 50 government-funded hospitals. All patients admitted to critical care units during this study were included for analysis. Results. Of the 3 927 SASOS patients, 255 (6.5% were admitted to critical care units; of these admissions, 144 (56.5% were planned, and 111 (43.5% unplanned. The incidence of confirmed or strongly suspected infection at the time of admission was 35.4%, with a significantly higher incidence in unplanned admissions (49.1 v. 24.8%, p<0.001. Unplanned admission cases were more frequently hypovolaemic, had septic shock, and required significantly more inotropic, ventilatory and renal support in the first 48 hours after admission. Overall mortality was 22.4%, with unplanned admissions having a significantly longer critical care length of stay and overall mortality (33.3 v. 13.9%, p<0.001. Conclusion. The outcome of patients admitted to public sector critical care units in SA is strongly associated with unplanned admissions. Adequate ‘high care-dependency units’ for postoperative care of elective surgical patients could potentially decrease the burden on critical care resources in SA by 23%. This study was registered on ClinicalTrials.gov (NCT02141867.

  2. Laser vaccine adjuvants

    Science.gov (United States)

    Kashiwagi, Satoshi; Brauns, Timothy; Gelfand, Jeffrey; Poznansky, Mark C

    2014-01-01

    Immunologic adjuvants are essential for current vaccines to maximize their efficacy. Unfortunately, few have been found to be sufficiently effective and safe for regulatory authorities to permit their use in vaccines for humans and none have been approved for use with intradermal vaccines. The development of new adjuvants with the potential to be both efficacious and safe constitutes a significant need in modern vaccine practice. The use of non-damaging laser light represents a markedly different approach to enhancing immune responses to a vaccine antigen, particularly with intradermal vaccination. This approach, which was initially explored in Russia and further developed in the US, appears to significantly improve responses to both prophylactic and therapeutic vaccines administered to the laser-exposed tissue, particularly the skin. Although different types of lasers have been used for this purpose and the precise molecular mechanism(s) of action remain unknown, several approaches appear to modulate dendritic cell trafficking and/or activation at the irradiation site via the release of specific signaling molecules from epithelial cells. The most recent study, performed by the authors of this review, utilized a continuous wave near-infrared laser that may open the path for the development of a safe, effective, low-cost, simple-to-use laser vaccine adjuvant that could be used in lieu of conventional adjuvants, particularly with intradermal vaccines. In this review, we summarize the initial Russian studies that have given rise to this approach and comment upon recent advances in the use of non-tissue damaging lasers as novel physical adjuvants for vaccines. PMID:25424797

  3. The Effects of Different Concentrations of Epinephrine Adjuvant to Levobupivacaine on Wound Healing

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    Suleyman Yeyen

    2013-04-01

    Conclusions: Epinephrine added to levobupivacaine in low concentrations accelerates wound healing in the early phase by stimulating fibrosis, and has no adverse effects on surgical sites. Long-term studies are needed for late effects of epinephrine adjuvant levobupivacaine. [Arch Clin Exp Surg 2013; 2(2.000: 92-96

  4. A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients

    International Nuclear Information System (INIS)

    Chi, K.-H.; Chang, Y.-C.; Guo, W.-Y.; Leung, M.-J.; Shiau, C.-Y.; Chen, S.-Y; Wang, L.-W.; Lai, Y.-L.; Hsu, M.-M.; Lian, S.-L.; Chang, C.-H.; Liu, T.-W.; Chin, Y.-H.; Yen, S.-H.; Perng, C.-H.; Chen, Kuang Y.

    2002-01-01

    Purpose: To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC. Methods and Materials: Between November 1994 and March 1999, 157 patients with Stage IV, M 0 (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35-40 fractions, 1.8-2.0 Gy/fraction/day, 5 days/week, to a total dose 70-72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m 2 cisplatin, 2,200 mg/m 2 5-fluorouracil, and 120 mg/m 2 leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis. Results: With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (≥ Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (≥ Grade 3). Conclusions: We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival

  5. Adjuvant endocrine therapy after breast cancer: a qualitative study of factors associated with adherence

    Directory of Open Access Journals (Sweden)

    Brett J

    2018-02-01

    Full Text Available Jo Brett,1 Mary Boulton,1 Debbie Fenlon,2 Nick J Hulbert-Williams,3 Fiona M Walter,4 Peter Donnelly,5 Bernadette A Lavery,6 Adrienne Morgan,7 Carolyn Morris,7 Eila K Watson1 1Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, 2College of Human and Health Sciences, Swansea University, Swansea, Wales, 3Department of Psychology, Chester Research Unit for the Psychology of Health, University of Chester, Chester, 4Department of Public Health and Primary Care, University of Cambridge, Cambridge, 5South Devon Healthcare NHS Foundation Trust, Torbay Hospital, Torquay, 6Cancer Services, Oxford University Hospitals Foundation NHS Trust, Oxford, 7Independent Cancer Patients’ Voice, London, UK Introduction: Despite evidence of the efficacy of adjuvant endocrine therapy (AET in reducing the risk of recurrence and mortality after treatment for primary breast cancer, adherence to AET is suboptimal. This study aimed to explore factors that influence adherence and nonadherence to AET following breast cancer to inform the development of supportive interventions.Methods: Interviews were conducted with 32 women who had been prescribed AET, 2–4 years following their diagnosis of breast cancer. Both adherers (n=19 and nonadherers (n=13 were recruited. The analysis was conducted using the Framework approach.Results: Factors associated with adherence were as follows: managing side effects including information and advice on side effects and taking control of side effects, supportive relationships, and personal influences. Factors associated with nonadherence were as follows: burden of side effects, feeling unsupported, concerns about long-term AET use, regaining normality, including valuing the quality of life over length of life, and risk perception.Conclusion: Provision of timely information to prepare women for the potential side effects of AET and education on medication management strategies are needed, including provision of timely and

  6. Rabies virus vaccine as an immune adjuvant against cancers and glioblastoma: new studies may resurrect a neglected potential.

    Science.gov (United States)

    Altinoz, M A; Guloksuz, S; Elmaci, I

    2017-07-01

    To review the literature about the use of Rabies Virus-Vaccine (RV-V) as an anticancer immunotherapeutic modality in the light of recent findings. The literature search in relevant databases with the following key words: Rabies virus, cancer, remission. Remissions occured following RV-V injections in patients with cervical cancer and melanoma. Pilot clinical studies showed that RV-V injections enhanced survival in glioblastoma patients, which is supported by findings in GL261 mouse glioma model. If public health studies demonstrate protective role of RV-V against certain types of cancers, it can be benefitted as a novel immune adjuvant in clinic.

  7. Management of Pediatric Myxopapillary Ependymoma: The Role of Adjuvant Radiation

    Energy Technology Data Exchange (ETDEWEB)

    Agbahiwe, Harold C.; Wharam, Moody [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Batra, Sachin [Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Cohen, Kenneth [Division of Pediatric Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Terezakis, Stephanie A., E-mail: sterezak@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States)

    2013-02-01

    Introduction: Myxopapillary ependymoma (MPE) is a rare tumor in children. The primary treatment is gross total resection (GTR), with no clearly defined role for adjuvant radiation therapy (RT). Published reports, however, suggest that children with MPE present with a more aggressive disease course. The goal of this study was to assess the role of adjuvant RT in pediatric patients with MPE. Methods: Sixteen patients with MPE seen at Johns Hopkins Hospital (JHH) between November 1984 and December 2010 were retrospectively reviewed. Fifteen of the patients were evaluable with a mean age of 16.8 years (range, 12-21 years). Kaplan-Meier curves and descriptive statistics were used for analysis. Results: All patients received surgery as the initial treatment modality. Surgery consisted of either a GTR or a subtotal resection (STR). The median dose of adjuvant RT was 50.4 Gy (range, 45-54 Gy). All patients receiving RT were treated at the involved site. After a median follow-up of 7.2 years (range, 0.75-26.4 years), all patients were alive with stable disease. Local control at 5 and 10 years was 62.5% and 30%, respectively, for surgery alone versus 100% at both time points for surgery and adjuvant RT. Fifty percent of the patients receiving surgery alone had local failure. All patients receiving STR alone had local failure compared to 33% of patients receiving GTR alone. One patient in the surgery and adjuvant RT group developed a distant site of recurrence 1 year from diagnosis. No late toxicity was reported at last follow-up, and neurologic symptoms either improved or remained stable following surgery with or without RT. Conclusions: Adjuvant RT improved local control compared to surgery alone and should be considered after surgical resection in pediatric patients with MPE.

  8. Phase II Study of Short-Course Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Elderly Patients With Glioblastoma

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    Minniti, Giuseppe, E-mail: Giuseppe.Minniti@ospedalesantandrea.it [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Lanzetta, Gaetano [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Scaringi, Claudia [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Caporello, Paola [Department of Medical Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Salvati, Maurizio [Department of Neurosurgery, Umberto I Hospital, University ' La Sapienza,' Rome (Italy); Arcella, Antonella [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); De Sanctis, Vitaliana [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Giangaspero, Felice [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Department of Pathology, Umberto I Hospital, University ' La Sapienza,' Rome (Italy); Enrici, Riccardo Maurizi [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy)

    2012-05-01

    Purpose: Radiotherapy (RT) and chemotherapy may prolong survival in older patients (age {>=}70 years) with glioblastoma multiforme (GBM), although the survival benefits remain poor. This Phase II multicenter study was designed to evaluate the efficacy and safety of an abbreviated course of RT plus concomitant and adjuvant temozolomide (TMZ) in older patients with GBM. Patients and Methods: Seventy-one eligible patients 70 years of age or older with newly diagnosed GBM and a Karnofsky performance status {>=}60 were treated with a short course of RT (40 Gy in 15 fractions over 3 weeks) plus TMZ at the dosage of 75 mg/m{sup 2} per day followed by 12 cycles of adjuvant TMZ (150-200 mg/m{sup 2} for 5 days during each 28-day cycle). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival and toxicity. Results: The Median OS was 12.4 months, and the 1-year and 2-year OS rates were 58% and 20%, respectively. The median and 1-year rates of progression-free survival were 6 months and 20%, respectively. All patients completed the planned programme of RT. Grade 3 or 4 adverse events occurred in 16 patients (22%). Grade 3 and 4 neutropenia and/or thrombocytopenia occurred in 10 patients (15%), leading to the interruption of treatment in 6 patients (8%). Nonhematologic Grade 3 toxicity was rare, and included fatigue in 4 patients and cognitive disability in 1 patient. Conclusions: A combination of an abbreviated course of RT plus concomitant and adjuvant TMZ is well tolerated and may prolong survival in elderly patients with GBM. Future randomized studies need to evaluate the efficacy and toxicity of different schedules of RT in association with chemotherapy.

  9. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

    International Nuclear Information System (INIS)

    Ishiguro, Megumi; Mori, Masaki; Kakeji, Yoshihiro; Kanazawa, Akiyoshi; Kobayashi, Michiya; Okajima, Masazumi; Hyodo, Ichinosuke; Miyakoda, Keiko; Sugihara, Kenichi; Kotake, Kenjiro; Nishimura, Genichi; Tomita, Naohiro; Ichikawa, Wataru; Takahashi, Keiichi; Watanabe, Toshiaki; Furuhata, Tomohisa; Kondo, Ken

    2013-01-01

    Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients’ clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results

  10. Gynaecological surgical training in the operating room : an exploratory study

    NARCIS (Netherlands)

    van der Houwen, Clasien; Boor, Klarke; Essed, Gerard G. M.; Boendermaker, Peter M.; Scherpbier, Albert A. J. J. A.; Scheele, Fedde

    Objective: One of the challenging goals of gynaecological education is preparing trainees for independent practice of surgery. Research, however, on how to acquire surgical skills in the operating room safely, effectively and efficiently is scarce. We performed this study to explore trainers' and

  11. Prospective study comparing laparoscopic and open radical cystectomy: Surgical and oncological results.

    Science.gov (United States)

    Esquinas, C; Alonso, J M; Mateo, E; Dotor, A; Martín, A M; Dorado, J F; Arance, I; Angulo, J C

    2018-03-01

    Laparoscopic radical cystectomy with lymphadenectomy and urinary diversion is an increasingly widespread operation. Studies are needed to support the oncological effectiveness and safety of this minimally invasive approach. A nonrandomised, comparative prospective study between open radical cystectomy (ORC) and laparoscopic radical cystectomy (LRC) was conducted in a university hospital. The main objective was to compare cancer-specific survival. The secondary objective was to compare the surgical results and complications according to the Clavien-Dindo scale. We treated 156 patients with high-grade invasive bladder cancer with either ORC (n=70) or LRC (n=86). The mean follow-up was 33.5±23.8 (range 12-96) months. The mean age was 66.9+9.4 years, and the male to female ratio was 19:1. Both groups were equivalent in age, stage, positive lymph nodes, in situ carcinoma, preoperative obstructive uropathy, adjuvant chemotherapy and type of urinary diversion. There were no differences between the groups in terms of cancer-specific survival (log-rank; P=.71). The histopathology stage was the only independent variable that predicted the prognosis. The hospital stay (P=.01) and operative transfusion rates (P=.002) were less for LRC. The duration of the surgery was greater for LRC (P<.001). There were no differences in the total complications rate (p=.62) or major complications (P=.69). The risk of evisceration (P=.02), surgical wound infection (P=.005) and pneumonia (P=.017) was greater for ORC. The risk of rectal lesion (P=.017) and urethrorectal fistulae (P=.065) was greater for LRC. LRC is an equivalent treatment to ORC in terms of oncological efficacy and is advantageous in terms of transfusion rates and hospital stays but not in terms of operating room time and overall safety. Studies are needed to better define the specific safety profile for each approach. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Validating a Local Failure Risk Stratification for Use in Prospective Studies of Adjuvant Radiation Therapy for Bladder Cancer

    International Nuclear Information System (INIS)

    Baumann, Brian C.; He, Jiwei; Hwang, Wei-Ting; Tucker, Kai N.; Bekelman, Justin E.; Herr, Harry W.; Lerner, Seth P.; Guzzo, Thomas J.; Malkowicz, S. Bruce; Christodouleas, John P.

    2016-01-01

    Purpose: To inform prospective trials of adjuvant radiation therapy (adj-RT) for bladder cancer after radical cystectomy, a locoregional failure (LF) risk stratification was proposed. This stratification was developed and validated using surgical databases that may not reflect the outcomes expected in prospective trials. Our purpose was to assess sources of bias that may affect the stratification model's validity or alter the LF risk estimates for each subgroup: time bias due to evolving surgical techniques; trial accrual bias due to inclusion of patients who would be ineligible for adj-RT trials because of early disease progression, death, or loss to follow-up shortly after cystectomy; bias due to different statistical methods to estimate LF; and subgrouping bias due to different definitions of the LF subgroups. Methods and Materials: The LF risk stratification was developed using a single-institution cohort (n=442, 1990-2008) and the multi-institutional SWOG 8710 cohort (n=264, 1987-1998) treated with radical cystectomy with or without chemotherapy. We evaluated the sensitivity of the stratification to sources of bias using Fine-Gray regression and Kaplan-Meier analyses. Results: Year of radical cystectomy was not associated with LF risk on univariate or multivariate analysis after controlling for risk group. By use of more stringent inclusion criteria, 26 SWOG patients (10%) and 60 patients from the single-institution cohort (14%) were excluded. Analysis of the remaining patients confirmed 3 subgroups with significantly different LF risks with 3-year rates of 7%, 17%, and 36%, respectively (P<.01), nearly identical to the rates without correcting for trial accrual bias. Kaplan-Meier techniques estimated higher subgroup LF rates than competing risk analysis. The subgroup definitions used in the NRG-GU001 adj-RT trial were validated. Conclusions: These sources of bias did not invalidate the LF risk stratification or substantially change the model's LF estimates.

  13. Experimental study on oral sulfhydryl as an adjuvant for improving nitrate ester tolerance in an animal model.

    Science.gov (United States)

    Chen, L; Jiang, J-Q; Zhang, Y; Feng, H

    2018-03-01

    As an initial step in exploring the feasibility of oral sulfhydryl as an adjuvant for improving nitrate ester tolerance, this study was designed to experimentally test the adjuvant therapy in a rabbit model of atherosclerosis (AS). New Zealand white rabbits with induced AS were randomly divided into four groups: AS group, AS + nitrate ester group, AS + nitrate ester tolerance group, and AS + drug combination group. Additionally, four equivalent groups with healthy New Zealand white rabbits without AS were also conformed. After feeding the animals for 5 days, the concentrations of superoxide anion (•O2-), superoxide dismutase (SOD), malondialdehyde (MDA), nitric oxide (NO), and endothelin-1 (ET-1) in blood and the relaxation response of the aortic ring were determined in each subject. The vascular plaques in different treatment groups were assessed by Hematoxylin and eosin (HE) staining to investigate the therapeutic value of sulfhydryl as coadjuvant for improving nitrate ester tolerance, and changes in blood vessels in different treatment groups were studied by immunohistochemical assays. Our results showed no significant differences through time in the concentrations of •O2-, SOD, MDA, NO, ET-1 between the healthy control and the nitrate ester groups (p > 0.05). The levels of SOD and MDA in the nitrate ester tolerance group increased with time, however, the levels of •O2-, NO and ET-1 decreased gradually (p tolerance groups were significantly decreased, but SOD and MDA were significantly increased (p tolerance, and this strategy was safe and looks promising for humans.

  14. Adjuvant Chemotherapy Improves the Probability of Freedom From Recurrence in Patients With Resected Stage IB Lung Adenocarcinoma.

    Science.gov (United States)

    Hung, Jung-Jyh; Wu, Yu-Chung; Chou, Teh-Ying; Jeng, Wen-Juei; Yeh, Yi-Chen; Hsu, Wen-Hu

    2016-04-01

    The benefit of adjuvant chemotherapy remains controversial for patients with stage IB non-small-cell lung cancer (NSCLC). This study investigated the effect of adjuvant chemotherapy and the predictors of benefit from adjuvant chemotherapy in patients with stage IB lung adenocarcinoma. A total of 243 patients with completely resected pathologic stage IB lung adenocarcinoma were included in the study. Predictors of the benefits of improved overall survival (OS) or probability of freedom from recurrence (FFR) from platinum-based adjuvant chemotherapy in patients with resected stage IB lung adenocarcinoma were investigated. Among the 243 patients, 70 (28.8%) had received platinum-based doublet adjuvant chemotherapy. A micropapillary/solid-predominant pattern (versus an acinar/papillary-predominant pattern) was a significantly worse prognostic factor for probability of FFR (p = 0.033). Although adjuvant chemotherapy (versus surgical intervention alone) was not a significant prognostic factor for OS (p = 0.303), it was a significant prognostic factor for a better probability of FFR (p = 0.029) on multivariate analysis. In propensity-score-matched pairs, there was no significant difference in OS between patients who received adjuvant chemotherapy and those who did not (p = 0.386). Patients who received adjuvant chemotherapy had a significantly better probability of FFR than those who did not (p = 0.043). For patients with a predominantly micropapillary/solid pattern, adjuvant chemotherapy (p = 0.033) was a significant prognostic factor for a better probability of FFR on multivariate analysis. Adjuvant chemotherapy is a favorable prognostic factor for the probability of FFR in patients with stage IB lung adenocarcinoma, particularly in those with a micropapillary/solid-predominant pattern. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  15. Stem cell Transplantation for Eradication of Minimal PAncreatic Cancer persisting after surgical Excision (STEM PACE Trial, ISRCTN47877138): study protocol for a phase II study

    International Nuclear Information System (INIS)

    Schmitz-Winnenthal, Friedrich H; Schmidt, Thomas; Lehmann, Monika; Beckhove, Philipp; Kieser, Meinhard; Ho, Anthony D; Dreger, Peter; Büchler, Markus W

    2014-01-01

    Pancreatic cancer is the third most common cancer related cause of death. Even in the 15% of patients who are eligible for surgical resection the outlook is dismal with less than 10% of patients surviving after 5 years. Allogeneic hematopoietic (allo-HSCT) stem cell transplantation is an established treatment capable of to providing cure in a variety of hematopoietic malignancies. Best results are achieved when the underlying neoplasm has been turned into a stage of minimal disease by chemotherapy. Allo-HSCT in advanced solid tumors including pancreatic cancer have been of limited success, however studies of allo-HSCT in solid tumors in minimal disease situations have never been performed. The aim of this trial is to provide evidence for the clinical value of allo-HSCT in pancreatic cancer put into a minimal disease status by effective surgical resection and standard adjuvant chemotherapy. The STEM PACE trial is a single center, phase II study to evaluate adjuvant allogeneic hematopoietic stem cell transplantation in pancreatic cancer after surgical resection. The study will evaluate as primary endpoint 2 year progression free survival and will generate first time state-of-the-art scientific clinical evidence if allo-HSCT is feasible and if it can provide long term disease control in patients with effectively resected pancreatic cancer. Screened eligible patients after surgical resection and standard adjuvant chemotherapy with HLA matched related stem cell donor can participate. Patients without a matched donor will be used as a historical control. Study patients will undergo standard conditioning for allo-HSCT followed by transplantation of allogeneic unmanipulated peripheral blood stem cells. The follow up of the patients will continue for 2 years. Secondary endpoints will be evaluated on 7 postintervention visits. The principal question addressed in this trial is whether allo-HSCT can change the unfavourable natural course of this disease. The underlying

  16. Dexmedetomidine infusion during middle ear surgery under general anaesthesia to provide oligaemic surgical field: A prospective study

    Directory of Open Access Journals (Sweden)

    Kumkum Gupta

    2015-01-01

    Full Text Available Background and Aims: Middle ear surgery requires bloodless surgical field for better operating conditions, deep level of anaesthesia and rapid emergence. Recent studies suggest that α2 agonists could provide desired surgical field, sedation and analgesia. The present study was aimed to evaluate the clinical effects of dexmedetomidine infusion as anaesthetic adjuvant during middle ear surgery using operating microscope. Methods: Sixty four adult patients aged 18-58 years, American Society of Anaesthesiologists Grades I and II, of both gender were randomised into two comparable equal groups of 32 patients each for middle ear surgery under general anaesthesia with standard anaesthetic technique. After induction of general anaesthesia, patients of Group I were given dexmedetomidine infusion of 0.5 μg/kg/h and patients of Group II were given placebo infusion of normal saline. Isoflurane concentration was titrated to achieve a systolic blood pressure 30% below the baseline value. All patients were assessed intra-operatively for bleeding at surgical field, haemodynamic changes, awakening time and post-operative recovery. Results: Statistically significant reduction was observed in the required percentage of isoflurane (0.8 ± 0.6% to maintain the systolic blood pressure 30% below the baseline values in patients receiving dexmedetomidine infusion when compared to those receiving placebo infusion (1.6 ± 0.7%. Patients receiving dexmedetomidine infusion had statistically significant lesser bleeding at surgical field (P < 0.05. The mean awakening time and recovery from anaesthesia did not show any significant difference between the groups. Conclusion: Dexmedetomidine infusion can be safely used to provide oligaemic surgical field for better visualization using operating microscope for middle ear surgery.

  17. Adjuvant therapy for locally advanced renal cell cancer: A systematic review with meta-analysis

    Directory of Open Access Journals (Sweden)

    Lima Carmen SP

    2011-03-01

    Full Text Available Abstract Background Many adjuvant trials have been undertaken in an attempt to reduce the risk of recurrence among patients who undergo surgical resection for locally advanced renal cancer. However, no clear benefit has been identified to date. This systematic review was conducted to examine the exact role of adjuvant therapy in renal cancer setting. Methods Randomized controlled trials were searched comparing adjuvant therapy (chemotherapy, vaccine, immunotherapy, biochemotherapy versus no active treatment after surgery among renal cell cancer patients. Outcomes were overall survival (OS, disease-free survival (DFS, and severe toxicities. Risk ratios (RR, hazard ratios (HR and 95% confidence intervals were calculated using a fixed-effects meta-analysis. Heterogeneity was measured by I2. Different strategies of adjuvant treatment were evaluated separately. Results Ten studies (2,609 patients were included. Adjuvant therapy provided no benefits in terms of OS (HR 1.07; 95%CI 0.89 to 1.28; P = 0.48 I2 = 0% or DFS (HR 1.03; 95%CI 0.87 to 1.21; P = 0.77 I2 = 15% when compared to no treatment. No subgroup analysis (immunotherapy, vaccines, biochemotherapy and hormone therapy had relevant results. Toxicity evaluation depicted a significantly higher frequency of serious adverse events in the adjuvant group. Conclusions This analysis provided no support for the hypothesis that the agents studied provide any clinical benefit for renal cancer patients although they increase the risk of toxic effects. Randomized trials are underway to test targeted therapies, which might open a new therapeutic frontier. Until these trials yield results, no adjuvant therapy can be recommended for patients who undergo surgical resection for renal cell cancer.

  18. [Study on processing adjuvant medicines in Lei Gong's treatise on preparation and broiling of materia medica (Leigong Paozhi Lun)].

    Science.gov (United States)

    Zhang, Wei; Zhang, Ruixian

    2010-09-01

    There were 268 kinds of medicines recorded in the book of Lei Gong's Treatise on preparation and broiling of materia medica (Leigong Paozhi Lun). Among these medicines, 178 medicines were prepared with adjuvant medicines, including general and special compatible adjuvant medicines. These adjuvant medicines used in this book can be explained by the theory of "seven-relation compatibility". The author tried to explain the usage and their compatibility of these adjuvant medicines and put forward that attention should be paid to the changes in functions of medicines and the influences of society should be paid attention.

  19. Hemipelvectomy: outcome in 84 dogs and 16 cats. A veterinary society of surgical oncology retrospective study.

    Science.gov (United States)

    Bray, Jonathan P; Worley, Deanna R; Henderson, Ralph A; Boston, Sarah E; Mathews, Kyle G; Romanelli, Giorgio; Bacon, Nicholas J; Liptak, Julius M; Scase, Tim J

    2014-01-01

    To report clinical findings, perioperative complications and long-term outcome in dogs and cats that had hemipelvectomy surgery for treatment of neoplasia. Multi-institutional retrospective case series. Dogs (n = 84) and cats (16). Medical records (January 2000 to December 2009) of dogs and cats that had hemipelvectomy at participating institutions were reviewed. Postoperative progress and current status of the patient at the time of the study was determined by either medical record review, or via telephone contact with the referring veterinarian or owner. Complications were infrequent and usually minor. Hemorrhage was the main intraoperative complication; 2 dogs required blood transfusion. One dog developed an incisional hernia. In dogs, hemangiosarcoma had the worst prognosis with a median survival time (MST) of 179 days. MST for chondrosarcoma (1232 days), osteosarcoma (533 days), and soft tissue sarcoma (373 days) were not statistically different. Median disease-free interval (DFI) for local recurrence of all tumor types was 257 days. Cats had 75% survival at 1 year, which was significantly longer than dogs. Survival times for most tumor types can be good, but surgical margins should be carefully evaluated to ensure complete tumor removal. Adjuvant therapies may be advisable particularly for dogs to reduce rates of local recurrence or distant metastasis. © Copyright 2013 by The American College of Veterinary Surgeons.

  20. Study comparing sequential (neo-adjuvant) versus concurrent chemo-radiotherapy in patients with squamous cell carcinoma

    International Nuclear Information System (INIS)

    Okawa, Tomohiko; Karasawa, Kumiko; Kaneyasu, Yuko; Tanaka, Makiko; Kita-Okawa, Midori; Ishii, Tetsuo

    1994-01-01

    Radiotherapy combined with chemotherapy is still used for standard treatment in patients with locally advanced unresectable cancer. A study was undertaken to compare a sequential (neo-adjuvant) with a simultaneous (concurrent) chemotherapy and radiotherapy program. Neo-adjuvant chemotherapy with cisplatin (80 mg/m 2 i.v. day 1) and 5FU (600 mg/m 2 continuous i.v. day 1-5) every 3 weeks prior to definitive conventional radiotherapy (60-65 Gy), or cisplatin (20 mg/m 2 i.v. day 1-5) and 5FU (250 mg/m 2 continuous i.v. infusion. day 1-14) were given simultaneously for same radiotherapy. Complete response rate was 45% in the sequential treatment and 43% in the simultaneous arm. Leukopenia and other adverse effects were slightly more frequent in the simultaneous arm, but there were no significant differences. These results suggested that individualization of treatment planning and establishment of optimum treatment were most important for combination of chemotherapy and radiotherapy. (author)

  1. Fluorouracil and high-dose leucovorin with radiotherapy as adjuvant therapy for rectal cancer. Results of a phase II study

    Energy Technology Data Exchange (ETDEWEB)

    Giralt, J. [Radiation Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Rubio, D. [Medical Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Maldonado, X. [Radiation Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Naval, J. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Casado, S. [Medical Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Lara, F. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Rosello, J.M. [Dept. of Preventive Medicine, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Armengol, M. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain)

    1997-07-01

    The purpose of this phase II study was to evaluate the efficacy and toxicity of fluorouracil and high-dose leucovorin (5-FU/LV) with pelvic irradiation as adjuvant therapy for patients with macroscopical resected rectal or recto-sigmoid cancer. Following surgery for stages II-III primary (52) or recurrent rectal cancer (4), 56 patients received 8 cycles of 5-FU/LV and pelvic irradiation. 5-FU doses were 200 mgr/m{sup 2} for cycles 2-3 and 300 mgr/m{sup 2} for cycles 1 and 4-8. LV doses remained fixed at 200 mgr/m{sup 2}. Pelvic radiation was started in the third week, between the first and second cycle. The total dose was 50.4 Gy. No serve complications had been recorded. The incidence of grade 3 diarrhea was 19%. Three patients presented leukopenia grade 3 (5%). In 44 patients (78%) the planned treatment could be administered. The median follow-up was 40 months (range 22-66). Seven patients had a local relapse (13%) and 6 developed distant metastasis (10%). The 3-year disease-free survival was 72% and the overall survival was 76%. These preliminary results show that combined post-operative 5-FU/LV and pelvic radiotherapy are well tolerated and present a reasonable local control and survival rates. This adjuvant treatment should be evaluated in randomized trials. (orig.).

  2. Comparison of Adjuvant Radiation Therapy Alone and Chemotherapy Alone in Surgically Resected Low-Grade Gliomas: Survival Analyses of 2253 Cases from the National Cancer Data Base.

    Science.gov (United States)

    Wu, Jing; Neale, Natalie; Huang, Yuqian; Bai, Harrison X; Li, Xuejun; Zhang, Zishu; Karakousis, Giorgos; Huang, Raymond; Zhang, Paul J; Tang, Lei; Xiao, Bo; Yang, Li

    2018-04-01

    It is becoming increasingly common to incorporate chemotherapy (CT) with radiotherapy (RT) in the treatment of low-grade gliomas (LGGs) after surgical resection. However, there is a lack of literature comparing survival of patients who underwent RT or CT alone. The U.S. National Cancer Data Base was used to identify patients with histologically confirmed, World Health Organization grade 2 gliomas who received either RT alone or CT alone after surgery from 2004 to 2013. Overall survival (OS) was evaluated by Kaplan-Meier analysis, multivariable Cox proportional hazard regression, and propensity-score-matched analysis. In total, 2253 patients with World Health Organization grade 2 gliomas were included, of whom 1466 (65.1%) received RT alone and 787 (34.9%) CT alone. The median OS was 98.9 months for the RT alone group and 125.8 months for the CT alone group. On multivariable analysis, CT alone was associated with a significant OS benefit compared with RT alone (hazard ratio [HR], 0.405; 95% confidence interval, 0.277-0.592; P < 0.001). On subgroup analyses, the survival advantage of CT alone over RT alone persisted across all age groups, and for the subtotal resection and biopsy groups, but not in the gross total resection group. In propensity-score-matched analysis, CT alone still showed significantly improved OS compared with RT alone (HR, 0.612; 95% confidence interval, 0.506-0.741; P < 0.001). Our results suggest that CT alone was independently associated with longer OS compared with RT alone in patients with LGGs who underwent surgery. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Validation of the da Vinci Surgical Skill Simulator across three surgical disciplines: A pilot study

    Science.gov (United States)

    Alzahrani, Tarek; Haddad, Richard; Alkhayal, Abdullah; Delisle, Josée; Drudi, Laura; Gotlieb, Walter; Fraser, Shannon; Bergman, Simon; Bladou, Frank; Andonian, Sero; Anidjar, Maurice

    2013-01-01

    Objective: In this paper, we evaluate face, content and construct validity of the da Vinci Surgical Skills Simulator (dVSSS) across 3 surgical disciplines. Methods: In total, 48 participants from urology, gynecology and general surgery participated in the study as novices (0 robotic cases performed), intermediates (1–74) or experts (≥75). Each participant completed 9 tasks (Peg board level 2, match board level 2, needle targeting, ring and rail level 2, dots and needles level 1, suture sponge level 2, energy dissection level 1, ring walk level 3 and tubes). The Mimic Technologies software scored each task from 0 (worst) to 100 (best) using several predetermined metrics. Face and content validity were evaluated by a questionnaire administered after task completion. Wilcoxon test was used to perform pair wise comparisons. Results: The expert group comprised of 6 attending surgeons. The intermediate group included 4 attending surgeons, 3 fellows and 5 residents. The novices included 1 attending surgeon, 1 fellow, 13 residents, 13 medical students and 2 research assistants. The median number of robotic cases performed by experts and intermediates were 250 and 9, respectively. The median overall realistic score (face validity) was 8/10. Experts rated the usefulness of the simulator as a training tool for residents (content validity) as 8.5/10. For construct validity, experts outperformed novices in all 9 tasks (p < 0.05). Intermediates outperformed novices in 7 of 9 tasks (p < 0.05); there were no significant differences in the energy dissection and ring walk tasks. Finally, experts scored significantly better than intermediates in only 3 of 9 tasks (matchboard, dots and needles and energy dissection) (p < 0.05). Conclusions: This study confirms the face, content and construct validities of the dVSSS across urology, gynecology and general surgery. Larger sample size and more complex tasks are needed to further differentiate intermediates from experts. PMID:23914275

  4. Adjuvant Therapy for Thymic Carcinoma--A Decade of Experience in a Taiwan National Teaching Hospital.

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    Yen-Han Tseng

    Full Text Available Thymic carcinomas are rare tumors for which surgical resection is the first treatment of choice. The role of adjuvant treatment after surgery is unknown because of limited available data. The present study evaluated the efficacy of post-surgery adjuvant chemotherapy or radiotherapy in patients with thymic carcinoma.To evaluate the role of adjuvant therapy in patients with thymic carcinoma, we retrospectively reviewed the records of patients with thymic carcinoma who were diagnosed and treated between 2004 and 2014.Among 78 patients with thymic carcinoma, 30 patients received surgical resection. Progression-free survival (PFS and overall survival (OS were significantly longer among these patients than among patients who received other treatments (PFS: 88.4 months vs 9.1 months, p<0.001; OS: 134.9 months vs 60.9 months; p = 0.003. Patients with stage III thymic carcinoma who received surgery had a longer OS than patients who did not receive surgery (70.1 months vs 23.9 months; p = 0.017, n = 11. Among 47 patients with stage IV carcinoma, 12 patients who received an extended thymothymectomy had a longer PFS than 35 patients who did not receive surgery (18.9 months vs 8.7 months; p = 0.029. Among 30 patients (with stage I- IV carcinoma who received primary lesion surgery, 19 patients received an R0 resection and 9 patients of the 19 patients received adjuvant radiotherapy. These patients had longer PFS (50.3 months than 2 patients who received adjuvant chemotherapy (5.9 months or 4 patients who received concurrent chemoradiotherapy (7.5 months after surgery (p = 0.003.Surgical resection should be considered for patients with thymic carcinoma, even for patients with locally advanced or stage IV carcinoma. Adjuvant radiotherapy resulted in a better PFS after R0 resection.

  5. Estimating the adjuvant chemotherapy effect in elderly stage II and III colon cancer patients in an observational study.

    Science.gov (United States)

    Kim, Ki-Yeol; Cha, In-Ho; Ahn, Joong Bae; Kim, Nam Kyu; Rha, Sun Young; Chung, Hyun Cheol; Roh, Jae Kyung; Shin, Sang Joon

    2013-05-01

    Adjuvant chemotherapy has been known as a standard treatment for patients with resected colon cancer. However, in elderly colon cancer patients, the characteristics of patients are heterogeneous with regard to life expectancy and comorbidities. Thus, with regard to the effectiveness of adjuvant chemotherapy for colon cancer, it is difficult to extrapolate data of clinical trials from the younger into the older general population. Data for 382 elderly colon cancer patients were analyzed: 217 in Stage II and 165 in Stage III. The efficacy of adjuvant chemotherapy was evaluated in elderly colon cancer patients after a match by the propensity score method. For matched patients with Stage II colon cancer, there was no significant efficacy of adjuvant chemotherapy in the risk of death during all follow-up periods (P-value, 0.06-0.37). Though there was a tendency that the adjuvant chemotherapy reduces the death rate during the follow-up periods, it was not statistically significant. In the case of Stage III, the adjuvant chemotherapy was significantly effective in matched patients for 5-year (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.30-0.90) and overall survival (HR, 0.56; 95% CI, 0.34-0.94). Adjuvant chemotherapy for elderly patients with Stage II colon cancer is not effective, whereas elderly patients with Stage III with adjuvant chemotherapy appear to have a better survival rate in the general population. Copyright © 2012 Wiley Periodicals, Inc.

  6. Assessing the real-world cost-effectiveness of adjuvant trastuzumab in HER-2/neu positive breast cancer.

    LENUS (Irish Health Repository)

    Hedden, Lindsay

    2012-01-01

    Among women with surgically removed, high-risk HER-2\\/neu-positive breast cancer, trastuzumab has demonstrated significant improvements in disease-free and overall survival. The objective of this study is to evaluate the cost-effectiveness of the currently recommended 12-month adjuvant protocol of trastuzumab using a Markov modeling approach and real-world cost data.

  7. Preclinical studies on the use of medicinal mushroom Ganoderma lucidum as an adjuvant in radiotherapy of cancer

    International Nuclear Information System (INIS)

    Gopakumar, G.; Martin, Femy; Antony, Sherin K.; Pillai, Thulasi G.; Nair, Cherupally Krishnan K.

    2010-01-01

    Our previous studies have demonstrated that an extract of Ganoderma lucidum occurring in South India possesses significant radioprotective property ex vivo. The present study describes the in vivo radioprotection of normal cells in tumour-bearing mice exposed to gamma radiation. Oral administration of G. lucidum extract (GLE) to tumour-bearing Swiss albino mice along with exposure to gamma radiation resulted in tumour regression. Single-cell gel electrophoresis (comet assay) on cells of normal and tumour tissues from tumour-bearing animals treated with GEE and radiation, revealed that there was significant reduction in radiation-induced damage to cellular DNA in normal tissues compared to the tumour, indicating preferential protection to normal tissues. The findings suggest the potential use of this mushroom extract as an adjuvant in radiotherapy, for tumour regression and prevention of radiation-induced cellular damages in normal tissues. (author)

  8. Adaptive coordination in surgical teams: an interview study.

    Science.gov (United States)

    Bogdanovic, Jasmina; Perry, Juliana; Guggenheim, Merlin; Manser, Tanja

    2015-04-01

    Effective teamwork has been recognised as a major contributor to safe patient care in surgery. Previous research has highlighted the importance of adaptive coordination for effective performance in acute care settings. Expanding this line of research this study explores the coordination behaviours and adaptive coordination strategies employed by surgical teams and identifies relevant situational characteristics influencing those coordination processes. We conducted a qualitative content analysis of semi-structured interviews with 33 surgical team members (nurses and physicians) from different specialties and hospitals. We identified coordination behaviours (i.e. task management, information management, teaching and leadership) and adaptive coordination strategies triggered by varying requirements due to non-routine events, intraoperative complications and differing level of experience among operating room staff. Interviewees highlighted the importance of effectively managing challenging moments and the supporting effect of positive climate on teamwork. This study complements previous research on the non-technical skills underpinning safe performance in surgical teams. It highlights the central role of coordination and points out the ways in which situational variability requires the team to behave adaptively.

  9. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study

    NARCIS (Netherlands)

    Chlibek, Roman; Smetana, Jan; Pauksens, Karlis; Rombo, Lars; van den Hoek, J. Anneke R.; Richardus, Jan H.; Plassmann, Georg; Schwarz, Tino F.; Ledent, Edouard; Heineman, Thomas C.

    2014-01-01

    This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E (gE) with or without the adjuvant system AS01B. In this phase II, single-blind, randomized, controlled study,

  10. Adjuvant interferon gamma in patients with drug – resistant pulmonary tuberculosis: a pilot study

    Directory of Open Access Journals (Sweden)

    Carbonell Dalia

    2004-10-01

    Full Text Available Abstract Background Tuberculosis (TB is increasing in the world and drug-resistant (DR disease beckons new treatments. Methods To evaluate the action of interferon (IFN gamma as immunoadjuvant to chemotherapy on pulmonary DR-TB patients, a pilot, open label clinical trial was carried out in the Cuban reference ward for the management of this disease. The eight subjects existing in the country at the moment received, as in-patients, 1 × 106 IU of recombinant human IFN gamma intramuscularly, daily for one month and then three times per week up to 6 months as adjuvant to the indicated chemotherapy, according to their antibiograms and WHO guidelines. Sputum samples collection for direct smear observation and culture as well as routine clinical and thorax radiography assessments were done monthly. Results Sputum smears and cultures became negative for acid-fast-bacilli before three months of treatment in all patients. Lesion size was reduced at the end of 6 months treatment; the lesions disappeared in one case. Clinical improvement was also evident; body mass index increased in general. Interferon gamma was well tolerated. Few adverse events were registered, mostly mild; fever and arthralgias prevailed. Conclusions These data suggest that IFN gamma is useful and well tolerated as adjunctive therapy in patients with DR-TB. Further controlled clinical trials are encouraged.

  11. A Phase I study of concurrent radiotherapy and capecitabine as adjuvant treatment for operable rectal cancer

    International Nuclear Information System (INIS)

    Jin Jing; Li Yexiong; Liu Yueping; Wang Weihu; Song Yongwen; Li Tao; Li Ning; Yu Zihao; Liu Xinfan

    2006-01-01

    Purpose: To determine the maximum tolerated dose and the dose-limiting toxicity of capecitabine with standard radiotherapy (RT) as adjuvant treatment in patients with rectal cancer. Methods and Materials: Patients with Stage II/III rectal cancer after surgery were eligible. Total RT dose was delivered as DT 50 Gy in fractions of 2.0 Gy/day for 5 weeks to the pelvic area. Capecitabine was administered concurrently with RT in escalating doses, twice daily with a 12-h interval, for two cycles of 14 days separated by a 7-day rest. Dose-limiting toxicity included Grade 3 or Grade 4 hematologic and nonhematologic toxicity. Results: Twenty-four patients were enrolled at the following dose levels: 1,000 (3 patients), 1,200 (3 patients), 1,400 (3 patients), 1,500 (3 patients), 1,600 (6 patients), and 1,700 mg/m 2 /day (6 patients). Dose-limiting toxicity was observed in 1 patient at 1,600 mg/m 2 /day (Grade 3 diarrhea) and in 2 patients at 1,700 mg/m 2 /day (1 patient had Grade 3 and 1 Grade 4 diarrhea). Conclusion: The maximum tolerated dose (MTD) of capecitabine given concurrently with RT was 1,600 mg/m 2 , daily from the 1st to the 14th day, with a 7-day rest, for two cycles

  12. Tumor tissue levels of Tissue Inhibitor of Metalloproteinases-1 (TIMP-1) and outcome following adjuvant chemotherapy in premenopausal lymph node-positive breast cancer patients: A retrospective study

    International Nuclear Information System (INIS)

    Schrohl, Anne-Sofie; Look, Maxime P; Meijer-van Gelder, Marion E; Foekens, John A; Brünner, Nils

    2009-01-01

    We have previously demonstrated that high tumor tissue levels of TIMP-1 are associated with no or limited clinical benefit from chemotherapy with CMF and anthracyclines in metastatic breast cancer patients. Here, we extend our investigations to the adjuvant setting studying outcome after adjuvant chemotherapy in premenopausal lymph node-positive patients. We hypothesize that TIMP-1 high tumors are less sensitive to chemotherapy and accordingly that high tumor tissue levels are associated with shorter survival. From our original retrospectively collected tumor samples we selected a group of 525 pre-menopausal lymph node-positive patients (adjuvant treatment: CMF, 324 patients; anthracycline-based, 99 patients; no adjuvant chemotherapy, 102 patients). TIMP-1 levels were measured using ELISA in cytosolic extracts of frozen primary tumors. TIMP-1 was analyzed as a continuous variable and as a dichotomized one using the median TIMP-1 concentration as a cut point between high and low TIMP-1 groups. We analyzed the benefit of adjuvant CMF and anthracyclines in univariate and multivariable survival models; endpoints were disease-free (DFS) and overall survival (OS). In this selected cohort of high-risk patients, and in the subgroup of patients receiving no adjuvant therapy, TIMP-1 was not associated with prognosis. In the subgroup of patients treated with anthracyclines, when analyzed as a continuous variable we observed a tendency for increasing TIMP-1 levels to be associated with shorter DFS (multivariable analysis, HR 1.75, 95% CI 1.00-3.07, P = 0.05) and a significant association between increasing TIMP-1 and shorter OS in both univariate (HR 3.52, 95% CI 1.54-8.06, P = 0.003) and multivariable analyses (HR 4.19, 95% CI 1.67-10.51, P = 0.002). No statistically significant association between TIMP-1 and DFS was observed in the CMF-treated patients although high TIMP-1 was associated with shorter OS when analyzed as a dichotomized variable (HR 1.64, 95% CI 1.02-2.65, P

  13. A CLINICAL AND SURGICAL STUDY OF INCISIONAL HERNIAS

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    Kethavath Changa Thavarya Naik

    2017-02-01

    Full Text Available BACKGROUND Incisions through the abdominal wall are based on anatomical principles. The intra-abdominal pressure is considerable and the surgeon aims at leaving the abdominal wall as strong as possible after operation, otherwise there exists a very real fear that portions of the abdominal contents may leave the abdominal cavity through the weak area, which are caused by a badly placed incision resulting in a condition known as scar incisional or ventral hernia. This study is intended to understand the clinical and surgical factors that may have been a contributory factor for the formation of the incisional hernias and also the treatment modality that is commonly employed to correct the discontinuity. This study is intended to help the practicing surgeons and also the young budding surgeons to understand the disease in detail. MATERIALS AND METHODS This study was done in the Department of General Surgery, RIMS Medical College, Ongole. Sixty patients who returned after undergoing the surgical procedures were included in the study. The study included 15 males and 45 females. The study was done from January 2014 to December 2016. RESULTS In the present study, the mean age of the total population was found to be 48.23 years. The female counterpart was found to be three times higher than that when compared to the males. The symptoms that tend to increase the intra-abdominal pressure tends to increase the mishap. The condition is more common in the early stages post-surgery. CONCLUSION In this study, the demographic pattern and the most common clinical and surgical factors that is thought to be directly involved with the condition has been reported.

  14. Global economic consequences of selected surgical diseases: a modelling study.

    Science.gov (United States)

    Alkire, Blake C; Shrime, Mark G; Dare, Anna J; Vincent, Jeffrey R; Meara, John G

    2015-04-27

    The surgical burden of disease is substantial, but little is known about the associated economic consequences. We estimate the global macroeconomic impact of the surgical burden of disease due to injury, neoplasm, digestive diseases, and maternal and neonatal disorders from two distinct economic perspectives. We obtained mortality rate estimates for each disease for the years 2000 and 2010 from the Institute of Health Metrics and Evaluation Global Burden of Disease 2010 study, and estimates of the proportion of the burden of the selected diseases that is surgical from a paper by Shrime and colleagues. We first used the value of lost output (VLO) approach, based on the WHO's Projecting the Economic Cost of Ill-Health (EPIC) model, to project annual market economy losses due to these surgical diseases during 2015-30. EPIC attempts to model how disease affects a country's projected labour force and capital stock, which in turn are related to losses in economic output, or gross domestic product (GDP). We then used the value of lost welfare (VLW) approach, which is conceptually based on the value of a statistical life and is inclusive of non-market losses, to estimate the present value of long-run welfare losses resulting from mortality and short-run welfare losses resulting from morbidity incurred during 2010. Sensitivity analyses were performed for both approaches. During 2015-30, the VLO approach projected that surgical conditions would result in losses of 1·25% of potential GDP, or $20·7 trillion (2010 US$, purchasing power parity) in the 128 countries with data available. When expressed as a proportion of potential GDP, annual GDP losses were greatest in low-income and middle-income countries, with up to a 2·5% loss in output by 2030. When total welfare losses are assessed (VLW), the present value of economic losses is estimated to be equivalent to 17% of 2010 GDP, or $14·5 trillion in the 175 countries assessed with this approach. Neoplasm and injury account

  15. A multicenter prospective study of surgical audit systems.

    Science.gov (United States)

    Haga, Yoshio; Ikejiri, Koji; Wada, Yasuo; Takahashi, Tadateru; Ikenaga, Masakazu; Akiyama, Noriyoshi; Koike, Shoichiro; Koseki, Masato; Saitoh, Toshihiro

    2011-01-01

    This study was undertaken to evaluate a modified form of Estimation of Physiologic Ability and Surgical Stress (E-PASS) for surgical audit comparing with other existing models. Although several scoring systems have been devised for surgical audit, no nation-wide survey has been performed yet. We modified our previous E-PASS surgical audit system by computing the weights of 41 procedures, using data from 4925 patients who underwent elective digestive surgery, designated it as mE-PASS. Subsequently, a prospective cohort study was conducted in 43 national hospitals in Japan from April 1, 2005, to April 8, 2007. Variables for the E-PASS and American Society of Anesthesiologists (ASA) status-based model were collected for 5272 surgically treated patients. Of the 5272 patients, we also collected data for the Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in 3128 patients. The area under the receiver operative characteristic curve (AUC) was used to evaluate discrimination performance to detect in-hospital mortality. The ratio of observed to estimated in-hospital mortality rates (OE ratio) was defined as a measure of quality. The numbers of variables required were 10 for E-PASS, 7 for mE-PASS, 20 for P-POSSUM, and 4 for the ASA status-based model. The AUC (95% confidence interval) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM, and 0.73 (0.63-0.83) for the ASA status-based model. The OE ratios for mE-PASS among large-volume hospitals significantly correlated with those for E-PASS (R = 0.93, N = 9, P = 0.00026), P-POSSUM (R = 0.96, N = 6, P = 0.0021), and ASA status-based model (R = 0.83, N = 9, P = 0.0051). Because of its features of easy use, accuracy, and generalizability, mE-PASS is a candidate for a nation-wide survey.

  16. A prospective phase II study of adjuvant postoperative radiation therapy following nodal surgery in malignant melanoma-Trans Tasman Radiation Oncology Group (TROG) Study 96.06

    International Nuclear Information System (INIS)

    Burmeister, Bryan H.; Mark Smithers, B.; Burmeister, Elizabeth; Baumann, Kathryn; Davis, Sidney; Krawitz, Hedley; Johnson, Carol; Spry, Nigel

    2006-01-01

    Background: The role of adjuvant postoperative therapy after resection of localised malignant melanoma involving regional lymph nodes remains controversial. There are no randomised trials that confirm that postoperative radiation conveys a benefit in terms of regional control or survival. Methods: Two hundred and thirty-four patients with melanoma involving lymph nodes were registered on a prospective study to evaluate the effect of postoperative radiation therapy. The regimen consisted of 48 Gy in 20 fractions to the nodal basin using recommended treatment guidelines for each of the major node sites. The primary endpoints were regional in-field relapse and late toxicity. Secondary endpoints were adjacent relapse, distant relapse, overall survival, progression-free survival and time to in-field progression. Results: Adjuvant radiation therapy was well tolerated by all of the patients. As the first site of relapse, regional in-field relapses occurred in 16/234 patients (6.8%). The overall survival was 36% at 5 years. The progression-free survival and regional control rates were 27% and 91%, respectively, at 5 years. Patients with more than 2 nodes involved had a significantly worse outcome in terms of distant relapse, overall and progression-free survival. Conclusion: We believe that adjuvant radiation therapy following nodal surgery could offer a possible benefit in terms of regional control. These results require confirmation in a randomised trial

  17. Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls.

    NARCIS (Netherlands)

    Schmeink, C.E.; Bekkers, R.L.M.; Josefsson, A.; Richardus, J.H.; Berndtsson Blom, K.; David, M.P.; Dobbelaere, K.; Descamps, D.

    2011-01-01

    BACKGROUND: To evaluate co-administration of GlaxoSmithKline Biologicals' human papillomavirus-16/18 AS04-adjuvanted vaccine (HPV) and hepatitis B vaccine (HepB). METHODS: This was a randomized, controlled, open, multicenter study. Healthy girls, aged 9-15 years, were randomized to receive HPV

  18. Benchmarking of surgical complications in gynaecological oncology: prospective multicentre study.

    Science.gov (United States)

    Burnell, M; Iyer, R; Gentry-Maharaj, A; Nordin, A; Liston, R; Manchanda, R; Das, N; Gornall, R; Beardmore-Gray, A; Hillaby, K; Leeson, S; Linder, A; Lopes, A; Meechan, D; Mould, T; Nevin, J; Olaitan, A; Rufford, B; Shanbhag, S; Thackeray, A; Wood, N; Reynolds, K; Ryan, A; Menon, U

    2016-12-01

    To explore the impact of risk-adjustment on surgical complication rates (CRs) for benchmarking gynaecological oncology centres. Prospective cohort study. Ten UK accredited gynaecological oncology centres. Women undergoing major surgery on a gynaecological oncology operating list. Patient co-morbidity, surgical procedures and intra-operative (IntraOp) complications were recorded contemporaneously by surgeons for 2948 major surgical procedures. Postoperative (PostOp) complications were collected from hospitals and patients. Risk-prediction models for IntraOp and PostOp complications were created using penalised (lasso) logistic regression using over 30 potential patient/surgical risk factors. Observed and risk-adjusted IntraOp and PostOp CRs for individual hospitals were calculated. Benchmarking using colour-coded funnel plots and observed-to-expected ratios was undertaken. Overall, IntraOp CR was 4.7% (95% CI 4.0-5.6) and PostOp CR was 25.7% (95% CI 23.7-28.2). The observed CRs for all hospitals were under the upper 95% control limit for both IntraOp and PostOp funnel plots. Risk-adjustment and use of observed-to-expected ratio resulted in one hospital moving to the >95-98% CI (red) band for IntraOp CRs. Use of only hospital-reported data for PostOp CRs would have resulted in one hospital being unfairly allocated to the red band. There was little concordance between IntraOp and PostOp CRs. The funnel plots and overall IntraOp (≈5%) and PostOp (≈26%) CRs could be used for benchmarking gynaecological oncology centres. Hospital benchmarking using risk-adjusted CRs allows fairer institutional comparison. IntraOp and PostOp CRs are best assessed separately. As hospital under-reporting is common for postoperative complications, use of patient-reported outcomes is important. Risk-adjusted benchmarking of surgical complications for ten UK gynaecological oncology centres allows fairer comparison. © 2016 Royal College of Obstetricians and Gynaecologists.

  19. Magnesium Sulphate and Dexmedetomidine used Intrathecally as Adjuvant to Bupivacaine: A Study

    Directory of Open Access Journals (Sweden)

    Zameer Farooq

    2017-08-01

    Full Text Available Background: Intrathecal adjuvants are used for prolongation of duration of subarachnoid block, and provide adequate analgesia. Aim: To evaluate the onset of sensory and motor block, level of sensory block, highest sensory level and Bromage grade at time of onset, induced by Dexmedetomidine and Magnesium sulphate when given intrathecally with 0.5% hyperbaric Bupivacaine for spinal anaesthesia. Materials and methods: 90 patients, of ASA grade I and grade II, age 18-65 years, of either gender, height 150 cm and above and weight 50 kg to 80 kg, scheduled for lower abdominal and lower limb surgery under spinal anaesthesia. They were randomly assigned according to table of randomization into three groups, 30 patients in each group. Patients in Group A were given 15 mg hyperbaric Bupivacaine and 10 μg (0.1 ml Dexmedetomidine and those in Group B were given 15 mg hyperbaric Bupivacaine and 50 mg (0.1 ml magnesium sulphate. Patients in Group C were given 15 mg hyperbaric Bupivacaine and normal saline (0.1 ml as control. The onset of sensory block, motor block, level of sensory and grade of motor block were recorded at the time of onset. Results: Onset of sensory and motor block was shorter in group Dexmed as compared to other two groups, and prolonged in group magnesium as compared to other two groups. The level of sensory block was higher at the time of onset and grade of motor block was more in group Dexmed than other two groups. Conclusion: Addition of Dexmedetomidine to Bupivacaine shortens the onset time whereas addition of Magnesium delays onset.

  20. Adjuvant use of antibiotics with corticosteroids in inflammatory bowel disease exacerbations requiring hospitalisation: a retrospective cohort study and meta-analysis.

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    Gupta, V; Rodrigues, R; Nguyen, D; Sauk, J; Khalili, H; Yajnik, V; Ananthakrishnan, A N

    2016-01-01

    Patients hospitalised with an exacerbation of inflammatory bowel disease (IBD) often receive antibiotics in addition to intravenous steroids. However, their efficacy in this setting is unclear. To ascertain if the addition of antibiotics to intravenous steroids modifies short and long-term clinical outcomes. Our study included IBD patients hospitalised between 2009 and 2014 who received intravenous (IV) steroids with or without adjuvant antibiotics. Outcomes of interest included length of stay (LOS), need for medical and surgical rescue therapy during the hospitalisation, and at 90 and 365 days. A meta-analysis of previously published randomised trials was additionally performed. A total of 354 patients were included [145 ulcerative colitis (UC); 209 Crohn's disease (CD)]. In CD, combination of IV steroids and antibiotics did not change need for in-hospital medical rescue therapy, surgery or hospitalisations at 1 year but was associated with greater LOS (6.1 vs. 4.6 days, P = 0.02). In UC, patients receiving antibiotics were less likely to require in-hospital medical rescue therapy [odds ratio (OR): 0.42, 95% confidence interval (CI): 0.19-0.93] but experienced no statistically significant differences in LOS, in-hospital surgery, re-hospitalisations or surgery by 1 year. A meta-analysis of three relevant randomised trials demonstrated no difference in clinical improvement with antibiotics over placebo (OR: 1.08, 95% CI: 0.50-2.32). The addition of antibiotics to intravenous steroids for treatment of IBD exacerbations was associated with a reduced need for in-hospital medical rescue therapy in ulcerative colitis without significant long-term benefit, and did not affect short- or long-term outcomes in Crohn's disease. © 2015 John Wiley & Sons Ltd.

  1. NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project-1 Results: Decision Making in Breast Cancer Risk Reduction.

    Science.gov (United States)

    Holmberg, Christine; Bandos, Hanna; Fagerlin, Angela; Bevers, Therese B; Battaglia, Tracy A; Wickerham, D Lawrence; McCaskill-Stevens, Worta J

    2017-11-01

    Selective estrogen receptor modulators (SERMs) reduce breast cancer risk. Adoption of SERMs as prevention medication remains low. This is the first study to quantify social, cultural, and psychologic factors driving decision making regarding SERM use in women counseled on breast cancer prevention options. A survey study was conducted with women counseled by a health care provider (HCP) about SERMs. A statistical comparison of responses was performed between those who decided to use and those who decided not to use SERMs. Independent factors associated with the decision were determined using logistic regression. Of 1,023 participants, 726 made a decision: 324 (44.6%) decided to take a SERM and 402 (55.4%) decided not to. The most important factor for deciding on SERM use was the HCP recommendation. Other characteristics associated with the decision included attitudes and perceptions regarding medication intake, breast cancer worry, trust in HCP, family members with blood clots, and others' experiences with SERMs. The odds of SERM intake when HCP recommended were higher for participants with a positive attitude toward taking medications than for those with a negative attitude ( P interaction = 0.01). This study highlights the importance of social and cultural aspects for SERM decision making, most importantly personal beliefs and experiences. HCPs' recommendations play a statistically significant role in decision making and are more likely to be followed if in line with patients' attitudes. Results indicate the need for developing interventions for HCPs that not only focus on the presentation of medical information but, equally as important, on addressing patients' beliefs and experiences. Cancer Prev Res; 10(11); 625-34. ©2017 AACR See related editorial by Crew, p. 609 . ©2017 American Association for Cancer Research.

  2. Adjuvant chemotherapy and cancer cure

    International Nuclear Information System (INIS)

    Bertino, J.R.

    1983-01-01

    The use of chemotherapy as an adjuvant to surgery and/or radiotherapy is well founded in experimental tumor systems and appears to be effective in patients in some circumstances. It is clear from both clinical and experimental studies that (1) the dose is important, (2) the earlier chemotherapy is started after primary therapy the better, and (3) combination chemotherapy may be more effective than single-agent treatment. The better the estimation of risk of recurrence, the better the assessment of the risk-benefit ratio with adjuvant therapy. Salvage therapy as well as relative risk of recurrence are considerations in the choice of patients to be treated. Finally, some evidence is presented to indicate that alkylating agents may not be necessary in combination regimens for adjuvant therapy if effective antimetabolite combinations are available

  3. A retrospective study of surgically excised phaeochromocytomas in Newfoundland, Canada

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    Joanna Holland

    2014-01-01

    Full Text Available Objective: A retrospective study detailing the circumstances surrounding diagnosis and treatment of pheochromocytomas with the associated genetic disorders. Materials and Methods: All patients with surgically excised pheochromocytomas in the Health Sciences Center, St. John′s, Newfoundland, Canada between January 2001 and December 2010 were retrospectively analyzed to determine associated familial syndromes, age, tumor size, symptomatology, and percentage of paragangliomas and bilateral pheochromocytomas. Pathology specimen reports, adrenalectomy lists and Meditech (electronic medical record diagnostic codes provided a comprehensive database for this study. Results: Twenty-four patients were studied; familial disorder patients comprised 42% (10/24. Average age at diagnosis was 57 among the sporadic and 34 in familial disorder groups (P = 0.006. Average tumor size was 4.5 cm in the sporadic group and 3 cm in the familial disorder group (P = 0.19. All atypical cases including bilateral or extra-adrenal tumors and malignancy occurred in familial disorder patients. Conclusions: The proportion of familial disorder patients (42% was higher in this study than would be expected, likely a result of the relatively high incidence of hereditary autosomal dominant disorders within Newfoundland. Among familial disorder patients, the average younger age at diagnosis and the smaller tumor size suggest syndromic pheochromocytomas may develop earlier, however they are more likely to be diagnosed sooner due to biochemical surveillance testing in known genetic disorder patients. We also demonstrate a relatively high incidence of surgically resected pheochromocytomas of 4.679/million/year in Newfoundland.

  4. Postoperative adjuvant chemotherapy in rectal cancer operated for cure.

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    Petersen, Sune Høirup; Harling, Henrik; Kirkeby, Lene Tschemerinsky; Wille-Jørgensen, Peer; Mocellin, Simone

    2012-03-14

    Colorectal cancer is one of the most common types of cancer in the Western world. Apart from surgery - which remains the mainstay of treatment for resectable primary tumours - postoperative (i.e., adjuvant) chemotherapy with 5-fluorouracil (5-FU) based regimens is now the standard treatment in Dukes' C (TNM stage III) colon tumours i.e. tumours with metastases in the regional lymph nodes but no distant metastases. In contrast, the evidence for recommendations of adjuvant therapy in rectal cancer is sparse. In Europe it is generally acknowledged that locally advanced rectal tumours receive preoperative (i.e., neoadjuvant) downstaging by radiotherapy (or chemoradiotion), whereas in the US postoperative chemoradiotion is considered the treatment of choice in all Dukes' C rectal cancers. Overall, no universal consensus exists on the adjuvant treatment of surgically resectable rectal carcinoma; moreover, no formal systematic review and meta-analysis has been so far performed on this subject. We undertook a systematic review of the scientific literature from 1975 until March 2011 in order to quantitatively summarize the available evidence regarding the impact of postoperative adjuvant chemotherapy on the survival of patients with surgically resectable rectal cancer. The outcomes of interest were overall survival (OS) and disease-free survival (DFS). CCCG standard search strategy in defined databases with the following supplementary search. 1. Rect* or colorect* - 2. Cancer or carcinom* or adenocarc* or neoplasm* or tumour - 3. Adjuv* - 4. Chemother* - 5. Postoper* Randomised controlled trials (RCT) comparing patients undergoing surgery for rectal cancer who received no adjuvant chemotherapy with those receiving any postoperative chemotherapy regimen. Two authors extracted data and a third author performed an independent search for verification. The main outcome measure was the hazard ratio (HR) between the risk of event between the treatment arm (adjuvant chemotherapy

  5. Chemokines as Cancer Vaccine Adjuvants

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    Agne Petrosiute

    2013-10-01

    Full Text Available We are witnessing a new era of immune-mediated cancer therapies and vaccine development. As the field of cancer vaccines advances into clinical trials, overcoming low immunogenicity is a limiting step in achieving full success of this therapeutic approach. Recent discoveries in the many biological roles of chemokines in tumor immunology allow their exploitation in enhancing recruitment of antigen presenting cells (APCs and effector cells to appropriate anatomical sites. This knowledge, combined with advances in gene therapy and virology, allows researchers to employ chemokines as potential vaccine adjuvants. This review will focus on recent murine and human studies that use chemokines as therapeutic anti-cancer vaccine adjuvants.

  6. Physical exercise during adjuvant chemotherapy

    NARCIS (Netherlands)

    van Waart, H.

    2017-01-01

    This thesis evaluates the effect of physical exercise during chemotherapy. In chapter two the study design, rationale and methods of the Physical exercise during Adjuvant Chemotherapy Study (PACES) are described. Chapter three presents the effects of the randomized controlled trial evaluating a

  7. Preliminary results of capecitabine metronomic chemotherapy in operable triple-negative breast cancer after standard adjuvant therapy - A singlearm phase II study

    International Nuclear Information System (INIS)

    Shawky, H.; Galal, S.

    2014-01-01

    Purpose: The aim of this study is to investigate efficacy and toxicity of 1 year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy in triple-negative breast cancer (TNBC) patients. Methods: Between June 2010 and February 2012, 19 women with pathologically proven operable TNBC, who had received standard adjuvant chemotherapy before were enrolled. Patients received 1 year of oral capecitabine metronomic therapy (650 mg/m2, twice every day), after standard adjuvant chemotherapy and radiotherapy if indicated. The primary endpoints of this study were disease-free survival rates (DFS) and safety profile. Secondary end point was overall survival (OS). Results: The maximal follow-up was 46.6 months with a median of 30.1 months ±11.525 (95% CI; 28.5-33.5 months). The median DFS was 41.7 months ±2.7 (95% CI; 36.5-46.9). No one developed locoregional recurrence. The actuarial rate of DFS was 88.8% and 82.05% at 2 and 3 years, respectively. At the time of the analyses, no patients had died and the median OS was not reached. Treatment-related adverse events were manageable with only 1 patient (5.3%) suffering from Grade 3/4 hand-foot syndrome and another 1 patient (5.3%) suffering from Grade 3 diarrhea. No Grade 3/4 hematologic toxicity was recorded. All patients received full doses of capecitabine throughout the study and dose reduction was not required in any of our patients. Conclusion: One year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in TNBC patients previously treated with standard adjuvant chemotherapy.

  8. Preliminary results of capecitabine metronomic chemotherapy in operable triple-negative breast cancer after standard adjuvant therapy--a single-arm phase II study.

    Science.gov (United States)

    Shawky, Hanan; Galal, Samar

    2014-12-01

    The aim of this study is to investigate efficacy and toxicity of 1 year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy in triple-negative breast cancer (TNBC) patients. Between June 2010 and February 2012, 19 women with pathologically proven operable TNBC, who had received standard adjuvant chemotherapy before were enrolled. Patients received 1 year of oral capecitabine metronomic therapy (650 mg/m2, twice every day), after standard adjuvant chemotherapy and radiotherapy if indicated. The primary endpoints of this study were disease-free survival rates (DFS) and safety profile. Secondary end point was overall survival (OS). The maximal follow-up was 46.6 months with a median of 30.1 months±11.525 (95% CI; 28.5-33.5 months). The median DFS was 41.7 months±2.7 (95% CI; 36.5-46.9). No one developed locoregional recurrence. The actuarial rate of DFS was 88.8% and 82.05% at 2 and 3 years, respectively. At the time of the analyses, no patients had died and the median OS was not reached. Treatment-related adverse events were manageable with only 1 patient (5.3%) suffering from Grade 3/4 hand-foot syndrome and another 1 patient (5.3%) suffering from Grade 3 diarrhea. No Grade 3/4 hematologic toxicity was recorded. All patients received full doses of capecitabine throughout the study and dose reduction was not required in any of our patients. One year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in TNBC patients previously treated with standard adjuvant chemotherapy. Copyright © 2014. Production and hosting by Elsevier B.V.

  9. Team play in surgical education: a simulation-based study.

    Science.gov (United States)

    Marr, Mollie; Hemmert, Keith; Nguyen, Andrew H; Combs, Ronnie; Annamalai, Alagappan; Miller, George; Pachter, H Leon; Turner, James; Rifkind, Kenneth; Cohen, Steven M

    2012-01-01

    Simulation-based training provides a low-stress learning environment where real-life emergencies can be practiced. Simulation can improve surgical education and patient care in crisis situations through a team approach emphasizing interpersonal and communication skills. This study assessed the effects of simulation-based training in the context of trauma resuscitation in teams of trainees. In a New York State-certified level I trauma center, trauma alerts were assessed by a standardized video review process. Simulation training was provided in various trauma situations followed by a debriefing period. The outcomes measured included the number of healthcare workers involved in the resuscitation, the percentage of healthcare workers in role position, time to intubation, time to intubation from paralysis, time to obtain first imaging study, time to leave trauma bay for computed tomography scan or the operating room, presence of team leader, and presence of spinal stabilization. Thirty cases were video analyzed presimulation and postsimulation training. The two data sets were compared via a 1-sided t test for significance (p role positions increased from 57.8% to 83.6% (p = 0.46). The time to intubation from paralysis decreased from 3.9 to 2.8 minutes (p team leader increased from 64% to 90% (p team interaction and educational competencies. Providing simulation training as a tool for surgical education may enhance patient care. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  10. Study of breast implant rupture: MRI versus surgical findings.

    Science.gov (United States)

    Vestito, A; Mangieri, F F; Ancona, A; Minervini, C; Perchinunno, V; Rinaldi, S

    2012-09-01

    This study evaluated the role of breast magnetic resonance (MR) imaging in the selective study breast implant integrity. We retrospectively analysed the signs of breast implant rupture observed at breast MR examinations of 157 implants and determined the sensitivity and specificity of the technique in diagnosing implant rupture by comparing MR data with findings at surgical explantation. The linguine and the salad-oil signs were statistically the most significant signs for diagnosing intracapsular rupture; the presence of siliconomas/seromas outside the capsule and/or in the axillary lymph nodes calls for immediate explantation. In agreement with previous reports, we found a close correlation between imaging signs and findings at explantation. Breast MR imaging can be considered the gold standard in the study of breast implants.

  11. Breast sarcoma surgical management: a five-year multicentric study

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    Răzvan V. Scăunașu

    2016-11-01

    Full Text Available Background. Breast sarcomas are a heterogeneous group of breast neoplasms with a low incidence and a reserved prognosis. No treatment protocol has been yet established, a guideline similar to soft tissue sarcomas is used. Materials and Methods. Our study analyzed all the patients admitted with the diagnosis of malignant breast disease in two specialized centers on a five-year time frame. We compared long term results for the patients who underwent conservative treatment and mastectomy. Results. A total of 76 cases received surgical treatment with curative intent, 24 conservative procedures and 52 mastectomies. Incidence of local recurrence does not appear to be closely related to the type of surgical procedure. There were a number of five local recurrences for patients who received conservative treatment and 7 local recurrences where we used mastectomy. Kaplan-Meier analysis conducted shows no differences statistically significant (sig = 0.459 between the results of conservative treatment and mastectomy. Basically conservative surgery seems to get similar results, provided that R0 resection objective can be met. Conclusions. Treatment options are more limited for breast sarcomas than carcinomas, the role of surgery being more important to therapeutic success. The biological characteristic of the tumor including histological type and sub-type, play an important role in determining the results and the treatment should be tailored and adapted for each case.

  12. Intrathecal dexmedetomidine as adjuvant for spinal anaesthesia for perianal ambulatory surgeries: A randomised double-blind controlled study

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    S S Nethra

    2015-01-01

    Full Text Available Background and Aim: The newer trend in regional anaesthesia for ambulatory anorectal surgeries advocate use of lower dose of local anaesthetic, providing segmental block with adjuvants such as opioids and α2 agonists to prolong analgesia. The current study investigated effects of addition of 5 μg of dexmedetomidine to 6 mg of hyperbaric bupivacaine on duration of analgesia, sensory and motor block characteristics for perianal ambulatory surgeries. Methods: This study is a prospective randomised controlled double blind study. Forty adult patients between 18 and 55 years of age were divided into 2 groups. Group D received intrathecal 0.5% hyperbaric bupivacaine 6 mg (1.2 ml with injection dexmedetomidine 5 μg in 0.5 ml of normal saline and Group N received intrathecal 0.5% hyperbaric bupivacaine 6 mg (1.2 ml with 0.5 ml of normal saline. The parameters assessed were time to regression of sensory blockade, motor blockade, ambulation, time to void, first administration of analgesic. Statistical analysis was done using appropriate tests. Results: Time for regression of sensory level and time for first administration of analgesic were prolonged in Group D (430.05 ± 89.13 min, 459.8 ± 100.9 min, respectively in comparison to Group N (301.10 ± 94.86 min, 321.85 ± 95.08 min, respectively. However, the duration of motor blockade, time to ambulation, and time to void were also significantly prolonged in Group D (323.05 ± 54.58 min, 329.55 ± 54.06 min, 422.30 ± 87.59 min than in Group N (220.10 ± 63.61 min, 221.60 ± 63.84 min, 328.45 ± 113.38 min. Conclusion: Intrathecal dexmedetomidine 5 μg added to intrathecal bupivacaine 6 mg as adjuvant may not be suitable for ambulatory perianal surgeries due to prolongation of motor blockade.

  13. Quantifying surgical access in eyebrow craniotomy with and without orbital bar removal: cadaver and surgical phantom studies.

    Science.gov (United States)

    Zador, Zsolt; Coope, David J; Gnanalingham, Kanna; Lawton, Michael T

    2014-04-01

    Eyebrow craniotomy is a recently described minimally invasive approach for tackling primarily pathology of the anterior skull base. The removal of the orbital bar may further expand the surgical corridor of this exposure, but the extent of benefit is poorly quantified. We assessed the effect of orbital bar removal with regards to surgical access in the eyebrow craniotomy using classic morphometric measurements in cadaver heads. Using surgical phantoms and neuronavigation, we also measured the 'working volume', a new parameter for characterising the volume of surgical access in these approaches. Silicon injected cadaver heads (n = 5) were used for morphometric analysis of the eyebrow craniotomy with and without orbital bar removal. Working depths and 'working areas' of surgical access were measured as defined by key anatomical landmarks. The eyebrow craniotomy with or without orbital bar removal was also simulated using surgical phantoms (n = 3, 90-120 points per trial), calibrated against a frameless neuronavigation system. Working volume was derived from reference coordinates recorded along the anatomical borders of the eyebrow craniotomy using the "α-shape algorithm" in R statistics. In cadaver heads, eyebrow craniotomy with removal of the orbital bar reduced the working depth to the ipsilateral anterior clinoid process (42 ± 2 versus 33 ± 3 mm; p < 0.05), but the working areas as defined by deep neurovascular and bony landmarks was statistically unchanged (total working areas of 418 ± 80 cm(2) versus 334 ± 48 cm(2); p = 0.4). In surgical phantom studies, however, working-volume for the simulated eyebrow craniotomies was increased with orbital bar removal (16 ± 1 cm(3) versus 21 ± 1 cm(3); p < 0.01). In laboratory studies, orbital bar removal in eyebrow craniotomy provides a modest reduction in working depth and increase in the working volume. But this must be weighed up against the added morbidity of the

  14. Adjuvant whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer (OVAR-IMRT-01) – Pilot trial of a phase I/II study: study protocol

    International Nuclear Information System (INIS)

    Rochet, Nathalie; Jensen, Alexandra D; Sterzing, Florian; Munter, Marc W; Eichbaum, Michael H; Schneeweiss, Andreas; Sohn, Christof; Debus, Juergen; Harms, Wolfgang

    2007-01-01

    The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy given its ability to sterilize small tumour volumes. Despite the clinically proven efficacy of whole abdominal irradiation, the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose. The OVAR-IMRT-01 study is a single center pilot trial of a phase I/II study. Patients with advanced ovarian cancer stage FIGO III (R1 or R2< 1 cm) after surgical resection and platinum-based chemotherapy will be treated with whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions. A total of 8 patients will be included in this trial. For treatment planning bone marrow, kidneys, liver, spinal cord, vertebral bodies and pelvic bones are defined as organs at risk. The planning target volume includes the entire peritoneal cavity plus pelvic and para-aortic node regions. The primary endpoint of the study is the evaluation of the feasibility of intensity-modulated WAI and the evaluation of the study protocol. Secondary endpoint is evaluation of the toxicity of intensity modulated WAI before continuing with the phase I/II study. The aim is to explore the potential of IMRT as a new method for WAI to decrease the dose to kidneys, liver, bone marrow while covering the peritoneal cavity with a homogenous dose, and to implement whole abdominal intensity-modulated radiotherapy into the adjuvant multimodal

  15. Role of chemoradiotherapy in oesophageal cancer -- adjuvant and neoadjuvant therapy

    NARCIS (Netherlands)

    Gwynne, S.; Wijnhoven, B. P. L.; Hulshof, M.; Bateman, A.

    2014-01-01

    Despite low postoperative mortality rates, the long-term outcomes from surgical-based treatment for oesophageal cancer remain poor. Chemoradiotherapy (CRT), either given before surgical resection as neoadjuvant therapy or after resection as adjuvant therapy, has been postulated to improve these

  16. Efficacy of aloe vera gel as an adjuvant treatment of oral submucous fibrosis.

    Science.gov (United States)

    Alam, Sarwar; Ali, Iqbal; Giri, K Y; Gokkulakrishnan, S; Natu, Subodh S; Faisal, Mohammad; Agarwal, Anshita; Sharma, Himanshu

    2013-12-01

    Definitive therapy is not defined for the management of oral submucous fibrosis (OSMF). This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF. A double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment (submucosal injection of hyaluronidase and dexamethasone, n = 30) and surgical treatment (n = 30) categories. Each category was randomly divided into groups A (with aloe vera, n = 15 per category) and B (without aloe vera, n = 15 per category). Follow-up assessment for various symptoms was performed, and results were analyzed using paired and unpaired Student t tests. The group receiving aloe vera had a significant improvement in most symptoms of OSMF (P aloe vera group, in both the medicinal and surgical categories. Aloe vera gel was effective as an adjuvant in treatment of OSMF. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Survival data for postoperative adjuvant chemotherapy comprising cisplatin plus vinorelbine after complete resection of non-small cell lung cancer.

    Science.gov (United States)

    Kenmotsu, Hirotsugu; Ohde, Yasuhisa; Wakuda, Kazushige; Nakashima, Kazuhisa; Omori, Shota; Ono, Akira; Naito, Tateaki; Murakami, Haruyasu; Kojima, Hideaki; Takahashi, Shoji; Isaka, Mitsuhiro; Endo, Masahiro; Takahashi, Toshiaki

    2017-09-01

    Despite the efficacy of postoperative adjuvant cisplatin (CDDP)-based chemotherapy for patients who have undergone surgical resection of non-small cell lung cancer (NSCLC), few reports have presented survival data for Asian patients treated with adjuvant chemotherapy involving a combination of CDDP and vinorelbine (VNR). This study was performed to evaluate the survival of patients with NSCLC who received postoperative adjuvant chemotherapy comprising CDDP + VNR. We retrospectively evaluated patients with NSCLC who received adjuvant chemotherapy comprising CDDP + VNR at the Shizuoka Cancer Center between February 2006 and October 2011. One hundred patients who underwent surgical resection of NSCLC were included in this study. The patients' characteristics were as follows: median age 63 years (range 36-74 years), female 34%, never-smokers 20%, and non-squamous NSCLC 73%. Pathological stages IIA, IIB, and IIIA were observed in 31, 22, and 47% of patients, respectively. The 5- and 2-year overall survival rates were 73 and 93%, respectively. The 5- and 2-year relapse-free survival rates were 53 and 62%, respectively. Univariate analysis of prognostic factors showed that patient characteristics (sex, histology, and pathological stage) and CDDP dose intensity were not significantly associated with survival. In 48 patients who developed NSCLC recurrence, the 5-year survival rate after recurrence was 29%, and the median survival time after recurrence was 37 months. Our results suggest that the prognosis after surgical resection of NSCLC and adjuvant chemotherapy comprising CDDP + VNR might be improving compared with previous survival data of adjuvant chemotherapy for NSCLC.

  18. Leptin, insulin and body composition changes during adjuvant taxane based chemotherapy in patients with breast cancer, preliminary study.

    Science.gov (United States)

    Alacacioglu, A; Kebapcilar, L; Gokgoz, Z; Oztekin, O; Bozkaya, G; Tarhan, O; Somali, I; Yuksel, A; Sop, G; Sari, I

    2016-01-01

    The objectives of the present study were to compare the effect of adjuvant chemotherapy for breast cancer on serum insulin levels, serum leptin levels, and body composition in early stage breast cancer patients. 17 breast cancer patients underwent 6 cycles of docetaxel (75 mg), epirubicine (100 mg) and cyclophosphamide (500 mg) (TEC). Anthropometrical and foot-to-foot body fat analyzer BIA, serum glucose, insulin, lipids, HOMA-IR and leptin were compared pre- and post-treatment. There was no statistically significant weight gain after treatment; however, there was an overall trend toward weight gain (69.7 ± 9.8 kg vs 71.03 ± 9.8; P= 0.05). From baseline to the end of the study, percentage of body fat and body fat mass showed an upward trend at the end of chemotherapy (1%; 2 kg P> 0.05). Pre and post-treatment period, leptin was strongly correlated with insulin and HOMA-IR (Spearman's pre-T; r = 0.74; P cancer outcome, and insulin resistance may be increased in taxane based chemotherapy regimen. These data may have broad implications for diet and lifestyle strategies for the prevention and treatment of cancers.

  19. Relationship between tumor gene expression and recurrence in four independent studies of patients with stage II/III colon cancer treated with surgery alone or surgery plus adjuvant fluorouracil plus leucovorin.

    Science.gov (United States)

    O'Connell, Michael J; Lavery, Ian; Yothers, Greg; Paik, Soonmyung; Clark-Langone, Kim M; Lopatin, Margarita; Watson, Drew; Baehner, Frederick L; Shak, Steven; Baker, Joffre; Cowens, J Wayne; Wolmark, Norman

    2010-09-01

    These studies were conducted to determine the relationship between quantitative tumor gene expression and risk of cancer recurrence in patients with stage II or III colon cancer treated with surgery alone or surgery plus fluorouracil (FU) and leucovorin (LV) to develop multigene algorithms to quantify the risk of recurrence as well as the likelihood of differential treatment benefit of FU/LV adjuvant chemotherapy for individual patients. We performed quantitative reverse transcription polymerase chain reaction (RT-qPCR) on RNA extracted from fixed, paraffin-embedded (FPE) tumor blocks from patients with stage II or III colon cancer who were treated with surgery alone (n = 270 from National Surgical Adjuvant Breast and Bowel Project [NSABP] C-01/C-02 and n = 765 from Cleveland Clinic [CC]) or surgery plus FU/LV (n = 308 from NSABP C-04 and n = 508 from NSABP C-06). Overall, 761 candidate genes were studied in C-01/C-02 and C-04, and a subset of 375 genes was studied in CC/C-06. A combined analysis of the four studies identified 48 genes significantly associated with risk of recurrence and 66 genes significantly associated with FU/LV benefit (with four genes in common). Seven recurrence-risk genes, six FU/LV-benefit genes, and five reference genes were selected, and algorithms were developed to identify groups of patients with low, intermediate, and high likelihood of recurrence and benefit from FU/LV. RT-qPCR of FPE colon cancer tissue applied to four large independent populations has been used to develop multigene algorithms for estimating recurrence risk and benefit from FU/LV. These algorithms are being independently validated, and their clinical utility is being evaluated in the Quick and Simple and Reliable (QUASAR) study.

  20. Value of sentinel lymph node biopsy and adjuvant interferon treatment in thick (>4 mm) cutaneous melanoma: an observational study.

    Science.gov (United States)

    Morera-Sendra, Natalia; Tejera-Vaquerizo, Antonio; Traves, Víctor; Requena, Celia; Bolumar, Isidro; Pla, Angel; Vázquez, Carlos; Soriano, Virtudes; Nagore, Eduardo

    2016-01-01

    The role of sentinel lymph node biopsy and the benefit of immunotherapy with interferon in thick (>4 mm) melanomas remain uncertain. Our aim was to assess the value of both sentinel lymph node (SLN) biopsy and immunotherapy in the prognosis of thick melanomas. A retrospective study based on a computerized patient database in which patients have been prospectively collected since 2005 was performed. Age, sex, location, Breslow thickness, tumor ulceration, regression, Clark level, tumor infiltrating lymphocytes, tumor mitotic rate, microscopic satellite and vascular invasion were included in the analysis. Disease-free (DFS), disease-specific (DSS) and overall (OS) survivals were evaluated by the Kaplan-Meier method and Cox regression analysis. A series of 141 patients with melanomas thicker than 4 mm were included. Multivariate regression showed a worse prognosis in SLN-positive patients with respect to SLN biopsy-negative patients (DFS, hazard ratio [HR] 2, p = 0.04; DSS, HR 2.2, p = 0.002; OS, HR 2.4, p = 0.02). The observational group was shown to have a worse prognosis than the SLN-positive group but was very similar to the clinically positive group. Immunotherapy with high-dose interferon showed a protective effect (DFS, HR 0.5, p = 0.02; DSS, HR 0.3, p = 0.001; OS, HR 0.3, p = 0.001). Our data indicate that SLN biopsy and adjuvant interferon should be considered for patients with thick melanomas.

  1. Pak1, adjuvant tamoxifen therapy, and breast cancer recurrence risk in a Danish population-based study

    DEFF Research Database (Denmark)

    Ahern, Thomas P; Cronin-Fenton, Deirdre P; Lash, Timothy L

    2016-01-01

    -/TAM - group. Pak1 cytoplasmic intensity was not associated with breast cancer recurrence in either group (ER+/TAM + ORadj for strong vs. no cytoplasmic staining = 0.91, 95% CI 0.57, 1.5; ER-/TAM - ORadj for strong vs. no cytoplasmic staining = 0.74, 95% CI 0.39, 1.4). Associations between Pak1 nuclear......Background Adjuvant tamoxifen therapy approximately halves the risk of estrogen receptor-positive (ER+) breast cancer recurrence, but many women do not respond to therapy. Observational studies nested in clinical trial populations suggest that overexpression or nuclear localization of p21-activated...... by immunohistochemical staining of primary breast tumors from recurrence cases and matched controls from two breast cancer populations; women diagnosed with ER-positive tumors who received at least one year of tamoxifen therapy (ER+/TAM+), and women diagnosed with ER-negative tumors who survived for at least one year...

  2. Better compliance with hypofractionation vs. conventional fractionation in adjuvant breast cancer radiotherapy. Results of a single, institutional, retrospective study

    International Nuclear Information System (INIS)

    Rudat, Volker; Nour, Alaa; Hammoud, Mohamed; Abou Ghaida, Salam

    2017-01-01

    The aim of the study was to identify factors significantly associated with the occurrence of unintended treatment interruptions in adjuvant breast cancer radiotherapy. Patients treated with postoperative radiotherapy of the breast or chest wall between March 2014 and August 2016 were evaluated. The radiotherapy regimens and techniques applied were either conventional fractionation (CF; 28 daily fractions of 1.8 Gy or 25 fractions of 2.0 Gy) or hypofractionation (HF; 15 daily fractions of 2.67 Gy) with inverse planned intensity-modulated radiotherapy (IMRT) or three-dimensional planned conformal radiotherapy (3DCRT). Logistic regression analysis was used to identify factors associated with noncompliance. Noncompliance was defined as the missing of at least one scheduled radiotherapy fraction. In all, 19 of 140 (13.6%) patients treated with HF and 39 of 146 (26.7%) treated with CF experienced treatment interruptions. Of 23 factors tested, the fractionation regimen emerged as the only independent significant prognostic factor for noncompliance on multivariate analysis (CF; p = 0.007; odds ratio, 2.3; 95% confidence interval, 1.3-4.2). No statistically significant differences concerning the reasons for treatment interruptions could be detected between patients treated with CF or HF. HF is significantly associated with a better patient compliance with the prescribed radiotherapy schedule compared with CF. The data suggest that this finding is basically related to the shorter overall treatment time of HF. (orig.) [de

  3. Adjuvant potential of virgin coconut oil extract on antiretroviral therapy-induced testicular toxicity: An ultrastructural study.

    Science.gov (United States)

    Ogedengbe, O O; Jegede, A I; Onanuga, I O; Offor, U; Peter, A I; Akang, E N; Naidu, E C S; Azu, O O

    2018-04-01

    The effects of Virgin coconut oil as an adjuvant to highly active antiretroviral therapy (HAART) were investigated on the testicular ultrastructure and biochemical markers in rats. Twenty male Sprague-Dawley rats, weighing 153-169 g were divided into four groups and treated as follows: control A (distilled water), B (HAART), C (HAART+Virgin coconut oil 10 ml/kg) and D (Virgin coconut oil [VCO] 10 ml/kg). Testicular segments were evaluated using transmission electron microscopy. Serum was assayed for testosterone, luteinising hormone, follicle stimulating hormone and testicular tissue for malondialdehyde and glutathione. Ultrastructure of basement membrane (Bm), mitochondria and spermatocytes was normal in the control group. HAART-treated group showed significant increase (p group. Mitochondrial cristae appear collapsed, and Sertoli cells showed cytoplasmic vacuolations. HAART+VCO group showed improved ultrastructural details in Bm, and Sertoli cell and Leydig cells show abundant lipid droplets. Virgin coconut oil-treated group showed thinning of Bm with otherwise normal ultrastructural features of organelles. HAART-treated group showed significant increase (p Virgin coconut oil improved testicular morphology and reversed HAART-induced ultrastructural alterations. Further studies on putative mechanism are required. © 2017 Blackwell Verlag GmbH.

  4. The benefit of a sentinel lymph node biopsy and adjuvant therapy in thick (>4 mm) melanoma: multicenter, retrospective study of 291 Japanese patients.

    Science.gov (United States)

    Fujisawa, Yasuhiro; Otsuka, Fujio

    2012-10-01

    The benefit of a sentinel lymph node (SLN) biopsy and adjuvant therapy for patients with thick (>4 mm) melanoma has not been well studied in the Asian population. We examined the benefit of an SLN biopsy and adjuvant therapy on prognosis in Japanese patients with thick melanoma. A review of the melanoma database collected from 26 institutions in Japan identified 291 patients with thick melanoma between 2005 and 2010. Univariate and multivariate analyses were performed to evaluate the factors predictive of the overall survival (OS) and the disease-free survival (DFS). Of the 242 patients with thick melanoma who underwent an SLN biopsy, the results for 96 (40%) were positive. On multivariate analysis, increased Breslow thickness (relative risk, 1.11; 95% confidence interval, 1.05-1.17; P=0.0002) and SLN metastasis (2.14; 1.04-4.43; P=0.040) were associated with a poor OS. Increased Breslow thickness (1.11; 1.04-1.18; P =0.0018), ulceration (3.11; 1.25-7.72; P=0.014), satellitosis (3.89; 1.62-9.31; P=0.0023), and SLN metastasis (2.24; 1.16-4.36; P=0.017) were associated with DFS. Adjuvant chemotherapy had no impact on either OS or DFS. Adjuvant use of a monthly dermal injection of interferon-β (IFN-β) was associated with a improvement in both OS (0.34; 0.17-0.67; P=0.0022) and DFS (0.42; 0.20-0.86; P=0.018). An SLN biopsy provided useful prognostic information and the adjuvant use of IFN-β improved both OS and DFS in Japanese patients with thick melanoma. These results were consistent with those of previous studies carried out on a white population. Therefore, we suggest that an SLN biopsy and adjuvant IFN should be considered for patients with thick melanoma irrespective of the Breslow thickness or ethnicity.

  5. Adjuvant Ab Interno Tumor Treatment After Proton Beam Irradiation.

    Science.gov (United States)

    Seibel, Ira; Riechardt, Aline I; Heufelder, Jens; Cordini, Dino; Joussen, Antonia M

    2017-06-01

    This study was performed to show long-term outcomes concerning globe preservation in uveal melanoma patients after proton beam therapy with the main focus on outcomes according to different adjuvant ab interno surgical procedures. Retrospective cohort study. All patients treated with primary proton beam therapy for choroidal or ciliary body melanoma between June 1998 and June 2015 were included. A total of 2499 patients underwent primary proton beam therapy, with local tumor control and globe preservation rates of 95.9% and 94.8% after 5 years, respectively. A total of 110 (4.4%) patients required secondary enucleation. Unresponsive neovascular glaucoma was the leading cause of secondary enucleation in 78 of the 2499 patients (3.1%). The 5-year enucleation-free survival rate was 94.8% in the endoresection group, 94.3% in the endodrainage group, and 93.5% in the comparator group. The log-rank test showed P = .014 (comparator group vs endoresection group) and P = .06 (comparator group vs endodrainage-vitrectomy group). Patients treated with endoresection or endodrainage-vitrectomy developed less radiation retinopathy (30.5% and 37.4% after 5 years, P = .001 and P = .048 [Kaplan-Meier], respectively) and less neovascular glaucoma (11.6% and 21.3% after 5 years, P = .001 and P = .01 [Kaplan-Meier], respectively) compared with the comparator group (52.3% radiation retinopathy and 57.8% neovascular glaucoma after 5 years). This study suggests that in larger tumors the enucleation and neovascular glaucoma rates might be reduced by adjuvant surgical procedures. Although endoresection is the most promising adjuvant treatment option, the endodrainage-vitrectomy is recommended in patients who are ineligible for endoresection. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Adjuvant chemotherapy for gastric cancer: Current evidence and future challenges

    OpenAIRE

    Miceli, Rosalba; Tomasello, Gianluca; Bregni, Giacomo; Di Bartolomeo, Maria; Pietrantonio, Filippo

    2014-01-01

    Gastric cancer still represents one of the major causes of cancer mortality worldwide. Patients survival is mainly related to stage, with a high proportion of patients with metastatic disease at presentation. Thus, the cure rate largely depend upon surgical resection. Despite the additional, albeit small, benefit of adjuvant chemotherapy has been clearly demonstrated, no general consensus has been reached on the best treatment option. Moreover, the narrow therapeutic index of adjuvant chemoth...

  7. A novel rabies vaccine based-on toll-like receptor 3 (TLR3) agonist PIKA adjuvant exhibiting excellent safety and efficacy in animal studies

    International Nuclear Information System (INIS)

    Zhang, Yi; Zhang, Shoufeng; Li, Wei; Hu, Yuchi; Zhao, Jinyan; Liu, Fang; Lin, Haixiang; Liu, Yuan; Wang, Liliang; Xu, Shu; Hu, Rongliang; Shao, Hui; Li, Lietao

    2016-01-01

    Vaccination alone is not sufficiently effective to protect human from post-exposure rabies virus infection due to delayed generation of rabies virus neutralizing antibodies and weak cellular immunity. Therefore, it is vital to develop safer and more efficacious vaccine against rabies. PIKA, a stabilized chemical analog of double-stranded RNA that interacts with TLR3, was employed as adjuvant of rabies vaccine. The efficacy and safety of PIKA rabies vaccine were evaluated. The results showed that PIKA rabies vaccine enhanced both humoral and cellular immunity. After viral challenge, PIKA rabies vaccine protected 70–80% of animals, while the survival rate of non-adjuvant vaccine group (control) was 20–30%. According to the results of toxicity tests, PIKA and PIKA rabies vaccine are shown to be well tolerated in mice. Thus, this study indicates that PIKA rabies vaccine is an effective and safe vaccine which has the potential to develop next-generation rabies vaccine and encourage the start of clinical studies. - Highlights: • Vaccination alone is not effective to protect human from rabies virus infection due to delayed generation of rabies virus neutralizing antibodies (RVNA) and weak cellular immunity. • Therefore, it is vital to develop safer and more efficacious vaccine against rabies. PIKA, a stabilized chemical analog of double-stranded RNA that interacts with TLR3, was employed as an adjuvant of rabies vaccine. • The efficacy and safety of PIKA rabies vaccine was evaluated in mice. • The results showed that PIKA rabies vaccine enhanced both humoral and cellular immunity. • After viral challenge, PIKA rabies vaccine protected 70–80% of animals, while the survival rate of non-adjuvant vaccine group was only 20–30%. • According to the results of toxicity tests, PIKA and PIKA rabies vaccine are shown to be well tolerated in mice. • Thus, this study indicates that PIKA rabies vaccine is an effective and safe vaccine which has the potential to

  8. POSSIBILITY OF NATURAL RAW MATERIALS USE IN THE FORMULATION OF ADJUVANT THERAPY OF TUBERCULOSIS: EXPERIENCE OF FOLK MEDICINE, MODERN STATE OF STUDIES

    Directory of Open Access Journals (Sweden)

    M. E. Kim

    2017-01-01

    Full Text Available The signs of growth in the prevalence of multidrug-resistant tuberculosis, low effectiveness of therapy indicate the urgent need to solve problems aimed at the improvement of the effectiveness of treatment: the reduction of toxicity and side effects of anti-tuberculosis drugs, the provision of good tolerability and continuity of chemotherapy; the removal of symptoms of intoxication associated with the action of the pathogen on the body, the improvement of the quality of life of patients during therapy and remission.The aim of the investigation is to study the data of folk medicine, scientific research data concerning the use of raw materials of natural (vegetable, animal and mineral origin in the adjuvant therapy of tuberculosis.Materials and methods. The study was carried out using information retrieval and library databases (PubMed, eLIBRARY, Cyberleninka, technical information of manufacturers of dietary supplements to food, as well as site materials dedicated to the use of vegetable, animal and mineral raw materials in folk medicine.Results and discussion. The adjuvant therapy of tuberculosis includes remedies of natural origin: vegetable, animal and mineral ones. According to the research data, the use of phytotherapy is aimed at enhancing diuresis, which ensures the elimination of toxic substances and their metabolites, as well as the decrease of the overall level of toxins; the strengthening of the body’s antioxidant defense, and liver specificity, the compensation for the increased consumption of vitamins, amino acids and microelements by the liver, which actively metabolizes xenobiotics, as well as the increase of the body’s overall resistance. A long-term benefit of using natural mineral raw materials in adjuvant therapy of tuberculosis is also observed.Conclusion. Thus, adjuvant therapy of tuberculosis includes the use of raw materials of natural (vegetable, animal and mineral origin, the effectiveness of which is confirmed by

  9. A novel rabies vaccine based-on toll-like receptor 3 (TLR3) agonist PIKA adjuvant exhibiting excellent safety and efficacy in animal studies

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Yi [Yisheng Biopharma. Co., Ltd., Beijing (China); Zhang, Shoufeng [Academy of Military Medical Sciences, Changchun (China); Li, Wei [National Center for Safety Evaluation of Drugs, Beijing (China); Hu, Yuchi; Zhao, Jinyan [Beijing Institute for Drug Control, Beijing (China); Liu, Fang; Lin, Haixiang; Liu, Yuan; Wang, Liliang; Xu, Shu [Yisheng Biopharma. Co., Ltd., Beijing (China); Hu, Rongliang, E-mail: ronglianghu@hotmail.com [Academy of Military Medical Sciences, Changchun (China); Shao, Hui, E-mail: hui.shao@yishengbio.com [Yisheng Biopharma. Co., Ltd., Beijing (China); Li, Lietao, E-mail: lietao.li@gmail.com [Yisheng Biopharma. Co., Ltd., Beijing (China)

    2016-02-15

    Vaccination alone is not sufficiently effective to protect human from post-exposure rabies virus infection due to delayed generation of rabies virus neutralizing antibodies and weak cellular immunity. Therefore, it is vital to develop safer and more efficacious vaccine against rabies. PIKA, a stabilized chemical analog of double-stranded RNA that interacts with TLR3, was employed as adjuvant of rabies vaccine. The efficacy and safety of PIKA rabies vaccine were evaluated. The results showed that PIKA rabies vaccine enhanced both humoral and cellular immunity. After viral challenge, PIKA rabies vaccine protected 70–80% of animals, while the survival rate of non-adjuvant vaccine group (control) was 20–30%. According to the results of toxicity tests, PIKA and PIKA rabies vaccine are shown to be well tolerated in mice. Thus, this study indicates that PIKA rabies vaccine is an effective and safe vaccine which has the potential to develop next-generation rabies vaccine and encourage the start of clinical studies. - Highlights: • Vaccination alone is not effective to protect human from rabies virus infection due to delayed generation of rabies virus neutralizing antibodies (RVNA) and weak cellular immunity. • Therefore, it is vital to develop safer and more efficacious vaccine against rabies. PIKA, a stabilized chemical analog of double-stranded RNA that interacts with TLR3, was employed as an adjuvant of rabies vaccine. • The efficacy and safety of PIKA rabies vaccine was evaluated in mice. • The results showed that PIKA rabies vaccine enhanced both humoral and cellular immunity. • After viral challenge, PIKA rabies vaccine protected 70–80% of animals, while the survival rate of non-adjuvant vaccine group was only 20–30%. • According to the results of toxicity tests, PIKA and PIKA rabies vaccine are shown to be well tolerated in mice. • Thus, this study indicates that PIKA rabies vaccine is an effective and safe vaccine which has the potential to

  10. Late effects of adjuvant chemotherapy on cognitive function: a follow-up study in breast cancer patients

    NARCIS (Netherlands)

    Schagen, S. B.; Muller, M. J.; Boogerd, W.; Rosenbrand, R. M.; van Rhijn, D.; Rodenhuis, S.; van Dam, F. S. A. M.

    2002-01-01

    BACKGROUND: Neuropsychological examinations have shown an elevated risk for cognitive impairment 2 years after therapy in breast cancer patients randomized to receive adjuvant high-dose cyclophosphamide, thiotepa, carboplatin (CTC) chemotherapy compared with a non-treated control group of stage I

  11. Does lipophilicity per se induce adjuvant effects?

    DEFF Research Database (Denmark)

    Hansen, Jitka Stilund; Larsen, Søren Thor; Poulsen, Lars K.

    2007-01-01

    Anthopogenically introduced substances and pollutants are suspected to promote sensitization and development of allergic airway diseases, that is, acting as adjuvants. Lipophilicity may serve as an immunological warning signal, promoting adjuvant effects. Whether the lipophilicity of an inhaled...... respiratory patterns were significantly affected in the MP groups. The OVA + Al(OH)3 group had a significantly higher IgG1 and IgE production, as well as higher eosinophil infiltration in the BAL fluid. These studies showed that effects of adjuvants not are necessarily due to their lipophilicity; that is...

  12. Neonatal necrotizing entero-colitis: A clinico-surgical study

    Directory of Open Access Journals (Sweden)

    A.I. Eid*

    2013-12-01

    Conclusion: Early diagnosis and intensive medical and surgical treatment were mandatory to minimize both morbidity and mortality from NEC. Surgical management should be determined according to the special circumstances of each case. However, the optimum choice between peritoneal drainage and laparotomy remains controversial. Gestational age, birth weight, age at admission, and treatment modality are definite prognostic factors as regard morbidity and mortality of patients with NEC.

  13. The adjuvant use of calcium fructoborate and borax with etanercept in patients with rheumatoid arthritis: Pilot study

    Directory of Open Access Journals (Sweden)

    Saad Abdulrahman Hussain

    2017-03-01

    Full Text Available Objective: The present study was designed to evaluate the effects calcium fructoborate (CFB and sodium tetraborate (NTB as supplements in Iraqi patients with active RA maintained on Etanercept. Materials and Methods: A double blind randomized placebo-controlled clinical trial with 60 days treatment period was carried out at Baghdad Teaching Hospital, Medical City, Baghdad, Iraq. Eighty RA patients were randomized into 3 groups to receive either 220 mg/day calcium fructoborate, 55 mg/day sodium tetraborate in capsule dosage form (equivalent to 6 mg elemental Boron, or placebo formula once daily. Only 72 patients completed the study. All patients were clinically evaluated utilizing DAS28-ESR, SDAI-CRP and CDAI scores at baseline and at the end of the study. Venous blood was obtained at baseline and after 60 days, and utilized for the measurement of erythrocyte sedimentation rate (ESR, hemoglobin (Hb, in addition to evaluation of C-reactive protein (hsCRP, TNF-α, interleukin-1α (IL-1α and IL-6. Results: After 60 days, both types of boron significantly improve the clinical scores, in association with significant decrease in the serum levels of ESR, hsCRP, IL-1α, IL-6, and TNF-α with remarkable superiority for CFB over NTB, compared to baseline and placebo-treated group. Conclusion: The use of boron, as adjuvant with etanercept, have potentiated therapeutic outcomes in RA patients, and may be a new strategy to improve treatment and avoid the problems associated with biologics utilized in RA treatment. [J Complement Med Res 2017; 6(1.000: 58-64

  14. The adjuvant use of calcium fructoborate and borax with etanercept in patients with rheumatoid arthritis: Pilot study.

    Science.gov (United States)

    Hussain, Saad Abdulrahman; Abood, Sattar Jabir; Gorial, Faiq Isho

    2017-01-01

    This study was designed to evaluate the effects calcium fructoborate (CFB) and sodium tetraborate (NTB) as supplements in Iraqi patients with active rheumatoid arthritis (RA) maintained on etanercept. A double-blind randomized placebo-controlled clinical trial with 60 days treatment period was carried out at Baghdad Teaching Hospital, Medical city, Baghdad, Iraq. Eighty RA patients were randomized into three groups to receive either 220 mg/day CFB, 55 mg/day NTB in capsule dosage form (equivalent to 6 mg elemental Boron), or placebo formula once daily. Only 72 patients completed the study. All patients were clinically evaluated utilizing DAS28-erythrocyte sedimentation rate (ESR), simple disease activity index-C-reactive protein (CRP), and clinical disease activity index scores at baseline, and at the end of the study. Venous blood was obtained at baseline and after 60 days, and utilized for the measurement of ESR, hemoglobin, in addition to evaluation of high-sensitivity CRP (hsCRP), tumor necrosis factor-α (TNF-α), interleukin-1α (IL-1α) and IL-6. After 60 days, both types of boron significantly improve the clinical scores, in association with significant decrease in the serum levels of ESR, hsCRP, IL-1α, IL-6, and TNF-α with remarkable superiority for calcium fructoborate (CFB) over sodium tetraborate (NTB), compared to baseline and placebo-treated group. The use of boron, as adjuvant with etanercept, has potentiated therapeutic outcomes in RA patients, and may be a new strategy to improve treatment, and avoid the problems associated with biologics utilized in RA treatment.

  15. Breast Cancer Patients' Preferences for Adjuvant Radiotherapy Post Lumpectomy: Whole Breast Irradiation vs. Partial Breast Irradiation-Single Institutional Study.

    Science.gov (United States)

    Bonin, Katija; McGuffin, Merrylee; Presutti, Roseanna; Harth, Tamara; Mesci, Aruz; Feldman-Stewart, Deb; Chow, Edward; Di Prospero, Lisa; Vesprini, Danny; Rakovitch, Eileen; Lee, Justin; Paszat, Lawrence; Doherty, Mary; Soliman, Hany; Ackerman, Ida; Cao, Xingshan; Kiss, Alex; Szumacher, Ewa

    2018-02-01

    This study was conducted to elucidate patients with early breast cancer preference for standard whole breast irradiation (WBI) or partial breast irradiation (PBI) following lumpectomy, as well as identify important factors for patients when making their treatment decisions. Based on relevant literature and ASTRO consensus statement guidelines, an educational tool and questionnaire were developed. Consenting, eligible women reviewed the educational tool and completed the trade-off questionnaire. Descriptive statistics were calculated, as well as chi-squares and a logistic regression model. Of the 90 patients who completed the study, 62 % preferred WBI, 30 % preferred PBI, 4 % required more information, and 3 % had no preferences. Of the patients who chose WBI, 58 % preferred hypofractionated RT, whereas 25 % preferred the conventional RT regimen. The majority of patients rated recurrence rate [WBI = 55/55 (100 %), PBI = 26/26 (100 %)] and survival [WBI = 54/55 (98 %), PBI = 26/26 (100 %)] as important factors contributing to their choice of treatment preference. Financial factors [WBI = 21/55 (38 %), PBI = 14/26 (53 %)] and convenience [WBI = 36/54 (67 %), PBI = 18/26 (69 %)] were rated as important less frequently. Significantly, more patients who preferred WBI also rated standard method of treatment as important when compared to patients who preferred PBI [WBI = 52/54 (96 %), PBI = 16/26 (61 %), χ 2  = 16.63, p = 0.001]. The majority of patients with early breast cancer who were surveyed for this study preferred WBI as an adjuvant treatment post lumpectomy, yet there was a sizeable minority who preferred PBI. This was associated with the importance patients place on standard treatment. These results will help medical professionals treat patients according to patient values.

  16. External influences and priority-setting for anti-cancer agents: a case study of media coverage in adjuvant trastuzumab for breast cancer

    Directory of Open Access Journals (Sweden)

    Fralick John

    2007-06-01

    Full Text Available Abstract Background Setting priorities for the funding of new anti-cancer agents is becoming increasingly complex. The funding of adjuvant trastuzumab for breast cancer has brought this dilemma to the fore. In this paper we review external factors that may influence decision-making bodies and present a case study of media response in Ontario, Canada to adjuvant trastuzumab for breast cancer. Methods A comprehensive search of the databases of Canadian national and local newspapers and television was performed. Articles pertaining to trastuzumab in adjuvant breast cancer as well as 17 other anti-cancer drugs and indications were retrieved. The search period was from the date when individual trial results were announced to the date funding was made available in Ontario. Results During the 2.6 months between the release of the trastuzumab results to funding approval in Ontario, we identified 51 episodes of media coverage. For the 17 other drugs/indications (7 breast and 10 non-breast, the median time to funding approval was 31 months (range 14–46. Other recent major advances in oncology such as adjuvant vinorelbine/cisplatin for resected NSCLC and docetaxel for advanced prostate cancer received considerably less media attention (17 media reports for each than trastuzumab. The median number of media reports for breast cancer drugs was 4.5 compared to 2.5 for non-breast cancer drugs (p = 0.56. Conclusion Priority-setting for novel anti-cancer agents is a complex process that tries to ensure fair use of constrained resources to fund therapies with the best evidence of clinical benefit. However, this process is subject to external factors including the influence of media, patient advocates, politicians, and industry. The data in this case study serve to illustrate the significant involvement one (or all of these external factors may play in the debate over priority-setting.

  17. Clinical Practice in the Use of Adjuvant Chemotherapy for Patients with Colon Cancer in South Korea: a Multi-Center, Prospective, Observational Study.

    Science.gov (United States)

    Kim, Jung Han; Baek, Moo Jun; Ahn, Byung-Kwon; Kim, Dae Dong; Kim, Ik Yong; Kim, Jin Soo; Bae, Byung-Noe; Seo, Bong-Gun; Jung, Sang Hun; Hong, Kwan Hee; Kim, Hungdai; Park, Dong Guk; Lee, Ji Hye

    2016-01-01

    Adjuvant chemotherapy is a crucial part of treatment for patients with locally advanced colon cancer. This study was conducted to investigate the actual practice in the use of adjuvant chemotherapy for patients with high-risk stage II or stage III colon cancer in South Korea. This was a 24-month open-label, prospective, observational study conducted at 12 centers across South Korea. Patients with high-risk stage II and stage III colon cancer receiving adjuvant chemotherapy after curative surgery were included, and data were collected at baseline, third, and sixth month. A total of 246 patients were included in the analyses. Of five available regimens (FOLFOX, CAPOX, 5-FU/LV, capecitabine, and UFT/LV), FOLFOX was most commonly used (82.5%). Investigators indicated the "efficacy" as the major cause for selecting FOLFOX or CAPOX. For 5-FU/LV, capecitabine, or UFT/LV, the "safety" or "patient's characteristics (age, comorbidity, and stage)" was one of the most important selecting factors. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX. Hematologic toxicities were the most common cause of dose adjustment and treatment delay. In South Korea, FOLFOX was the most commonly used regimen for adjuvant chemotherapy and its efficacy was the main cause for selecting this regimen. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX.

  18. Factors Influencing Decision-Making for or against Adjuvant and Neoadjuvant Chemotherapy in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study

    Science.gov (United States)

    Gaß, Paul; Fasching, Peter A.; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W.; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesselt, Thomas; Fischer, Gunnar; Henschen, Stephan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M.; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y.; Beckmann, Matthias W.; Wallwiener, Diethelm; Kümmel, Sherko; Löhberg, Christian R.

    2016-01-01

    Background Decision-making for or against neoadjuvant or adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive breast cancer does not follow any clear guidelines, and some patients may unnecessarily undergo chemotherapy and be exposed to the associated toxicity. The aim of this study was to identify the patient population for whom this issue may bear relevance. Methods Patients being treated with letrozole in the prospective multicenter noninterventional EvAluate-TM study were recruited. The percentage of patients receiving chemotherapy and factors associated with chemotherapy administration were identified. Results In all, 3,924 (37.4%) patients received chemotherapy before treatment with letrozole. Of these, 293 (20%) underwent neoadjuvant therapy. Younger age was predictive for both adjuvant and neoadjuvant therapy. Overall, decisions in favor of administering chemotherapy are more likely to be made in patients with a higher body mass index (BMI), and neoadjuvant chemotherapy is administered at a higher rate in women with a lower BMI. Concomitant medication influenced the overall decision-making regarding chemotherapy, irrespective of whether it was given on a neoadjuvant or adjuvant basis. Conclusion There is an ongoing debate as to whether all of the many patients who receive chemotherapy actually benefit from it. Neoadjuvant chemotherapy is frequently administered in this patient population, and this should encourage further research to resolve current clinical and research issues. PMID:27920623

  19. Utilization pattern and survival outcomes of adjuvant therapies in high-grade nonretroperitoneal abdominal soft tissue sarcoma: A population-based study.

    Science.gov (United States)

    Green, William Ross; Chokshi, Ravi; Jabbour, Salma K; DeLaney, Thomas F; Mahmoud, Omar

    2018-02-01

    Nonretroperitoneal abdominal soft tissue sarcoma (NRA-STS) is a rare disease with limited data supporting its management. Our study aimed to reveal the utilization patterns of adjuvant therapy and its potential survival benefits using the National Cancer Data Base. The analysis included patients with resected high-grade NRA-STS. Chi-square analysis was used to evaluate distribution of patient and tumor-related factors within treatment groups. The Kaplan-Meier and Cox proportional hazards model were utilized to evaluate overall survival according to treatment approach. Multivariate analysis was used to determine the impact of these factors on patients' outcome. Matched propensity score analysis was implemented to control for imbalance of confounding variables. At median follow-up of 49 months, 5-year overall survival improved from 46% without adjuvant radiation therapy to 52% (P = 0.009) with radiotherapy delivery with a 30% reduction in hazard of death (95% confidence interval = 0.58-0.84). On multivariate analysis, age <50, tumor <8 cm, negative margins and radiotherapy delivery were significant predictors of improved survival. Chemotherapy was not associated with significant survival improvement (Hazard Ratios [HR]: 0.89, P = 0.28). Adjuvant radiotherapy was associated with improved survival in high-grade NRA-STS. Chemotherapy was not associated with a survival improvement; however, further studies are needed to refine treatment strategies. © 2017 John Wiley & Sons Australia, Ltd.

  20. Phase 3 study of adjuvant radiotherapy versus wait and see in pT3 prostate cancer: impact of pathology review on analysis.

    Science.gov (United States)

    Bottke, Dirk; Golz, Reinhard; Störkel, Stephan; Hinke, Axel; Siegmann, Alessandra; Hertle, Lothar; Miller, Kurt; Hinkelbein, Wolfgang; Wiegel, Thomas

    2013-08-01

    In a randomised trial, radical prostatectomy (RP) followed by adjuvant radiotherapy (aRT) was compared with RP alone in patients with pT3 pN0 prostate cancer with or without positive margin at local pathology (German Cancer Society trial numbers ARO 96-02/AUO AP 09/95). A pathology review was performed on 85% of RP specimens of patients to investigate the influence of pathology review on the analysis. Patients post-RP (n=385) were randomised before achieving an undetectable prostate-specific antigen (PSA) level to either wait and see (n=192) or 60Gy aRT (n=193). Of 307 patients with undetectable PSA after RP, 262 had pathology review. These results were included prospectively into the analysis. Agreement between local and review pathology was measured by the total percentage of agreement and by simple kappa statistics. The prognostic reliability for the different parameters was analysed by Cox regression model. Event-free rates were determined by Kaplan-Meier analysis with a median follow-up of 40 mo for the wait-and-see arm and 38.5 mo for the aRT arm. There was fair concordance between pathology review and local pathologists for seminal vesicle invasion (pT3c: 91%; κ=0.76), surgical margin status (84%; κ=0.65), and for extraprostatic extension (pT3a/b: 75%; κ=0.74). Agreement was much less for Gleason score (47%; κ=0.42), whereby the review pathology resulted in a shift to Gleason score 7. In contrast to the analysis of progression-free survival with local pathology, the multivariate analysis including review pathology revealed PSMs and Gleason score >6 as significant prognostic factors. Phase 3 studies of postoperative treatment of prostate cancer should be accomplished in the future with a pathology review. In daily practice, a second opinion by a pathologist experienced in urogenital pathology would be desirable, in particular, for high-risk patients after RP. Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  1. Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development

    Directory of Open Access Journals (Sweden)

    Samantha Sayers

    2012-01-01

    Full Text Available Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO in the Web Ontology Language (OWL format.

  2. Vaxjo: a web-based vaccine adjuvant database and its application for analysis of vaccine adjuvants and their uses in vaccine development.

    Science.gov (United States)

    Sayers, Samantha; Ulysse, Guerlain; Xiang, Zuoshuang; He, Yongqun

    2012-01-01

    Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO) in the Web Ontology Language (OWL) format.

  3. Surgical crown lengthening: a 12-month study - radiographic results

    Directory of Open Access Journals (Sweden)

    Daniela Eleutério Diniz

    2007-08-01

    Full Text Available OBJECTIVE: The purpose of this study was to perform a radiographic follow-up evaluation after a 12-month healing period, following crown lengthening surgery. MATERIAL AND METHODS: Twenty-three periodontally healthy subjects (mean age 32.5 years that required crown lengthening surgery in premolars were recruited. In a total of 30 premolars, full thickness flaps, osseous resection, and flap suturing were performed. The restorative margin was defined in the pre-surgical phase and maintained unaltered during the healing period, serving as a reference point. Standardized bitewing radiographs were taken before and after osseous reduction, and at 2, 3, 6, and 12-month healing periods. RESULTS: Intact lamina dura was observed at both mesial and distal alveolar crests only from the 3rd month. At 12-months, all alveolar crests presented lamina dura. The overall mean distance from the restorative margin to the alveolar crest achieved after osseous resection was 3.28±0.87 mm at mesial and 2.81±0.51 mm at distal sites. No significant radiographic changes in the bone crest were observed during a 12-month healing period. CONCLUSION: The findings of this study suggest that the radiographic proximal bone level observed on bitewing radiographs following crown lengthening surgery can be used as a reference to predict the future level of the healed alveolar crest.

  4. Assessing brain volume changes in older women with breast cancer receiving adjuvant chemotherapy: a brain magnetic resonance imaging pilot study.

    Science.gov (United States)

    Chen, Bihong T; Sethi, Sean K; Jin, Taihao; Patel, Sunita K; Ye, Ningrong; Sun, Can-Lan; Rockne, Russell C; Haacke, E Mark; Root, James C; Saykin, Andrew J; Ahles, Tim A; Holodny, Andrei I; Prakash, Neal; Mortimer, Joanne; Waisman, James; Yuan, Yuan; Somlo, George; Li, Daneng; Yang, Richard; Tan, Heidi; Katheria, Vani; Morrison, Rachel; Hurria, Arti

    2018-05-02

    Cognitive decline is among the most feared treatment-related outcomes of older adults with cancer. The majority of older patients with breast cancer self-report cognitive problems during and after chemotherapy. Prior neuroimaging research has been performed mostly in younger patients with cancer. The purpose of this study was to evaluate longitudinal changes in brain volumes and cognition in older women with breast cancer receiving adjuvant chemotherapy. Women aged ≥ 60 years with stage I-III breast cancer receiving adjuvant chemotherapy and age-matched and sex-matched healthy controls were enrolled. All participants underwent neuropsychological testing with the US National Institutes of Health (NIH) Toolbox for Cognition and brain magnetic resonance imaging (MRI) prior to chemotherapy, and again around one month after the last infusion of chemotherapy. Brain volumes were measured using Neuroreader™ software. Longitudinal changes in brain volumes and neuropsychological scores were analyzed utilizing linear mixed models. A total of 16 patients with breast cancer (mean age 67.0, SD 5.39 years) and 14 age-matched and sex-matched healthy controls (mean age 67.8, SD 5.24 years) were included: 7 patients received docetaxel and cyclophosphamide (TC) and 9 received chemotherapy regimens other than TC (non-TC). There were no significant differences in segmented brain volumes between the healthy control group and the chemotherapy group pre-chemotherapy (p > 0.05). Exploratory hypothesis generating analyses focusing on the effect of the chemotherapy regimen demonstrated that the TC group had greater volume reduction in the temporal lobe (change = - 0.26) compared to the non-TC group (change = 0.04, p for interaction = 0.02) and healthy controls (change = 0.08, p for interaction = 0.004). Similarly, the TC group had a decrease in oral reading recognition scores (change = - 6.94) compared to the non-TC group (change = - 1.21, p for

  5. One-Year Longitudinal Study of Fatigue, Cognitive Functions, and Quality of Life After Adjuvant Radiotherapy for Breast Cancer

    International Nuclear Information System (INIS)

    Noal, Sabine; Levy, Christelle; Hardouin, Agnes; Rieux, Chantal; Heutte, Natacha; Segura, Carine; Collet, Fabienne; Allouache, Djelila; Switsers, Odile; Delcambre, Corinne; Delozier, Thierry; Henry-Amar, Michel; Joly, Florence

    2011-01-01

    Purpose: Most patients with localized breast cancer (LBC) who take adjuvant chemotherapy (CT) complain of fatigue and a decrease in quality of life during or after radiotherapy (RT). The aim of this longitudinal study was to compare the impact of RT alone with that occurring after previous CT on quality of life. Methods and Materials: Fatigue (the main endpoint) and cognitive impairment were assessed in 161 CT-RT and 141 RT patients during RT and 1 year later. Fatigue was assessed with Functional Assessment of Cancer Therapy-General questionnaires, including breast and fatigue modules. Results: At baseline, 60% of the CT-RT patients expressed fatigue vs. 33% of the RT patients (p <0.001). Corresponding values at the end of RT were statistically similar (61% and 53%), and fatigue was still reported at 1 year by more than 40% of patients in both groups. Risk factors for long-term fatigue included depression (odds ratio [OR] = 6), which was less frequent in the RT group at baseline (16% vs. 28 %, respectively, p = 0.01) but reached a similar value at the end of RT (25% in both groups). Initial mild cognitive impairments were reported by RT (34 %) patients and CT-RT (24 %) patients and were persistent at 1 year for half of them. No biological disorders were associated with fatigue or cognitive impairment. Conclusions: Fatigue was the main symptom in LBC patients treated with RT, whether they received CT previously or not. The correlation of persistent fatigue with initial depressive status favors administering medical and psychological programs for LBC patients treated with CT and/or RT, to identify and manage this main quality-of-life-related symptom.

  6. Colonic healing: the effect of irradiation and chemotherapy - an experimental study, resembling adjuvant therapy for colorectal carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Weiber, S.

    1993-08-01

    Adjuvant treatment of colon and rectal carcinoma is of major interest. Irradiation and chemotherapy are modalities used widely. The purpose of this study was to evaluate the effect of preoperative irradiation and postoperative intraperitoneal 5-fluorouracil treatment on colonic healing. In rats preoperative irradiation of the lower abdominal region by 10 + 10 Gy four days apart caused inflammatory reaction in the colon as evaluated by histology and determination of myeloperoxidase activity. The inflammatory reaction reached its peek within a week of the second irradiation. When standard used colonic resections and anastomes were performed within the irradiate part of the colon the anastomotic healing was not affected during the first week after operation as judged by complications and breaking strength. A lower breaking strength and an increase in myeloperoxidase activity two months after operation may indicate late changes within the intestinal wall. Intraperitoneal 5-fluorouracil in rat given immediately after colonic resection and repeated as daily injections caused a weight loss and marked reduction in breaking strength of the anastomosis as well as in the abdominal skin wound. A reduction in 5-fluorouracil concentration did not alter the negative wound healing effect of the chemotherapy. In a group of rats subjected to nutritional depletion, mimicking the weight curve of 5-fluorouracil treated animals, anastomotic breaking strength was not compromised to the same extent as when 5-fluorouracil was given. This indicated a direct toxic effect rather than an effect of reduced food intake caused by 5-FU treatment. Collagen synthesis and the formation of new tissue in the wound gap was reduced in 5-fluorouracil treated animals compared to controls as judged by in vivo incorporation of {sup 3}H-proline in the anastomotic segment and determination of anastomotic breaking strength after removal of sutures. 108 refs.

  7. Colonic healing: the effect of irradiation and chemotherapy - an experimental study, resembling adjuvant therapy for colorectal carcinoma

    International Nuclear Information System (INIS)

    Weiber, S.

    1993-08-01

    Adjuvant treatment of colon and rectal carcinoma is of major interest. Irradiation and chemotherapy are modalities used widely. The purpose of this study was to evaluate the effect of preoperative irradiation and postoperative intraperitoneal 5-fluorouracil treatment on colonic healing. In rats preoperative irradiation of the lower abdominal region by 10 + 10 Gy four days apart caused inflammatory reaction in the colon as evaluated by histology and determination of myeloperoxidase activity. The inflammatory reaction reached its peek within a week of the second irradiation. When standard used colonic resections and anastomes were performed within the irradiate part of the colon the anastomotic healing was not affected during the first week after operation as judged by complications and breaking strength. A lower breaking strength and an increase in myeloperoxidase activity two months after operation may indicate late changes within the intestinal wall. Intraperitoneal 5-fluorouracil in rat given immediately after colonic resection and repeated as daily injections caused a weight loss and marked reduction in breaking strength of the anastomosis as well as in the abdominal skin wound. A reduction in 5-fluorouracil concentration did not alter the negative wound healing effect of the chemotherapy. In a group of rats subjected to nutritional depletion, mimicking the weight curve of 5-fluorouracil treated animals, anastomotic breaking strength was not compromised to the same extent as when 5-fluorouracil was given. This indicated a direct toxic effect rather than an effect of reduced food intake caused by 5-FU treatment. Collagen synthesis and the formation of new tissue in the wound gap was reduced in 5-fluorouracil treated animals compared to controls as judged by in vivo incorporation of 3 H-proline in the anastomotic segment and determination of anastomotic breaking strength after removal of sutures. 108 refs

  8. Lithium as adjuvant to radioiodine therapy in differentiated thyroid carcinoma: clinical and in vitro studies

    NARCIS (Netherlands)

    Liu, Y. Y.; van der Pluijm, G.; Karperien, M.; Stokkel, M. P. M.; Pereira, A. M.; Morreau, J.; Kievit, J.; Romijn, J. A.; Smit, J. W. A.

    2006-01-01

    Lithium has been reported to increase radioactive iodine (RaI) doses in benign thyroid disease and in differentiated thyroid carcinoma (DTC). It is not known whether lithium influences the outcome of RaI therapy in DTC. We therefore studied the clinical effects of RaI without and with lithium

  9. Randomized study: small cell anaplastic lung cancer treated by combination chemotherapy and adjuvant radiotherapy

    International Nuclear Information System (INIS)

    Fox, R.M.; Woods, R.L.; Brodie, G.N.; Tattersall, M.H.N.

    1980-01-01

    Chemotherapy and primary site radiation therapy were compared to chemotherapy alone in a randomized study of 125 patients with small cell cancer of the lung. The sites of initial relapse, as well as disease free and overall survival were analyzed. Radiotherapy to the primary site reduced the rate of local relapse, but median survival was not prolonged in patients with either limited or extensive disease, when the radiation therapy-chemotherapy group was compared to the group that received chemotherapy alone

  10. A systemic literature review of neuroimaging studies in women with breast cancer treated with adjuvant chemotherapy

    Directory of Open Access Journals (Sweden)

    Paulina Andryszak

    2017-03-01

    Full Text Available Chemotherapy-induced cognitive deficits in patients with breast cancer, predominantly in attention and verbal memory, have been observed in numerous studies. These neuropsychological findings are corroborated by the results of neuroimaging studies. The aim of this paper was to survey the reports on cerebral structural and functional alterations in women with breast cancer treated with chemotherapy (CTx. First, we discuss the host-related and disease-related mechanisms underlying cognitive impairment after CTx. We point out the direct and indirect neurotoxic effect of cytostatics, which may cause: a damage to neurons or glial cells, changes in neurotransmitter levels, deregulation of the immune system and/or cytokine release. Second, we focus on the results of neuroimaging studies on brain structure and function that revealed decreased: density of grey matter, integrity of white matter and volume of multiple brain regions, as well as their lower activation during cognitive task performance. Finally, we concentrate on compensatory mechanisms, which activate additional brain areas or neural connection to reach the premorbid cognitive efficiency.

  11. Adjuvant radiotherapy after breast conserving surgery - a comparative effectiveness research study.

    Science.gov (United States)

    Corradini, Stefanie; Niyazi, Maximilian; Niemoeller, Olivier M; Li, Minglun; Roeder, Falk; Eckel, Renate; Schubert-Fritschle, Gabriele; Scheithauer, Heike R; Harbeck, Nadia; Engel, Jutta; Belka, Claus

    2015-01-01

    The purpose of this retrospective outcome study was to validate the effectiveness of postoperative radiotherapy in breast conserving therapy (BCT) and to evaluate possible causes for omission of radiotherapy after breast conserving surgery (BCS) in a non-trial population. Data were provided by the population-based Munich Cancer Registry. The study included epidemiological data of 30.811 patients diagnosed with breast cancer from 1998 to 2012. The effect of omitting radiotherapy was analysed using Kaplan-Meier-estimates and Cox proportional hazard regression. Variables predicting omission of radiotherapy were analysed using multivariate logistic regression. Use of postoperative radiotherapy after BCS was associated with significant improvements in local control and survival. 10-year loco-regional recurrence-free-survival was 90.8% with postoperative radiotherapy vs. 77.6% with surgery alone (pstudy shows a decrease in local control and a survival disadvantage if postoperative radiotherapy after breast conserving surgery is omitted in an unselected cohort of primary breast cancer patients. Due to its epidemiological nature, it cannot answer the question in whom postoperative radiotherapy can be safely omitted. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  12. Studies on adjuvant parenteral nutrition during chemotherapeutic and radiotherapeutic measures in haematological disorders

    International Nuclear Information System (INIS)

    Heim, F.

    1988-01-01

    In patients subjected to bone marrow transplantation the aggressive measures necessarily preceding this treatment lead to drastic metabolic changes which, in turn, are a cause of marked disturbances of homeostasis. The general preparatory measures in the form of cytoreduction by cytostatic drugs are broadened for leukaemic patients to include wholebody irradiation. During the study described here investigations were carried out into the resulting strain on the metabolism. One of the most essential changes observed in those patients was a nitrogen loss of up to approx. 20 g/day that occurred during the immunosuppressive phase. This was accompanied by markedly pronounced variations in fluid elimination, which partly were of an iatrogenic nature. An immediate and sufficient substitution of amino acids in connection with complete parenteral nutrition rapidly acted to compensate for the nitrogen losses, even though these could not be totally reversed to achieve a positive nitrogen balance. (orig./MG) [de

  13. Surgical management of low grade isthmic spondylolisthesis; a randomized controlled study of the surgical fixation with and without reduction

    Directory of Open Access Journals (Sweden)

    Bashaireh Khaldoon M

    2011-07-01

    Full Text Available Abstract Background spondylolisthesis is a condition in which a vertebra slips out of the proper position onto the bone below it as a result of pars interarticularis defect. The slipped segment produces abnormal positioning of the vertebrae in relation to each other along the spinal column and causes mechanical back pain and neural breach. Materials and methods A randomized and double blinded study consisted of 41 patients aged 36-69 years (18 females and 28 males treated for symptomatic spondylolisthesis between December,2006 and December, 2009. All patients were randomly distributed into two groups I and II. Twenty patients were in Group I; they underwent reduction of the slipped vertebrae by using Reduction-Screw Technique and posterior lumbar interbody fixation (PLIF. Group II consisted of twenty one patients who underwent only surgical fixation (PLIF without reduction. All patients in this study had same pre and post operative management. Results only one case had broken rod in group I that required revision. Superficial wound infection was experienced in two patients and one patient, from group II, developed wound hematoma. The outcome in both groups was variable on the short term but was almost the same on the long term follow up. Conclusion surgical management of symptomatic low grade spondylolisthesis should include neural decompression and surgical fixation. Reduction of slipped vertebral bodies is unnecessary as the ultimate outcome will be likely similar.

  14. Low-dose intravenous alpha-2 agonists as adjuvants to spinal levobupivacaine: A randomized study

    Directory of Open Access Journals (Sweden)

    Pranav Jetley

    2017-01-01

    Full Text Available Background: Alpha-2 agonists have been used with spinal anesthesia for anxiolysis, analgesia, and hypnosis and for postoperative pain relief. These beneficial effects may, however, be offset by their propensity to prolong the duration of motor block and adversely affect hemodynamics when used in higher doses. This study compares the effects of low-dose premedication with intravenous (IV dexmedetomidine and IV clonidine with placebo, on spinal blockade duration, analgesia, and sedation with intrathecal levobupivacaine. Materials and Methods: In this prospective, randomized, double-blinded, placebo-controlled study, ninety American Society of Anesthesiologists Status I and II patients were randomly allocated into three groups: Group A (control received 10 ml normal saline IV, Group B received IV dexmedetomidine 0.6 μg/kg, and Group C received IV clonidine 1.2 μg/kg over 10 min, before spinal anesthesia with 0.5% levobupivacaine. Hemodynamics, total duration of analgesia, onset and duration of sensory and motor block, visual analog scale score, and sedation score were assessed. Complications, if any, were noted. Results: The level of sensory block achieved was higher with dexmedetomidine (T4.2 ± 0.8 and clonidine (T4.4 ± 0.7 as compared to control (T5.1 ± 0.7; P< 0.001. Time to two segment regression was greater with dexmedetomidine (146.5 ± 12.5 min and clonidine (138.9 ± 17.4 min compared to control (90.1 ± 9.4; P< 0.001. Dexmedetomidine maximally prolonged the duration to first patient request for analgesia (245.2 ± 26.8 min, followed by clonidine (175.3 ± 20.1 min, P< 0.001 and control (121.3 ± 16.1 min, P< 0.001. The duration of motor block was similar in all three groups. Incidence of bradycardia was significantly greater with both dexmedetomidine and clonidine compared to saline (P < 0.05. Conclusion: Premedication with low-dose IV dexmedetomidine and clonidine prolonged sensory blockade and analgesic duration and provided

  15. Randomized controlled study on the effect of adjuvant immunotherapy with OK-432 on malignant gliomas

    International Nuclear Information System (INIS)

    Shibata, Shobu; Mori, Kazuo; Moriyama, Tadayoshi; Tanaka, Keisei; Moroki, Jiro.

    1985-01-01

    During periods from January, 1981 to December, 1983, 51 patients (31 malignant astrocytomas, 17 glioblastomas, and others 3) were treated with radiochemotherapy using Nimustine hydrochloride, ACNU (group B) and radiochemoimmunotherapy with Picibanil, OK-432 (group A) by randomized controlled study. Group A consisted of 24 patients and group B of 27 patients. The differences in the background of the two groups were not statistically significant. Survival curves of both groups were shown by the Kaplan-Meier method. The postoperative survival rate at 1 year and 2 years were 70 % and 30 %, respectively, equal in both groups, and the differences between groups A and B were not statistically significant by the Cox-Mantel test. The side effects by group B therapy were most prominent in the bone marrow, and severe leukopenia occurred. However, group A therapy suppressed leukopenia after 2 months. Immunological parameters, such as purified protein derivative skin reaction test did not change, but streptococcal Su-polysaccharide skin reaction test became positive after group A therapy. (author)

  16. Risk factors for locoregional recurrence in patients with resected N1 non-small cell lung cancer: a retrospective study to identify patterns of failure and implications for adjuvant radiotherapy

    International Nuclear Information System (INIS)

    Fan, Chengcheng; Gao, Shugeng; Hui, Zhouguang; Liang, Jun; Lv, Jima; Wang, Xiaozhen; He, Jie; Wang, Luhua

    2013-01-01

    Meta-analysis of randomized trials has shown that postoperative radiotherapy (PORT) had a detrimental effect on overall survival (OS) in patients with resected N1 non–small cell lung cancer (NSCLC). Conversely, the locoregional recurrence (LR) rate is reported to be high without adjuvant PORT in these patients. We have evaluated the pattern of failure, actuarial risk and risk factors for LR in order to identify the subset of N1 NSCLC patients with the highest risk of LR. These patients could potentially benefit from PORT. We conducted a retrospective study on 199 patients with pathologically confirmed T1–3N1M0 NSCLC who underwent surgery. None of the patients had positive surgical margins or received preoperative therapy or PORT. The median follow-up was 53.8 months. Complete mediastinal lymph node (MLN) dissection and examination was defined as ≥3 dissected and examined MLN stations; incomplete MLN dissection or examination (IMD) was defined as <3 dissected or examined MLN stations. The primary end point of this study was freedom from LR (FFLR). Differences between patient groups were compared and risk factors for LR were identified by univariate and multivariate analyses. LR was identified in 41 (20.6%) patients, distant metastasis (DM) was identified in 79 (39.7%) patients and concurrent LR and DM was identified in 25 (12.6%) patients. The 3- and 5-year OS rates in patients with resected N1 NSCLC were 78.4% and 65.6%, respectively. The corresponding FFLR rates were 80.8% and 77.3%, respectively. Univariate analyses identified that nonsmokers, ≤23 dissected lymph nodes, visceral pleural invasion and lymph node ratio >10% were significantly associated with lower FFLR rates (P < 0.05). Multivariate analyses further confirmed positive lymph nodes at station 10 and IMD as risk factors for LR (P < 0.05). The 5-year LR rate was highest in patients with both these risk factors (48%). The incidence of LR in patients with surgically resected T1–3N1M0 NSCLC is

  17. Reproductive hormone analyses and effects of adjuvant zoledronic acid in early breast cancer – An AZURE (BIG 01/04 sub-study

    Directory of Open Access Journals (Sweden)

    Caroline Wilson

    2017-11-01

    Full Text Available Purpose: Adjuvant bisphosphonates have been shown to improve disease outcomes in early breast cancer in women who are postmenopausal at the start of treatment. We explored the influence of pretreatment serum levels of reproductive hormones in the hypothalamic-pituitary-gonadal (HPG axis from a subset of patients included in the AZURE trial to investigate their impact on disease recurrence and whether reproductive hormone measurements are of value in selecting patients for treatment with adjuvant zoledronic acid.Patients and methods; The AZURE trial is an academic, multi-centre, international phase III trial that randomised patients to standard adjuvant therapy (chemotherapy and/or endocrine therapy±intravenous zoledronic acid, 4 mg for 5 years. Serum from 865 patients taken at randomisation was stored at −80 °C prior to central batch analysis for inhibin A, oestradiol and follicle stimulating hormone (FSH. We assessed the clinical value of pretreatment hormone levels for predicting invasive disease free survival (IDFS, skeletal recurrence and distant recurrence and response to treatment with zoledronic acid. Results: Oestradiol in the postmenopausal range (26 IU/l was associated with a longer time to bone as first recurrence (HR 0.66 95%CI: 0.41–1.04 p=0.072 compared to an FSH ≤26 IU/l. When all 3 hormone levels were within the assay specified postmenopausal range, a trend to improved IDFS was seen with addition of zoledronic acid in biochemically postmenopausal women only (postmenopausal HR=0.81; 95%CI: 0.54–1.22, non-postmenopausal HR=0.99; 95%CI: 0.69–1.39 with risk reductions that mirrored the results of the main AZURE study, although the interaction between menopausal status and treatment effect was not statistically significant (p=0.47. Conclusion: Oestradiol and FSH may influence the pattern of disease recurrence with postmenopausal levels possibly creating a less conducive environment for the

  18. Skin-sparing Helical Tomotherapy vs 3D-conformal Radiotherapy for Adjuvant Breast Radiotherapy: In Vivo Skin Dosimetry Study

    International Nuclear Information System (INIS)

    Capelle, Lisa; Warkentin, Heather; MacKenzie, Marc; Joseph, Kurian; Gabos, Zsolt; Pervez, Nadeem; Tankel, Keith; Chafe, Susan; Amanie, John; Ghosh, Sunita; Parliament, Matthew; Abdulkarim, Bassam

    2012-01-01

    Purpose: We investigated whether treatment-planning system (TPS)-calculated dose accurately reflects skin dose received for patients receiving adjuvant breast radiotherapy (RT) with standard three-dimensional conformal RT (3D-CRT) or skin-sparing helical tomotherapy (HT). Methods and Materials: Fifty patients enrolled in a randomized controlled trial investigating acute skin toxicity from adjuvant breast RT with 3D-CRT compared to skin-sparing HT, where a 5-mm strip of ipsilateral breast skin was spared. Thermoluminescent dosimetry or optically stimulated luminescence measurements were made in multiple locations and were compared to TPS-calculated doses. Skin dosimetric parameters and acute skin toxicity were recorded in these patients. Results: With HT there was a significant correlation between calculated and measured dose in the medial and lateral ipsilateral breast (r = 0.67, P V50 (1.4% vs 5.9%, respectively; P=.001) but higher skin V40 and skin V30 (71.7% vs 64.0%, P=.02; and 99.0% vs 93.8%, P=.001, respectively) than 3D-CRT plans. Conclusion: The 3D-CRT TPS more accurately reflected skin dose than the HT TPS, which tended to overestimate dose received by 14% in patients receiving adjuvant breast RT.

  19. [Surgical treatment of diffuse adult orbital lymphangioma: two case studies].

    Science.gov (United States)

    Berthout, A; Jacomet, P V; Putterman, M; Galatoire, O; Morax, S

    2008-12-01

    Orbital lymphangioma is a rare vascular malformation; it is a benign but severe anomaly because of its infiltrative, diffuse, and hemorrhagic nature, and its high morbidity rate. Surgical resection is a real challenge on account of the intricate architecture of the lesion. The authors report their surgical experience concerning two cases of diffuse orbital lymphangioma whose diagnosis was established in adulthood and whose surgical treatment was successful. Two patients presented with adult orbital lymphangioma. Progression was slow during the first decade and then was quickly followed by complications: major exorbitism, compressive optic neuropathy, and corneal exposure. Neuroimaging showed a diffuse and cystic orbital malformation. Surgical resection was performed as completely as possible, in one case with a Krönlein orbitotomy and in the other case only via a conjunctive route. An aspirate drain was put in the orbit for 48 h so as to prevent dead spaces forming after resection, an essential risk factor of hemorrhagic or cystic recurrence. Systemic corticotherapy was administered for the 5 days following surgery. The resection was total in one case and subtotal in the other. The surgical follow-up was uneventful with an excellent aesthetic result and an improvement in visual acuity. After 12 months, no tumoral or hemorrhagic recurrence was noted. The surgical treatment of orbital lymphangiomas is challenging because of their infiltrative nature. In diffuse forms, a complete resection is rarely possible because of the risk of sacrificing visual function. In the two cases reported herein, the resection of the extraconal portion was complete, but the intraconal portion was completely removed only in one case. Using the aspirate drain, negative pressure was maintained in the orbital cavity, preventing the formation of chocolate cysts induced by surgery. Although the clinical result was very satisfying, long-term follow-up is necessary to evaluate recurrence

  20. Studies on correlation of positive surgical margin with clinicopathological factors and prognoses in breast conserving surgery

    International Nuclear Information System (INIS)

    Nishimura, Reiki; Nagao, Kazuharu; Miyayama, Haruhiko

    1999-01-01

    Out of 484 cases with breast conserving surgery between April 1989 and March 1999, surgical procedures of 34 cases were changed to total mastectomy due to positive surgical margins. In this study we evaluated a clinical significance of surgical margin in relation to clinicopathological factors and prognoses. Ninety-nine cases (20.5%) had positive margins that were judged when cancer cells existed within 5 mm from margin. In multivariate analysis of factors for surgical margin, EIC-comedo status, ly, located site, proliferative activity, and age were significant and independent factors. Regarding local recurrence, positive margin, age, ER and proliferative activity were significant factors in multivariate analysis, especially in cases not receiving postoperative radiation therapy. Radiation therapy may be beneficial for patients with positive surgical margin. And patients with breast recurrence alone had significantly higher survival rates. Therefore, it is suggested that surgical margin may not reflect survival, although it is a significant factor for local recurrence. (author)

  1. Studies on correlation of positive surgical margin with clinicopathological factors and prognoses in breast conserving surgery

    Energy Technology Data Exchange (ETDEWEB)

    Nishimura, Reiki; Nagao, Kazuharu; Miyayama, Haruhiko [Kumamoto City Hospital (Japan)

    1999-09-01

    Out of 484 cases with breast conserving surgery between April 1989 and March 1999, surgical procedures of 34 cases were changed to total mastectomy due to positive surgical margins. In this study we evaluated a clinical significance of surgical margin in relation to clinicopathological factors and prognoses. Ninety-nine cases (20.5%) had positive margins that were judged when cancer cells existed within 5 mm from margin. In multivariate analysis of factors for surgical margin, EIC-comedo status, ly, located site, proliferative activity, and age were significant and independent factors. Regarding local recurrence, positive margin, age, ER and proliferative activity were significant factors in multivariate analysis, especially in cases not receiving postoperative radiation therapy. Radiation therapy may be beneficial for patients with positive surgical margin. And patients with breast recurrence alone had significantly higher survival rates. Therefore, it is suggested that surgical margin may not reflect survival, although it is a significant factor for local recurrence. (author)

  2. A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

    Science.gov (United States)

    Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

    2018-04-01

    Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

  3. 78 FR 11207 - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation...

    Science.gov (United States)

    2013-02-15

    ...] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for... devices intended for the treatment of atrial fibrillation. DATES: Submit either electronic or written... Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation'' to the Division of...

  4. Adjuvant and Definitive Radiotherapy for Adrenocortical Carcinoma

    International Nuclear Information System (INIS)

    Sabolch, Aaron; Feng, Mary; Griffith, Kent; Hammer, Gary; Doherty, Gerard; Ben-Josef, Edgar

    2011-01-01

    Purpose: To evaluate the impact of both adjuvant and definitive radiotherapy on local control of adrenocortical carcinoma. Methods and Materials: Outcomes were analyzed from 58 patients with 64 instances of treatment for adrenocortical carcinoma at the University of Michigan's Multidisciplinary Adrenal Cancer Clinic. Thirty-seven of these instances were for primary disease, whereas the remaining 27 were for recurrent disease. Thirty-eight of the treatment regimens involved surgery alone, 10 surgery plus adjuvant radiotherapy, and 16 definitive radiotherapy for unresectable disease. The effects of patient, tumor, and treatment factors were modeled simultaneously using multiple variable Cox proportional hazards regression for associations with local recurrence, distant recurrence, and overall survival. Results: Local failure occurred in 16 of the 38 instances that involved surgery alone, in 2 of the 10 that consisted of surgery plus adjuvant radiotherapy, and in 1 instance of definitive radiotherapy. Lack of radiotherapy use was associated with 4.7 times the risk of local failure compared with treatment regimens that involved radiotherapy (95% confidence interval, 1.2-19.0; p = 0.030). Conclusions: Radiotherapy seems to significantly lower the risk of local recurrence/progression in patients with adrenocortical carcinoma. Adjuvant radiotherapy should be strongly considered after surgical resection.

  5. Surgical site infections in Italian Hospitals: a prospective multicenter study

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    Ippolito Giuseppe

    2008-03-01

    Full Text Available Abstract Background Surgical site infections (SSI remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Methods In 2002, a one-month, prospective national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals. Case ascertainment of SSI was carried out using standardized surveillance methodology. To assess potential risk factors for SSI we used a conditional logistic regression model. We also reported the odds ratios of in-hospital and postdischarge SSI. Results SSI occurred in 241 (5.2% of 4,665 patients, of which 148 (61.4% during in-hospital, and 93 (38.6% during postdischarge period. Of 93 postdischarge SSI, sixty-two (66.7% and 31 (33.3% were detected through telephone interview and questionnaire survey, respectively. Higher SSI incidence rates were observed in colon surgery (18.9%, gastric surgery (13.6%, and appendectomy (8.6%. If considering risk factors for SSI, at multivariate analysis we found that emergency interventions, NNIS risk score, pre-operative hospital stay, and use of drains were significantly associated with SSI occurrence. Moreover, risk factors for total SSI were also associated to in-hospital SSI. Additionally, only NNIS, pre-operative hospital stay, use of drains, and antibiotic prophylaxis were associated with postdischarge SSI. Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy. Standardized postdischarge surveillance detected 38.6% of all SSI. We also compared risk factors for in-hospital and postdischarge SSI

  6. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

  7. Better compliance with hypofractionation vs. conventional fractionation in adjuvant breast cancer radiotherapy. Results of a single, institutional, retrospective study

    Energy Technology Data Exchange (ETDEWEB)

    Rudat, Volker; Nour, Alaa; Hammoud, Mohamed; Abou Ghaida, Salam [Saad Specialist Hospital, Department of Radiation Oncology, Al Khobar (Saudi Arabia)

    2017-05-15

    The aim of the study was to identify factors significantly associated with the occurrence of unintended treatment interruptions in adjuvant breast cancer radiotherapy. Patients treated with postoperative radiotherapy of the breast or chest wall between March 2014 and August 2016 were evaluated. The radiotherapy regimens and techniques applied were either conventional fractionation (CF; 28 daily fractions of 1.8 Gy or 25 fractions of 2.0 Gy) or hypofractionation (HF; 15 daily fractions of 2.67 Gy) with inverse planned intensity-modulated radiotherapy (IMRT) or three-dimensional planned conformal radiotherapy (3DCRT). Logistic regression analysis was used to identify factors associated with noncompliance. Noncompliance was defined as the missing of at least one scheduled radiotherapy fraction. In all, 19 of 140 (13.6%) patients treated with HF and 39 of 146 (26.7%) treated with CF experienced treatment interruptions. Of 23 factors tested, the fractionation regimen emerged as the only independent significant prognostic factor for noncompliance on multivariate analysis (CF; p = 0.007; odds ratio, 2.3; 95% confidence interval, 1.3-4.2). No statistically significant differences concerning the reasons for treatment interruptions could be detected between patients treated with CF or HF. HF is significantly associated with a better patient compliance with the prescribed radiotherapy schedule compared with CF. The data suggest that this finding is basically related to the shorter overall treatment time of HF. (orig.) [German] Ziel der Untersuchung war es, Faktoren zu identifizieren, die mit ungeplanten Behandlungsunterbrechungen bei der adjuvanten Strahlentherapie des Mammakarzinoms assoziiert sind. Es wurden Patienten untersucht, die eine adjuvante Strahlentherapie der Mamma oder Brustwand zwischen Maerz 2014 und August 2016 erhielten. Zur Anwendung kamen als Fraktionierungsprotokoll und strahlentherapeutische Technik eine konventionell fraktionierte (CF; 28 Fraktionen mit

  8. Adjuvant and salvage irradiation following radical prostatectomy for prostate cancer

    Energy Technology Data Exchange (ETDEWEB)

    Morris, M M; Dallow, K C; Zietman, A L; Althausen, A F; Heney, N M; McGovern, F J; Shipley, W U

    1995-07-01

    Purpose: To assess the ability of adjuvant irradiation to prevent PSA failure in cases of pT3N0 disease, and of salvage irradiation to durably suppress a rising PSA following radical prostatectomy. Methods and Materials: 62 patients treated by post-operative radiation therapy (60-64Gy in 1.8Gy fractions to the tumor bed) between 1988 and 1993 were evaluated. All had complete pre- and post-radiation PSA data. Median follow up was 3.2 years from time of surgery and 2.2 years from irradiation. 20 patients had Gleason grade 3 disease (moderately differentiated) and 41 Gleason 4-5 (poorly differentiated). 46 had positive inked surgical margins, 18 involved seminal vesicles and 5 had palpable recurrent disease. None had known nodal or metastatic disease. 32 patients underwent adjuvant treatment (undetectable PSA at time of irradiation) and 30 salvage (detectable PSA at time of irradiation). Kaplan-Meier life table analysis was employed. The endpoint studied was freedom from biochemical failure. This was defined as a rise in the PSA of greater than 10% (intra laboratory error <8%) or a previously undetectable PSA becoming detectable. Results: The overall actuarial freedom from biochemical failure at 4 years from radiotherapy was 59%. A significant difference was seen between those receiving adjuvant and those receiving salvage irradiation (71% vs 51%, p=0.03). Amongst those in the salvage group neither the PSA prior to surgery, the PSA at the time of irradiation, the seminal vesicle status, nor the Gleason score (3 vs 4-5) correlated significantly with outcome. The time interval between surgery and irradiation was, however, significant. Those being treated within 6 months fared better than those treated later (60% vs 36%, p=0.04). Further, those treated early were more likely to achieve an undetectable nadir PSA level (94% vs 71%). Conclusion: The addition of adjuvant irradiation appears to improve the 4 year biochemical disease-free survival of patients with poor

  9. Alarmins as biomarkers of gastrointestinal surgical injury - a pilot study.

    Science.gov (United States)

    Maca, Jan; Holub, Michal; Bursa, Filip; Ihnat, Peter; Reimer, Petr; Svagera, Zdenek; Burda, Michal; Sevcik, Pavel

    2018-02-01

    The dysregulation of inflammatory response to surgical injury affects outcomes. Alarmins, the earliest bioactive substances from damaged cells, play a crucial role in initiating the inflammation. We analyzed serum levels of alarmins (S100A8, S100A12, high mobility group box, and heat shock protein 70) after major abdominal surgery (MAS) in surgical (S) (n = 82) and nonsurgical (NS) groups (n = 35). The main objective was determining a role of selected alarmins in host response to MAS. The secondary objectives were (i) evaluation of the relationship among alarmins and selected biomarkers (C-reactive protein, interleukin-6), (ii) influence of the place of gastrointestinal resection, and (iii) role of alarmins in MAS for cancer. Except for HMGB1, the levels of all alarmins were higher in the S group compared with the NS group. In the S group, positive correlations were found between S100A8 and both IL-6 and CRP. Additionally, the S100A8 level was higher (p < 0.01) in patients who underwent upper gastrointestinal tract (GIT) surgery compared to middle and lower GIT resections. Alarmins levels did not differ between cancer and noncancer patients. MAS is able to elicit increase in alarmin levels. S100A8 can be considered a potential biomarker of surgical injury, especially in the upper part of the GIT. © 2018 APMIS. Published by John Wiley & Sons Ltd.

  10. Treatment of carcinoma of uterine cervix stage III by adriamycin, bleomycin and cisplatinum, neoadjuvant, modified radical hysterectomy and adjuvant chemotherapy

    International Nuclear Information System (INIS)

    Valle, J.C. do; Ribeiro, C.W.; Rezende, Magda C.; Figueiredo, E.; Chu, C.

    1987-01-01

    Forty-eight patients with untreated carcinoma of the cervix stage III A and IIIB, were submitted to 3 to 5 cycles of a combination of adriamycin (ADR), bleomycin (BLEO) and cisplatinum (CDDP), followed by modified radical hysterectomy and adjuvant chemotherapy, 6 cycles, of the same association. The surgical aspect is emphasized and the operative sequence is described. A comparative evaluation between the treatment presented and the radiotherapy is done. The survical rate is studied. (M.A.C.) [pt

  11. Retrospective study of surgical cases of ruminants at Veterinary Teaching Hospital, Bangladesh Agricultural University

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    Zakaria Al Noman

    2018-03-01

    Conclusion: This study emphasizes the factors related to successful surgical cases management at VTH. The results may help in controlling surgical related cases in Mymensingh region of Bangladesh. [J Adv Vet Anim Res 2018; 5(1.000: 81-87

  12. Antibiotic prophylaxis adequacy in knee arthroplasty and surgical wound infection: Prospective cohort study.

    Science.gov (United States)

    Del-Moral-Luque, J A; Checa-García, A; López-Hualda, Á; Villar-Del-Campo, M C; Martínez-Martín, J; Moreno-Coronas, F J; Montejo-Sancho, J; Rodríguez-Caravaca, G

    Antibiotic prophylaxis is the most suitable tool for preventing surgical wound infection. This study evaluated adequacy of antibiotic prophylaxis in surgery for knee arthroplasty and its effect on surgical site infection. Prospective cohort study. We assessed the degree of adequacy of antibiotic prophylaxis, the causes of non-adequacy, and the effect of non-adequacy on surgical site infection. Incidence of surgical site infection was studied after a maximum incubation period of a year. To assess the effect of prophylaxis non-adequacy on surgical site infection we used the relative risk adjusted with the aid of a logistic regression model. The study covered a total of 1749 patients. Antibiotic prophylaxis was indicated in all patients and administered in 99.8% of cases, with an overall protocol adequacy of 77.6%. The principal cause of non-compliance was the duration of prescription of the antibiotics (46.5%). Cumulative incidence of surgical site infection was 1.43%. No relationship was found between prophylaxis adequacy and surgical infection (RR=1.15; 95% CI: .31-2.99) (P>.05). Surveillance and infection control programs enable risk factors of infection and improvement measures to be assessed. Monitoring infection rates enables us to reduce their incidence. Adequacy of antibiotic prophylaxis was high but could be improved. We did not find a relationship between prophylaxis adequacy and surgical site infection rate. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Roll of the adjuvant radiotherapy. Kidney cancer. Stage III. Results to 5 years. Observational, descriptive, retrospective, quantitative and comparative study with data numerical description

    International Nuclear Information System (INIS)

    Lione, M.; Tissera, N.; Mandachain, M.

    2007-01-01

    Kidney cancer represents 3 % of the tumors in adults. In the United States, the 45% is diagnosed in early stages. Its natural history is characterized for being absolutely unpredictable and probably related to hormonal, immunologic and unknown factors. There are patients in advanced stage with prolonged or low average survival and even with metastasis declination. These particularities along with the lack of prospective random studies make difficult to establish which is the roll of the adjuvant radiotherapy, being considered not standard since 1997 [es

  14. A qualitative study on perceptions of surgical careers in Rwanda: A gender-based approach.

    Science.gov (United States)

    Yi, Sojung; Lin, Yihan; Kansayisa, Grace; Costas-Chavarri, Ainhoa

    2018-01-01

    Access to surgical care in low- and middle-income countries (LMICs) remains deficient without an adequate workforce. There is limited understanding of the gender gap in surgical trainees in LMICs. In Rwanda, females fill only one of 20 positions available. Understanding surgeons' experiences and perceptions of surgical careers may help facilitate support for females to contribute to the global surgical workforce. We performed qualitative analysis on perceptions of surgical careers through semi-structured interviews of all female surgeons (n = 6) and corresponding male surgeons (n = 6) who are training or have trained at University of Rwanda. Transcripts were analyzed with code structure formed through an integrated approach. Question categories formed the deductive framework, while theoretical saturation was reached through inductive grounded theory. Themes were organized within two key points of the career timeline. First, for developing interest in surgery, three main themes were identified: role models, patient case encounters, and exposure to surgery. Second, for selecting and sustaining surgical careers, four main themes emerged: social expectations about roles within the family, physical and mental challenges, professional and personal support, and finances. All female surgeons emphasized gender assumptions and surgical working culture as obstacles, with a corresponding strong sense of self-confidence and internal motivation that drew them to select and maintain careers in surgery. Family, time, and physical endurance were cited as persistent challenges for female participants. Our study reveals concepts for further exploration about gendered perceptions of surgical careers. Efforts to improve support for female surgical careers as a strategy for shaping surgical work culture and professional development in Rwanda should be considered. Such strategies may be beneficial for improving the global surgical workforce.

  15. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study

    International Nuclear Information System (INIS)

    Potthoff, Karin; Steindorf, Karen; Schmidt, Martina E; Wiskemann, Joachim; Hof, Holger; Klassen, Oliver; Habermann, Nina; Beckhove, Philipp; Debus, Juergen; Ulrich, Cornelia M

    2013-01-01

    Cancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce. Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood. In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy. The BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed. The BEST study is the first randomized controlled trial comparing progressive

  16. SURVIVAL OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS CATHETERS: AN EVALUATION OF SURGICAL AND NON-SURGICAL FACTORS (SINGLE CENTER STUDY

    Directory of Open Access Journals (Sweden)

    A. Keshvari

    2006-06-01

    Full Text Available Peritoneal dialysis is an established form of renal replacement therapy used in many patients with end-stage renal disease. The key to a successful chronic peritoneal dialysis is a permanent and safe access to the peritoneal cavity. This study was conducted in order to evaluate the catheter survival and its related factors in Imam Khomeini Hospital. A total of 80 catheters were inserted into 69 patients (52 men and 28 women with end-stage chronic renal failure during a period of 84 months. Retrospectively the correlation between catheter survival (overall and event free with demographic factors (sex and age, surgical factors (surgeons and surgical methods, nephrologic factors (the causes of peritoneal dialysis selection and the history of hemodialysis and peritonitis factors (the history and number of peritonitis has been evaluated. The mean age of the patients was 48.35 years (16 to 79 years. The overall survival of catheters or the probability of having a functioning catheter after one, two and three years was 53%, 41%, 22%, respectively. The event free survival of the catheter or the probability of having a functioning catheter without any problems after one year was 14%. It has been found out that among all factors in this study only history of hemodialysis had statistically significant effect on the overall survival of continuous ambulatory peritoneal dialysis catheter (P = 0.04. It seems that the overall survival of catheters is better when CAPD is started before any other attempts for hemodialysis.

  17. Adjuvant radiotherapy with brachytherapy boost in soft tissue sarcomas

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    Annalisa Cortesi

    2017-06-01

    Full Text Available Purpose: The standard primary treatment for soft tissue sarcoma (STS is a wide surgical resection, preceded or followed by radiotherapy. Purpose of this retrospective study was to assess the efficacy of perioperative brachytherapy (BRT plus postoperative external beam radiation therapy (EBRT in patients with intermediate-high risk STS. Material and methods : BRT delivered dose was 20 Gy. External beam radiation therapy was delivered with 3D-technique using multiple beams. The prescribed dose was 46 Gy to the PTV. Neoadjuvant and adjuvant chemotherapy (CHT was used in patients with potentially chemosensitive histological subtypes. The primary aim of the study was to analyze overall survival (OS and local control (LC in a large patient population treated with surgery, perioperative BRT, and adjuvant EBRT ± CHT. Secondary objective was to identify prognostic factors for patients outcome in terms of LC, disease-free survival (DFS, and OS. Results : From 2000 to 2011, 107 patients presenting 2-3 grade (FNLCC primary or recurrent STS were treated with surgery, perioperative BRT, and adjuvant EBRT ± CHT. Five-year LC and OS were 80.9% and 87.4%, respectively. At univariate analysis, a higher LC was recorded in primary vs. recurrent tumors (p = 0.015, and in lower limb tumors vs. other sites (p = 0.027. An improved DFS was recorded in patients with lower limb tumors vs. other sites (p = 0.034. Conclusions : The combination of BRT and EBRT was able to achieve satisfactory results even in a patients population with intermediate-high risk STS. Patients with recurrent or other than lower limb sited tumors show a worse LC.

  18. Adjuvant radiotherapy with brachytherapy boost in soft tissue sarcomas

    Science.gov (United States)

    Cortesi, Annalisa; Galuppi, Andrea; Arcelli, Alessandra; Romani, Fabrizio; Mattiucci, Gian Carlo; Bianchi, Giuseppe; Ferrari, Stefano; Ferraro, Andrea; Farioli, Andrea; Gambarotti, Marco; Righi, Alberto; Macchia, Gabriella; Deodato, Francesco; Cilla, Savino; Buwenge, Milly; Valentini, Vincenzo; Morganti, Alessio Giuseppe; Donati, Davide; Cammelli, Silvia

    2017-01-01

    Purpose The standard primary treatment for soft tissue sarcoma (STS) is a wide surgical resection, preceded or followed by radiotherapy. Purpose of this retrospective study was to assess the efficacy of perioperative brachytherapy (BRT) plus postoperative external beam radiation therapy (EBRT) in patients with intermediate-high risk STS. Material and methods BRT delivered dose was 20 Gy. External beam radiation therapy was delivered with 3D-technique using multiple beams. The prescribed dose was 46 Gy to the PTV. Neoadjuvant and adjuvant chemotherapy (CHT) was used in patients with potentially chemosensitive histological subtypes. The primary aim of the study was to analyze overall survival (OS) and local control (LC) in a large patient population treated with surgery, perioperative BRT, and adjuvant EBRT ± CHT. Secondary objective was to identify prognostic factors for patients outcome in terms of LC, disease-free survival (DFS), and OS. Results From 2000 to 2011, 107 patients presenting 2-3 grade (FNLCC) primary or recurrent STS were treated with surgery, perioperative BRT, and adjuvant EBRT ± CHT. Five-year LC and OS were 80.9% and 87.4%, respectively. At univariate analysis, a higher LC was recorded in primary vs. recurrent tumors (p = 0.015), and in lower limb tumors vs. other sites (p = 0.027). An improved DFS was recorded in patients with lower limb tumors vs. other sites (p = 0.034). Conclusions The combination of BRT and EBRT was able to achieve satisfactory results even in a patients population with intermediate-high risk STS. Patients with recurrent or other than lower limb sited tumors show a worse LC. PMID:28725250

  19. Adjuvant Treatment after Surgery in Stage IIIA Endometrial Adenocarcinoma

    Science.gov (United States)

    Yoon, Mee Sun; Huh, Seung Jae; Kim, Hak Jae; Kim, Young Seok; Kim, Yong Bae; Kim, Joo-Young; Lee, Jong-Hoon; Kim, Hun Jung; Cha, Jihye; Kim, Jin Hee; Kim, Juree; Yoon, Won Sup; Choi, Jin Hwa; Chun, Mison; Choi, Youngmin; Lee, Kang Kyoo; Kim, Myungsoo; Jeong, Jae-Uk; Chang, Sei Kyung; Park, Won

    2016-01-01

    Purpose We evaluated the role of adjuvant therapy in stage IIIA endometrioid adenocarcinoma patients who underwent surgery followed by radiotherapy (RT) alone or chemoradiotherapy (CTRT) according to risk group. Materials and Methods A multicenter retrospective study was conducted including patients with surgical stage IIIA endometrial cancertreated by radical surgery and adjuvant RT or CTRT. Disease-free survival (DFS) and overall survival (OS) were analyzed. Results Ninety-three patients with stage IIIA disease were identified. Nineteen patients (20.4%) experienced recurrence, mostly distant metastasis (17.2%). Combined CTRT did not affect DFS (74.1% vs. 82.4%, p=0.130) or OS (96.3% vs. 91.9%, p=0.262) in stage IIIA disease compared with RT alone. Patients with age ≥ 60 years, grade G2/3, and lymphovascular space involvement had a significantly worse DFS and those variables were defined as risk factors. The high-risk group showed a significant reduction in 5-year DFS (≥ 2 risk factors) (49.0% vs. 88.0%, p < 0.001) compared with the low-risk group (< 2). Multivariate analysis confirmed that more than one risk factor was the only predictor of worse DFS (hazard ratio, 5.45; 95% confidence interval, 2.12 to 13.98; p < 0.001). Of patients with no risk factors, a subset treated with RT alone showed an excellent 5-year DFS and OS (93.8% and 100%, respectively). Conclusion We identified a low-risk subset of stage IIIA endometrioid adenocarcinoma patients who might be reasonable candidates for adjuvant RT alone. Further randomized studies are needed to determine which subset might benefit from combined CTRT. PMID:26511800

  20. CLINICAL STUDIES ON THE ADMINISTRATION OF AMOXYCYLIN® AND METRONIDAZOLE® AS AN ADJUVANT TREATMENT IN GENERALIZED AGGRESSIVE PERIODONTITES

    Directory of Open Access Journals (Sweden)

    Vanda Raluca Popa

    2011-12-01

    Full Text Available The aim of the study: The aim of the study was to determine whether the additional systemic treatment with 7 day course of Metronidazole® and Amoxycylin® significantly modified the results of non-surgical treatment in patients suffering from generalized aggressive periodontitis (PAG. Materials and method: The experimental group included 41 patients sufferring from PAG, with at least 3 sites at different teeth, and probing depth of the periodontal pockets (PPD of 5-7 mm. The patients, divided into 2 groups, received identical recipients, containing either antibiotics or placebo. To the former group, first an antibiotic and then a placebo had been administered, while the latter received first placebo and then antibiotics. Results: The main result of the measurements performed in the study, quite significant in the former group, was a reduction of PPD in the sites with an initial PPD =7 mm. Conclusions: The protocol of the present study permits the following conclusion: patients receiving antibiotics as an initial therapy demonstrated significant improvements, comparatively with those who were given such treatments after the etiological one.

  1. Selecting Infants With Cryptorchidism and High Risk of Infertility for Optional Adjuvant Hormonal Therapy and Cryopreservation of Germ Cells: Experience From a Pilot Study

    Directory of Open Access Journals (Sweden)

    Jorgen Thorup

    2018-06-01

    Full Text Available IntroductionOrchiopexy for congenital cryptorchid testes is recommended between ½ and 1 year of age to preserve testicular germ cell maturation. Early operation is not enough to preserve fertility in 22 and 36% of cases. Aim of this study was to set up a protocol for optional adjuvant hormonal therapy after orchiopexy and thereafter cryopreservation of testicular biopsies from infants with bilateral cryptorchidism and high infertility risk.Materials and methodsWe included 17 boys with bilateral cryptorchidism, normal FSH, and impaired germ cell number per tubular transverse section (G/T in testicular biopsies at orchiopexy, 7 months to 3½ years old. Postoperatively, optional adjuvant LHRH (kryptocur® 0.2 mg/0.1 mL 2× every second day in 16 weeks were offered. Ten boys were applicable for age matching according to parent’s choice of treatment regime and G/T. Five of them had kryptocur®, and five were controls. Repeat bilateral testicular biopsy evaluation and cryopreservation were offered to all boys 12 months after primary orchiopexy. For cryopreservation, tissue pieces were incubated with a cryoprotectant with a slow program freezing.ResultsTwo out of five kryptorcur®-treated boys normalized both the average G/T and the number of adult dark spermatogonia (Ad-S. Another kryptocur®-treated boy with initial low G/T and no Ad-S increased the G/T and achieved normal number of Ad-S at time of cryopreservation. In the control group, two patients reached only normal lower range regarding the G/T and the number of Ad-S. None of boys with less than average 0.2 G/T improved significantly, whether they were kryptocur®-treated or not.ConclusionBased on literature and the present results, we recommend adjuvant LHRH treatment to boys with cryptorchidism and insufficient genuine gonadotropin stimulation at time of surgery, as these patients have high infertility risk. Cryopreservation should be an option in case of treatment failure

  2. The Basic Surgical Skills Course in Sub-Saharan Africa: An Observational Study of Effectiveness.

    Science.gov (United States)

    Fergusson, Stuart J; Sedgwick, David M; Ntakiyiruta, Georges; Ntirenganya, Faustin

    2018-04-01

    The Basic Surgical Skills (BSS) course is a common component of postgraduate surgical training programmes in sub-Saharan Africa, but was originally designed in a UK context, and its efficacy and relevance have not been formally assessed in Africa. An observational study was carried out during a BSS course delivered to early-stage surgical trainees from Rwanda and the Democratic Republic of the Congo. Technical skill in a basic wound closure task was assessed in a formal Objective Structured Assessment of Technical Skills (OSAT) before and after course completion. Participants completed a pre-course questionnaire documenting existing surgical experience and self-perceived confidence levels in surgical skills which were to be taught during the course. Participants repeated confidence ratings and completed course evaluation following course delivery. A cohort of 17 participants had completed a pre-course median of 150 Caesarean sections as primary operator. Performance on the OSAT improved from a mean of 10.5/17 pre-course to 14.2/17 post-course (mean of paired differences 3.7, p skills taught, and the course was assessed as highly relevant by trainees. The Basic Surgical Skills course is effective in improving the basic surgical technique of surgical trainees from sub-Saharan Africa and their confidence in key technical skills.

  3. Adjuvant Chemotherapy for Stage II Colon Cancer: A Clinical Dilemma.

    Science.gov (United States)

    Kannarkatt, Joseph; Joseph, Joe; Kurniali, Peter C; Al-Janadi, Anas; Hrinczenko, Borys

    2017-04-01

    The decision to treat a patient with stage II colon cancer with adjuvant chemotherapy can be challenging. Although the benefit of treatment is clear in most patients with stage III disease, the decision to provide chemotherapy after surgical resection in stage II disease must be made on an individual basis. Several trials have demonstrated the small but absolute benefits of receiving adjuvant chemotherapy for stage II colon cancer for disease-free survival and overall survival. In an attempt to better understand the role of chemotherapy, several studies were performed that identified high-risk characteristics that can be used prognostically and predictively to aid in the clinical decision making process. ASCO, the National Comprehensive Cancer Network, and the European Society of Medical Oncology have published guidelines describing these high-risk characteristics. Since then, several other molecular markers have emerged that may offer more information on a given patient's risk for recurrence. The decision to treat a patient with stage II colon cancer must be made on an individual basis, considering the risks and benefits of treatment. In this short review, we will present the available evidence and offer possible directions for future study.

  4. Speech-language therapy program for mouth opening in patients with oral and oropharyngeal cancer undergoing adjuvant radiotherapy: a pilot study.

    Science.gov (United States)

    Marrafon, Caroline Somera; Matos, Leandro Luongo; Simões-Zenari, Marcia; Cernea, Claudio Roberto; Nemr, Katia

    2018-01-01

    Purpose Assess the effectiveness of an orofacial myofunctional therapeutic program in patients with oral or oropharyngeal cancer submitted to adjuvant radiotherapy through pre- and post-program comparison of maximum mandibular opening. Methods Prospective study involving five adult patients and five elderly patients postoperatively to oral cavity/oropharynx surgery who were awaiting the beginning of radiotherapy or had undergone fewer than five treatment sessions. The study participants had their maximum jaw opening measured using a sliding caliper at the beginning and end of the program. Two mobility exercises and three mandibular traction exercises were selected and weekly monitored presentially for 10 weeks. Descriptive data and pre- and post-therapy comparative measures were statistically analyzed using the Wilcoxon test. Results Ten patients (two women and eight men) with mean age of 58.4 years, median of 57.0 years, completed the therapeutic program. They presented mean maximum mandibular opening of 31.6 ± 11.7 and 36.4 ± 8.0 mm pre- and post-therapy, respectively (p =0.021). Conclusion The proposed orofacial myofunctional therapeutic program increased the maximum jaw opening of patients referred to adjuvant radiotherapy for oral cavity or oropharynx cancer treatment.

  5. Surgical education and training in an outer metropolitan hospital: a qualitative study of surgical trainers and trainees.

    Science.gov (United States)

    Nestel, Debra; Harlim, Jennifer; Bryant, Melanie; Rampersad, Rajay; Hunter-Smith, David; Spychal, Bob

    2017-08-01

    The landscape of surgical training is changing. The anticipated increase in the numbers of surgical trainees and the shift to competency-based surgical training places pressures on an already stretched health service. With these pressures in mind, we explored trainers' and trainees' experiences of surgical training in a less traditional rotation, an outer metropolitan hospital. We considered practice-based learning theories to make meaning of surgical training in this setting, in particular Actor-network theory. We adopted a qualitative approach and purposively sampled surgical trainers and trainees to participate in individual interviews and focus groups respectively. Transcripts were made and thematically analysed. Institutional human research ethics approval was obtained. Four surgical trainers and fourteen trainees participated. Almost without exception, participants' report training needs to be well met. Emergent inter-related themes were: learning as social activity; learning and programmatic factors; learning and physical infrastructure; and, learning and organizational structure. This outer metropolitan hospital is suited to the provision of surgical training with the current rotational system for trainees. The setting offers experiences that enable consolidation of learning providing a rich and varied overall surgical training program. Although relational elements of learning were paramount they occurred within a complex environment. Actor-network theory was used to give meaning to emergent themes acknowledging that actors (both people and objects) and their interactions combine to influence training quality, shifting the focus of responsibility for learning away from individuals to the complex interactions in which they work and learn.

  6. Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG Study

    Directory of Open Access Journals (Sweden)

    Arie Figer, Aviram Nissan, Adi Shani, Riva Borovick, Mariana Stiener, Mario Baras, Herbert R. Freund, Aaron Sulkes, Alexander Stojadinovic, Tamar Peretz

    2011-01-01

    Full Text Available Objective: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC. This study evaluates long-term (10-year outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV or 5-FU/Levamisole (5FU+LEV.Methods: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months.Results: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02 and gastrointestinal toxicity with 5FU+LV (p=0.03. Female patients treated with 5FU+LEV had improved overall survival.Conclusions: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset.

  7. Glutathione S-transferase Pi expression predicts response to adjuvant chemotherapy for stage C colon cancer: a matched historical control study

    Directory of Open Access Journals (Sweden)

    Jankova Lucy

    2012-05-01

    Full Text Available Abstract Background This study examined the association between overall survival and Glutathione S-transferase Pi (GST Pi expression and genetic polymorphism in stage C colon cancer patients after resection alone versus resection plus 5-fluourouracil-based adjuvant chemotherapy. Methods Patients were drawn from a hospital registry of colorectal cancer resections. Those receiving chemotherapy after it was introduced in 1992 were compared with an age and sex matched control group from the preceding period. GST Pi expression was assessed by immunohistochemistry. Overall survival was analysed by the Kaplan-Meier method and Cox regression. Results From an initial 104 patients treated with chemotherapy and 104 matched controls, 26 were excluded because of non-informative immunohistochemistry, leaving 95 in the treated group and 87 controls. Survival did not differ significantly among patients with low GST Pi who did or did not receive chemotherapy and those with high GST Pi who received chemotherapy (lowest pair-wise p = 0.11 whereas patients with high GST Pi who did not receive chemotherapy experienced markedly poorer survival than any of the other three groups (all pair-wise p Conclusion Stage C colon cancer patients with low GST Pi did not benefit from 5-fluourouracil-based adjuvant chemotherapy whereas those with high GST Pi did.

  8. Feasibility Study of Adjuvant Chemotherapy Using Taxane Plus Carboplatin for High-Risk Patients With Uterine Cervical Non-Squamous Cell Carcinoma After Radical Hysterectomy.

    Science.gov (United States)

    Sato, Seiya; Shimada, Muneaki; Ohta, Tsuyoshi; Kojimahara, Takanobu; Tokunaga, Hideki; Takano, Tadao; Yamaguchi, Satoshi; Tanabe, Hiroshi; Nishio, Shin; Kigawa, Junzo

    2016-03-01

    We conducted this study to evaluate the efficacy and safety of adjuvant chemotherapy using taxane plus carboplatin (CBDCA) for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy. Thirty-seven patients were eligible. Pelvic lymph node involvement and/or parametrial invasion were defined as high-risk factors. The patients were treated with 6 cycles of paclitaxel (PTX, 175 mg/m(2)) or docetaxel (DTX, 60 mg/m(2)) followed by CBDCA (area under the curve, 6) every 3 weeks. The primary end point was 2-year progression-free survival (PFS) rate, and the secondary end point was the assessment of adverse events. Twenty-two patients received PTX/CBDCA (TC) chemotherapy, and the remaining 15 patients underwent DTX/CBDCA (DC) chemotherapy. The 2-year PFS rate was 62.1% (95% confidence interval, 44.6%-75.5%). Patients receiving DC chemotherapy showed a better 2-year PFS rate compared to those with TC chemotherapy, but the difference was not statistically significant (80.0% vs 50.0%, P = 0.1400). The most common grade 3/4 adverse events were hematologic toxicities, which were generally well tolerable. Nonhematologic toxicity was generally mild. Taxane and CBDCA combination chemotherapy, especially DC chemotherapy, may be one of the useful adjuvant treatments for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy.

  9. Surgical care for the aged: a retrospective cross-sectional study of a national surgical mortality audit

    Science.gov (United States)

    Allen, Jennifer; North, John B; Ware, Robert S

    2015-01-01

    Objectives It is assumed that increased age signifies increased surgical care. Few surgical studies describe the differences in care provided to older patients compared with younger patients. We aimed to examine the relationships between increasing age, preoperative factors and markers of postoperative care in adults who died in-hospital after surgery in Australia. Design This retrospective cross-sectional study extracted data from a national surgical mortality audit—an independent, peer-reviewed process. Setting From January 2009 to December 2012, 111 public and 61 private Australian hospitals notified the audit of in-hospital deaths after general anaesthetic surgery or if the patient was admitted under a surgeon. Participants Notified deaths totalled 19 723. We excluded deaths if patients were brain dead, younger than 17 years or never had an operation (n=11 376). From this baseline population, we divided 11 201 deaths into three patient age groups: youngest (17–64 years), medium (65–79 years) and oldest (≥80 years). Outcome measures Univariable and multivariable logistic regression analyses determined the relationships between increasing age and the measured preoperative factors and postoperative variables. Results The baseline population's median age was 78 years (IQR 66–85), 43.7% (4892/11 201) were 80 years or older and 83.4% (9319/11 173) had emergency admissions. The oldest group had increased trauma and emergency admissions than the medium and youngest age groups. Seven of the eight measured markers of postoperative care demonstrate strong and significant relationships with increasing age. The oldest group compared with the medium group had decreased rates of: unplanned returns to theatre (11.2% (526/4709) vs 20.2% (726/3586)), unplanned intensive care admissions (16.3% (545/3350) vs 24.0% (601/2504)) and treatment in intensive care units (59.7% (2689/4507) vs 76.7% (2754/3590)). Conclusions The oldest patients received

  10. Surgical reintervention after antireflux surgery for gastroesophageal reflux disease: a prospective cohort study in 130 patients

    NARCIS (Netherlands)

    Furnée, Edgar J. B.; Draaisma, Werner A.; Broeders, Ivo A. M. J.; Smout, Andre J. P. M.; Gooszen, Hein G.

    2008-01-01

    HYPOTHESIS: Surgical reintervention after antireflux surgery for gastroesophageal reflux disease is required in 3% to 6% of patients. The subjective outcome after reintervention has been reported in several studies, but objective results after these subsequent operations have rarely been published.

  11. Effect of different adjuvant formulations on the immunogenicity and protective effect of a live Mycoplasma hyopneumoniae vaccine after intramuscular inoculation.

    Science.gov (United States)

    Xiong, Qiyan; Wei, Yanna; Xie, Haidong; Feng, Zhixin; Gan, Yuan; Wang, Chunlai; Liu, Maojun; Bai, Fangfang; Xie, Fang; Shao, Guoqing

    2014-06-05

    Mycoplasma hyopneumoniae (M. hyopneumoniae) vaccine strain 168 is an intrapulmonically injected attenuated live vaccine that is available in the Chinese market. The aim of this study was to develop suitable adjuvants for this live vaccine to provide effective protection after intramuscular inoculation. Several adjuvant components were screened to assess their toxicity for the live vaccine, and various adjuvant formulations were then designed and prepared. Vaccines supplemented with these adjuvants were used to immunize mice intramuscularly to assess the capacity of the adjuvants to induce a specific immune response. The screened formulations were then evaluated in pigs. Seven of the eight adjuvant components did not affect the viability of the live vaccine, and seven different adjuvant formulations were then designed. In mice, the ISCOM-matrix adjuvant and the levamisole-chitosan mixture adjuvant significantly enhanced serum IgG responses against M. hyopneumoniae, while lymphocyte proliferation was enhanced by the ISCOM-matrix adjuvant, the carbomer-astragalus polysaccharide mixture adjuvant and an oil-in-water emulsion adjuvant. These four adjuvants were evaluated in pigs. Enhancement of specific lymphocyte proliferation responses was observed in the groups vaccinated with the ISCOM-matrix adjuvant and the carbomer-astragalus polysaccharide mixture adjuvant. Significant enhancement of serum IgG antibody production was observed before challenge in pigs vaccinated with the carbomer-astragalus polysaccharide mixture adjuvant and the levamisole-chitosan mixture adjuvant, while after challenge, all of the animals that received vaccines containing adjuvants had higher antibody concentrations against M. hyopneumoniae than unvaccinated animals. Animals inoculated with a vaccine containing the ISCOM-matrix adjuvant (median score 3.57) or the carbomer-astragalus polysaccharide mixture adjuvant (median score 5.28) had reduced lesion scores compared to unvaccinated animals

  12. The Sex Difference in Basic Surgical Skills Learning: A Comparative Study.

    Science.gov (United States)

    Lou, Zheng; Yan, Fei-Hu; Zhao, Zhi-Qing; Zhang, Wei; Shui, Xian-Qi; Liu, Jia; Zhuo, Dong-Lan; Li, Li; Yu, En-da

    2016-01-01

    Very little is known of sex-related differences among medical students in the acquisition of basic surgical skills at an undergraduate level. The aim of this study was to investigate the sex differences in basic surgical skills learning and the possible explanations for sex disparities within basic surgical skills education. A didactic description of 10 surgical skills was performed, including knot tying, basic suture I, basic suture II, sterile technique, preoperative preparation, phlebotomy, debridement, laparotomy, cecectomy, and small bowel resection with hand-sewn anastomosis. The students were rated on a 100-point scale for each basic surgical skill. Later during the same semester all the students took the final theoretical examination. A total of 342 (male = 317 and female = 25) medical students participated in a single skills laboratory as part of their third-year medical student clerkship. The mean scores for each of the 10 surgical skills were higher in female group. The difference in sterile technique, preoperative preparation, cecectomy, and small bowel resection with hand-sewn anastomosis reached the significant level. Compared with male medical students, the mean theory examination score was significantly higher in female medical students. Approximately 76% of the (19 of 25) female students expressed their interest in pursuing a surgical career, whereas only 65.5% (207 of 317) male students wanted to be surgical professionals (p = 0.381). Female medical students completed basic surgical skills training more efficiently and passed the theoretical examination with significantly higher scores than male medical students. In the future, studies should be done in other classes in our institution and perhaps other schools to see if these findings are reliable or valid or just a reflection of this 1 sample. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  13. Synthetic Self-Adjuvanting Glycopeptide Cancer Vaccines

    Science.gov (United States)

    Payne, Richard; McDonald, David; Byrne, Scott

    2015-10-01

    Due to changes in glycosyltransferase expression during tumorigenesis, the glycoproteins of cancer cells often carry highly truncated carbohydrate chains compared to those on healthy cells. These glycans are known as tumor-associated carbohydrate antigens, and are prime targets for use in vaccines for the prevention and treatment of cancer. Herein, we review the state-of-the-art in targeting the immune system towards tumor-associated glycopeptide antigens via synthetic self adjuvanting vaccines, in which the antigenic and adjuvanting moieties of the vaccines are present in the same molecule. The majority of the self-adjuvanting glycopeptide cancer vaccines reported to date employ antigens from mucin 1, a protein which is highly over-expressed and aberrantly glycosylated in many forms of cancer. The adjuvants used in these vaccines predominantly include lipopeptide- or lipoamino acid-based TLR2 agonists, although studies investigating stimulation of TLR9 and TLR4 are also discussed. Most of these adjuvants are highly lipophilic, and, upon conjugation to antigenic peptides, provide amphiphilic vaccine molecules. The amphiphilic nature of these vaccine constructs can lead to the formation of higher-order structures by vaccines in solution, which are likely to be important for their efficacy in vivo.

  14. Risk factors for acute surgical site infections after lumbar surgery: a retrospective study.

    Science.gov (United States)

    Lai, Qi; Song, Quanwei; Guo, Runsheng; Bi, Haidi; Liu, Xuqiang; Yu, Xiaolong; Zhu, Jianghao; Dai, Min; Zhang, Bin

    2017-07-19

    Currently, many scholars are concerned about the treatment of postoperative infection; however, few have completed multivariate analyses to determine factors that contribute to the risk of infection. Therefore, we conducted a multivariate analysis of a retrospectively collected database to analyze the risk factors for acute surgical site infection following lumbar surgery, including fracture fixation, lumbar fusion, and minimally invasive lumbar surgery. We retrospectively reviewed data from patients who underwent lumbar surgery between 2014 and 2016, including lumbar fusion, internal fracture fixation, and minimally invasive surgery in our hospital's spinal surgery unit. Patient demographics, procedures, and wound infection rates were analyzed using descriptive statistics, and risk factors were analyzed using logistic regression analyses. Twenty-six patients (2.81%) experienced acute surgical site infection following lumbar surgery in our study. The patients' mean body mass index, smoking history, operative time, blood loss, draining time, and drainage volume in the acute surgical site infection group were significantly different from those in the non-acute surgical site infection group (p operative type in the acute surgical site infection group were significantly different than those in the non-acute surgical site infection group (p operative type, operative time, blood loss, and drainage time were independent predictors of acute surgical site infection following lumbar surgery. In order to reduce the risk of infection following lumbar surgery, patients should be evaluated for the risk factors noted above.

  15. Unicameral bone cyst: a retrospective study of three surgical treatments.

    Science.gov (United States)

    Sung, Anthony D; Anderson, Megan E; Zurakowski, David; Hornicek, Francis J; Gebhardt, Mark C

    2008-10-01

    Between 1979 and 2004, 167 patients younger than 20 years were treated surgically for humeral or femoral unicameral bone cysts with either injection of corticosteroids (steroids), curettage plus bone grafting (curettage), or a combination injection of steroids, demineralized bone matrix, and bone marrow aspirate (SDB) at Children's Hospital of Boston and Massachusetts General Hospital (mean followup, 7.3 years; range, 1 month-27 years). Outcomes included treatment failure (defined clinically as subsequent pathologic fracture or need for retreatment to prevent pathologic fracture) and complications. Information was obtained from medical records and by telephone questionnaire. After one treatment, 84% of cysts treated with steroids experienced failed treatment versus 64% with curettage and 50% with SDB. For unicameral bone cysts requiring retreatment (regardless of first treatment), 76% retreated with steroids had failed treatment versus 63% with curettage and 71% with SDB. Curettage was associated with the lowest rate of posttreatment pathologic fractures and highest rate of pain and other complications. Multivariate logistic regression indicated treatment with steroids alone and younger age were independent predictors of failure. We believe SDB is a reasonable first treatment for unicameral bone cysts in the humerus and femur in patients younger than 20 years, being less invasive yet comparable to curettage in preventing recurrence.

  16. Assessing Residents' Readiness for OR Autonomy: A Qualitative Descriptive Study of Expert Surgical Teachers' Best Practices.

    Science.gov (United States)

    Chen, Xiaodong Phoenix; Sullivan, Amy M; Alseidi, Adnan; Kwakye, Gifty; Smink, Douglas S

    Providing resident autonomy in the operating room (OR) is one of the major challenges for surgical educators today. The purpose of this study was to explore what approaches expert surgical teachers use to assess residents' readiness for autonomy in the OR. We particularly focused on the assessments that experts make prior to conducting the surgical time-out. We conducted semistructured in-depth interviews with expert surgical teachers from March 2016 to September 2016. Purposeful sampling and snowball sampling were applied to identify and recruit expert surgical teachers from general surgery residency programs across the United States to represent a range of clinical subspecialties. All interviews were audio-recorded, deidentified, and transcribed. We applied the Framework Method of content analysis, discussed and reached final consensus on the themes. We interviewed 15 expert teachers from 9 institutions. The majority (13/15) were Program or Associate Program Directors; 47% (7/15) primarily performed complex surgical operations (e.g., endocrine surgery). Five themes regarding how expert surgical teachers determine residents' readiness for OR autonomy before the surgical time-out emerged. These included 3 domains of evidence elicited about the resident (resident characteristics, medical knowledge, and beyond the current OR case), 1 variable relating to attending characteristics, and 1 variable composed of contextual factors. Experts obtained one or more examples of evidence, and adjusted residents' initial autonomy using factors from the attending variable and the context variable. Expert surgical teachers' assessments of residents' readiness for OR autonomy included 5 key components. Better understanding these inputs can contribute to both faculty and resident development, enabling increased resident autonomy and preparation for independent practice. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  17. A comparative study of thoracoscopic sympathicotomy versus local surgical treatment for axillary hyperhidrosis

    DEFF Research Database (Denmark)

    Heidemann, Erik; Licht, Peter B

    2013-01-01

    Axillary hyperhidrosis affects approximately 1.4% of the population. Medical management is often frustrating, and the response generally transient. Surgical methods include thoracoscopic sympathectomy or sympathicotomy and local axillary surgery such as suction-curettage or en-bloc skin resection....... Many case series with retrospective follow-up are available in the literature, but no comparative studies between surgical techniques have been published....

  18. Protein antigen adsorption to the DDA/TDB liposomal adjuvant

    DEFF Research Database (Denmark)

    Hamborg, Mette; Jorgensen, Lene; Bojsen, Anders Riber

    2013-01-01

    Understanding the nature of adjuvant-antigen interactions is important for the future design of efficient and safe subunit vaccines, but remains an analytical challenge. We studied the interactions between three model protein antigens and the clinically tested cationic liposomal adjuvant composed...... of dimethyldioctadecylammonium (DDA) and trehalose 6,6'-dibehenate (TDB)....

  19. Long-term heart function after adjuvant epirubicin chemotherapy for breast cancer

    DEFF Research Database (Denmark)

    Appel, Jon M; Zerahn, Bo; Møller, Susanne

    2012-01-01

    Newer studies raise concern that adjuvant anthracycline treatment for breast cancer (BC) causes long-term heart damage. We aimed to examine whether heart failure or impairment could be demonstrated several years after low-dose epirubicin-based adjuvant treatment.......Newer studies raise concern that adjuvant anthracycline treatment for breast cancer (BC) causes long-term heart damage. We aimed to examine whether heart failure or impairment could be demonstrated several years after low-dose epirubicin-based adjuvant treatment....

  20. The adjuvant potential of synthetic alkylglycerols.

    Science.gov (United States)

    Acevedo, Reinaldo; Gil, Danay; del Campo, Judith; Bracho, Gustavo; Valdés, Yolanda; Pérez, Oliver

    2006-04-12

    Alkylglycerols (AGs) have shown immune stimulant and adjuvant activity in many studies, but natural sources are not so accessible and their extraction from them is very complicated. Therefore, a group of chemists at IFAL have synthesized AG analogs. The aim of this work was to evaluate the adjuvant potential of different synthetic AGs. A mix of ovoalbumin (Ova) and AGs increase anti-Ova IgG antibodies production in sera of immunized mice. The predominant subclass was IgG1 although higher levels of IgG2a were observed as the carbon chain length of AGs increased. AGs also induced the production of IL-12 and nitric oxide (NO) in the U937 human histiocyte and J774 mouse macrophage cell lines, respectively. These results indicate that synthetic AGs are effective adjuvants for the standardized antigen, Ova.

  1. Adjuvant chemo- and radiotherapy in gastrointestinal tumors; Adjuvante Chemo- und Strahlentherapie bei gastrointestinalen Tumoren

    Energy Technology Data Exchange (ETDEWEB)

    Sendler, A. [Technische Univ. Muenchen (Germany). Chirurgische Klinik und Poliklinik; Feldmann, H.J. [Technische Univ. Muenchen (Germany). Inst. und Poliklinik fuer Strahlentherapie und Radiologische Onkologie; Fink, U. [Technische Univ. Muenchen (Germany). Chirurgische Klinik und Poliklinik; Molls, M. [Technische Univ. Muenchen (Germany). Inst. und Poliklinik fuer Strahlentherapie und Radiologische Onkologie; Siewert, J.R. [Technische Univ. Muenchen (Germany). Chirurgische Klinik und Poliklinik

    1995-04-21

    In modern surgical oncology, adjuvant therapies are important complementary strategies. In local advanced carcinomas of the gastrointestinal tract, 5-year survival data are still disappointing despite standardized surgery. In this context, it has to be differentiated between adjuvant therapy following complete tumor exstirpation (so-called UICC R{sub 0} resection) and additive therapies following incomplete tumor resections (UICC R{sub 1} or R{sub 2} resection). Modalities in the adjuvant setting are chemotherapy, radiotherapy or the combined radio-/chemotherapy. In esophageal and gastric cancer there is up to now no benefit of postoperative adjuvant therapy. In pancreatic cancer, there are studies indicating a benefit of combined radio-/chemotherapy after complete tumor resection. A standard adjuvant chemotherapeutic treatment is proven in colon cancer stage III (Dukes C) with levamisole and 5-FU. Completely resected rectal carcinoma should be treated postoperatively with combined radio-/chemotherapy. In the common clinical or practical setting, adjuvant therapy is indicated only in locally advanced gastrointestinal tumors following R{sub 0} resection. Postoperative therapy following incomplete tumor resection has its reason only in a palliative intention. (orig.) [Deutsch] Adjuvante Therapiestrategien sind wichtige flankierende Massnahmen der modernen onkologischen Chirurgie, da u.a. die 5-Jahres-Ueberlebensquoten bei lokal fortgeschrittenen Tumoren des Gastrointestinaltraktes nach wie vor unbefriedingend sind. Dabei muss grundsaetzlich zwischen adjuvanten Behandlungen nach kompletter Tumorexstirpation (UICC-R{sub 0}-Resektion) und der additiven Therapie nach palliativer Resektion (UICC-R{sub 1}- oder -R{sub 2}-Resektion) unterschieden werden. Als Modalitaeten kommen Chemotherapie, Strahlentherapie und ihre Kombination in Frage. Bei Oesophagus- und Magenkarzinomen kann derzeit keine gueltige Empfehlung zur adjuvanten Therapie gegeben werden. Die Radio

  2. Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: A randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Sánchez-de la Osa Reinaldo B

    2008-02-01

    Full Text Available Abstract Background High antibiotic resistance is described in atypical Mycobacteriosis, mainly by Mycobacterium avium complex (MAC. Methods A randomized, double-blind, placebo-controlled clinical trial was carried out in two hospitals to evaluate the effect of interferon (IFN gamma as immunoadjuvant to chemotherapy on patients with atypical mycobacteria lung disease. Patients received placebo or 1 × 106 IU recombinant human IFN gamma intramuscularly, daily for one month and then three times per week up to 6 months as adjuvant to daily oral azithromycin, ciprofloxacin, ethambutol and rifampin. Sputum samples collection for direct smear observation and culture as well as clinical and thorax radiography assessments were done during treatment and one year after. Cytokines and oxidative stress determinations were carried out in peripheral blood before and after treatment. Results Eighteen patients were included in the IFN group and 14 received placebo. Groups were homogeneous at entry; average age was 60 years, 75% men, 84% white; MAC infection prevailed (94%. At the end of treatment, 72% of patients treated with IFN gamma were evaluated as complete responders, but only 36% in the placebo group. The difference was maintained during follow-up. A more rapid complete response was obtained in the IFN group (5 months before, with a significantly earlier improvement in respiratory symptoms and pulmonary lesions reduction. Disease-related deaths were 35.7% of the patients in the placebo group and only 11.1% in the IFN group. Three patients in the IFN group normalized their globular sedimentation rate values. Although differences in bacteriology were not significant during the treatment period, some patients in the placebo group converted again to positive during follow-up. Significant increments in serum TGF-beta and advanced oxidation protein products were observed in the placebo group but not among IFN receiving patients. Treatments were well tolerated

  3. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    International Nuclear Information System (INIS)

    Chintamani; Singhal, Vinay; Singh, JP; Lyall, Ashima; Saxena, Sunita; Bansal, Anju

    2004-01-01

    Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins) brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio). Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide) were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was assessed using chi-square test and coefficient

  4. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    Directory of Open Access Journals (Sweden)

    Singh JP

    2004-08-01

    Full Text Available Abstract Background Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. Methods 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio. Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was

  5. Adjuvant chemotherapy for osteosarcoma.

    Science.gov (United States)

    Eilber, F R; Rosen, G

    1989-08-01

    From this review of chemotherapy trials, several observations can be made. Osteosarcoma is a complex disease involving multiple histologies, each with a different prognosis. Prognostic factors that have been shown to be important include anatomic location of the primary tumor, stage at presentation (patients with metastatic or local recurrent disease fair far worse than those with primary disease), age at onset (children fair worse than the teenager with osteosarcoma), and location within the extremity (patients with more distal tumors fairing better than patients with more proximal tumors). There is convincing evidence for the efficacy of chemotherapeutic agents such as methotrexate in high doses (at least 8 g/m2 for adults, 12 g/m2 for children), Adriamycin, and cisplatin. The combination of Adriamycin and cisplatin appears to be more beneficial relative to either one of these agents alone. The efficacy of the combination of BCD as a triple-drug regimen, although useful in several different trials, has not been convincingly shown. Finally, from several of the recent randomized trials, it appears, that chemotherapeutic regimens containing an Adriamycin and cisplatin combination appear to be superior to those that do not include this combination. However, these observations are made from a historical perspective and have not been conclusively proven by randomized prospective investigations. The observations concerning the natural history of the disease and the activity of various chemotherapeutic agents suggest certain clinical practice algorithms. Essential staging procedures would include a bone scan looking for multifocal or metastatic disease, and CT scans of the chest looking for metastases to the lung. From all studies, it is apparent that surgery is mandatory for the primary tumor and should be an integral portion of all treatment methods. Chemotherapy should be considered for all patients with osteosarcoma, and the essential drugs in the regimen appear at

  6. Surgical referral coordination from a first-level hospital: a prospective case study from rural Nepal.

    Science.gov (United States)

    Fleming, Matthew; King, Caroline; Rajeev, Sindhya; Baruwal, Ashma; Schwarz, Dan; Schwarz, Ryan; Khadka, Nirajan; Pande, Sami; Khanal, Sumesh; Acharya, Bibhav; Benton, Adia; Rogers, Selwyn O; Panizales, Maria; Gyorki, David; McGee, Heather; Shaye, David; Maru, Duncan

    2017-09-25

    Patients in isolated rural communities typically lack access to surgical care. It is not feasible for most rural first-level hospitals to provide a full suite of surgical specialty services. Comprehensive surgical care thus depends on referral systems. There is minimal literature, however, on the functioning of such systems. We undertook a prospective case study of the referral and care coordination process for cardiac, orthopedic, plastic, gynecologic, and general surgical conditions at a district hospital in rural Nepal from 2012 to 2014. We assessed the referral process using the World Health Organization's Health Systems Framework. We followed the initial 292 patients referred for surgical services in the program. 152 patients (52%) received surgery and four (1%) suffered a complication (three deaths and one patient reported complication). The three most common types of surgery performed were: orthopedics (43%), general (32%), and plastics (10%). The average direct and indirect cost per patient referred, including food, transportation, lodging, medications, diagnostic examinations, treatments, and human resources was US$840, which was over 1.5 times the local district's per capita income. We identified and mapped challenges according to the World Health Organization's Health Systems Framework. Given the requirement of intensive human capital, poor quality control of surgical services, and the overall costs of the program, hospital leadership decided to terminate the referral coordination program and continue to build local surgical capacity. The results of our case study provide some context into the challenges of rural surgical referral systems. The high relative costs to the system and challenges in accountability rendered the program untenable for the implementing organization.

  7. Epidemiology and treatment outcome of surgically treated mandibular condyle fractures. A five years retrospective study.

    Science.gov (United States)

    Zrounba, Hugues; Lutz, Jean-Christophe; Zink, Simone; Wilk, Astrid

    2014-09-01

    Surgical management of mandibular condyle fractures is still controversial. Although it provides better outcome than closed treatment questions still remain about the surgical approach and the osteosynthesis devices to be used. Between 2005 and 2010, we managed 168 mandibular condyle fractures with open treatment. Two surgical approaches were used in this study, a pre-auricular and a high submandibular approach (one or the other or as a combined approach). Internal fixation was performed using TCP(®) plates (Medartis, Basel, Switzerland) or with two lag screws (15 and 17 mm). Delta plates were used in 15 cases (8.9%). We report the epidemiology of these fractures and the outcomes of the surgical treatment. We assessed the complications related to the surgical procedure and those related to the osteosynthesis material. The facial nerve related complication rate was very low and the osteosynthesis materials used proved to be strong enough to realize a stable fixation. The two approaches used in this study appeared to be safe with good aesthetic results. Most of the surgical procedure failures occurred in high subcondylar fractures especially when bilateral. Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  8. Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study

    Science.gov (United States)

    Touillaud, M; Foucaut, A-M; Berthouze, S E; Reynes, E; Kempf-Lépine, A-S; Carretier, J; Pérol, D; Guillemaut, S; Chabaud, S; Bourne-Branchu, V; Perrier, L; Trédan, O; Fervers, B; Bachmann, P

    2013-01-01

    Introduction After a diagnosis of localised breast cancer, overweight, obesity and weight gain are negatively associated with prognosis. In contrast, maintaining an optimal weight through a balanced diet combined with regular physical activity appears to be effective protective behaviour against comorbidity or mortality after a breast cancer diagnosis. The primary aim of the Programme pour une Alimentation Saine et une Activité Physique Adaptée pour les patientes atteintes d'un cancer du Sein (PASAPAS) randomised controlled trial is to evaluate the feasibility of implementing an intervention of adapted physical activity (APA) for 6 months concomitant with the prescription of a first line of adjuvant chemotherapy. Secondary aims include assessing the acceptability of the intervention, compliance to the programme, process implementation, patients’ satisfaction, evolution of biological parameters and the medicoeconomic impact of the intervention. Methods and analysis The study population consists of 60 women eligible for adjuvant chemotherapy after a diagnosis of localised invasive breast cancer. They will be recruited during a 2-year inclusion period and randomly allocated between an APA intervention arm and a control arm following a 2:1 ratio. All participants should benefit from personalised dietetic counselling and patients allocated to the intervention arm will be offered an APA programme of two to three weekly sessions of Nordic walking and aerobic fitness. During the 6-month intervention and 6-month follow-up, four assessments will be performed including blood draw, anthropometrics and body composition measurements, and questionnaires about physical activity level, diet, lifestyle factors, psychological criteria, satisfaction with the intervention and medical data. Ethics and dissemination The study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud-Est IV) and the national agencies for biomedical studies and for privacy

  9. Sentinel lymph node biopsy using dye alone method is reliable and accurate even after neo-adjuvant chemotherapy in locally advanced breast cancer - a prospective study

    Directory of Open Access Journals (Sweden)

    Mishra Ashwani

    2011-02-01

    Full Text Available Abstract Background Sentinel lymph node biopsy (SLNB is now considered a standard of care in early breast cancers with N0 axillae; however, its role in locally advanced breast cancer (LABC after neo-adjuvant chemotherapy (NACT is still being debated. The present study assessed the feasibility, efficacy and accuracy of sentinel lymph node biopsy (SLNB using "dye alone" (methylene blue method in patients with LABC following NACT. Materials and methods Thirty, biopsy proven cases of LABC that had received three cycles of neo-adjuvant chemotherapy (cyclophosphamide, adriamycin, 5-fluorouracil were subjected to SLNB (using methylene blue dye followed by complete axillary lymph node dissection (levels I-III. The sentinel node(s was/were and the axilla were individually assessed histologically. The SLN accuracy parameters were calculated employing standard definitions. The SLN identification rate in the present study was 100%. The sensitivity of SLNB was 86.6% while the accuracy was 93.3%, which were comparable with other studies done using dual lymphatic mapping method. The SLN was found at level I in all cases and no untoward reaction to methylene blue dye was observed. Conclusions This study confirms that SLNB using methylene blue dye as a sole mapping agent is reasonably safe and almost as accurate as dual agent mapping method. It is likely that in the near future, SLNB may become the standard of care and provide a less morbid alternative to routine axillary lymph node dissection even in patients with LABC that have received NACT.

  10. Expression of the DNA repair gene MLH1 correlates with survival in patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704.

    Science.gov (United States)

    Lawrence, Yaacov R; Moughan, Jennifer; Magliocco, Anthony M; Klimowicz, Alexander C; Regine, William F; Mowat, Rex B; DiPetrillo, Thomas A; Small, William; Simko, Jeffry P; Golan, Talia; Winter, Kathryn A; Guha, Chandan; Crane, Christopher H; Dicker, Adam P

    2018-02-01

    The majority of patients with pancreatic cancer who undergo curative resection experience rapid disease recurrence. In previous small studies, high expression of the mismatch-repair protein mutL protein homolog 1 (MLH1) in pancreatic cancers was associated with better outcomes. The objective of this study was to validate the association between MLH1 expression and survival in patients who underwent resection of pancreatic cancer and received adjuvant chemoradiation. Samples were obtained from the NRG Oncology Radiation Therapy Oncology Group 9704 prospective, randomized trial (clinicaltrials.gov identifier NCT00003216), which compared 2 adjuvant protocols in patients with pancreatic cancer who underwent resection. Tissue microarrays were prepared from formalin-fixed, paraffin-embedded, resected tumor tissues. MLH1 expression was quantified using fluorescence immunohistochemistry and automated quantitative analysis, and expression was dichotomized above and below the median value. Immunohistochemical staining was successfully performed on 117 patients for MLH1 (60 and 57 patients from the 2 arms). The characteristics of the participants who had tissue samples available were similar to those of the trial population as a whole. At the time of analysis, 84% of participants had died, with a median survival of 17 months. Elevated MLH1 expression levels in tumor nuclei were significantly correlated with longer disease-free and overall survival in each arm individually and in both arms combined. Two-year overall survival was 16% in patients who had low MLH1 expression levels and 53% in those who had high MLH1 expression levels (P MLH1 expression was correlated with long-term survival. Further studies should assess whether MLH1 expression predicts which patients with localized pancreatic cancer may benefit most from aggressive, multimodality treatment. Cancer 2018;124:491-8. © 2017 American Cancer Society. © 2017 American Cancer Society.

  11. Surgical Treatment of Severe Traumatic Brain Injury in Switzerland: Results from a Multicenter Study.

    Science.gov (United States)

    Rossi-Mossuti, Frédéric; Fisch, Urs; Schoettker, Patrick; Gugliotta, Marinella; Morard, Marc; Schucht, Philippe; Schatlo, Bawarjan; Levivier, Marc; Walder, Bernhard; Fandino, Javier

    2016-01-01

    Since the introduction of modern surgical techniques and monitoring tools for the treatment of severe traumatic brain injury (TBI) in Switzerland, standardized nationwide operative procedures are still lacking. This study aimed to assess surgical management and monitoring strategies in patients admitted throughout Switzerland with severe TBI. Demographic, clinical, and radiologic data from a prospective national cohort study on severe brain-injured patients (Patient-relevant Endpoints after Brain Injury from Traumatic Accidents [PEBITA]) were collected during a 3-year period. This study evaluated patients admitted to 7 of the 11 trauma centers included in PEBITA. We retrospectively analyzed surgery-related computed tomography (CT) findings prior to and after treatment, intracranial pressure (ICP) monitoring, size and technical features of craniotomy, as well as surgical complications. ResULTS: This study included 353 of the 921 patients enrolled in PEBITA who underwent surgical treatment for severe TBI. At admission, acute subdural hematoma was the most frequent focal lesion diagnosed (n = 154 [44%]), followed by epidural hematoma (n = 96 [27%]) and intracerebral hematoma (n = 84 [24%]). A total of 198 patients (61%) presented with midline shift. Clinical deterioration in terms of Glasgow Coma Scale scores or intractable ICP values as an indication for surgical evacuation or decompression were documented in 20% and 6%, respectively. A total of 97 (27.5%) only received a catheter/probe for ICP monitoring. Surgical procedures to treat a focal lesion or decompress the cerebrum were performed in 256 patients (72.5%). Of the 290 surgical procedures (excluding ICP probe implantation), craniotomy (137 [47.2%]) or decompressive craniectomy (133 [45.9%]) were performed most frequently. The mean size of craniectomy in terms of maximal linear width on the CT axial slice was 8.4 ± 2.9 cm. Intraoperative ICP monitoring was reported in 61% of the interventions. Significant

  12. The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study

    DEFF Research Database (Denmark)

    Møller, Tom; Lillelund, Christian; Andersen, Christina

    2015-01-01

    Introduction Anti-neoplastic treatment is synonymous with an inactive daily life for a substantial number of patients. It remains unclear what is the optimal setting, dosage and combination of exercise and health promoting components that best facilitate patient adherence and symptom management...... in order to support cardio-respiratory fitness and lifestyle changes in an at-risk population of pre-illness physically inactive cancer patients.Methods Patients with breast or colon cancer referred to adjuvant chemotherapy and by the oncologists pre-screening verified as physically inactive were eligible...... to enter a randomised three-armed feasibility study comparing a 12-week supervised hospital-based moderate to high intensity exercise intervention or alternate an instructive home-based12-week pedometer intervention, with usual care.Results Using a recommendation based physical activity screening...

  13. Adjuvant radiotherapy for phyllodes tumor of the breast

    International Nuclear Information System (INIS)

    Chaney, Arthur W.; Pollack, Alan; Zagars, Gunar K.

    1997-01-01

    Purpose/Objective: The role of radiotherapy for the treatment of phyllodes tumors of the breast remains controversial. Adjuvant radiotherapy is often cited in the existing literature as not providing any benefit over surgical treatment alone. The data supporting this belief are anecdotal. There are also anecdotal reports that radiotherapy may have a role in cases wherein the risk of local failure is high. As with breast carcinomas, conservative surgery (wide local excision) for phyllodes tumors is associated with about a 50% local recurrence rate; diffuse or bulky disease and/or malignant histology are also associated with high local failure rates. We are unaware of any series that examines the role of adjuvant radiotherapy in the management of phyllodes tumor of the breast. We present here a retrospective study of eight patients so treated at MD Anderson Cancer Center. Materials and Methods: Eight patients have been treated with radiotherapy for non-metastatic phyllodes tumor of the breast at MD Anderson Cancer Center between December 1988 and August 1993. All patients were female; the median age was 43 years, with a range of 19 to 62 years. All patients presented with a breast mass, which was associated with pain in one patient, and was ulcerative in three. Results: Tumor size ranged from 3.5 to 16 cm, with a median diameter of 10.4 cm. Six patients had tumors in the upper outer quadrant, and two patients had upper inner tumors. Five patients had malignant tumors, two patients were classified as benign, and one was of indeterminate malignant potential. All five of the malignant tumors displayed stromal overgrowth on pathologic review. The remaining benign and indeterminate tumors lacked this feature. One patient with a benign tumor had a history of two prior recurrences. Primary surgery consisted of either lumpectomy in two patients or mastectomy in six patients. Axillary level I/II lymph node dissections were performed in 5 patients and no involvement was seen

  14. Changes in Weight and Body Composition Among Women With Breast Cancer During and After Adjuvant Treatment: A Prospective Follow-up Study.

    Science.gov (United States)

    Pedersen, Birgith; Delmar, Charlotte; Bendtsen, Mette Dahl; Bosaeus, Ingvar; Carus, Andreas; Falkmer, Ursula; Groenkjaer, Mette

    Antineoplastic adjuvant treatment for breast cancer can cause changes in women's weight and body composition and influence their general health and survival. The aim of this study is to investigate the extent and patterns of change in weight and body composition after current standard adjuvant antineoplastic treatment for breast cancer. Data on weight and body composition from 95 women with breast cancer Stage I to III were obtained during 18 months on a bioelectric impedance analyzer. Changes and odds ratio (OR) were calculated by a linear mixed model and logistic regression. At 18 months, there was an increase in weight of 0.9 kg (95% confidence interval [CI], 0.3-1.5; P = .003) and an average positive association of 0.35 kg/cm increased waist circumference (95% CI, 0.29-0.42 kg; P body fat were observed mainly in premenopausal women receiving chemotherapy (1.4 kg; 95% CI, 0.4-2.4; P = .007). For menopausal status, OR was 2.9 (95% CI, 1.14-7.1; P = .025), and for chemotherapy, OR was 2.6 (95% CI, 1.03-6.41; P = .043). The OR for weight loss in Stage III breast cancer was 12.5 (95% CI, 1.21-128.84; P = .034) and 4.3 (CI, 1.07-17.24; P = .40) for comorbidity. Results demonstrate that weight changes in a pooled sample are overestimated. However, premenopausal women receiving anthracycline-based chemotherapy show a tendency toward a body composition with increasing fat mass. A scheduled assessment of changes in weight and body composition is relevant at 18 months after treatment. To compare future studies, common measuring and cutoff points are needed.

  15. A cost-effectiveness analysis of adjuvant therapies for resected adenocarcinoma of the rectum

    International Nuclear Information System (INIS)

    Lee, Jason H.

    1997-01-01

    PURPOSE: Several prospective randomized trials have shown a significant survival advantage with adjuvant chemotherapy and radiation therapy following surgical resection of adenocarcinoma of the rectum. Recent and ongoing trials are evaluating the role of modulated and/or protracted venous infusion [PVI] chemotherapy with pelvic irradiation [PRT]. The economic implications of additional therapies compared with their incremental benefits have not been rigorously analyzed. This study attempts to assess the incremental cost effectiveness of adjuvant therapy over surgery alone, and secondly, adjuvant therapy with PVI delivery systems versus rapid infusion. METHODS: A Markov model was constructed to describe the natural history of rectal carcinoma [stage B2, C] following surgical resection in a hypothetical cohort of 60 year old patients. This model was used to perform two sets of comparisons: [1] surgery alone versus adjuvant bolus fluorouracil [5-FU] with PRT, and [2] bolus 5-FU with PRT versus PVI 5-FU with PRT. Relapse rates and overall survival were derived from an early GITSG trial for the first comparison and from the NCCTG 86-47-51 trial for the second comparison. Medicare reimbursement rates and reports from health maintenance organizations were used to obtain net medical costs of adjuvant treatments, routine follow-up, advanced recurrent disease, and terminal illness as a result of rectal carcinoma. Total years of life and medical costs were projected over an 8-year time horizon for the first comparison [GITSG data] and over a 5-year time horizon for the second comparison [NCCTG data]. Monetary and nonmonetary benefits were discounted at 5% per year. Adjustments for quality of life, costs of adverse effects from treatment, and indirect costs of disease or treatment were not included in this current analysis. RESULTS: The main survival and economic outcomes for each treatment arm in the two comparisons are reported in the table below. For the first comparison

  16. Disseminated tumor cells as selection marker and monitoring tool for secondary adjuvant treatment in early breast cancer. Descriptive results from an intervention study

    International Nuclear Information System (INIS)

    Synnestvedt, Marit; Schirmer, Cecilie; Nesland, Jahn Martin; Naume, Bjørn; Borgen, Elin; Wist, Erik; Wiedswang, Gro; Weyde, Kjetil; Risberg, Terje; Kersten, Christian; Mjaaland, Ingvil; Vindi, Lise

    2012-01-01

    Presence of disseminated tumor cells (DTCs) in bone marrow (BM) after completion of systemic adjuvant treatment predicts reduced survival in breast cancer. The present study explores the use of DTCs to identify adjuvant insufficiently treated patients to be offered secondary adjuvant treatment intervention, and as a surrogate marker for therapy response. A total of 1121 patients with pN1-3 or pT1c/T2G2-3pN0-status were enrolled. All had completed primary surgery and received 6 cycles of anthracycline-containing chemotherapy. BM-aspiration was performed 8-12 weeks after chemotherapy (BM1), followed by a second BM-aspiration 6 months later (BM2). DTC-status was determined by morphological evaluation of immunocytochemically detected cytokeratin-positive cells. If DTCs were present at BM2, docetaxel (100 mg/m 2 , 3qw, 6 courses) was administered, followed by DTC-analysis 1 month (BM3) and 13 months (BM4) after the last docetaxel infusion. Clinical follow-up (FU) is still ongoing. Here, the descriptive data from the study are presented. Of 1085 patients with a reported DTC result at both BM1 and BM2, 94 patients (8.7%) were BM1 positive and 83 (7.6%) were BM2 positive. The concordance between BM1 and BM2 was 86.5%. Both at BM1 and BM2 DTC-status was significantly associated with lobular carcinomas (p = 0.02 and p = 0.03, respectively; chi-square). In addition, DTC-status at BM2 was also associated with pN-status (p = 0.009) and pT-status (p = 0.03). At BM1 28.8% and 12.8% of the DTC-positive patients had ≥2 DTCs and ≥3 DTCs, respectively. At BM2, the corresponding frequencies were 47.0% and 25.3%. Of 72 docetaxel-treated patients analyzed at BM3 and/or BM4, only 15 (20.8%) had persistent DTCs. Of 17 patients with ≥3 DTCs before docetaxel treatment, 12 patients turned negative after treatment (70.6%). The change to DTC-negativity was associated with the presence of ductal carcinoma (p = 0.009). After docetaxel treatment, the majority of patients experienced

  17. Study of new ways of supplementary and combinatory therapy of rheumatoid arthritis with immunomodulators. Glucomannan and Imunoglukán in adjuvant arthritis.

    Science.gov (United States)

    Bauerová, K; Paulovicová, E; Mihalová, D; Svík, K; Ponist, S

    2009-01-01

    We studied the anti-arthritic activity of glucomannan (GM) isolated from Candida utilis and of Imunoglukán, a beta-(1,3/1,6)-D-glucan (IMG) isolated from Pleurotus ostreatus. Adjuvant arthritis (AA) was induced intradermally by the injection of Mycobacterium butyricum in incomplete Freund's adjuvant to Lewis rats. Blood for biochemical and immunological analysis was collected on experimental days 1, 14, 21, and 28. A clinical parameter--hind paw volume (HPV)--was also measured. The detection of IL-1 alpha, IL-4, TNF alpha, and MCP-1 was done by immunoflowcytometry. On day 28--the end of the experiment--we determined spectrophotometrically: the total anti-oxidant status (TAS) of plasma samples along with thiobarbituric acid-reacting substances (TBARS) levels in plasma and we assessed the activity of gamma-glutamyl transferase (GGT) in hind paw joint homogenate. The experiments included healthy animals, arthritic animals without treatment, and arthritic animals with administration of glucomannan (GM-AA) in the oral daily dose of 15 mg/kg b.w. and of IMG (IMG-AA) in the oral daily dose of 2 mg/kg b.w. The progress of AA was manifested by all parameters monitored. Both substances had beneficial effects on HPV, TBARS levels, GGT activity, and TAS levels. For cytokine assessment, only IMG-AA samples were selected, considering the significant HPV improvement accompanied with the observed anti-oxidant action. IMG administration had a positive immunomodulating effect on all cytokine plasma levels measured, changed markedly due to arthritis progression. Thus, IMG may be considered as a candidate for combinatorial therapy of rheumatoid arthritis.

  18. Active prospective surveillance study with post-discharge surveillance of surgical site infections in Cambodia

    Directory of Open Access Journals (Sweden)

    José Guerra

    2015-05-01

    Full Text Available Summary: Barriers to the implementation of the Centers for Disease Control and Prevention (CDC guidelines for surgical site infection (SSI surveillance have been described in resource-limited settings. This study aimed to estimate the SSI incidence rate in a Cambodian hospital and to compare different modalities of SSI surveillance. We performed an active prospective study with post-discharge surveillance. During the hospital stay, trained surveyors collected the CDC criteria to identify SSI by direct examination of the surgical site. After discharge, a card was given to each included patient to be presented to all practitioners examining the surgical site. Among 167 patients, direct examination of the surgical site identified a cumulative incidence rate of 14 infections per 100 patients. An independent review of medical charts presented a sensitivity of 16%. The sensitivity of the purulent drainage criterion to detect SSIs was 83%. After hospital discharge, 87% of the patients provided follow-up data, and nine purulent drainages were reported by a practitioner (cumulative incidence rate: 20%. Overall, the incidence rate was dependent on the surveillance modalities. The review of medical charts to identify SSIs during hospitalization was not effective; the use of a follow-up card with phone calls for post-discharge surveillance was effective. Keywords: Surgical wound infection, Cambodia, Infection control, Developing countries, Follow-up studies, Feasibility studies

  19. Comparative study of two doses of intrathecal dexmedetomidine as adjuvant with low dose hyperbaric bupivacaine in ambulatory perianal surgeries: A prospective randomised controlled study

    Directory of Open Access Journals (Sweden)

    K Sudheesh

    2015-01-01

    Full Text Available Background and Aims: Dexmedetomidine (DMT, as intrathecal adjuvant has been shown to successfully prolong duration of analgesia but delay the motor recovery. Hence, this study was designed to find out the dose of DMT which can provide satisfactory analgesia without prolonging motor block. Methods: A total of 50 patients scheduled for elective perianal surgeries were randomly allocated to Groups C or D (n = 25. Group D received hyperbaric bupivacaine 0.5% 4 mg + DMT 5 μg and Group C received hyperbaric bupivacaine 0.5% 4 mg + DMT 3 μg intrathecally. Onset and duration of sensory and motor blockade, duration of analgesia, time for ambulation and first urination were recorded. Adverse effects if any were noted. Results: Demographic characters, duration of surgery were comparable. The onset of sensory block to S1 was 9.61 ± 5.53 min in Group C compared to 7.69 ± 4.80 min in Group D (P = 0.35. Duration of sensory (145.28 ± 83.17 min – C, 167.85 ± 93.75 min – D, P = 0.5 and motor block (170.53 ± 73.44 min – C, 196.14 ± 84.28 min, P = 0.39 were comparable. Duration of analgesia (337.86 ± 105.11 min – C, 340.78 ± 101.81 min – D, P = 0.9 and time for ambulation (252.46 ± 93.72 min – C, 253.64 ± 88.04 min – D, P = 0.97 were also comparable. One patient in each group had urinary retention requiring catheterization. No other side effects were observed. Conclusion: Intrathecal DMT 3 μg dose does not produce faster ambulation compared to intrathecal DMT 5 μg though it produces comparable duration of analgesia for perianal surgeries.

  20. Surgical and Antimicrobial Treatment of Prosthetic Vascular Graft Infections at Different Surgical Sites: A Retrospective Study of Treatment Outcomes

    Science.gov (United States)

    Elzi, Luigia; Gurke, Lorenz; Battegay, Manuel; Widmer, Andreas F.; Weisser, Maja

    2014-01-01

    Objective Little is known about optimal management of prosthetic vascular graft infections, which are a rare but serious complication associated with graft implants. The goal of this study was to compare and characterize these infections with respect to the location of the graft and to identify factors associated with outcome. Methods This was a retrospective study over more than a decade at a tertiary care university hospital that has an established multidisciplinary approach to treating graft infections. Cases of possible prosthetic vascular graft infection were identified from the hospital's infectious diseases database and evaluated against strict diagnostic criteria. Patients were divided into groups according to the locations of their grafts: thoracic-aortic, abdominal-aortic, or peripheral-arterial. Statistical analyses included evaluation of patient and infection characteristics, time to treatment failure, and factors associated specifically with cure rates in aortic graft infections. The primary endpoint was cure at one year after diagnosis of the infection. Results Characterization of graft infections according to the graft location did show that these infections differ in terms of their characteristics and that the prognosis for treatment seems to be influenced by the location of the infection. Cure rate and all-cause mortality at one year were 87.5% and 12.5% in 24 patients with thoracic-aortic graft infections, 37.0% and 55.6% in 27 patients with abdominal-aortic graft infections, and 70.0% and 30.0% in 10 patients with peripheral-arterial graft infections. In uni- and multivariate analysis, the type of surgical intervention used in managing infections (graft retention versus graft replacement) did not affect primary outcome, whereas a rifampicin-based antimicrobial regimen was associated with a higher cure rate. Conclusions We recommend that future prospective studies differentiate prosthetic vascular graft infections according to the location of the

  1. Some Aspects Of Adjuvant Treatment Of Colorectal Cancer

    International Nuclear Information System (INIS)

    Hlavata, Z.

    2008-01-01

    Colorectal cancer is one of the most common cancers in Europe and in North America. Cornerstone of the treatment of localized colorectal cancer is surgical resection followed by chemotherapy or radio-chemotherapy in indicated cases. For patients with Stage III colon cancer recent data have shown efficacy through the combining fluorouracil-based chemotherapy with oxaliplatin into adjuvant treatment program. For patients with Stage II colon cancer, the use of adjuvant chemotherapy remains controversial, but may be appropriate in a subset of individuals at high risk for disease recurrence. Current randomized clinical trials in the adjuvant therapy of colorectal cancer are examining the value of adding agents known to be active in metastatic disease, including those that modify specific molecular targets. (author)

  2. Music for surgical abortion care study: a randomized controlled pilot study.

    Science.gov (United States)

    Wu, Justine; Chaplin, William; Amico, Jennifer; Butler, Mark; Ojie, Mary Jane; Hennedy, Dina; Clemow, Lynn

    2012-05-01

    The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; pMusic as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. Condition-specific Quality of Life Assessment at Each Stage of Class III Surgical Orthodontic Treatment -A Prospective Study.

    Science.gov (United States)

    Tachiki, Chie; Nishii, Yasushi; Takaki, Takashi; Sueishi, Kenji

    2018-01-01

    Surgical orthodontic treatment has been reported to improve oral health-related quality of life (OHRQL). Such treatment comprises three stages: pre-surgical orthodontic treatment; orthognathic surgery; and post-surgical orthodontic treatment. Most studies have focused on change in OHRQL between before and after surgery. However, it is also necessary to evaluate OHRQL at the pre-surgical orthodontic treatment stage, as it may be negatively affected by dental decompensation compared with at pre-treatment. The purpose of this prospective study was to investigate the influence of surgical orthodontic treatment on QOL by assessing change in condition-specific QOL at each stage of treatment in skeletal class III cases. Twenty skeletal class III patients requiring surgical orthodontic treatment were enrolled in the study. Each patient completed the Orthognathic Quality of Life Questionnaire (OQLQ), which was developed for patients with dentofacial deformity. Its items are grouped into 4 domains: "social aspects of dentofacial deformity"; "facial esthetics"; "oral function"; and "awareness of dentofacial esthetics". The questionnaire was completed at the pre-treatment, pre-surgical orthodontic treatment, and post-surgical orthodontic treatment stages. The results revealed a significant worsening in scores between at pre-treatment and pre-surgical orthodontic treatment in the domains of facial esthetics and oral function (ppre-surgical orthodontic and post-surgical orthodontic treatment in all domains except awareness of dentofacial esthetics (ppre-surgical orthodontic treatment stage. Significant correlations were also observed between improvement in upper and lower lip difference, soft tissue pogonion protrusion, and ANB angle and improvement in OQLQ scores at the post-surgical orthodontic treatment stage. These results indicate that morphologic change influences OHRQL in patients undergoing surgical orthodontic treatment not only after surgery, but also during pre-surgical

  4. The South African Surgical Outcomes Study: a seven-day ...

    African Journals Online (AJOL)

    LR Mathivha, TR Mokoena, S Monokoane, Rui Moreno, David ... Method: A seven-day national, multicentre, prospective, observational cohort study was conducted in 50 government-funded hospitals in South .... Dr George Mukhari Hospital.

  5. Adjuvant Biological Therapies in Chronic Leg Ulcers

    Directory of Open Access Journals (Sweden)

    Natalia Burgos-Alonso

    2017-11-01

    Full Text Available Current biological treatments for non-healing wounds aim to address the common deviations in healing mechanisms, mainly inflammation, inadequate angiogenesis and reduced synthesis of extracellular matrix. In this context, regenerative medicine strategies, i.e., platelet rich plasmas and mesenchymal stromal cell products, may form part of adjuvant interventions in an integral patient management. We synthesized the clinical experience on ulcer management using these two categories of biological adjuvants. The results of ten controlled trials that are included in this systematic review favor the use of mesenchymal stromal cell based-adjuvants for impaired wound healing, but the number and quality of studies is moderate-low and are complicated by the diversity of biological products. Regarding platelet-derived products, 18 controlled studies investigated their efficacy in chronic wounds in the lower limb, but the heterogeneity of products and protocols hinders clinically meaningful quantitative synthesis. Most patients were diabetic, emphasizing an unmet medical need in this condition. Overall, there is not sufficient evidence to inform routine care, and further clinical research is necessary to realize the full potential of adjuvant regenerative medicine strategies in the management of chronic leg ulcers.

  6. The South African Surgical Outcomes Study: A 7-day prospective ...

    African Journals Online (AJOL)

    To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at ...

  7. Hospital-acquired acute kidney injury in medical, surgical, and intensive care unit: A comparative study

    Directory of Open Access Journals (Sweden)

    T B Singh

    2013-01-01

    Full Text Available Acute kidney injury (AKI is a common complication in hospitalized patients. There are few comparative studies on hospital-acquired AKI (HAAKI in medical, surgical, and ICU patients. This study was conducted to compare the epidemiological characteristics, clinical profiles, and outcomes of HAAKI among these three units. All adult patients (>18 years of either gender who developed AKI based on RIFLE criteria (using serum creatinine, 48 h after hospitalization were included in the study. Patients of acute on chronic renal failure and AKI in pregnancy were excluded. Incidence of HAAKI in medical, surgical, and ICU wards were 0.54%, 0.72%, and 2.2% respectively ( P < 0.0001. There was no difference in age distribution among the groups, but onset of HAAKI was earliest in the medical ward ( P = 0.001. RIFLE-R was the most common AKI in medical (39.2% and ICU (50% wards but in the surgical ward, it was RIFLE-F that was most common (52.6%. Acute tubular necrosis was more common in ICU ( P = 0.043. Most common etiology of HAAKI in medical unit was drug induced (39.2%, whereas in surgical and ICU, it was sepsis (34% and 35.2% respectively. Mortality in ICU, surgical and medical units were 73.5%, 43.42%, and 37.2%, respectively ( P = 0.003. Length of hospital stay in surgical, ICU and medical units were different ( P = 0.007. This study highlights that the characters of HAAKI are different in some aspects among different hospital settings.

  8. Peroral endoscopic myotomy is a viable option for failed surgical esophagocardiomyotomy instead of redo surgical Heller myotomy: a single center prospective study.

    Science.gov (United States)

    Onimaru, Manabu; Inoue, Haruhiro; Ikeda, Haruo; Yoshida, Akira; Santi, Esperanza Grace; Sato, Hiroki; Ito, Hiroaki; Maselli, Roberta; Kudo, Shin-ei

    2013-10-01

    Surgical Heller myotomy has high rates of successful long-term results, but failed cases still remain. Moreover, the treatment strategy in patients with surgical myotomy failure is controversial. Recently, peroral endscopic myotomy (POEM) was reported to be efficient and safe in primary treatment of achalasia. In this study, we aimed to evaluate the efficacy and safety of POEM for surgical myotomy failure as a rescue second-line treatment, and we discuss the treatment options adapted in achalasia recurrence. A total of 315 consecutive achalasia patients received POEM from September 2008 to December 2012 in our hospital. Eleven (3.5%) patients who had persistent or recurrent achalasia and had received surgical myotomy as a first-line treatment from other hospitals were included in this study. Patient background, barium swallow studies, esophagogastroduodenoscopy (EGD), manometry, and symptom scores were prospectively evaluated. In principle, all patients in whom surgical myotomy failed received pneumatic balloon dilatation (PBD) as the first line "rescue" treatment, and only if PBD failed were patients considered for rescue POEM. The PBD alone was effective in 1 patient, and in the remaining 10 patients, rescue POEM was performed successfully without complications. Three months after rescue POEM, significant reduction in lower esophageal sphincter (LES) resting pressures (22.1 ± 6.6 mmHg vs 10.9 ± 4.5 mmHg, p myotomy were excellent. Long-term results are awaited. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Impact of workflow on the use of the Surgical Safety Checklist: a qualitative study.

    Science.gov (United States)

    Gillespie, Brigid M; Marshall, Andrea P; Gardiner, Therese; Lavin, Joanne; Withers, Teresa K

    2016-11-01

    Regardless of the benefits associated of the Surgical Safety Checklist, adherence across its three phases remains inconsistent. The aim of this study was to systematically identify issues around workflow that impact on surgical teams' ability to use the Surgical Safety Checklist in a large tertiary facility in Queensland, Australia. Observational audit of 10 surgical teams and 33 semi-structured interviews with 70 participants from nursing, medicine and the community were conducted. Data were collected during 2014-2015. Inductive and deductive approaches were used to analyse field observations and interview transcripts. The domain, impact of workflow on checklist utilization, was identified. Within this domain, seven categories illustrated the causal conditions which determined the ways in which workflow influenced checklist use. These categories included: 'busy doing the task'; 'clashing task priorities'; 'being pressured, running out of time'; 'adapting processes to work patterns'; 'doubling up on work'; 'a domino effect, leading to delays' and 'reality of the workflow'. One of the greatest systemic challenges to checklist use in surgery is workflow. Process changes in the way that surgical safety checklists are used need to incorporate the temporal demands of the workflow. Any changes made must ensure the process is reliable, is easily embedded into existing work routines and is not disruptive. © 2016 Royal Australasian College of Surgeons.

  10. Cooperative Study of the Spanish Pancreas Transplant Group (GETP): Surgical Complications.

    Science.gov (United States)

    Moya-Herraiz, Angel; Muñoz-Bellvis, Luis; Ferrer-Fábrega, Joana; Manrique Municio, Alejandro; Pérez-Daga, José Antonio; Muñoz-Casares, Cristóbal; Alarcó-Hernández, Antonio; Gómez-Gutiérrez, Manuel; Casanova-Rituerto, Daniel; Sanchez-Bueno, Francisco; Jimenez-Romero, Carlos; Fernández-Cruz Pérez, Laureano

    2015-05-01

    Technical failure in pancreas transplant has been the main cause of the loss of grafts. In the last few years, the number of complications has reduced, and therefore the proportion of this problem. The Spanish Pancreas Transplant Group wanted to analyze the current situation with regard to surgical complications and their severity. A retrospective and multicenter study was performed. 10 centers participated, with a total of 410 pancreas transplant recipients between January and December 2013. A total of 316 transplants were simultaneous with kidney, 66 after kidney, pancreas-only 10, 7 multivisceral and 11 retrasplants. Surgical complication rates were 39% (n=161). A total of 7% vascular thrombosis, 13% bleeding, 6% the graft pancreatitis, 12% surgical infections and others to a lesser extent. Relaparotomy rate was 25%. The severity of complications were of type IIIb (13%), type II (12%) and type IVa (8.5%). Graft loss was 8%. Early mortality was 0.5%. The percentage of operations for late complications was 17%. The number of surgical complications after transplantation is not negligible, affecting one in 3 patients. They are severe in one out of 5 and, in one of every 10 patients graft loss occurs. Therefore, there is still a significant percentage of surgical complications in this type of activity, as shown in our country. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Study of hormonal status of surgical patients with endometrial carcinoma

    International Nuclear Information System (INIS)

    Musina, R.Kh.; Kiseleva, N.S.; Modnikov, O.P.

    1987-01-01

    A radioimmunoassay was conducted in the pituitary-ovary and pituitary-adrenals systems in 37 cases of endometrial carcinoma treatment and 1, 3, 5 and 14 days after extirpation of the uterus and appendages. The levels of follicle - stimulating (FSH) and luteinizing (LH) hormones of the pituitary, prolactin, ACTH, estradiol, progesterone, testosterone, cortisol and aldosterone were studied. Such disturbances as decreased production of FSH, LH, progesterone and testosterone were observed before operation. Surgery was followed by a considerable rise in prolactin production and basal levels of FSH and LH, a decrease in estradiol, progesterone and testosterone concentrations and was accompanied by a sizeable release of cortisol and aldosterone

  12. Mandibular kinematics after orthognathic surgical treatment a pilot study.

    Science.gov (United States)

    Sforza, Chiarella; Ugolini, Alessandro; Rocchetta, Davide; Galante, Domenico; Mapelli, Andrea; Giannì, Aldo Bruno

    2010-03-01

    We recorded three-dimensional mandibular movements, while the mouth was being opened and closed, using an optoelectronic motion analyser in 14 patients (5 skeletal Class II, 9 skeletal Class III) who were being assessed 7-49 months after orthognathic operations, and in 44 healthy subjects. All 14 patients had satisfactory healing on clinical examination, and function had been restored. Mandibular movement was divided into its rotational and translational components. On maximum mouth opening, the patients had significantly less total displacement of the mandibular interincisor point (p=0.05), and more mandibular movement that was explained by pure condylar rotation (p=0.006), than control subjects. There was no significant relation between maximum mouth opening and percentage rotation. While mandibular motion was well restored clinically by orthognathic surgery, the kinematics of the joint were modified. Larger studies and longitudinal investigations are necessary to appreciate the clinical relevance of the variations in condylar rotational and translational components.

  13. Access to Orthopaedic Surgical Care in Northern Tanzania: A Modelling Study.

    Science.gov (United States)

    Premkumar, Ajay; Ying, Xiaohan; Mack Hardaker, W; Massawe, Honest H; Mshahaba, David J; Mandari, Faiton; Pallangyo, Anthony; Temu, Rogers; Masenga, Gileard; Spiegel, David A; Sheth, Neil P

    2018-04-25

    The global burden of musculoskeletal disease and resulting disability is enormous and is expected to increase over the next few decades. In the world's poorest regions, the paucity of information defining and quantifying the current state of access to orthopaedic surgical care is a major problem in developing effective solutions. This study estimates the number of individuals in Northern Tanzania without adequate access to orthopaedic surgical services. A chance tree was created to model the probability of access to orthopaedic surgical services in the Northern Tanzanian regions of Arusha, Kilimanjaro, Tanga, Singida, and Manyara, with respect to four dimensions: timeliness, surgical capacity, safety, and affordability. Timeliness was estimated by the proportion of people living within a 4-h driving distance from a hospital with an orthopaedic surgeon, capacity by comparing number of surgeries performed to the number of surgeries indicated, safety by applying WHO Emergency and Essential Surgical Care infrastructure and equipment checklists, and affordability by approximating the proportion of the population protected from catastrophic out-of-pocket healthcare expenditure. We accounted for uncertainty in our model with one-way and probabilistic sensitivity analyses. Data sources included the Tanzanian National Bureau of Statistics and Ministry of Finance, World Bank, World Health Organization, New Zealand Ministry of Health, Google Corporation, NASA population estimator, and 2015 hospital records from Kilimanjaro Christian Medical Center, Machame Hospital, Nkoroanga Hospital, Mt. Meru Hospital, and Arusha Lutheran Medical Center. Under the most conservative assumptions, more than 90% of the Northern Tanzanian population does not have access to orthopaedic surgical services. There is a near absence of access to orthopaedic surgical care in Northern Tanzania. These findings utilize more precise country and region-specific data and are consistent with prior published

  14. The use of Chinese herbal medicine as an adjuvant therapy to reduce incidence of chronic hepatitis in colon cancer patients: A Taiwanese population-based cohort study.

    Science.gov (United States)

    Lin, Tsai-Hui; Yen, Hung-Rong; Chiang, Jen-Huai; Sun, Mao-Feng; Chang, Hen-Hong; Huang, Sheng-Teng

    2017-04-18

    There is a decided lack of in-depth studies to evaluate the effectiveness of Chinese Herbal Medicine (CHM) as an adjuvant therapy on the incidence of chronic hepatitis in patients with colon cancer. The aim of this study is to assess whether CHM treatment decreased the incidence of chronic hepatitis in colon cancer patients who received conventional Western medical treatment. A Taiwanese nationwide population-based study of colon cancer patients receiving Western medicine treatment in conjunction with CHM treatment, using data provided by the National Health Insurance (NHI) Research Database, was conducted. A total of 61676 patients were diagnosed with colon cancer in Taiwan within the defined study period, from 1997 to 2010. After randomly equal matching for age, sex, excluding patients younger than 18 years of age, chronic hepatitis before colon cancer diagnosis date, receiving acupuncture and/or moxibustion and taking CHM for less than 30 days, data from 155 patients were analyzed. Hazard ratios of incidence rate of chronic hepatitis were used to determine the influence of CHM and the therapeutic potential of herbal products in treating patients with colon cancer. CHM used for patients with colon cancer exhibited significantly decreased incidence rates of chronic hepatitis [hazard ratio (HR)=0.53; 95% confidence interval (CI):0.38-0.74], with multivariate adjustment, compared to those without CHM use. The protective effect of CHM treatment with statistical significance across the stratification of age, gender, co-morbidity and treatment modality was noted. The cumulative incidence of chronic hepatitis was also reduced in patients with colon cancer receiving CHM treatment during a five-year period. In this study, we provide the ten most used single herbs and herbal formulas that were prescribed for patients with colon cancer; moreover, we identify the eight single herbs and five formulas used in CHM treatment which significantly decreased incidence of chronic

  15. Correction of sampling bias in a cross-sectional study of post-surgical complications.

    Science.gov (United States)

    Fluss, Ronen; Mandel, Micha; Freedman, Laurence S; Weiss, Inbal Salz; Zohar, Anat Ekka; Haklai, Ziona; Gordon, Ethel-Sherry; Simchen, Elisheva

    2013-06-30

    Cross-sectional designs are often used to monitor the proportion of infections and other post-surgical complications acquired in hospitals. However, conventional methods for estimating incidence proportions when applied to cross-sectional data may provide estimators that are highly biased, as cross-sectional designs tend to include a high proportion of patients with prolonged hospitalization. One common solution is to use sampling weights in the analysis, which adjust for the sampling bias inherent in a cross-sectional design. The current paper describes in detail a method to build weights for a national survey of post-surgical complications conducted in Israel. We use the weights to estimate the probability of surgical site infections following colon resection, and validate the results of the weighted analysis by comparing them with those obtained from a parallel study with a historically prospective design. Copyright © 2012 John Wiley & Sons, Ltd.

  16. Plastic surgical management of a cobra bite – a case study

    Directory of Open Access Journals (Sweden)

    Kuhbier, Jörn W.

    2017-02-01

    Full Text Available Cobra bites are quite rare in European countries as these snakes are not native there. Toxins are devastating for tissue resulting in massive necrosis, thus plastic surgery might play a role in reconstruction of the lost tissue. A case of a male patient bitten by a thai cobra in the left index finger is presented. Antitoxin administration was delayed due to secondary patient admission. Progressive tissue necrosis made radical debridement necessary, resulting in the need for plastic surgical defect coverage with a flap. While a radical debridement to prevent toxic necrosis due to lytic enzymes in cobra venom has been favoured beforehand, large case studies led to a more restrained initial surgical intervention. However, antitoxin administration should be first line therapy in management of these cases. If severe necrosis is present as it might occur in delayed admission, a plastic surgical management of the patient might be advantageous.

  17. A Prospective Study on Cardiovascular Dysfunction in Patients with Hyperthyroidism and Its Reversal After Surgical Cure.

    Science.gov (United States)

    Muthukumar, Sankaran; Sadacharan, Dhalapathy; Ravikumar, Krishnan; Mohanapriya, Gajarajan; Hussain, Zahir; Suresh, R V

    2016-03-01

    Cardiovascular dysfunction (CVD) is a major cause of mortality and morbidity in hyperthyroidism. CVD and its reversibility after total thyroidectomy (TT) are not adequately addressed. This prospective case-control study evaluates the effect of hyperthyroidism on myocardium and its reversibility after TT. Surgical candidates of new onset hyperthyroidism, Group A (n = 41, age Hyperthyroidism. Various parameters of CVD improved consistently after surgical cure. NT-proBNP levels correlated well with the severity and duration of CVD and hence can be an objective tool in monitoring of hyperthyroid cardiac dysfunction.

  18. A prospective randomized study of postoperative adjuvant chemo-radiotherapy (CT+RT) vs. radiotherapy(RT) alone in resected stage II and IIIA non-small cell lung cancer (NSCLC)

    International Nuclear Information System (INIS)

    Chang, Geol Lee; Joo, Hang Kim; Kyung, Young Chung; Doo, Yun Lee; Kil, Dong Kim; Won, Young Lee; Sung, Kyu Kim; Sei, Kyu Kim; Gwi, Eon Kim

    1995-01-01

    Objective: A prospective randomized study has been conducted to compare the results of treatment between CT+RT and RT alone as an adjuvant setting in completely resected stage II and IIIA NSCLC. Materials and Methods: Patients who had completely resected stage II and IIIA NSCLC were randomized into a CT+RT arm(arm A) and a RT alone arm(arm B) as an adjuvant setting after stratification according to cell type(squamous vs. non-squamous) and stage(II vs. IIIA). CT(Etoposide 100mg/m2 I.V. infusion d1-3, Cisplatin 20mg/m2 I.V. infusion d1-5, total 6cycles) was started in postop. 3 weeks with a 4 weeks interval. RT(5040cGy/5-6wks, 180cGy/fr) was started in postoperative 5 weeks after the first cycle of CT for group A and in postoperative 4 weeks for group B. A total of 69 patients were registered from Sep. 1990 to Jun. 1993. Sixty five of these patients were evaluable because 4 patients were ineligible due to distant metastasis before adjuvant treatment. Two patients who refused adjuvant treatment were included in this study to avoid selection bias. Results: Sixteen patients (48%) have received CT of more than 3 cycles and 51 patients(78%) have received RT of more than 50Gy. Four patients died due to treatment-related complications [broncho-pleural fistula 3(arm A:B=2:1), pneumonia 1(arm A)]. Survival and the patterns of failure are as follows: Conclusion: There is no statistical significance in either the overall survival or the patterns of failure between the CT+RT arm and RT alone arm as an adjuvant setting in resected stage II and IIIA NSCLC

  19. Laser vaccine adjuvants. History, progress, and potential.

    Science.gov (United States)

    Kashiwagi, Satoshi; Brauns, Timothy; Gelfand, Jeffrey; Poznansky, Mark C

    2014-01-01

    Immunologic adjuvants are essential for current vaccines to maximize their efficacy. Unfortunately, few have been found to be sufficiently effective and safe for regulatory authorities to permit their use in vaccines for humans and none have been approved for use with intradermal vaccines. The development of new adjuvants with the potential to be both efficacious and safe constitutes a significant need in modern vaccine practice. The use of non-damaging laser light represents a markedly different approach to enhancing immune responses to a vaccine antigen, particularly with intradermal vaccination. This approach, which was initially explored in Russia and further developed in the US, appears to significantly improve responses to both prophylactic and therapeutic vaccines administered to the laser-exposed tissue, particularly the skin. Although different types of lasers have been used for this purpose and the precise molecular mechanism(s) of action remain unknown, several approaches appear to modulate dendritic cell trafficking and/or activation at the irradiation site via the release of specific signaling molecules from epithelial cells. The most recent study, performed by the authors of this review, utilized a continuous wave near-infrared laser that may open the path for the development of a safe, effective, low-cost, simple-to-use laser vaccine adjuvant that could be used in lieu of conventional adjuvants, particularly with intradermal vaccines. In this review, we summarize the initial Russian studies that have given rise to this approach and comment upon recent advances in the use of non-tissue damaging lasers as novel physical adjuvants for vaccines.

  20. A quality improvement study on avoidable stressors and countermeasures affecting surgical motor performance and learning.

    Science.gov (United States)

    Conrad, Claudius; Konuk, Yusuf; Werner, Paul D; Cao, Caroline G; Warshaw, Andrew L; Rattner, David W; Stangenberg, Lars; Ott, Harald C; Jones, Daniel B; Miller, Diane L; Gee, Denise W

    2012-06-01

    To explore how the 2 most important components of surgical performance--speed and accuracy-are influenced by different forms of stress and what the impact of music is on these factors. On the basis of a recently published pilot study on surgical experts, we designed an experiment examining the effects of auditory stress, mental stress, and music on surgical performance and learning and then correlated the data psychometric measures to the role of music in a novice surgeon's life. Thirty-one surgeons were recruited for a crossover study. Surgeons were randomized to 4 simple standardized tasks to be performed on the SurgicalSIM VR laparoscopic simulator (Medical Education Technologies, Inc, Sarasota, FL), allowing exact tracking of speed and accuracy. Tasks were performed under a variety of conditions, including silence, dichotic music (auditory stress), defined classical music (auditory relaxation), and mental loading (mental arithmetic tasks). Tasks were performed twice to test for memory consolidation and to accommodate for baseline variability. Performance was correlated to the brief Musical Experience Questionnaire (MEQ). Mental loading influences performance with respect to accuracy, speed, and recall more negatively than does auditory stress. Defined classical music might lead to minimally worse performance initially but leads to significantly improved memory consolidation. Furthermore, psychologic testing of the volunteers suggests that surgeons with greater musical commitment, measured by the MEQ, perform worse under the mental loading condition. Mental distraction and auditory stress negatively affect specific components of surgical learning and performance. If used appropriately, classical music may positively affect surgical memory consolidation. It also may be possible to predict surgeons' performance and learning under stress through psychological tests on the role of music in a surgeon's life. Further investigation is necessary to determine the

  1. Surgical Treatment of Nonlesional Neocortical Epilepsy: Long-term Longitudinal Study.

    Science.gov (United States)

    Kim, Dong Wook; Lee, Sang Kun; Moon, Hye-Jin; Jung, Ki-Young; Chu, Kon; Chung, Chun-Ki

    2017-03-01

    The proportion of surgery for nonlesional neocortical epilepsy has recently increased, with a decrease in surgery for mesial temporal lobe epilepsy. However, there are only a few studies regarding the long-term surgical outcome and the potential prognostic factors for patients with nonlesional neocortical epilepsy. To evaluate the long-term surgical outcome and to identify possible prognostic factors in patients with nonlesional neocortical epilepsy. In a surgical cohort from September 1995 to December 2005 at the Seoul National University Hospital, we included 109 consecutive patients without lesions identifiable by magnetic resonance imaging who underwent focal surgical resection for drug-resistant neocortical epilepsy. Follow-up information for at least 10 years was available for all but 1 patient. Univariate and standard multiple logistic regression analyses were performed to identify the predictors of surgical outcomes, and a generalized estimation equation model was used for the longitudinal multiple logistic regression analysis of up to 21 years of follow-up. The patients consisted of 64 men and 45 women with ages at surgery ranging from 7 to 56 years (mean [SD], 27.1 [7.8] years). At 1 year after surgery, 59 of 109 patients (54.1%) achieved seizure freedom, and 64 of 108 patients (59.3%) achieved seizure freedom at the last follow-up. Only 11 of 108 patients (10.2%) experienced definite changes in postoperative seizure status. Localizing patterns in functional neuroimaging (strongest odds ratio [OR], 0.30 [95% CI, 0.14-0.66] for fluorodeoxyglucose-positron emission tomography; 0.37 [95% CI, 0.15-0.87] for ictal single-photon emission computed tomography), concordant results in presurgical diagnostic evaluations (OR, 3.15 [95% CI, 1.42-7.02]), the presence of aura (OR, 3.49 [95% CI, 1.54-7.92]), and complete resection of areas of ictal onset with frequent interictal spikes during the intracranial electroencephalographic study (OR, 0.37 [95% CI, 0

  2. Dendritic Cell-Based Adjuvant Vaccination Targeting Wilms’ Tumor 1 in Patients with Advanced Colorectal Cancer

    Directory of Open Access Journals (Sweden)

    Shigetaka Shimodaira

    2015-12-01

    Full Text Available Despite significant recent advances in the development of immune checkpoint inhibitors, the treatment of advanced colorectal cancer involving metastasis to distant organs remains challenging. We conducted a phase I study to investigate the safety and immunogenicity of Wilms’ tumor (WT1 class I/II peptides-pulsed dendritic cell DC vaccination for patients with advanced colorectal cancer. Standard treatment comprising surgical resection and chemotherapy was followed by one course of seven biweekly administrations of 1–2 × 107 DCs with 1–2 KE of OK-432 (streptococcal preparation in three patients. Clinical efficacy was confirmed based on WT1 expression using immunohistochemistry on paraffin-embedded tissues and immune monitoring using tetramer analysis and enzyme-linked immunosorbent spot (ELISPOT assays. WT1 expression with human leukocyte antigen (HLA-class I molecules was detected in surgical resected tissues. Adverse reactions to DC vaccinations were tolerable under an adjuvant setting. WT1-specific cytotoxic T cells were detected by both modified WT1-peptide/HLA-A*24:02 tetramer analysis and/or interferon-γ-producing cells through the use of ELISPOT assays after the first DC vaccination. Immunity acquired from DC vaccination persisted for two years with prolonged disease-free and overall survival. The present study indicated that DC vaccination targeting WT1 demonstrated the safety and immunogenicity as an adjuvant therapy in patients with resectable advanced colorectal cancer.

  3. Surgical Assisting

    Science.gov (United States)

    ... instruction, including: Microbiology Pathophysiology Pharmacology Anatomy and physiology Medical terminology Curriculum . Course content includes: Advanced surgical anatomy Surgical microbiology Surgical pharmacology Anesthesia methods and agents Bioscience Ethical ...

  4. Systematic Review of Studies Reporting Positive Surgical Margins After Bladder Neck Sparing Radical Prostatectomy.

    Science.gov (United States)

    Bellangino, Mariangela; Verrill, Clare; Leslie, Tom; Bell, Richard W; Hamdy, Freddie C; Lamb, Alastair D

    2017-11-07

    Bladder neck preservation (BNP) during radical prostatectomy (RP) has been proposed as a method to improve early recovery of urinary continence after radical prostatectomy. However, there is concern over a possible increase in the risk of positive surgical margins and prostate cancer recurrence rate. A recent systematic review and meta-analysis reported improved early recovery and overall long-term urinary continence without compromising oncologic control. The aim of our study was to perform a critical review of the literature to assess the impact on bladder neck and base margins after bladder neck sparing radical prostatectomy. We carried out a systematic review of the literature using Pubmed, Scopus and Cochrane library databases in May 2017 using medical subject headings and free-text protocol according to PRISMA guidelines. We used the following search terms: bladder neck preservation, prostate cancer, radical prostatectomy and surgical margins. Studies focusing on positive surgical margins (PSM) in bladder neck sparing RP pertinent to the objective of this review were included. Overall, we found 15 relevant studies reporting overall and site-specific positive surgical margins rate after bladder neck sparing radical prostatectomy. This included two RCTs, seven prospective comparative studies, two retrospective comparative studies and four case series. All studies were published between 1993 and 2015 with sample sizes ranging between 50 and 1067. Surgical approaches included open, laparoscopic and robot-assisted radical prostatectomy. The overall and base-specific PSM rates ranged between 7-36% and 0-16.3%, respectively. Mean base PSM was 4.9% in those patients where bladder neck sparing was performed, but only 1.85% in those without sparing. Bladder neck preservation during radical prostatectomy may increase base-positive margins. Further studies are needed to better investigate the impact of this technique on oncological outcomes. A future paradigm could

  5. A Prospective Randomized Study Comparing Mini-surgical Percutaneous Dilatational Tracheostomy With Surgical and Classical Percutaneous Tracheostomy

    Science.gov (United States)

    Hashemian, Seyed Mohammad-Reza; Digaleh, Hadi

    2015-01-01

    Abstract Although percutaneous dilatational tracheostomy (PDT) is more accessible and less time-demanding compared with surgical tracheostomy (ST), it has its own limitations. We introduced a modified PDT technique and brought some surgical knowledge to the bedside to overcome some standard percutaneous dilatational tracheostomy relative contraindications. PDT uses a blind route of tracheal access that usually requires perioperational imaging guidance to protect accidental injuries. Moreover, there are contraindications in certain cases, limiting widespread PDT application. Different PDT modifications and devices have been represented to address the problem; however, these approaches are not generally popular among professionals due to limited accessibility and/or other reasons. We prospectively analyzed the double-blinded trial, patient and nurse head evaluating the complications, and collected data from 360 patients who underwent PDT, ST, or our modified mini-surgical PDT (msPDT, Hashemian method). These patients were divided into 2 groups—contraindicated to PDT—and randomization was done for msPDT or PDT in PDT-indicated group and msPDT or ST for PDT-contraindicated patients. The cases were compared in terms of pre and postoperational complications. Data analysis demonstrated that the mean value of procedural time was significantly lower in the msPDT group, either compared with the standard PDT or the ST group. Paratracheal insertion, intraprocedural hypoxemia, and bleeding were also significantly lower in the msPDT group compared with the standard PDT group. Other complications were not significantly different between msPDT and ST patients. The introduced msPDT represented a semiopen incision, other than blinded PDT route of tracheal access that allowed proceduralist to withdraw bronchoscopy and reduced the total time of procedure. Interestingly, the most important improvement was performing msPDT on PDT-contraindicated patients with the complication rate

  6. Cost study of dermal substitutes and topical negative pressure in the surgical treatment of burns

    NARCIS (Netherlands)

    Hop, M.J.; Bloemen, M.C.T.; van Baar, M.E.; Nieuwenhuis, M.K.; van Zuijlen, P.P.M.; Polinder, S.; Middelkoop, E.

    2014-01-01

    AbstractBackground A recently performed randomised controlled trial investigated the clinical effectiveness of dermal substitutes (DS) and split skin grafts (SSG) in combination with topical negative pressure (TNP) in the surgical treatment of burn wounds. In the current study, medical and

  7. Medical versus surgical abortion: comparing satisfaction and potential confounders in a partly randomized study

    DEFF Research Database (Denmark)

    Rørbye, Christina; Nørgaard, Mogens; Nilas, Lisbeth

    2005-01-01

    BACKGROUND: The aim of the study was to compare satisfaction with medical and surgical abortion and to identify potential confounders affecting satisfaction. METHODS: 1033 women with gestational age (GA) < or = 63 days had either a medical (600 mg mifepristone followed by 1 mg gemeprost) or a sur...

  8. A comparative study of a happiness intervention in medical-surgical nurses.

    Science.gov (United States)

    Appel, Linda; Labhart, Lana; Balczo, Pam; McCleary, Nancy; Raley, Mary; Winsett, Rebecca P

    2013-01-01

    An intervention study evaluating the impact of journaling on nurse happiness was conducted with 91 medical-surgical nurses. No differences in general happiness, percentage of time happy, and gratitude were detected among groups although journaling was qualitatively described as meaningful.

  9. Adjuvant radiation for vulvar carcinoma: improved local control

    International Nuclear Information System (INIS)

    Faul, Clare M.; Mirmow, Dwight; Huang Qingshon; Gerszten, Kristina; Day, Roger; Jones, Mirka W.

    1997-01-01

    Purpose: Local recurrence is a significant problem following primary surgery for advanced vulva carcinoma. The objectives of this study were to evaluate the impact of adjuvant vulvar radiation on local control in high risk patients and the impact of local recurrence on overall survival. Methods and Materials: From 1980-1994, 62 patients with invasive vulva carcinoma and either positive or close (less 8 mm) margins of excision were retrospectively studied. Thirty-one patients were treated with adjuvant radiation therapy to the vulva and 31 patients were observed after surgery. Kaplan-Meier estimates and the Cox proportional hazard regression model were used to evaluate the effect of adjuvant radiation therapy on local recurrence and overall survival. Independent prognostic factors for local recurrence and survival were also assessed. Results: Local recurrence occurred in 58% of observed patients and 16% in patients treated with adjuvant radiation therapy. Adjuvant radiation therapy significantly reduced local recurrence rates in both the close margin and positive margin groups (p = 0.036, p = 0.0048). On both univariate and multivariate analysis adjuvant radiation and margins of excision were significant prognostic predictors for local control. Significant determinants of actuarial survival included International Federation of Gynecologists and Obstetricians (FIGO) stage, percentage of pathologically positive inguinal nodes and margins of excision. The positive margin observed group had a significantly poorer actuarial 5 year survival than the other groups (p = 0.0016) and adjuvant radiation significantly improved survival for this group. The 2 year actuarial survival after developing local recurrence was 25%. Local recurrence was a significant predictor for death from vulva carcinoma (risk ratio 3.54). Conclusion: Local recurrence is a common occurrence in high risk patients. In this study adjuvant radiation therapy significantly reduced local recurrence rates and

  10. Significance of PIK3CA Mutations in Patients with Early Breast Cancer Treated with Adjuvant Chemotherapy: A Hellenic Cooperative Oncology Group (HeCOG Study.

    Directory of Open Access Journals (Sweden)

    George Papaxoinis

    Full Text Available The PI3K-AKT pathway is frequently activated in breast cancer. PIK3CA mutations are most frequently found in the helical (exon 9 and kinase (exon 20 domains of this protein. The aim of the present study was to examine the role of different types of PIK3CA mutations in combination with molecular biomarkers related to PI3K-AKT signaling in patients with early breast cancer.Tumor tissue samples from 1008 early breast cancer patients treated with adjuvant chemotherapy in two similar randomized trials of HeCOG were examined. Tumors were subtyped with immunohistochemistry (IHC and FISH for ER, PgR, Ki67, HER2 and androgen receptor (AR. PIK3CA mutations were analyzed by Sanger sequencing (exon 20 and qPCR (exon 9 (Sanger/qPCR mutations. In 610 cases, next generation sequencing (NGS PIK3CA mutation data were also available. PIK3CA mutations and PTEN protein expression (IHC were analyzed in luminal tumors (ER and/or PgR positive, molecular apocrine carcinomas (MAC; ER/PgR negative / AR positive and hormone receptor (ER/PgR/AR negative tumors.PIK3CA mutations were detected in 235/1008 tumors (23% with Sanger/qPCR and in 149/610 tumors (24% with NGS. Concordance between the two methods was good with a Kappa coefficient of 0.76 (95% CI 0.69-0.82. Lobular histology, low tumor grade and luminal A tumors were associated with helical domain mutations (PIK3CAhel, while luminal B with kinase domain mutations (PIK3CAkin. The overall incidence of PIK3CA mutations was higher in luminal as compared to MAC and hormone receptor negative tumors (p = 0.004. Disease-free and overall survival did not significantly differ with respect to PIK3CA mutation presence and type. However, a statistically significant interaction between PIK3CA mutation status and PTEN low protein expression with regard to prognosis was identified.The present study did not show any prognostic significance of specific PIK3CA mutations in a large group of predominantly lymph-node positive breast cancer

  11. Long-term prognosis of young breast cancer patients (≤40 years) who did not receive adjuvant systemic treatment: protocol for the PARADIGM initiative cohort study.

    Science.gov (United States)

    Dackus, Gwen Mhe; Ter Hoeve, Natalie D; Opdam, Mark; Vreuls, Willem; Varga, Zsuzsanna; Koop, Esther; Willems, Stefan M; Van Deurzen, Carolien Hm; Groen, Emilie J; Cordoba, Alicia; Bart, Jos; Mooyaart, Antien L; van den Tweel, Jan G; Zolota, Vicky; Wesseling, Jelle; Sapino, Anna; Chmielik, Ewa; Ryska, Ales; Amant, Frederic; Broeks, Annegien; Kerkhoven, Ron; Stathonikos, Nikolas; Veta, Mitko; Voogd, Adri; Jozwiak, Katarzyna; Hauptmann, Michael; Hoogstraat, Marlous; Schmidt, Marjanka K; Sonke, Gabe; van der Wall, Elsken; Siesling, Sabine; van Diest, Paul J; Linn, Sabine C

    2017-11-14

    Currently used tools for breast cancer prognostication and prediction may not adequately reflect a young patient's prognosis or likely treatment benefit because they were not adequately validated in young patients. Since breast cancers diagnosed at a young age are considered prognostically unfavourable, many treatment guidelines recommend adjuvant systemic treatment for all young patients. Patients cured by locoregional treatment alone are, therefore, overtreated. Lack of prognosticators for young breast cancer patients represents an unmet medical need and has led to the initiation of the PAtients with bReAst cancer DIaGnosed preMenopausally (PARADIGM) initiative. Our aim is to reduce overtreatment of women diagnosed with breast cancer aged ≤ 40 years. All young, adjuvant systemic treatment naive breast cancer patients, who had no prior malignancy and were diagnosed between 1989 and 2000, were identified using the population based Netherlands Cancer Registry (n=3525). Archival tumour tissues were retrieved through linkage with the Dutch nationwide pathology registry. Tissue slides will be digitalised and placed on an online image database platform for clinicopathological revision by an international team of breast pathologists. Immunohistochemical subtype will be assessed using tissue microarrays. Tumour RNA will be isolated and subjected to next-generation sequencing. Differences in gene expression found between patients with a favourable and those with a less favourable prognosis will be used to establish a prognostic classifier, using the triple negative patients as proof of principle. Observational data from the Netherlands Cancer Registry and left over archival patient material are used. Therefore, the Dutch law on Research Involving Human Subjects Act (WMO) is not applicable. The PARADIGM study received a 'non-WMO' declaration from the Medical Ethics Committee of the Netherlands Cancer Institute - Antoni van Leeuwenhoek hospital, waiving individual patient

  12. Treatment of Oral Cavity Squamous Cell Carcinoma With Adjuvant or Definitive Intensity-Modulated Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Sher, David J., E-mail: dsher@lroc.harvard.edu [Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women' s Hospital, Boston, Massachusetts (United States); Thotakura, Vijaya [Department of Medical Oncology, Dana-Farber Cancer Institute and Department of Medicine, Brigham and Women' s Hospital, Boston, Massachusetts (United States); Balboni, Tracy A. [Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women' s Hospital, Boston, Massachusetts (United States); Norris, Charles M.; Haddad, Robert I.; Posner, Marshall R.; Lorch, Jochen [Department of Medical Oncology, Dana-Farber Cancer Institute and Department of Medicine, Brigham and Women' s Hospital, Boston, Massachusetts (United States); Goguen, Laura A.; Annino, Donald J. [Department of Surgery, Division of Otolaryngology, Brigham and Women' s Hospital, Boston, Massachusetts (United States); Tishler, Roy B. [Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women' s Hospital, Boston, Massachusetts (United States)

    2011-11-15

    Purpose: The optimal management of oral cavity squamous cell carcinoma (OCSCC) typically involves surgical resection followed by adjuvant radiotherapy or chemoradiotherapy (CRT) in the setting of adverse pathologic features. Intensity-modulated radiation therapy (IMRT) is frequently used to treat oral cavity cancers, but published IMRT outcomes specific to this disease site are sparse. We report the Dana-Farber Cancer Institute experience with IMRT-based treatment for OCSCC. Methods and Materials: Retrospective study of all patients treated at Dana-Farber Cancer Institute for OCSCC with adjuvant or definitive IMRT between August 2004 and December 2009. The American Joint Committee on Cancer disease stage criteria distribution of this cohort included 5 patients (12%) with stage I; 10 patients (24%) with stage II (n = 10, 24%),; 14 patients (33%) with stage III (n = 14, 33%),; and 13 patients (31%) with stage IV. The primary endpoint was overall survival (OS); secondary endpoints were locoregional control (LRC) and acute and chronic toxicity. Results: Forty-two patients with OCSCC were included, 30 of whom were initially treated with surgical resection. Twenty-three (77%) of 30 surgical patients treated with adjuvant IMRT also received concurrent chemotherapy, and 9 of 12 (75%) patients treated definitively without surgery were treated with CRT or induction chemotherapy and CRT. With a median follow-up of 2.1 years (interquartile range, 1.1-3.1 years) for all patients, the 2-year actuarial rates of OS and LRC following adjuvant IMRT were 85% and 91%, respectively, and the comparable results for definitive IMRT were 63% and 64% for OS and LRC, respectively. Only 1 patient developed symptomatic osteoradionecrosis, and among patients without evidence of disease, 35% experienced grade 2 to 3 late dysphagia, with only 1 patient who was continuously gastrostomy-dependent. Conclusions: In this single-institution series, postoperative IMRT was associated with promising LRC

  13. Treatment of Oral Cavity Squamous Cell Carcinoma With Adjuvant or Definitive Intensity-Modulated Radiation Therapy

    International Nuclear Information System (INIS)

    Sher, David J.; Thotakura, Vijaya; Balboni, Tracy A.; Norris, Charles M.; Haddad, Robert I.; Posner, Marshall R.; Lorch, Jochen; Goguen, Laura A.; Annino, Donald J.; Tishler, Roy B.

    2011-01-01

    Purpose: The optimal management of oral cavity squamous cell carcinoma (OCSCC) typically involves surgical resection followed by adjuvant radiotherapy or chemoradiotherapy (CRT) in the setting of adverse pathologic features. Intensity-modulated radiation therapy (IMRT) is frequently used to treat oral cavity cancers, but published IMRT outcomes specific to this disease site are sparse. We report the Dana-Farber Cancer Institute experience with IMRT-based treatment for OCSCC. Methods and Materials: Retrospective study of all patients treated at Dana-Farber Cancer Institute for OCSCC with adjuvant or definitive IMRT between August 2004 and December 2009. The American Joint Committee on Cancer disease stage criteria distribution of this cohort included 5 patients (12%) with stage I; 10 patients (24%) with stage II (n = 10, 24%),; 14 patients (33%) with stage III (n = 14, 33%),; and 13 patients (31%) with stage IV. The primary endpoint was overall survival (OS); secondary endpoints were locoregional control (LRC) and acute and chronic toxicity. Results: Forty-two patients with OCSCC were included, 30 of whom were initially treated with surgical resection. Twenty-three (77%) of 30 surgical patients treated with adjuvant IMRT also received concurrent chemotherapy, and 9 of 12 (75%) patients treated definitively without surgery were treated with CRT or induction chemotherapy and CRT. With a median follow-up of 2.1 years (interquartile range, 1.1–3.1 years) for all patients, the 2-year actuarial rates of OS and LRC following adjuvant IMRT were 85% and 91%, respectively, and the comparable results for definitive IMRT were 63% and 64% for OS and LRC, respectively. Only 1 patient developed symptomatic osteoradionecrosis, and among patients without evidence of disease, 35% experienced grade 2 to 3 late dysphagia, with only 1 patient who was continuously gastrostomy-dependent. Conclusions: In this single-institution series, postoperative IMRT was associated with promising LRC

  14. Introducing the nurse practitioner into the surgical ward: an ethnographic study of interprofessional teamwork practice.

    Science.gov (United States)

    Kvarnström, Susanne; Jangland, Eva; Abrandt Dahlgren, Madeleine

    2017-08-22

    The first nurse practitioners in surgical care were introduced into Swedish surgical wards in 2014. Internationally, organisations that have adopted nurse practitioners into care teams are reported to have maintained or improved the quality of care. However, close qualitative descriptions of teamwork practice may add to existing knowledge of interprofessional collaboration when introducing nurse practitioners into new clinical areas. The aim was to report on an empirical study describing how interprofessional teamwork practice was enacted by nurse practitioners when introduced into surgical ward teams. The study had a qualitative, ethnographic research design, drawing on a sociomaterial conceptual framework. The study was based on 170 hours of ward-based participant observations of interprofessional teamwork practice that included nurse practitioners. Data were gathered from 2014 to 2015 across four surgical sites in Sweden, including 60 interprofessional rounds. The data were analysed with an iterative reflexive procedure involving inductive and theory-led approaches. The study was approved by a Swedish regional ethics committee (Ref. No.: 2014/229-31). The interprofessional teamwork practice enacted by the nurse practitioners that emerged from the analysis comprised a combination of the following characteristic role components: clinical leader, bridging team colleague and ever-present tutor. These role components were enacted at all the sites and were prominent during interprofessional teamwork practice. The participant nurse practitioners utilised the interprofessional teamwork practice arrangements to enact a role that may be described in terms of a quality guarantee, thereby contributing to the overall quality and care flow offered by the entire surgical ward team. © 2017 Nordic College of Caring Science.

  15. Abortion - surgical

    Science.gov (United States)

    Suction curettage; Surgical abortion; Elective abortion - surgical; Therapeutic abortion - surgical ... Surgical abortion involves dilating the opening to the uterus (cervix) and placing a small suction tube into the uterus. ...

  16. Efficacy of vitamin B complex as an adjuvant therapy for the treatment of complicated vulvovaginal candidiasis: An in vivo and in vitro study.

    Science.gov (United States)

    Sun, Mei-Guo; Huang, Ying; Xu, Yuan-Hong; Cao, Yun-Xia

    2017-04-01

    This study aimed to explore the efficacy of vitamin B complex as an adjuvant therapy for the treatment of complicated vulvovaginal candidiasis (VVC) in vitro and in vivo. One-hundred fifty-eight complicated VVC patients were randomly divided into group A (treated with suppository+oral antifungal agents), group B (treated with suppository+vaginal cream), and group C (treated with suppository+vaginal cream+oral vitamin B complex). A mouse model of VVC was established. Eighty VVC mice were randomly divided into 4 groups according to the dose of vitamin B complex (20 mice in each group): V1 group (injected with 150μL normal salin), V2 group (injected with 50μL vitamin B complex solution+100μL normal saline), V3 group (injected with 100μL vitamin B complex solution+50μL normal saline), and V4 group (injected with 150μL vitamin B complex solution). After 4 weeks of treatment, the vaginal secretion was obtained for microscopic smear examination. HE stainning was performed to observe histopathological changes of vaginal tissues. The expressions of inflammatory factors were detected by ELISA. Meanwhile, VVC model of vaginal epithelial cells was established. The effects of different concentrations of vitamin B complex on anti-fungal effect of fluconazole were detected in vitro. After the treatment, complicated patients in the group C had significantly higher effective rates than those in the group A and group B. After the intra-gastric administration, the microscopic smear examination found that obvious pseudohypha in cluster with a lot of blastospores can be seen in the vaginal secretions of mice in the V1 group under the microscope. There was significant difference between mice treated with different dosages of vitamin B complex. The inflammatory response of mice in the V1 group was significantly higher than those in other groups and the inflammation response reduced with the increase of vitamin B complex dosage. The vitamin B complex elevated the curative effects of

  17. Adjuvants for vaccines to drugs of abuse and addiction.

    Science.gov (United States)

    Alving, Carl R; Matyas, Gary R; Torres, Oscar; Jalah, Rashmi; Beck, Zoltan

    2014-09-22

    Immunotherapeutic vaccines to drugs of abuse, including nicotine, cocaine, heroin, oxycodone, methamphetamine, and others are being developed. The theoretical basis of such vaccines is to induce antibodies that sequester the drug in the blood in the form of antibody-bound drug that cannot cross the blood brain barrier, thereby preventing psychoactive effects. Because the drugs are haptens a successful vaccine relies on development of appropriate hapten-protein carrier conjugates. However, because induction of high and prolonged levels of antibodies is required for an effective vaccine, and because injection of T-independent haptenic drugs of abuse does not induce memory recall responses, the role of adjuvants during immunization plays a critical role. As reviewed herein, preclinical studies often use strong adjuvants such as complete and incomplete Freund's adjuvant and others that cannot be, or in the case of many newer adjuvants, have never been, employed in humans. Balanced against this, the only adjuvant that has been included in candidate vaccines in human clinical trials to nicotine and cocaine has been aluminum hydroxide gel. While aluminum salts have been widely utilized worldwide in numerous licensed vaccines, the experience with human responses to aluminum salt-adjuvanted vaccines to haptenic drugs of abuse has suggested that the immune responses are too weak to allow development of a successful vaccine. What is needed is an adjuvant or combination of adjuvants that are safe, potent, widely available, easily manufactured, and cost-effective. Based on our review of the field we recommend the following adjuvant combinations either for research or for product development for human use: aluminum salt with adsorbed monophosphoryl lipid A (MPLA); liposomes containing MPLA [L(MPLA)]; L(MPLA) adsorbed to aluminum salt; oil-in-water emulsion; or oil-in-water emulsion containing MPLA. Copyright © 2014. Published by Elsevier Ltd.

  18. Adjuvant radiation therapy for pancreatic cancer: a 15-year experience

    International Nuclear Information System (INIS)

    Dobelbower, Ralph R.; Merrick, Hollis W.; Khuder, Sadik; Battle, Joyce A.; Herron, Lisa M.; Pawlicki, Todd

    1997-01-01

    Purpose: A retrospective analysis to determine differences in survival of patients with pancreatic aden carcinoma treated by radical surgery with and without adjuvant radiation therapy. Methods and Materials: Between 1980 and 1995, 249 patients with pancreatic tumors were identified at the Medical College of Ohio. Forty-four of these patients underwent radical surgical procedures with curative intent. These patients were divided into four groups according to treatment: surgery alone (n = 14), surgery plus intraoperative radiation therapy (IORT) (n = 6), surgery plus external beam radiation therapy (EBRT) (n = 14), or surgery plus both IORT and EBRT (n = 10). Outcome and survival were analyzed among the four groups. Results: The median survival time of patients treated with radical surgery alone was 6.5 months. The median survival time for the surgery plus IORT group was 9 months; however, 33.3% (two of six) of these patients survived longer than 5 years. This survival pattern was borderline significantly better than that for the surgery alone group (p = 0.0765). The surgery plus EBRT and the surgery plus IORT and EBRT groups had median survival times of 14.5 and 17.5 months, respectively. These were significantly better than that of the surgery alone group (p = 0.0004 and p = 0.0002, respectively). The addition of radiation therapy did not affect the treatment complication rate. Conclusion: The survival of patients who were treated with radical surgery alone was significantly poorer than that of patients who received adjuvant radiation therapy. These results are consistent with other studies in the literature. Patients treated with all three modalities (surgery, IORT, and EBRT) displayed the best median survival time

  19. Prognosis after surgical treatment for pancreatic cancer in patients aged 80 years or older: a multicenter study.

    Science.gov (United States)

    Sho, Masayuki; Murakami, Yoshiaki; Kawai, Manabu; Motoi, Fuyuhiko; Satoi, Sohei; Matsumoto, Ippei; Honda, Goro; Uemura, Kenichiro; Yanagimoto, Hiroaki; Kurata, Masanao; Akahori, Takahiro; Kinoshita, Shoichi; Nagai, Minako; Nishiwada, Satoshi; Fukumoto, Takumi; Unno, Michiaki; Yamaue, Hiroki; Nakajima, Yoshiyuki

    2016-03-01

    The optimal therapeutic strategy for very elderly pancreatic cancer patients remains to be determined. The aim of this study was to clarify the role of pancreatic resection in patients 80 years of age or older. A retrospective multicenter analysis of 1401 patients who had undergone pancreatic resection for pancreatic cancer was performed. The patients aged ≥ 80 years (n = 99) were compared with a control group <80 years of age (n = 1302). There were no significant differences in the postoperative complications and mortality between the two groups. However, the prognosis of octogenarians was poorer than that of younger patients for both resectable and borderline resectable tumors. Importantly, there were few long-term survivors in the elderly group, especially among those with borderline resectable pancreatic cancer. A multivariate analysis of the prognostic factors in the very elderly patients indicated that the completion of adjuvant chemotherapy was the only significant factor. In addition, preoperative albumin level was the only independent risk factor for a failure to complete adjuvant chemotherapy. This study demonstrates that the postoperative prognosis in octogenarian patients was not good as that in younger patients possibly due to less frequent completion of adjuvant chemotherapy. © 2016 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  20. Women’s Beliefs on Early Adherence to Adjuvant Endocrine Therapy for Breast Cancer: A Theory-Based Qualitative Study to Guide the Development of Community Pharmacist Interventions

    Directory of Open Access Journals (Sweden)

    Brittany Humphries

    2018-06-01

    Full Text Available Adjuvant endocrine therapy (AET taken for a minimum of five years reduces the recurrence and mortality risks among women with hormone-sensitive breast cancer. However, adherence to AET is suboptimal. To guide the development of theory-based interventions to enhance AET adherence, we conducted a study to explore beliefs regarding early adherence to AET. This qualitative study was guided by the Theory of Planned Behavior (TPB. We conducted focus groups and individual interviews among women prescribed AET in the last two years (n = 43. The topic guide explored attitudinal (perceived advantages and disadvantages, normative (perception of approval or disapproval, and control beliefs (barriers and facilitating factors towards adhering to AET. Thematic analysis was conducted. Most women had a positive attitude towards AET regardless of their medication-taking behavior. The principal perceived advantage was protection against a recurrence while the principal inconvenience was side effects. Almost everyone approved of the woman taking her medication. The women mentioned facilitating factors to encourage medication-taking behaviors and cope with side effects. For adherent women, having trouble establishing a routine was their main barrier to taking medication. For non-adherent women, it was side effects affecting their quality of life. These findings could inform the development of community pharmacy-based adherence interventions.

  1. ERM immersion vaccination and adjuvants

    DEFF Research Database (Denmark)

    Skov, J.; Chettri, J. K.; Jaafar, R. M.

    2015-01-01

    Two candidate adjuvants were tested with a commercial ERM dip vaccine (AquaVac™ Relera, MSD Animal Health) for rainbow trout in an experimental design compatible with common vaccination practices at farm level, i.e. immersion of fish in vaccine (±adjuvant) for 30 s. The adjuvants were...... the commercial product Montanide™ IMS 1312 VG PR (SEPPIC), and a soluble and ≥98% pure β-glucan from yeast (Saccharomyces cerevisiae) (Sigma-Aldrich). Hence, five experimental groups in duplicate were established and exposed to vaccine and adjuvants in the following combinations: AquaVac™ Relera (alone); Aqua......Vac™ Relera + Montanide™; AquaVac™ Relera + β-glucan; Montanide™ (alone); and β-glucan (alone). Approximately 450 degree days post-vaccination, the fish were bath-challenged with live Yersinia ruckeri to produce survival curves. Blood, skin and gills were sampled at selected time points during the course...

  2. Engineering of an Inhalable DDA/TDB Liposomal Adjuvant

    DEFF Research Database (Denmark)

    Ingvarsson, Pall Thor; Yang, Mingshi; Mulvad, Helle

    2013-01-01

    The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB).......The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB)....

  3. AQUACEL® Ag Surgical Dressing Reduces Surgical Site Infection and Improves Patient Satisfaction in Minimally Invasive Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study

    Directory of Open Access Journals (Sweden)

    Feng-Chih Kuo

    2017-01-01

    Full Text Available The use of modern surgical dressings to prevent wound complications and surgical site infection (SSI after minimally invasive total knee arthroplasty (MIS-TKA is lacking. In a prospective, randomized, controlled study, 240 patients were randomized to receive either AQUACEL Ag Surgical dressing (study group or a standard dressing (control group after MIS-TKA. The primary outcome was wound complication (SSI and blister. The secondary outcomes were wear time and number of dressing changes in the hospital and patient satisfaction (pain, comfort, and ease of use. In the intention-to-treat analysis, there was a significant reduction in the incidence of superficial SSI (0.8%, 95% CI∶ 0.00–2.48 in the study group compared to 8.3% (95% CI∶ 3.32–13.3 in the control group (p=0.01. There were no differences in blister and deep/organ-space SSIs between the two groups. Multivariate analysis revealed that AQUACEL Ag Surgical dressing was an independent risk factor for reduction of SSI (odds ratio: 0.07, 95% CI: 0.01–0.58, p=0.01. The study group had longer wear time (5.2±0.7 versus 1.7±0.4 days, p<0.0001 and lower number of dressing changes (1.0±0.2 versus 3.6±1.3 times, p<0.0001. Increased patient satisfaction (p<0.0001 was also noted in the study group. AQUACEL Ag Surgical dressing is an ideal dressing to provide wound care efficacy, patient satisfaction, reduction of SSI, and cost-effectiveness following MIS-TKA.

  4. Influence of Internet dissemination on hospital selection for benign surgical disease: A single center retrospective study.

    Science.gov (United States)

    Lee, Sung Ryul; Koo, Bum Hwan; Byun, Geon Young; Lee, Seung Geun; Kim, Myoung Jin; Hong, Soo Kyung; Kim, Su Yeon; Lee, Yu Jin

    2018-05-17

    The Internet is used worldwide, but its effect on hospital selection of minor surgical disease has not hitherto been thoroughly studied. To investigate the effect of the Internet dissemination on hospital selection of minor surgical disease and information affecting selection, we conducted a survey of patients who underwent laparoscopic surgery from January 2016 to April 2017. We analyzed the questionnaire responses of 1916 patients. Over 80% of patients in all groups selected the hospital based on Internet information. Among patients aged over 60 years, 65.1% selected the hospital based on Internet information. With regard to hospital selection factors, the highest number of responses was for sophisticated surgical treatment (93.1%). The second highest was for a simplified medical care system (33.0%); third was a comprehensive nursing care system (18.1%). Among responses about surgical treatment, the most were obtained for short operation time and fewer hospitalization days (81.5%). Copyright © 2018 John Wiley & Sons, Ltd.

  5. Direct Cost of Reprocessing Cotton-woven Surgical Drapes: a Case Study

    Directory of Open Access Journals (Sweden)

    Mariana Fexina Tomé

    Full Text Available OBJECTIVE Identify the direct cost of reprocessing double and single cotton-woven drapes of the surgical LAP package. METHOD A quantitative, exploratory and descriptive case study, performed at a teaching hospital. The direct cost of reprocessing cotton-woven surgical drapes was calculated by multiplying the time spent by professionals involved in reprocessing the unit with the direct cost of labor, adding to the cost of materials. The Brazilian currency (R$ originally used for the calculations was converted to US currency at the rate of US$0.42/R$. RESULTS The average total cost for surgical LAP package was US$9.72, with the predominance being in the cost of materials (US$8.70 or 89.65%. It is noteworthy that the average total cost of materials was mostly impacted by the cost of the cotton-woven drapes (US$7.99 or 91.90%. CONCLUSION The knowledge gained will subsidize discussions about replacing reusable cotton-woven surgical drapes for disposable ones, favoring arguments regarding the advantages and disadvantages of this possibility considering human resources, materials, as well as structural, environmental and financial resources.

  6. Challenges for the surgical capacity building of township hospitals among the Central China: a retrospective study.

    Science.gov (United States)

    Li, Zhong; Yang, Jian; Wu, Yue; Pan, Zijin; He, Xiaoqun; Li, Boyang; Zhang, Liang

    2018-05-02

    China's rapid transition in healthcare service system has posed considerable challenges for the primary care system. Little is known regarding the capacity of township hospitals (THs) to deliver surgical care in rural China with over 600 million lives. We aimed to ascertain its current performance, barriers, and summary lessons for its re-building in central China. This study was conducted in four counties from two provinces in central China. The New Rural Cooperative Medical System (NRCMS) claim data from two counties in Hubei province was analyzed to describe the current situation of surgical care provision. Based on previous studies, self-administered questionnaire was established to collect key indicators from 60 THs from 2011 to 2015, and social and economic statuses of the sampling townships were collected from the local statistical yearbook. Semi-structured interviews were conducted among seven key administrators in the THs that did not provide appendectomy care in 2015. Determinants of appendectomy care provision were examined using a negative binominal regression model. First, with the rapid increase in inpatient services provided by the THs, their proportion of surgical service provision has been nibbled by out-of-county facilities. Second, although DY achieved a stable performance, the total amount of appendectomy provided by the 60 THs decreased to 589 in 2015 from 1389 in 2011. Moreover, their proportion reduced to 26.77% in 2015 from 41.84% in 2012. Third, an increasing number of THs did not provide appendectomy in 2015, with the shortage of anesthesiologists and equipment as the most mentioned reasons (46.43%). Estimation results from the negative binomial model indicated that the annual average per capita disposable income and tightly integrated delivery networks (IDNs) negatively affected the amount of appendectomy provided by THs. By contrast, the probability of appendectomy provision by THs was increased by performance-related payment (PRP). Out

  7. Postoperative adverse outcomes in intellectually disabled surgical patients: a nationwide population-based study.

    Directory of Open Access Journals (Sweden)

    Jui-An Lin

    Full Text Available BACKGROUND: Intellectually disabled patients have various comorbidities, but their risks of adverse surgical outcomes have not been examined. This study assesses pre-existing comorbidities, adjusted risks of postoperative major morbidities and mortality in intellectually disabled surgical patients. METHODS: A nationwide population-based study was conducted in patients who underwent inpatient major surgery in Taiwan between 2004 and 2007. Four controls for each patient were randomly selected from the National Health Insurance Research Database. Preoperative major comorbidities, postoperative major complications and 30-day in-hospital mortality were compared between patients with and without intellectual disability. Use of medical services also was analyzed. Adjusted odds ratios using multivariate logistic regression analyses with 95% confidence intervals were applied to verify intellectual disability's impact. RESULTS: Controls were compared with 3983 surgical patients with intellectual disability. Risks for postoperative major complications were increased in patients with intellectual disability, including acute renal failure (odds ratio 3.81, 95% confidence interval 2.28 to 6.37, pneumonia (odds ratio 2.01, 1.61 to 2.49, postoperative bleeding (odds ratio 1.35, 1.09 to 1.68 and septicemia (odds ratio 2.43, 1.85 to 3.21 without significant differences in overall mortality. Disability severity was positively correlated with postoperative septicemia risk. Medical service use was also significantly higher in surgical patients with intellectual disability. CONCLUSION: Intellectual disability significantly increases the risk of overall major complications after major surgery. Our findings show a need for integrated and revised protocols for postoperative management to improve care for intellectually disabled surgical patients.

  8. Trends in the incidence rate, type and treatment of surgically verified endometriosis - a nationwide cohort study.

    Science.gov (United States)

    Saavalainen, Liisu; Tikka, Tuulia; But, Anna; Gissler, Mika; Haukka, Jari; Tiitinen, Aila; Härkki, Päivi; Heikinheimo, Oskari

    2018-01-01

    To study the trends in incidence rate, type and surgical treatment, and patient characteristics of surgically verified endometriosis during 1987-2012. This is a register-based cohort study. We identified women receiving their first diagnosis of endometriosis in surgery from the Finnish Hospital Discharge Register (FHDR). Quality of the FHDR records was assessed bidirectionally. The age-standardized incidence rates of the first surgically verified endometriosis was assessed by calendar year. The cohort comprises 49 956 women. The quality assessment suggested the FHDR data to be of good quality. The most common diagnosis, ovarian endometriosis (46%), was associated with highest median age 38.5 years (interquartile range 31.0-44.8) and the second most common diagnosis, peritoneal endometriosis (40%), with median age 34.9 years (28.6-41.7). Between 1987 and 2012, a decrease was observed in the median age, from 38.8 (32.3-43.6) to 34.0 (28.9-41.0) years, and in the age-standardized incidence rate from 116 [95% confidence interval (CI) 112-121] to 45 (42-48) per 100 000 women. The proportion of hysterectomy as a first surgical treatment decreased from 38 to 19%, whereas that of laparoscopy increased from 42 to 73% when comparing 1987-1995 with 1996-2012. This nationwide cohort of surgically verified endometriosis showed a decrease in the incidence rate and in the patient age at the time of first diagnosis, even though the proportion of laparoscopy has increased. The number of hysterectomies has decreased. These changes are likely to reflect the evolving diagnostics, increasing awareness of endometriosis, and effective use of medical treatment before surgery. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

  9. Quadrantectomy and adjuvant radiotherapy for breast cancer

    International Nuclear Information System (INIS)

    Gabriele, A.M.; Boidi Trotti, A.; Tardy, A.

    1987-01-01

    The conservative treatment of early breast cancer always requires irradiation of residual mammary tissue. The preliminary results obtained in 45 early breast cancer patients, who received quadrantectomy plus axillary dissection, followed by radiation of residual breast are reported. Radiation was performed by the two opposed field technique. In some cases the residual breast tissue was compressed using a special accessory provided with the Theratron 780. In addition to the tumor dose of 50 GY, 10 GY boots was added to the surgical scar using 7 MeV electrons. The 6 patients with positive axillary nodes received 6 courses of adjuvant chemotherapy (CMF) after radiotherapy. All patients are currently alive and free of disease. The 64% (29 patients) were followed up for at least 5 years, and 36% (16 patients) for at least 3 years. Only 2 cases of local recurrence were encountered (4,4%). The esthetic result was satisfactory in all cases. No side effects due to treatment were noted

  10. Surgically treated cases of lumbar spondylolysis and isthmic spondylolisthesis: a multicenter study.

    Science.gov (United States)

    Hirano, Kenichi; Imagama, Shiro; Matsuyama, Yukihiro; Kawakami, Noriaki; Yukawa, Yasutsugu; Kato, Fumihiko; Hachiya, Yudo; Kanemura, Tokumi; Kamiya, Mitsuhiro; Deguchi, Masao; Ito, Zenya; Wakao, Norimitsu; Ando, Kei; Tauchi, Ryoji; Muramoto, Akio; Ishiguro, Naoki

    2015-06-01

    Prospective database study. To grasp the characteristics of surgically treated cases with lumbar spondylolysis or isthmic spondylolisthesis. A detailed analysis of surgically treated cases with spondylolysis or isthmic spondylolisthesis has never been reported. An epidemiological study in Japan conducted on 2000 subjects found the incidence of lumbar spondylolysis in the Japanese general population (population-based study) to be 5.9% (males: 7.9%, females: 3.9%). Among 124 vertebrae with spondylolysis, there were 0.8% L2 lesions, 3.2% L3 lesions, 5.6% L4 lesions, and 90.3% L5 lesions, including 5 cases (4.3%) with multiple-level lesions. We have been registering surgically treated spine cases in our database since 2000. From this database, we prospectively collected cases with lumbar spondylolysis or isthmic spondylolisthesis that were treated surgically between January 2000 and December 2009. We determined the age at surgery, sex, and vertebral level of spondylolysis. Of the 564 spondylolysis patients treated surgically, 66.8% were male and 33.2% were female. The mean age at surgery was 52.5 years (range, 13-84 y). There were 585 vertebrae with spondylolysis including 21 cases (3.7%) with multiple-level lesions. L5 spondylolysis affected 432 vertebrae and was the most common location (73.8%), followed by 125 L4 lesions (21.4%), 24 L3 lesions (4.1%), and 2 L2 lesions (0.7%). The percentage of L4 lesions in our study was significantly higher and of L5 lesions was significantly lower than those lesions' percentages in the population-based study. L4 spondylolysis may be more unstable or cause clinical symptoms more frequently leading to more surgical intervention. The percentage of multiple-level spondylolysis was similar between the 2 studies, suggesting these patients respond relatively well to conservative treatment. The male/female ratio was 2:1 in both studies, indicating that males and females require surgery at a similar frequency.

  11. Understanding the Essential Meaning of Measured Changes in Weight and Body Composition Among Women During and After Adjuvant Treatment for Breast Cancer: A Mixed-Methods Study.

    Science.gov (United States)

    Pedersen, Birgith; Groenkjaer, Mette; Falkmer, Ursula; Delmar, Charlotte

    Changes in weight and body composition among women during and after adjuvant antineoplastic treatment for breast cancer may influence long-term survival and quality of life. Research on factual weight changes is diverse and contrasting, and their influence on women's perception of body and self seems to be insufficiently explored. The aim of this study was to expand the understanding of the association between changes in weight and body composition and the women's perception of body and selves. A mixed-methods research design was used. Data consisted of weight and body composition measures from 95 women with breast cancer during 18 months past surgery. Twelve women from this cohort were interviewed individually at 12 months. Linear mixed model and logistic regression were used to estimate changes of repeated measures and odds ratio. Interviews were analyzed guided by existential phenomenology. Joint displays and integrative mixed-methods interpretation demonstrated that even small weight gains, extended waist, and weight loss were associated with fearing recurrence of breast cancer. Perceiving an ambiguous transforming body, the women moved between a unified body subject and the body as an object dissociated in "I" and "it" while fighting against or accepting the body changes. Integrating findings demonstrated that factual weight changes do not correspond with the perceived changes and may trigger existential threats. Transition to a new habitual body demand health practitioners to enter a joint narrative work to reveal how the changes impact on the women's body and self-perception independent of how they are displayed quantitatively.

  12. Anti-Müllerian hormone (AMH) levels in premenopausal breast cancer patients treated with taxane-based adjuvant chemotherapy - A translational research project of the SUCCESS A study.

    Science.gov (United States)

    Trapp, Elisabeth; Steidl, J; Rack, B; Kupka, M S; Andergassen, U; Jückstock, J; Kurt, A; Vilsmaier, T; de Gregorio, A; de Gregorio, N; Tzschaschel, M; Lato, C; Polasik, A; Tesch, H; Schneeweiss, A; Beckmann, M W; Fasching, P A; Janni, W; Müller, V

    2017-10-01

    Premenopausal women undergoing chemotherapy are at high risk for premature ovarian failure and its long-term consequences. Data on potential markers to evaluate ovarian reserve pre- and posttreatment are limited. Anti-Müllerian hormone (AMH) known for ovarian reserve in reproductive medicine could be a surrogate marker and was assessed in premenopausal breast cancer patients of the SUCCESS A study (EUDRA-CT no. 2005-000490-21). We identified 170 premenopausal patients, age ≤ 40 years at trial entry, who received FEC-Doc as taxane-anthracylince based chemotherapy. Blood samples were taken at three time points: Before, four weeks after and two years after adjuvant chemotherapy. Serum AMH-levels were evaluated in a central laboratory by a quantitative immunoassay AMH Gen II ELISA (Beckman Coulter, Brea, USA). Median age was 36 years (21-40 years). Median serum AMH-level before chemotherapy was 1.37 ng/ml (range chemotherapy AMH-levels dropped in 98.6% of the patients to chemotherapy induced amenorrhea occurred only in 50.6% of the patients. In this analysis, premenopausal patients showed a high rate of ovarian impairment reflected by low AMH-levels after chemotherapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. A Comparative Dosimetric Study of Adjuvant 3D Conformal Radiotherapy for Operable Stomach Cancer Versus AP-PA Conventional Radiotherapy in NCI-Cairo

    International Nuclear Information System (INIS)

    El-Hossiny, H.A.; Diab, N.A.; El-Taher, M.M.

    2009-01-01

    This study was to compare this multiple field conformal technique to the AP-PA technique with respect to target volume coverage and dose to normal tissues. Materials and Methods: Seventeen patients with stages II-III denocarcinoma of the stomach were treated with adjuvant postoperative chemoradiotherapy presented to radiotherapy department in National Cancer Institute, Cairo in period between February 2009 to March 2010 using 3D conformal radiotherapy technique that consisted of a mono isocentric arrangement employing 4-6 radiation fields. For each patient, a second radiotherapy treatment plan was done using an antroposterior (AP-PA) fields, the two techniques were then compared using dose volume histogram (DVH) analysis. Results: Comparing different DVHs, it was found that the planning target volume (PTV) was adequately covered in both (3D and 2D) plans while the left kidney and spinal cord demonstrate lower radiation doses on using the conformal technique. The liver doses is higher in the 3D tecq, but still well below liver tolerance. Conclusions: Both 3D conformal radiotherapy and AP-PA conventional techniques doses are within range of normal tissues tolerance. Regarding the left kidney and spinal cord the 3D conformal radiotherapy is superior than the AP-PA conventional techniques but with higher doses to the liver in the 3D conformal radiotherapy compared to the AP-PA conventional techniques

  14. Using Qualitative Comparative Analysis of Key Informant Interviews in Health Services Research: Enhancing a Study of Adjuvant Therapy Use in Breast Cancer Care.

    Science.gov (United States)

    McAlearney, Ann Scheck; Walker, Daniel; Moss, Alexandra D; Bickell, Nina A

    2016-04-01

    Qualitative comparative analysis (QCA) is a methodology created to address causal complexity in social sciences research by preserving the objectivity of quantitative data analysis without losing detail inherent in qualitative research. However, its use in health services research (HSR) is limited, and questions remain about its application in this context. To explore the strengths and weaknesses of using QCA for HSR. Using data from semistructured interviews conducted as part of a multiple case study about adjuvant treatment underuse among underserved breast cancer patients, findings were compared using qualitative approaches with and without QCA to identify strengths, challenges, and opportunities presented by QCA. Ninety administrative and clinical key informants interviewed across 10 NYC area safety net hospitals. Transcribed interviews were coded by 3 investigators using an iterative and interactive approach. Codes were calibrated for QCA, as well as examined using qualitative analysis without QCA. Relative to traditional qualitative analysis, QCA strengths include: (1) addressing causal complexity, (2) results presentation as pathways as opposed to a list, (3) identification of necessary conditions, (4) the option of fuzzy-set calibrations, and (5) QCA-specific parameters of fit that allow researchers to compare outcome pathways. Weaknesses include: (1) few guidelines and examples exist for calibrating interview data, (2) not designed to create predictive models, and (3) unidirectionality. Through its presentation of results as pathways, QCA can highlight factors most important for production of an outcome. This strength can yield unique benefits for HSR not available through other methods.

  15. The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

    NARCIS (Netherlands)

    Abbott, T. E. F.; Ahmad, T.; Phull, M. K.; Fowler, A. J.; Hewson, R.; Biccard, B. M.; Chew, M. S.; Gillies, M.; Pearse, R. M.; Pearse, Rupert M.; Beattie, Scott; Clavien, Pierre-Alain; Demartines, Nicolas; Fleisher, Lee A.; Grocott, Mike; Haddow, James; Hoeft, Andreas; Holt, Peter; Moreno, Rui; Pritchard, Naomi; Rhodes, Andrew; Wijeysundera, Duminda; Wilson, Matt; Ahmed, Tahania; Everingham, Kirsty; Hewson, Russell; Januszewska, Marta; Phull, Mandeep-Kaur; Halliwell, Richard; Shulman, Mark; Myles, Paul; Schmid, Werner; Hiesmayr, Michael; Wouters, Patrick; de Hert, Stefan; Lobo, Suzana; Fang, Xiangming; Rasmussen, Lars; Futier, Emmanuel; Biais, Matthieu; Venara, Aurélien; Slim, Karem; Sander, Michael; Koulenti, Despoina; Arvaniti, Kostoula; Chan, Mathew; Kulkarni, Atul; Chandra, Susilo; Tantri, Aida; Geddoa, Emad; Abbas, Muntadhar; Della Rocca, Giorgio; Sivasakthi, Datin; Mansor, Marzida; Luna, Pastor; Bouwman, Arthur; Buhre, Wolfgang; Beavis, Vanessa; Campbell, Douglas; Short, Tim; Osinaike, Tunde; Matos, Ricardo; Grigoras, Ioana; Kirov, Mikhail; Protsenko, Denis; Biccard, Bruce; Aldecoa, Cesar; Chew, Michelle; Hofer, Christoph; Hubner, Martin; Ditai, James; Szakmany, Tamas; Fleisher, Lee; Ferguson, Marissa; MacMahon, Michael; Cherian, Ritchie; Currow, Helen; Kanathiban, Kathirgamanathan; Gillespie, David; Pathmanathan, Edward; Phillips, Katherine; Reynolds, Jenifer; Rowley, Joanne; Douglas, Jeanene; Kerridge, Ross; Garg, Sameer; Bennett, Michael; Jain, Megha; Alcock, David; Terblanche, Nico; Cotter, Rochelle; Leslie, Kate; Stewart, Marcelle; Zingerle, Nicolette; Clyde, Antony; Hambidge, Oliver; Rehak, Adam; Cotterell, Sharon; Huynh, Wilson Binh Quan; McCulloch, Timothy; Ben-Menachem, Erez; Egan, Thomas; Cope, Jennifer; Fellinger, Paul; Haisjackl, Markus; Haselberger, Simone; Holaubek, Caroline; Lichtenegger, Paul; Scherz, Florian; Hoffer, Franz; Cakova, Veronika; Eichwalder, Andreas; Fischbach, Norbert; Klug, Reinhold; Schneider, Elisabeth; Vesely, Martin; Wickenhauser, Reinhart; Grubmueller, Karl Gernot; Leitgeb, Marion; Lang, Friedrich; Toro, Nancy; Bauer, Marlene; Laengle, Friedrich; Haberl, Claudia; Mayrhofer, Thomas; Trybus, Christoph; Buerkle, Christian; Forstner, Karin; Germann, Reinhard; Rinoesl, Harald; Schindler, Elke; Trampitsch, Ernst; Bogner, Gerhard; Dankl, Daniel; Duenser, Martin; Fritsch, Gerhard; Gradwohl-Matis, Ilse; Hartmann, Andreas; Hoelzenbein, Thomas; Jaeger, Tarkan; Landauer, Franz; Lindl, Gregor; Lux, Michael; Steindl, Johannes; Stundner, Ottokar; Szabo, Christian; Bidgoli, Jawad; Verdoodt, Hans; Forget, Patrice; Kahn, David; Lois, Fernande; Momeni, Mona; Prégardien, Caroline; Pospiech, Audrey; Steyaert, Arnaud; Veevaete, Laurent; de Kegel, Dirk; de Jongh, Karen; Foubert, Luc; Smitz, Carine; Vercauteren, Marcel; Poelaert, Jan; van Mossevelde, Veerle; Abeloos, Jacques; Bouchez, Stefaan; Coppens, Marc; de Baerdemaeker, Luc; Deblaere, Isabel; de Bruyne, Ann; Fonck, Kristine; Heyse, Bjorn; Jacobs, Tom; Lapage, Koen; Moerman, Anneliese; Neckebroek, Martine; Parashchanka, Aliaksandra; Roels, Nathalie; van den Eynde, Nancy; Vandenheuvel, Michael; Limmen, JurgenVan; Vanluchene, Ann; Vanpeteghem, Caroline; Wyffels, Piet; Huygens, Christel; Vandenbempt, Punitha; van de Velde, Marc; Dylst, Dimitri; Janssen, Bruno; Schreurs, Evelien; Aleixo, Fábia Berganton; Candido, Keulle; Batista, Hugo Dias; Guimarães, Mario; Guizeline, Jaqueline; Hoffmann, João; Lobo, Francisco Ricardo Marques; Nascimento, Vinícius; Nishiyama, Katia; Pazetto, Lucas; Souza, Daniela; Rodrigues, Rodrigo Souza; Vilela Dos Santos, Ana Maria; Jardim, Jaquelline; Sá Malbouisson, Luiz Marcelo; Silva, Joao; Nascimento Junior, Paulo do; Baio, Thalissa Hermínia; Pereira de Castro, Gabriel Isaac; Watanabe Oliveira, Henri Roger; Amendola, Cristina Prata; Cardoso, Gutemberg; Ortega, Daniela; Brotto, Ana Flavia; de Oliveira, Mirella Cristine; Réa-Neto, Álvaro; Dias, Fernando; Travi, Maria Eduarda; Zerman, Luiza; Azambuja, Pedro; Knibel, Marcos Freitas; Martins, Antonio; Almeida, William; Neto, Calim Neder; Tardelli, Maria Angela; Caser, Eliana; Machado, Marcio; Aguzzoli, Crisitiano; Baldisserotto, Sérgio; Tabajara, Fernanda Beck; Bettega, Fernanda; Rodrigues Júnior, La Hore Correa; de Gasperi, Julia; Faina, Lais; Nolasco, Marcos Farias; Ferreira da Costa Fischer, Bruna; Fosch de Campos Ferreira, Mariana; Hartmann, Cristina; Kliemann, Marta; Hubert Ribeiro, Gustavo Luis; Fraga, Julia Merladete; Netto, Thiago Motta; Pozza, Laura Valduga; Wendling, Paulo Rafael; Azevedo, Caroline; Garcia, Juliana; Lopes, Marcel; Maia, Bernardo; Maselli, Paula; Melo, Ralph; Mendes, Weslley; Neves, Matheus; Ney, Jacqueline; Piras, Claudio; Applewhaite, Christopher; Carr, Adrienne; Chow, Lorraine; Duttchen, Kaylene; Foglia, Julena; Greene, Michael; Hinther, Ashley; Houston, Kendra; McCormick, Thomas Jared; Mikhayel, Jennifer; Montasser, Sam; Ragan, Alex; Suen, Andrew; Woolsey, Adrianna; Yu, Hai Chuan; Funk, Duane; Kowalski, Stephen; Legaspi, Regina; McDonald, Heather; Siddiqui, Faisal; Pridham, Jeremy; Rowe, Bernadette; Sampson, Sonia; Thiessen, Barton; Zbitnew, Geoff; Bernard, Andre; George, Ronald; Jones, Philip; Moor, Rita; Siddiqui, Naveed; Wolfer, Alexandra; Tran, Diem; Winch, Denyse; Dobson, Gary; McCormick, Thomas; Montasser, Osama; Hall, Richard; Baghirzada, Leyla; Curley, Gerard; Dai, Si Yuan; Hare, Gregory; Lee, Esther; Shastri, Uma; Tsui, Albert; Yagnik, Anmol; Alvares, Danielle; Choi, Stephen; Dwyer, Heather; Flores, Kathrina; McCartney, Colin; Somascanthan, Priya; Carroll, Jo; Pazmino-Canizares, Janneth; Ami, Noam; Chan, Vincent; Perlas, Anahi; Argue, Ruth; Huang, Yang; Lavis, Katie; Mayson, Kelly; Cao, Ying; Gao, Hong; Hu, Tingju; Lv, Jie; Yang, Jian; Yang, Yang; Zhong, Yi; Zhou, Jing; Zou, Xiaohua; He, Miao; Li, Xiaoying; Luo, Dihuan; Wang, Haiying; Yu, Tian; Chen, Liyong; Wang, Lijun; Cai, Yunfei; Cao, Zhongming; Li, Yanling; Lian, Jiaxin; Sun, Haiyun; Wang, Sheng; Wang, Zhipeng; Wang, Kenru; Zhu, Yi; Du, Xindan; Fan, Hao; Fu, Yunbin; Huang, Lixia; Huang, Yanming; Hwan, Haifang; Luo, Hong; Qu, Pi-Sheng; Tao, Fan; Wang, Zhen; Wang, Guoxiang; Wang, Shun; Zhang, Yan; Zhang, Xiaolin; Chen, Chao; Wang, Weixing; Liu, Zhengyuan; Fan, Lihua; Tang, Jing; Chen, Yijun; Chen, Yongjie; Han, Yangyang; Huang, Changshun; Liang, Guojin; Shen, Jing; Wang, Jun; Yang, Qiuhong; Zhen, Jungang; Zhou, Haidong; Chen, Junping; Chen, Zhang; Li, Xiaoyu; Meng, Bo; Ye, Haiwang; Zhang, Xiaoyan; Bi, Yanbing; Cao, Jianqiao; Guo, Fengying; Lin, Hong; Liu, Yang; Lv, Meng; Shi, Pengcai; Song, Xiumei; Sun, Chuanyu; Sun, Yongtao; Wang, Yuelan; Wang, Shenhui; Zhang, Min; Chen, Rong; Hou, Jiabao; Leng, Yan; Meng, Qing-Tao; Qian, Li; Shen, Zi-Ying; Xia, Zhong-Yuan; Xue, Rui; Zhang, Yuan; Zhao, Bo; Zhou, Xian-Jin; Chen, Qiang; Guo, Huinan; Guo, Yongqing; Qi, Yuehong; Wang, Zhi; Wei, Jianfeng; Zhang, Weiwei; Zheng, Lina; Bao, Qi; Chen, Yaqiu; Chen, Yijiao; Fei, Yue; Hu, Nianqiang; Hu, Xuming; Lei, Min; Li, Xiaoqin; Lv, Xiaocui; Miao, Fangfang; Ouyang, Lingling; Qian, Lu; Shen, Conyu; Sun, Yu; Wang, Yuting; Wang, Dong; Wu, Chao; Xu, Liyuan; Yuan, Jiaqi; Zhang, Lina; Zhang, Huan; Zhang, Yapping; Zhao, Jinning; Zhao, Chong; Zhao, Lei; Zheng, Tianzhao; Zhou, Dachun; Zhou, Haiyan; Zhou, Ce; Lu, Kaizhi; Zhao, Ting; He, Changlin; Chen, Hong; Chen, Shasha; Cheng, Baoli; He, Jie; Jin, Lin; Li, Caixia; Li, Hui; Pan, Yuanming; Shi, Yugang; Wen, Xiao Hong; Wu, Shuijing; Xie, Guohao; Zhang, Kai; Zhao, Bing; Lu, Xianfu; Chen, Feifei; Liang, Qisheng; Lin, Xuewu; Ling, Yunzhi; Liu, Gang; Tao, Jing; Yang, Lu; Zhou, Jialong; Chen, Fumei; Cheng, Zhonggui; Dai, Hanying; Feng, Yunlin; Hou, Benchao; Gong, Haixia; Hu, Chun Hua; Huang, Haijin; Huang, Jian; Jiang, Zhangjie; Li, Mengyuan; Lin, Jiamei; Liu, Mei; Liu, Weicheng; Liu, Zhen; Liu, Zhiyi; Luo, Foquan; Ma, Longxian; Min, Jia; Shi, Xiaoyun; Song, Zhiping; Wan, Xianwen; Xiong, Yingfen; Xu, Lin; Yang, Shuangjia; Zhang, Qin; Zhang, Hongyan; Zhang, Huaigen; Zhang, Xuekang; Zhao, Lili; Zhao, Weihong; Zhao, Weilu; Zhu, Xiaoping; Bai, Yun; Chen, Linbi; Chen, Sijia; Dai, Qinxue; Geng, Wujun; Han, Kunyuan; He, Xin; Huang, Luping; Ji, Binbin; Jia, Danyun; Jin, Shenhui; Li, Qianjun; Liang, Dongdong; Luo, Shan; Lwang, Lulu; Mo, Yunchang; Pan, Yuanyuan; Qi, Xinyu; Qian, Meizi; Qin, Jinling; Ren, Yelong; Shi, Yiyi; Wang, Junlu; Wang, Junkai; Wang, Leilei; Xie, Junjie; Yan, Yixiu; Yao, Yurui; Zhang, Mingxiao; Zhao, Jiashi; Zhuang, Xiuxiu; Ai, Yanqiu; Du, Fang; He, Long; Huang, Ledan; Li, Zhisong; Li, Huijuan; Li, Yetong; Li, Liwei; Meng, Su; Yuan, Yazhuo; Zhang, Enman; Zhang, Jie; Zhao, Shuna; Ji, Zhenrong; Pei, Ling; Wang, Li; Chen, Chen; Dong, Beibei; Li, Jing; Miao, Ziqiang; Mu, Hongying; Qin, Chao; Su, Lin; Wen, Zhiting; Xie, Keliang; Yu, Yonghao; Yuan, Fang; Hu, Xianwen; Zhang, Ye; Xiao, Wangpin; Zhu, Zhipeng; Dai, Qingqing; Fu, Kaiwen; Hu, Rong; Hu, Xiaolan; Huang, Song; Li, Yaqi; Liang, Yingping; Yu, Shuchun; Guo, Zheng; Jing, Yan; Tang, Na; Wu, Jie; Yuan, Dajiang; Zhang, Ruilin; Zhao, Xiaoying; Li, Yuhong; Bai, Hui-Ping; Liu, Chun-Xiao; Liu, Fei-Fei; Ren, Wei; Wang, Xiu-Li; Xu, Guan-Jie; Hu, Na; Li, Bo; Ou, Yangwen; Tang, Yongzhong; Yao, Shanglong; Zhang, Shihai; Kong, Cui-Cui; Liu, Bei; Wang, Tianlong; Xiao, Wei; Lu, Bo; Xia, Yanfei; Zhou, Jiali; Cai, Fang; Chen, Pushan; Hu, Shuangfei; Wang, Hongfa; Xu, Qiong; Hu, Liu; Jing, Liang; Li, Bin; Liu, Qiang; Liu, Yuejiang; Lu, Xinjian; Peng, Zhen Dan; Qiu, Xiaodong; Ren, Quan; Tong, Youliang; Wang, Jin; Wen, Yazhou; Wu, Qiong; Xia, Jiangyan; Xie, Jue; Xiong, Xiapei; Xu, Shixia; Yang, Tianqin; Ye, Hui; Yin, Ning; Yuan, Jing; Zeng, Qiuting; Zhang, Baoling; Zheng, Kang; Cang, Jing; Chen, Shiyu; Fan, Yu; Fu, Shuying; Ge, Xiaodong; Guo, Baolei; Huang, Wenhui; Jiang, Linghui; Jiang, Xinmei; Liu, Yi; Pan, Yan; Ren, Yun; Shan, Qi; Wang, Jiaxing; Wang, Fei; Wu, Chi; Zhang, Xiaoguang; Christiansen, Ida Cecilie; Granum, Simon Nørgaard; Rasmussen, Bodil Steen; Daugaard, Morten; Gambhir, Rajiv; Brandsborg, Birgitte; Steingrímsdóttir, Guðný Erla; Jensen-Gadegaard, Peter; Olsen, Karsten Skovgaard; Siegel, Hanna; Eskildsen, Katrine Zwicky; Gätke, Mona Ring; Wibrandt, Ida; Heintzelmann, Simon Bisgaard; Wiborg Lange, Kai Henrik; Lundsgaard, Rune Sarauw; Amstrup-Hansen, Louise; Hovendal, Claus; Larsen, Michael; Lenstrup, Mette; Kobborg, Tina; Larsen, Jens Rolighed; Pedersen, Anette Barbre; Smith, Søren Hübertz; Oestervig, Rebecca Monett; Afshari, Arash; Andersen, Cheme; Ekelund, Kim; Secher, Erik Lilja; Beloeil, Helene; Lasocki, Sigismond; Ouattara, Alexandre; Sineus, Marlene; Molliex, Serge; Legouge, Marie Lim; Wallet, Florent; Tesniere, Antoine; Gaudin, Christophe; Lehur, Paul; Forsans, Emma; de Rudnicki, Stéphane; Maudet, Valerie Serra; Mutter, Didier; Sojod, Ghassan; Ouaissi, Mehdi; Regimbeau, Jean-Marc; Desbordes, Jacques; Comptaer, Nicolas; Manser, Diae El; Ethgen, Sabine; Lebuffe, Gilles; Auer, Patrick; Härtl, Christine; Deja, Maria; Legashov, Kirill; Sonnemann, Susanne; Wiegand-Loehnert, Carola; Falk, Elke; Habicher, Marit; Angermair, Stefan; Laetsch, Beatrix; Schmidt, Katrin; von Heymann, Christian; Ramminger, Axel; Jelschen, Florian; Pabel, Svenja; Weyland, Andreas; Czeslick, Elke; Gille, Jochen; Malcharek, Michael; Sablotzki, Armin; Lueke, Katharina; Wetzel, Peter; Weimann, Joerg; Lenhart, Franz-Peter; Reichle, Florian; Schirmer, Frederike; Hüppe, Michael; Klotz, Karl; Nau, Carla; Schön, Julika; Mencke, Thomas; Wasmund, Christina; Bankewitz, Carla; Baumgarten, Georg; Fleischer, Andreas; Guttenthaler, Vera; Hack, Yvonne; Kirchgaessner, Katharina; Männer, Olja; Schurig-Urbaniak, Marlen; Struck, Rafael; van Zyl, Rebekka; Wittmann, Maria; Goebel, Ulrich; Harris, Sarah; Veit, Siegfried; Andreadaki, Evangelia; Souri, Flora; Katsiadramis, Ioannis; Skoufi, Anthi; Vasileiou, Maria; Aimoniotou-Georgiou, Eleni; Katsourakis, Anastasios; Veroniki, Fotini; Vlachogianni, Glyceria; Petra, Konstantina; Chlorou, Dimitra; Oloktsidou, Eirini; Ourailoglou, Vasileios; Papapostolou, Konstantinos; Tsaousi, Georgia; Daikou, Panagoula; Dedemadi, Georgia; Kalaitzopoulos, Ioannis; Loumpias, Christos; Bristogiannis, Sotirios; Dafnios, Nikolaos; Gkiokas, Georgios; Kontis, Elissaios; Kozompoli, Dimitra; Papailia, Aspasia; Theodosopoulos, Theodosios; Bizios, Christol; Koutsikou, Anastasia; Moustaka, Aleaxandra; Plaitakis, Ioannis; Armaganidis, Apostolos; Christodoulopoulou, Theodora; Lignos, Mihail; Theodorakopoulou, Maria; Asimakos, Andreas; Ischaki, Eleni; Tsagkaraki, Angeliki; Zakynthinos, Spyros; Antoniadou, Eleni; Koutelidakis, Ioannis; Lathyris, Dimitrios; Pozidou, Irene; Voloudakis, Nikolaos; Dalamagka, Maria; Elena, Gkonezou; Chronis, Christos; Manolakaki, Dimitra; Mosxogiannidis, Dimitris; Slepova, Tatiana; Tsakiridou, Isaia-Sissy; Lampiri, Claire; Vachlioti, Anastasia; Panagiotakis, Christos; Sfyras, Dimitrios; Tsimpoukas, Fotios; Tsirogianni, Athanasia; Axioti, Elena; Filippopoulos, Andreas; Kalliafa, Elli; Kassavetis, George; Katralis, Petros; Komnos, Ioannis; Pilichos, Georgios; Ravani, Ifigenia; Totis, Antonis; Apagaki, Eymorfia; Efthymiadi, Andromachi; Kampagiannis, Nikolaos; Paraforou, Theoniki; Tsioka, Agoritsa; Georgiou, Georgios; Vakalos, Aristeidis; Bairaktari, Aggeliki; Charitos, Efthimios; Markou, George; Niforopoulou, Panagiota; Papakonstantinou, Nikolaos; Tsigou, Evdoxia; Xifara, Archontoula; Zoulamoglou, Menelaos; Gkioni, Panagiota; Karatzas, Stylianos; Kyparissi, Aikaterini; Mainas, Efstratios; Papapanagiotou, Ioannis; Papavasilopoulou, Theonymfi; Fragandreas, George; Georgopoulou, Eleni; Katsika, Eleni; Psarras, Kyriakos; Synekidou, Eirini; Verroiotou, Maria; Vetsiou, Evangelia; Zaimi, Donika; Anagnou, Athina; Apostolou, Konstantinos; Melissopoulou, Theodora; Rozenberg, Theophilos; Tsigris, Christos; Boutsikos, Georgios; Kalles, Vasileios; Kotsalas, Nikolaos; Lavdaiou, Christina; Paikou, Fotini; Panagou, Georgia-Laura; Spring, Anna; Botis, Ioannis; Drimala, Maria; Georgakakis, Georgios; Kiourtzieva, Ellada; Ntouma, Panagiota; Prionas, Apostolos; Xouplidis, Kyriakos; Dalampini, Eleftheria; Giannaki, Chrysavgi; Iasonidou, Christina; Ioannidis, Orestis; Lavrentieva, Athina; Lavrentieva, Athena; Papageorgiou, George; Kokkinoy, Maria; Stafylaraki, Maria; Gaitanakis, Stylianos; Karydakis, Periclis; Paltoglou, Josef; Ponireas, Panagiotis; Chaloulis, Panagiotis; Provatidis, Athanasios; Sousana, Anisoglou; Gardikou, Varvara Vanessa; Konstantivelli, Maria; Lataniotou, Olga; Lisari, Elisavet; Margaroni, Maria; Stamatiou, Konstantinos; Nikolaidis, Edouardos; Pnevmatikos, Ioannis; Sertaridou, Eleni; Andreou, Alexandros; Arkalaki, Eleni; Athanasakis, Elias; Chaniotaki, Fotini; Chatzimichali, Chatzimichali Aikaterini; Christofaki, Maria; Dermitzaki, Despina; Fiorentza, Klara; Frantzeskos, Georgios; Geromarkaki, Elisavet; Kafkalaki, Kalliopi; Kalogridaki, Marina; Karydi, Konstyllia; Kokkini, Sofia; Kougentakis, Georgios; Lefaki, Tatiana; Lilitsis, Emmanouhl; Makatounaki, Aikaterini; Malliotakis, Polychronis; Michelakis, Dimosthenis; Neonaki, Maria; Nyktari, Vasileia; Palikyra, Iliana; Papadakis, Eleftherios; Papaioannou, Alexandra; Sfakianakis, Konstantinos; Sgouraki, Maria; Souvatzis, Xenia; Spartinou, Anastasia; Stefanidou, Nefeli; Syrogianni, Paulina; Tsagkaraki, Georgia; Arnaoutoglou, Elena; Arnaoutoglou, Christina; Bali, Christina; Bouris, Vasilios; Doumos, Rodamanthos; Gkini, Konstantia-Paraskevi; Kapaktsi, Clio; Koulouras, Vasilios; Lena, Arian; Lepida, Dimitra; Michos, Evangelos; Papadopoulos, Dimitrios; Paschopoulos, Minas; Rompou, Vaia Aliki; Siouti, Ioanna; Tsampalas, Stavros; Ververidou, Ourania; Zilis, Georgios; Charlalampidoy, Alexandra; Christodoulidis, Gregory; Flossos, Andreas; Stamoulis, Konstantinos; Chan, Matthew; Tsang, Man Shing Caleb; Tsang, Man Shing; Lai, Man Ling; Yip, Chi Pang; Heymans Chan, Hey Man; Law, Bassanio; Li, Wing Sze; Chu, Hiu Man; Koo, Emily Gar Yee; Lam, Chi Cheong Joe; Cheng, Ka Ho; Lam, Tracy; Chu, Susanna; Lam, Wing Yan; Wong, Kin Wai Kevin; Kwok, Dilys; Hung, Ching Yue Janice; Chan, Wai Kit Jacky; Wong, Wing Lam; Chung, Chun Kwong Eric; Ma, Shu Kai; Kaushik, Shuchi; Shah, Bhagyesh; Shah, Dhiren; Shah, Sanjay; Ar, Praburaj; Muthuchellappan, Radhakrishnan; Agarwal, Vandana; Divatia, Jigeeshu; Mishra, Sanghamitra; Nimje, Ganesh; Pande, Swati; Savarkar, Sukhada; Shrivastava, Aditi; Thomas, Martin; Yegnaram, Shashikant; Hidayatullah, Rahmat; Puar, Nasman; Niman, Sumara; Indra, Imai; Hamzah, Zulkarnain; Yuliana, Annika; Abidin, Ucu Nurhadiat; Dursin, Ade Nurkacan; Kurnia, Andri; Susanti, Ade; Handayani, Dini; Alit, Mahaalit Aribawa; Arya, Aryabiantara; Senapathi, Tjokorda Gde Agung; Utara, Utara Hartawan; Wid, Widnyana Made; Wima, Semarawima; Wir, Wiryana Made; Jehosua, Brillyan; Kaunang, Jonathan; Lantang, Eka Yudha; Najoan, Rini; Waworuntu, Neil; Awad, Hadi; Fuad, Akram; Geddoa, Burair; Khalaf, Abdel Razzaq; Al Hussaini, Sabah; Albaj, Safauldeensalem; Kenber, Maithem; Bettinelli, Alessandra; Spadaro, Savino; AlbertoVolta, Carlo; Giancarlo, Luigi; Sottosanti, Vicari; Copetti, Elisa; Spagnesi, Lorenzo; Toretti, Ilaria; Alloj, Chiara; Cardellino, Silvano; Carmino, Livio; Costanzo, Eleonora; Fanfani, Lucia Caterina; Novelli, Maria Teresa; Roasio, Agostino; Bellandi, Mattia; Beretta, Luigi; Bignami, Elena; Bocchino, Speranza; Cabrini, Luca; Corti, Daniele; Landoni, Giovanni; Meroni, Roberta; Moizo, Elena; Monti, Giacomo; Pintaudi, Margherita; Plumari, Valentina Paola; Taddeo, Daiana; Testa, Valentina; Winterton, Dario; Zangrillo, Alberto; Cloro, Luigi Maria; Colangelo, Chiara; Colangelo, Antonio; Rotunno, Giuseppe; Paludi, Miguel Angel; Maria, Cloro Paolo; Pata, Antonio; Parrini, Vieri; Gatta, Alessandro; Nastasi, Mauro; Tinti, Carla; Baroselli, Antonio; Arrigo, Mario; Benevento, Angelo; Bottini, Corrado; Cannavo', Maurizio; Gastaldi, Christian; Marchesi, Alessandro; Pascazio, Angelantonio; Pata, Francesco; Pozzi, Emilio; Premoli, Alberto; Tessera, Gaetano; Boschi, Luca; D'Andrea, Rocco; Ghignone, Federico; Poggioli, Gilberto; Sibilio, Andrea; Taffurelli, Mario; Ugolini, Giampaolo; Ab Majid, Mohd Azuan; Ab Rahman, Rusnah; Joseph, James; Pathan, Furquan; Sybil Shah, Mohammad Hafizshah; Yap, Huey Ling; Cheah, Seleen; Chin, Im Im; Looi, Ji Keon; Tan, Siew Ching; Visvalingam, Sheshendrasurian; Kwok, Fan Yin; Lee, Chew Kiok; Tan, Tse Siang; Wong, Sze Meng; Abdullah, Noor Hairiza; Liew, Chiat Fong; Luxuman, Lovenia; Mohd Zin, Nor Hafizah; Norddin, Muhamad Faiz; Raja Alias, Raja Liza; Wong, Juan Yong; Yong, Johnny; Bin Mustapha, Mohd Tarmimi; Chan, Weng Ken; Dzulkipli, Norizawati; Kuan, Pei Xuan; Lee, Yew Ching; Alias, Anita; Guok, Eng Ching; Jee, Chiun Chen; Ramon, Brian Rhadamantyne; Wong, Cheng Weng; Abd Ghafar, Fara Nur Idayu; Aziz, Faizal Zuhri; Hussain, Nabilah; Lee, Hooi Sean; Sukawi, Ismawaty; Woon, Yuan Liang; Abd Hadi, Husni Zaeem; Ahmad Azam, Ummi Azmira; Alias, Abdul Hafiz; Kesut, Saiful Aizar; Lee, Jun May; Ooi, Dar Vin; Sulaiman, Hetty Ayuni; Lih, Tengku Alini Tengku; Veerakumaran, Jeyaganesh; Rojas, Eder; Resendiz, Gerardo Esteban Alvarez; Zapata, Darcy Danitza Mari; López, Julio Cesar Jesús Aguilar; Flores, Armando Adolfo Alvarez; Amador, Juan Carlos Bravo; Avila, Erendira Jocelin Dominguez; Aquino, Laura Patricia González; Rodriguez, Ricardo Lopez; Landa, Mariana Torres; Urias, Emma; Hollmann, Markus; Hulst, Abraham; Preckel, Benedikt; Koopman-van Gemert, Ankie; Buise, Marc; Tolenaar, Noortje; Weber, Eric; de Fretes, Jennifer; Houweling, Peter; Ormskerk, Patricia; van Bommel, Jasper; Lance, Marcus; Smit-Fun, Valerie; van Zundert, Tom; Baas, Peter; Donald de Boer, Hans; Sprakel, Joost; Elferink-Vonk, Renske; Noordzij, Peter; van Zeggeren, Laura; Brand, Bastiaan; Spanjersberg, Rob; ten Bokkel-Andela, Janneke; Numan, Sandra; van Klei, Wilton; van Zaane, Bas; Boer, Christa; van Duivenvoorde, Yoni; Hering, Jens Peter; van Rossum, Sylvia; Zonneveldt, Harry; Campbell, Doug; Hoare, Siobhan; Santa, Sahayam; Ali, Marlynn; Allen, Sara Jane; Bell, Rachel; Choi, Hyun-Min David; Drake, Matthew; Farrell, Helen; Hayes, Katia; Higgie, Kushlin; Holmes, Kerry; Jenkins, Nicole; Kim, Chang Joon; Kim, Steven; Law, Kiew Chai; McAllister, Davina; Park, Karen; Pedersen, Karen; Pfeifer, Leesa; Pozaroszczyk, Anna; Salmond, Timothy; Steynor, Martin; Tan, Michael; Waymouth, Ellen; Ab Rahman, Ahmad Sufian; Armstrong, John; Dudson, Rosie; Jenkins, Nia; Nilakant, Jayashree; Richard, Seigne; Virdi, Pardeep; Dixon, Liane; Donohue, Roana; Farrow, Mehreen; Kennedy, Ross; Marissa, Henderson; McKellow, Margie; Nicola, Delany; Pascoe, Rebecca; Roberts, Stephen John; Rowell, George; Sumner, Matthew; Templer, Paul; Chandrasekharan, Shardha; Fulton, Graham; Jammer, Ib; More, Richard; Wilson, Leona; Chang, Yuan Hsuan; Foley, Julia; Fowler, Carolyn; Panckhurst, Jonathan; Sara, Rachel; Stapelberg, Francois; Cherrett, Veronica; Ganter, Donna Louise; McCann, Lloyd; Gilmour, Fiona; Lumsden, Rachelle; Moores, Mark; Olliff, Sue; Sardareva, Elitza; Tai, Joyce; Wikner, Matthew; Wong, Christopher; Chaddock, Mark; Czepanski, Carolyn; McKendry, Patrick; Polakovic, Daniel; Polakovich, Daniel; Robert, Axe; Belda, Margarita Tormo; Norton, Tracy; Alherz, Fadhel; Barneto, Lisa; Ramirez, Alberto; Sayeed, Ahmed; Smith, Nicola; Bennett, Cambell; McQuoid, Shane; Jansen, Tracy-Lee; Nico, Zin; Scott, John; Freschini, David; Freschini, Angela; Hopkins, Brian; Manson, Lara; Stoltz, Deon; Bates, Alexander; Davis, Simon; Freeman, Victoria; McGaughran, Lynette; Williams, Maya; Sharma, Swarna Baskar; Burrows, Tom; Byrne, Kelly; English, Duane; Johnson, Robert; Manikkam, Brendon; Naidoo, Shaun; Rumball, Margot; Whittle, Nicola; Franks, Romilla; Gibson-Lapsley, Hannah; Salter, Ryan; Walsh, Dean; Cooper, Richard; Perry, Katherine; Obobolo, Amos; Sule, Umar Musa; Ahmad, Abdurrahman; Atiku, Mamuda; Mohammed, Alhassan Datti; Sarki, Adamu Muhammad; Adekola, Oyebola; Akanmu, Olanrewaju; Durodola, Adekunle; Olukoju, Olusegun; Raji, Victor; Olajumoke, Tokunbo; Oyebamiji, Emmanuel; Adenekan, Anthony; Adetoye, Adedapo; Faponle, Folayemi; Olateju, Simeon; Owojuyigbe, Afolabi; Talabi, Ademola; Adenike, Odewabi; Adewale, Badru; Collins, Nwokoro; Ezekiel, Emmanuel; Fatungase, Oluwabunmi Motunrayo; Grace, Anuforo; Sola, Sotannde; Stella, Ogunmuyiwa; Ademola, Adeyinka; Adeolu, Augustine A.; Adigun, Tinuola; Akinwale, Mukaila; Fasina, Oluyemi; Gbolahan, Olalere; Idowu, Olusola; Olonisakin, Rotimi Peter; Osinaike, Babatunde Babasola; Asudo, Felicia; Mshelia, Danladi; Abdur-Rahman, Lukman; Agodirin, Olayide; Bello, Jibril; Bolaji, Benjamin; Oyedepo, Olanrewaju Olubukola; Ezike, Humphrey; Iloabachie, Ikechukwu; Okonkwo, Ikemefuna; Onuora, Elias; Onyeka, Tonia; Ugwu, Innocent; Umeh, Friday; Alagbe-Briggs, Olubusola; Dodiyi-Manuel, Amabra; Echem, Richard; Obasuyi, Bright; Onajin-Obembe, Bisola; Bandeira, Maria Expedito; Martins, Alda; Tomé, Miguel; Costa, Ana Cristina Miranda Martins; Krystopchuk, Andriy; Branco, Teresa; Esteves, Simao; Melo, Marco António; Monte, Júlia; Rua, Fernando; Martins, Isabel; Pinho-Oliveira, Vítor Miguel; Rodrigues, Carla Maria; Cabral, Raquel; Marques, Sofia; Rêgo, Sara; Jesus, Joana Sofia Teixeira; Marques, Maria Conceição; Romao, Cristina; Dias, Sandra; Santos, Ana Margarida; Alves, Maria Joao; Salta, Cristina; Cruz, Salome; Duarte, Célia; Paiva, António Armando Furtado; Cabral, Tiago do Nascimento; Faria E Maia, Dionisio; Correia da Silva, Rui Freitas Mendonça; Langner, Anuschka; Resendes, Hernâni Oliveira; Soares, Maria da Conceição; Abrunhosa, Alexandra; Faria, Filomena; Miranda, Lina; Pereira, Helena; Serra, Sofia; Ionescu, Daniela; Margarit, Simona; Mitre, Calin; Vasian, Horatiu; Manga, Gratiela; Stefan, Andreea; Tomescu, Dana; Filipescu, Daniela; Paunescu, Marilena-Alina; Stefan, Mihai; Stoica, Radu; Gavril, Laura; Pătrășcanu, Emilia; Ristescu, Irina; Rusu, Daniel; Diaconescu, Ciresica; Iosep, Gabriel Florin; Pulbere, Dorin; Ursu, Irina; Balanescu, Andreea; Grintescu, Ioana; Mirea, Liliana; Rentea, Irina; Vartic, Mihaela; Lupu, Mary-Nicoleta; Stanescu, Dorin; Streanga, Lavinea; Antal, Oana; Hagau, Natalia; Patras, Dumitru; Petrisor, Cristina; Tosa, Flaviu; Tranca, Sebastian; Copotoiu, Sanda Maria; Ungureanu, Liviu Lucian; Harsan, Cristian Remus; Papurica, Marius; Cernea, Daniela Denisa; Dragoescu, Nicoleta Alice; CarmenVaida, Laura Aflori; Ciobotaru, Oana Roxana; Aignatoaie, Mariana; Carp, Cristina Paula; Cobzaru, Isabelle; Mardare, Oana; Purcarin, Bianca; Tutunaru, Valentin; Ionita, Victor; Arustei, Mirela; Codita, Anisoara; Busuioc, Mihai; Chilinciuc, Ion; Ciobanu, Cristina; Belciu, Ioana; Tincu, Eugen; Blaj, Mihaela; Grosu, Ramona-Mihaela; Sandu, Gigel; Bruma, Dana; Corneci, Dan; Dutu, Madalina; Krepil, Adriana; Copaciu, Elena; Dumitrascu, Clementina Oana; Jemna, Ramona; Mihaescu, Florentina; Petre, Raluca; Tudor, Cristina; Ursache, Elena; Kulikov, Alexander; Lubnin, Andrey; Grigoryev, Evgeny; Pugachev, Stanislav; Tolmasov, Alexander; Hussain, Ayyaz; Ilyina, Yana; Roshchina, Anna; Iurin, Aleksandr; Chazova, Elena; Dunay, Artem; Karelov, Alexey; Khvedelidze, Irina; Voldaeva, Olga; Belskiy, Vladislav; Dzhamullaev, Parvin; Grishkowez, Elena; Kretov, Vladimir; Levin, Valeriy; Molkov, Aleksandr; Puzanov, Sergey; Samoilenko, Aleksandr; Tchekulaev, Aleksandr; Tulupova, Valentina; Utkin, Ivan; Allorto, Nikki Leigh; Bishop, David Gray; Builu, Pierre Monji; Cairns, Carel; Dasrath, Ashish; de Wet, Jacques; Hoedt, Marielle den; Grey, Ben; Hayes, Morgan Philip; Küsel, Belinda Senta; Shangase, Nomcebo; Wise, Robert; Cacala, Sharon; Farina, Zane; Govindasamy, Vishendran; Kruse, Carl-Heinz; Lee, Carolyn; Marais, Leonard; Naidoo, Thinagrin Dhasarthun; Rajah, Chantal; Rodseth, Reitze Nils; Ryan, Lisa; von Rhaden, Richard; Adam, Suwayba; Alphonsus, Christella; Ameer, Yusuf; Anderson, Frank; Basanth, Sujith; Bechan, Sudha; Bhula, Chettan; Biccard, Bruce M.; Biyase, Thuli; Buccimazza, Ines; Cardosa, Jorge; Chen, James; Daya, Bhavika; Drummond, Leanne; Elabib, Ali; Abdel Goad, Ehab Helmy; Goga, Ismail E.; Goga, Riaz; Harrichandparsad, R.; Hodgson, Richard E.; Jordaan, J.; Kalafatis, Nicky; Kampik, Christian; Landers, A. T.; Loots, Emil; Madansein, Rajhmum; Madaree, Anil; Madiba, Thandinkosi E.; Manzini, Vukani T.; Mbuyisa, Mbali; Moodley, Rajan; Msomi, Mduduzi; Mukama, Innocent; Naidoo, Desigan; Naidoo, Rubeshan; Naidu, Tesuven K.; Ntloko, Sindiswa; Padayachee, Eneshia; Padayachee, Lucelle; Phaff, Martijn; Pillay, Bala; Pillay, Desigan; Pillay, Lutchmee; Ramnarain, Anupa; Ramphal, Suren R.; Ryan, Paul; Saloojee, Ahmed; Sebitloane, Motshedisi; Sigcu, Noluyolo; Taylor, Jenna L.; Torborg, Alexandra; Visser, Linda; Anderson, Philip; Conradie, Alae; de Swardt, Mathew; de Villiers, Martin; Eikman, Johan; Liebenberg, Riaan; Mouton, Johan; Paton, Abbey; van der Merwe, Louwrence; Wilscott-Davids, Candice; Barrett, Wendy Joan; Bester, Marlet; de Beer, Johan; Geldenhuys, Jacques; Gouws, Hanni; Potgieter, Jan-Hendrik; Strydom, Magdel; WilberforceTurton, Edwin; Chetty, Rubendraj R.; Chirkut, Subash; Cronje, Larissa; de Vasconcellos, Kim; Dube, Nokukhanya Z.; Gama, N. Sibusiso; Green, Garyth M.; Green-Thompson, Randolph; Kinoo, Suman Mewa; Kistnasami, Prenolin; Maharaj, Kapil; Moodley, Manogaran S.; Mothae, Sibongile J.; Naidoo, Ruvashni; Aslam F Noorbhai, M.; Rughubar, Vivesh; Reddy, Jenendhiran; Singh, Avesh; Skinner, David L.; Smith, Murray J.; Singh, Bhagwan; Misra, Ravi; Naidoo, Maheshwar; Ramdharee, Pireshin; Selibea, Yvonne; Sewpersad, Selina; Sham, Shailendra; Wessels, Joseph D.; Africander, Cucu; Bejia, Tarek; Blakemore, Stephen P.; Botes, Marisa; Bunwarie, Bimalshakth; Hernandez, Carlos B.; Jeeraz, Mohammud A.; Legutko, Dagmara A.; Lopez, Acela G.; de Meyer, Jenine N.; Muzenda, Tanaka; Naidoo, Noel; Patel, Maryam; Pentela, Rao; Junge, Marina; Mansoor, Naj; Rademan, Lana; Scislowski, Pawel; Seedat, Ismail; van den Berg, Bianca; van der Merwe, Doreen; van Wyk, Steyn; Govender, Komalan; Naicker, Darshan; Ramjee, Rajesh; Saley, Mueen; Kuhn, Warren Paul; Matos-Puig, Roel; Alberto Lisi, Zaheer Moolla; Perez, Gisela; Beltran, Anna Valle; Lozano, Angels; Navarro, Carlos Delgado; Duca, Alejandro; Ernesto, Ernesto Pastor Martinez; Ferrando, Carlos; Fuentes, Isabel; García-Pérez, Maria Luisa; Gracia, Estefania; Palomares, Ana Izquierdo; Katime, Antonio; Miñana, Amanda; Incertis, Raul Raul; Romero, Esther; Romero Garcia, Carolina Soledad; Rubio, Concepcion; Artiles, Tania Socorro; Soro, Marina; Valls, Paola; Laguarda, Gisela Alaman; Benavent, Pau; Cuenca, Vicente Chisbert; Cueva, Andreu; Lafuente, Matilde; Parra, Asuncion Marques; Rodrigo, Alejandra Romero; Sanchez-Morcillo, Silvia; Tormo, Sergi; Redondo, Francisco Javier; de Andrés Ibanez, José Antonio; Diago, Lorena Gómez; José Hernández Cádiz, Maria; Manuel, Granell Gil; Peris, Raquel; Saiz, Cristina; Vivo, Jose Tatay; Soto, Maria Teresa Tebar; Brunete, Tamara; Cancho, David; Delgado García, David R.; Zamudio, Diana; del Valle, Santiago Garcia; Serrano, M. Luz; Alonso, Eduardo; Anillo, Victor; Maseda, Emilio; Salgado, Patricia; Suarez, Luis; Suarez-de-la-Rica, Alejandro; Villagrán, María José; Alonso, José Ignacio; Cabezuelo, Estefania; Garcia-Saiz, Irene; Lopez del Moral, Olga; Martín, Silvia; Gonzalez, Alba Perez; Doncel, Ma Sherezade Tovar; Vera, Martin Agüero; José Ávila Sánchez, Francisco; Castaño, Beatriz; Moreira, Beatriz Castaño; Risco, Sahely Flores; Martín, Daniel Paz; Martín, Fernando Pérez; Poza, Paloma; Ruiz, Adela; Serna Martínez, Wilson Fabio; Vicente, Bárbara Vázquez; Dominguez, Saul Velaz; Fernández, Salvador; Munoz-López, Alfonso; Bernat, Maria Jose; Mas, Arantxa; Planas, Kenneth; Jawad, Monir; Saeed, Yousif; Hedin, Annika; Levander, Helena; Holmström, Sandra; Lönn, David; Zoerner, Frank; Åkring, Irene; Widmark, Carl; Zettergren, Jan; Liljequist, Victor Aspelund; Nystrom, Lena; Odeberg-Wernerman, Suzanne; Oldner, Anders; Fagerlund, Malin Jonsson; Reje, Patrik; Lyckner, Sara; Sperber, Jesper; Adolfsson, Anne; Klarin, Bengt; Ögren, Katrin; Barras, Jean-Pierre; Bührer, Thomas; Despotidis, Vasileios; Helmy, Naeder; Holliger, Stephan; Raptis, Dimitri Aristotle; Schmid, Roger; Meyer, Antoine; Jaquet, Yves; Kessler, Ulf; Muradbegovic, Mirza; Nahum, Solange R.; Rotunno, Teresa; Schiltz, Boris; Voruz, François; Worreth, Marc; Christoforidis, Dimitri; Popeskou, Sotirios Georgios; Furrer, Markus; Prevost, Gian Andrea; Stocker, Andrea; Lang, Klaus; Breitenstein, Stefan; Ganter, Michael T.; Geisen, Martin; Soll, Christopher; Korkmaz, Michelle; Lubach, Iris; Schmitz, Michael; Meyer Zu Schwabedissen, Moritz; Moritz, Meyer Zu Schwabedissen; Zingg, Urs; Hillermann, Thomas; Wildi, Stefan; Pinto, Bernardo Bollen; Walder, Bernhard; Mariotti, Giustina; Slankamenac, Ksenija; Namuyuga, Mirioce; Kyomugisha, Edward; Kituuka, Olivia; Shikanda, Anne Wesonga; Kakembo, Nasser; Tom, Charles Otim; Antonina, Webombesa; Bua, Emmanuel; Ssettabi, Eden Michael; Epodoi, Joseph; Kabagenyi, Fiona; Kirya, Fred; Dempsey, Ged; Seasman, Colette; Nawaz Khan, Raja Basit; Kurasz, Claire; Macgregor, Mark; Shawki, Burhan; Francis, Daren; Hariharan, Vimal; Chau, Simon; Ellis, Kate; Butt, Georgina; Chicken, Dennis-Wayne; Christmas, Natasha; Allen, Samantha; Daniel, Gayatri Daniel; Dempster, Angie; Kemp, Juliette; Matthews, Lewis; Mcglone, Philip; Tambellini, Joanne; Trodd, Dawn; Freitas, Katie; Garg, Atul; Gupta, Janesh Kumar; Karpate, Shilpaja; Kulkarni, Aditi; O'Hara, Chloe; Troko, Jtroko; Angus, Kirsty; Bradley, Jacqueline; Brennan, Emma; Brooks, Carolyn; Brown, Janette; Brown, Gemma; Finch, Amanda; Gratrix, Karen; Hesketh, Sue; Hill, Gillian; Jeffs, Carol; Morgan, Maureen; Pemberton, Chris; Slawson, Nicola; Spickett, Helen; Swarbrick, Gemma; Thomas, Megan; van Duyvenvoorde, Greta; Brennan, Andrew; Briscoe, Richard; Cooper, Sarah; Lawton, Tom; Northey, Martin; Senaratne, Rashmi; Stanworth, Helen; Burrows, Lorna; Cain, Helen; Craven, Rachael; Davies, Keith; Jonas, Attila; Pachucki, Marcin; Walkden, Graham; Davies, Helen; Gudaca, Mariethel; Hobrok, Maria; Arawwawala, Dilshan; Fergey, Lauren; Gardiner, Matthew; Gunn, Jacqueline; Johnson, Lyndsay; Lofting, Amanda; Lyle, Amanda; Neela, Fiona Mc; Smolen, Susan; Topliffe, Joanne; Williams, Sarah; Bland, Martin; Balaji, Packianathaswamy; Kaura, Vikas; Lanka, Prasad; Smith, Neil; Ahmed, Ahmed; Myatt, John; Shenoy, Ravikiran; Soon, Wai Cheong; Tan, Jessica; Karadia, Sunny; Self, James; Durant, Emma; Tripathi, Shiva; Bullock, Clare; Campbell, Debbie; Ghosh, Alison; Hughes, Thomas; Zsisku, Lajos; Bengeri, Sheshagiri; Cowton, Amanda; Khalid, Mohammed Shazad; Limb, James; McAdam, Colin; Porritt, Mandy; Rafi, M. Amir; Shekar, Priya; Adams, David; Harden, Catherine; Hollands, Heidi; King, Angela; March, Linda; Minto, Gary; Patrick, Abigail; Squire, Rosalyn; Waugh, Darren; Kumara, Paramesh; Simeson, Karen; Yarwood, Jamie; Browning, Julie; Hatton, Jonathan; Julian, Howes; Mitra, Atideb; Newton, Maria; Pernu, Pawan Kootelu; Wilson, Alison; Commey, Thelma; Foot, Helen; Glover, Lyn; Gupta, Ajay; Lancaster, Nicola; Levin, Jill; Mackenzie, Felicity; Mestanza, Claire; Nofal, Emma; Pout, Lauren; Varden, Rosanna; Wild, Jonathan; Jones, Stephanie; Moreton, Sarah; Pulletz, Mark; Davies, Charlotte; Martin, Matthew; Thomas, Sian; Burns, Karen; McArthur, Carol; Patel, Panna; Lau, Gary; Rich, Natalie; Davis, Fiona; Lyons, Rachel; Port, Beth; Prout, Rachel; Smith, Christopher; Adelaja, Yemi; Bennett, Victoria; Bidd, Heena; Dumitrescu, Alexandra; Murphy, Jacqui Fox; Keen, Abigail; Mguni, Nhlanhla; Ong, Cheng; Adams, George; Boshier, Piers; Brown, Richard; Butryn, Izabella; Chatterjee, Jayanta; Freethy, Alexander; Lockwood, Geoffrey; Tsakok, Maria; Tsiligiannis, Sophia; Peat, William; Stephenson, Lorraine; Bradburn, Mike; Pick, Sara; Cunha, Pedro; Olagbaiye, Olufemi; Tayeh, Salim; Packianathaswamy, Balaji; Abernethy, Caroline; Balasubramaniam, Madhu; Bennett, Rachael; Bolton, David; Martinson, Victoria; Naylor, Charde; Bell, Stephanie; Heather, Blaylock; Kushakovsky, Vlad; Alcock, Liam; Alexander, Hazel; Anderson, Colette; Baker, Paul; Brookes, Morag; Cawthorn, Louise; Cirstea, Emanuel; Clarkson, Rachel; Colling, Kerry; Coulter, Ian; Das, Suparna; Haigh, Kathryn; Hamdan, Alhafidz; Hugill, Keith; Kottam, Lucksy; Lisseter, Emily; Mawdsley, Matthew; McGivern, Julie; Padala, Krishnaveni; Phelps, Victoria; Ramesh Kumar, Vineshykaa; Stewart, Kirsten; Towse, Kayley; Tregonning, Julie; Vahedi, Ali; Walker, Alycon; Baines, Duncan; Bilolikar, Anjali; Chande, Shiv; Copley, Edward; Dunk, Nigel; Kulkarni, Raghavendra; Kumar, Pawan; Metodiev, Yavor; Ncomanzi, Dumisani; Raithatha, Bhavesh; Raymode, Parizade; Szafranski, Jan; Twohey, Linda; Watt, Philip; Weatherall, Lucie; Weatherill, J.; Whitman, Zoe; Wighton, Elinor; Abayasinghe, Chamika; Chan, Alexander; Darwish, Sharif; Gill, James; Glasgow, Emma; Hadfield, Daniel; Harris, Clair; Hopkins, Phil; Kochhar, Arun; Kunst, Gudrun; Mellis, Clare; Pool, Andrew; Riozzi, Paul; Selman, Andrew; Smith, Emma-Jane; Vele, Liana; Gercek, Yuksel; Guy, Kramer; Holden, Douglas; Watson, Nicholas; Whysall, Karen; Andreou, Prematie; Hales, Dawn; Thompson, Jonathan; Bowrey, Sarah; McDonald, Shara; Gilmore, Jemma; Hills, Vicky; Kelly, Chan; Kelly, Sinead; Lloyd, Geraint; Abbott, Tom; Gall, Lewis; Torrance, Hew; Vivian, Mark; Berntsen, Emer; Nolan, Tracey; Turner, Angus; Vohra, Akbar; Brown, Andrew; Clark, Richard; Coughlan, Elaine; Daniel, Conway; Patvardhan, Chinmay; Pearson, Rachel; Predeep, Sheba; Saad, Hesham; Shanmugam, Mohanakrishnan; Varley, Simon; Wylie, Katharine; Cooper, Lucy; Makowski, Arystarch; Misztal, Beata; Moldovan, Eliza; Pegg, Claire; Donovan, Andrew; Foot, Jayne; Large, Simon; Claxton, Andrew; Netke, Bhagyashree; Armstrong, Richard; Calderwood, Claire; Kwok, Andy; Mohr, Otto; Oyeniyi, Peter; Patnaik, Lisa; Post, Benjamin; Ali, Sarah; Arshad, Homa; Baker, Gerard; Brenner, Laura; Brincat, Maximilian; Brunswicker, Annemarie; Cox, Hannah; Cozar, Octavian Ionut; Cheong, Edward; Durst, Alexander; Fengas, Lior; Flatt, Jim; Glister, Georgina; Narwani, Vishal; Photi, Evangelos; Rankin, Adeline; Rosbergen, Melissa; Tan, Mark; Beaton, Ceri; Horn, Rachel; Hunt, Jane; Rousseau, Guy; Stancombe, Lucia; Absar, Mohammed; Allsop, Joanne; Drinkwater, Zoe; Hodgkiss, Tracey; Smith, Kirsty; Brown, Jamie; Alexander-Sefre, Farhad; Campey, Lorraine; Dudgeon, Lucy; Hall, Kathryn; Hitchcock, Rachael; James, Lynne; Smith, Kate; Winstone, Ulrika; Ahmad, Norfaizan; Bauchmuller, Kris; Harrison, Jonathan; Jeffery, Holly; Miller, Duncan; Pinder, Angela; Pothuneedi, Sailaja; Rosser, Jonathan; Sanghera, Sumayer; Swift, Diane; Walker, Rachel; Bester, Delia; Cavanagh, Sarah; Cripps, Heather; Daniel, Harvey; Lynch, Julie; Paton, Alison; Pyke, Shirley; Scholefield, John; Whitworth, Helen; Bottrill, Fiona; Ramalingam, Ganesh; Webb, Stephen; Akerman, Nik; Antill, Philip; Bourner, Lynsey; Buckley, Sarah; Castle, Gail; Charles, Rob; Eggleston, Christopher; Foster, Rebecca; Gill, Satwant; Lindley, Kate; Lklouk, Mohamed; Lowery, Tracey; Martin, Oliver; Milne, David; O'Connor, Patrick; Ratcliffe, Andrew; Rose, Alastair; Smith, Annie; Varma, Sandeep; Ward, Jackie; Barcraft-Barnes, Helena; Camsooksai, Julie; Colvin, Carolyn; Reschreiter, Henrik; Tbaily, Lee; Venner, Nicola; Hamilton, Caroline; Kelly, Lewis; Toth-Tarsoly, Piroska; Dodsworth, Kerry; Foord, Denise; Gordon, Paul; Hawes, Elizabeth; Lamb, Nikki; Mouland, Johanna; Nightingale, Jeremy; Rose, Steve; Schrieber, Joe; Al'Amri, Khalid; Aladin, Hafiz; Arshad, Mohammed Asif; Barraclough, James; Bentley, Conor; Bergin, Colin; Carrera, Ronald; Clarkson, Aisling; Collins, Michelle; Cooper, Lauren; Denham, Samuel; Griffiths, Ewen; Ip, Peter; Jeyanthan, Somasundaram; Joory, Kavita; Kaur, Satwant; Marriott, Paul; Mitchell, Natalie; Nagaiah, Sukumar; Nilsson, Annette; Parekh, Nilesh; Pope, Martin; Seager, Joseph; Serag, Hosam; Tameem, Alifia; Thomas, Anna; Thunder, Joanne; Torrance, Andrew; Vohra, Ravinder; Whitehouse, Arlo; Wong, Tony; Blunt, Mark; Wong, Kate; Giles, Julian; Reed, Isabelle; Weller, Debbie; Bell, Gillian; Birch, Julie; Damant, Rose; Maiden, Jane; Mewies, Clare; Prince, Claire; Radford, Jane; Reynolds, Tim; Balain, Birender; Banerjee, Robin; Barnett, Andrew; Burston, Ben; Davies, Kirsty; Edwards, Jayne; Evans, Chris; Ford, David; Gallacher, Pete; Hill, Simon; Jaffray, David; Karlakki, Sudheer; Kelly, Cormac; Kennedy, Julia; Kiely, Nigel; Lewthwaite, Simon; Marquis, Chris; Ockendon, Matthew; Phillips, Stephen; Pickard, Simon; Richardson, James; Roach, Richard; Smith, Tony; Spencer-Jones, Richard; Steele, Niall; Steen, Julie; van Liefland, Marck; White, Steve; Faulds, Matthew; Harris, Meredyth; Kelly, Carrie; Nicol, Scott; Pearson, Sally Anne; Chukkambotla, Srikanth; Andrew, Alyson; Attrill, Elizabeth; Campbell, Graham; Datson, Amanda; Fouracres, Anna; Graterol, Juan; Graves, Lynne; Hong, Bosun; Ishimaru, Alexander; Karthikeyan, Arvind; King, Helen; Lawson, Tom; Lee, Gregory; Lyons, Saoirse; Hall, Andrew Macalister; Mathoulin, Sophie; Mcintyre, Eilidh; Mclaughlin, Danny; Mulcahy, Kathleen; Paddle, Jonathan; Ratcliffe, Anna; Robbins, James; Sung, Weilin; Tayo, Adeoluwa; Trembath, Lisa; Venugopal, Suneetha; Walker, Robert; Wigmore, Geoffrey; Boereboom, Catherine; Downes, Charlotte; Humphries, Ryan; Melbourne, Susan; Smith, Coral; Tou, Samson; Ullah, Shafa; Batchelor, Nick; Boxall, Leigh; Broomby, Rupert; Deen, Tariq; Hellewell, Alistair; Helliwell, Laurence; Hutchings, Melanie; Hutchins, David; Keenan, Samantha; Mackie, Donna; Potter, Alison; Smith, Frances; Stone, Lucy; Thorpe, Kevin; Wassall, Richard; Woodgate, Andrew; Baillie, Shelley; Campbell, Tara; James, Sarah; King, Chris; Marques de Araujo, Daniela; Martin, Daniel; Morkane, Clare; Neely, Julia; Rajendram, Rajkumar; Burton, Megan; James, Kathryn; Keevil, Edward; Minik, Orsolya; Morgan, Jenna; Musgrave, Anna; Rajanna, Harish; Roberts, Tracey; Adamson, Michael; Jumbe, Sandra; Kendall, Jennie; Muthuswamy, Mohan Babu; Anderson, Charlotte; Cruikshanks, Andrew; Wrench, Ian; Zeidan, Lisa; Ardern, Diane; Harris, Benjamin; Hellstrom, Johanna; Martin, Jane; Thomas, Richard; Varsani, Nimu; Brown, Caroline Wrey; Docherty, Philip; Gillies, Michael; McGregor, Euan; Usher, Helen; Craig, Jayne; Smith, Andrew; Ahmad, Tahania; Bodger, Phoebe; Creary, Thais; Fowler, Alexander; Hewson, Russ; Ijuo, Eke; Jones, Timothy; Kantsedikas, Ilya; Lahiri, Sumitra; McLean, Aaron Lawson; Niebrzegowska, Edyta; Phull, Mandeep; Wang, Difei; Wickboldt, Nadine; Baldwin, Jacqueline; Doyle, Donna; Mcmullan, Sean; Oladapo, Michelle; Owen, Thomas; Williams, Alexandra; Daniel, Hull; Gregory, Peter; Husain, Tauqeer; Kirk-Bayley, Justin; Mathers, Edward; Montague, Laura; Harper, Mark; White, Stuart; Jack, James; Ridley, Carrie; Avis, Joanne; Cook, Tim; Dali-Kemmery, Lola; Kerslake, Ian; Lambourne, Victoria; Pearson, Annabel; Boyd, Christine; Callaghan, Mark; Lawson, Cathy; McCrossan, Roopa; Nesbitt, Vanessa; O'connor, Laura; Scott, Julia; Sinclair, Rhona; Farid, Nahla; Morgese, Ciro; Bhatia, Kailash; Karmarkar, Swati; Ahmed, Jamil; Branagan, Graham; Hutton, Monica; Swain, Andrew; Brookes, Jamie; Cornell, Jonathan; Dolan, Rachael; Hulme, Jonathan; Jansen van Vuuren, Amanda; Jowitt, Tom; Kalashetty, Gunasheela; Lloyd, Fran; Patel, Kiran; Sherwood, Nicholas; Brown, Lynne; Chandler, Ben; Deighton, Kerry; Emma, Temlett; Haunch, Kirsty; Cheeseman, Michelle; Dent, Kathy; Garg, Sanjeev; Gray, Carol; Hood, Marion; Jones, Dawn; Juj, Joanne; Rao, Roshan; Walker, Tara; Al Anizi, Mashel; Cheah, Clarissa; Cheing, Yushio; Coutinho, Francisco; Gondo, Prisca; Hadebe, Bernard; Hove, Mazvangu Onie; Khader, Ahamed; Krishnachetty, Bobby; Rhodes, Karen; Sokhi, Jagdish; Baker, Katie-Anne; Bertram, Wendy; Looseley, Alex; Mouton, Ronelle; Hanna, George; Arnold, Glenn; Arya, Shobhit; Balfoussia, Danai; Baxter, Linden; Harris, James; Jones, Craig; Knaggs, Alison; Markar, Sheraz; Perera, Anisha; Scott, Alasdair; Shida, Asako; Sirha, Ravneet; Wright, Sally; Frost, Victoria; Gray, Catherine; Andrews, Emma; Arrandale, Lindsay; Barrett, Stephen; Cifra, Elna; Cooper, Mariese; Dragnea, Dragos; Elna, Cifra; Maclean, Jennifer; Meier, Sonja; Milliken, Donald; Munns, Christopher; Ratanshi, Nadir; Ramessur, Suneil; Salvana, Abegail; Watson, Anthony; Ali, Hani; Campbell, Gill; Critchley, Rebecca; Endersby, Simon; Hicks, Catherine; Liddle, Alison; Pass, Marc; Ritchie, Charlotte; Thomas, Charlotte; Too, Lingxi; Welsh, Sarah; Gill, Talvinder; Johnson, Joanne; Reed, Joanne; Davis, Edward; Papadopoullos, Sam; Attwood, Clare; Biffen, Andrew; Boulton, Kerenza; Gray, Sophie; Hay, David; Mills, Sarah; Montgomery, Jane; Riddell, Rory; Simpson, James; Bhardwaj, Neeraj; Paul, Elaine; Uwubamwen, Nosakhare; Alexander, Maini; Arrich, James; Arumugam, Swarna; Blackwood, Douglas; Boggiano, Victoria; Brown, Robyn; Chan, Yik Lam; Chatterjee, Devnandan; Chhabra, Ashok; Christian, Rachel; Costelloe, Hannah; Matthewman, Madeline Coxwell; Dalton, Emma; Darko, Julia; Davari, Maria; Dave, Tejal; Deacon, Matthew; Deepak, Shantal; Edmond, Holly; Ellis, Jessica; El-Sayed, Ahmed; Eneje, Philip; English, Rose; Ewe, Renee; Foers, William; Franklin, John; Gallego, Laura; Garrett, Emily; Goldberg, Olivia; Goss, Harry; Greaves, Rosanna; Harris, Rudy; Hennings, Charles; Jones, Eleanor; Kamali, Nelson; Kokkinos, Naomi; Lewis, Carys; Lignos, Leda; Malgapo, Evaleen Victoria; Malik, Rizwana; Milne, Andrew; Mulligan, John-Patrick; Nicklin, Philippa; Palipane, Natasha; Parsons, Thomas; Piper, Rebecca; Prakash, Rohan; Ramesh, Byron; Rasip, Sarah; Reading, Jacob; Rela, Mariam; Reyes, Anna; Stephens, Robert; Rooms, Martin; Shah, Karishma; Simons, Henry; Solanki, Shalil; Spowart, Emma; Stevens, Amy; Thomas, Christopher; Waggett, Helena; Yassaee, Arrash; Kennedy, Anthony; Scott, Sara; Somanath, Sameer; Berg, Andrew; Hernandez, Miguel; Nanda, Rajesh; Tank, Ghanshyambhai; Wilson, Natalie; Wilson, Debbie; Al-Soudaine, Yassr; Baldwin, Matthew; Cornish, Julie; Davies, Zoe; Davies, Leigh; Edwards, Marc; Frewer, Natasha; Gallard, Sian; Glasbey, James; Harries, Rhiannon; Hopkins, Luke; Kim, Taeyang; Koompirochana, Vilavan; Lawson, Simon; Lewis, Megan; Makzal, Zaid; Scourfield, Sarah; Ahmad, Yousra; Bates, Sarah; Blackwell, Clare; Bryant, Helen; Collins, Hannah; Coulter, Suzanne; Cruickshank, Ross; Daniel, Sonya; Daubeny, Thomas; Edwards, Mark; Golder, Kim; Hawkins, Lesley; Helen, Bryant; Hinxman, Honor; Levett, Denny; Salmon, Karen; Seaward, Leanne; Skinner, Ben; Tyrell, Bryony; Wadams, Beverley; Walsgrove, Joseph; Dickson, Jane; Constantin, Kathryn; Karen, Markwell; O'Brien, Peter; O'Donohoe, Lynn; Payne, Hannah; Sundayi, Saul; Walker, Elaine; Brooke, Jenny; Cardy, Jon; Humphreys, Sally; Kessack, Laura; Kubitzek, Christiane; Kumar, Suhas; Cotterill, Donna; Hodzovic, Emil; Hosdurga, Gurunath; Miles, Edward; Saunders, Glenn; Campbell, Marta; Chan, Peter; Jemmett, Kim; Raj, Ashok; Naik, Aditi; Oshowo, Ayo; Ramamoorthy, Rajarajan; Shah, Nimesh; Sylvan, Axel; Blyth, Katharine; Burtenshaw, Andrew; Freeman, David; Johnson, Emily; Lo, Philip; Martin, Terry; Plunkett, Emma; Wollaston, Julie; Allison, Joanna; Carroll, Christine; Craw, Nicholas; Craw, Sarah; Pitt-Kerby, Tressy; Rowland-Axe, Rebecca; Spurdle, Katie; McDonald, Andrew; Simon, Davies; Sinha, Vivek; Smith, Thomas; Banner-Goodspeed, Valerie; Boone, Myles; Campbell, Kathleen; Lu, Fengxin; Scannell, Joseph; Sobol, Julia; Balajonda, Naraida; Clemmons, Karen; Conde, Carlos; Elgasim, Magdi; Funk, Bonita; Hall, Roger; Hopkins, Thomas; Olaleye, Omowunmi; Omer, Omer; Pender, Michelle; Porto, Angelo; Stevens, Alice; Waweru, Peter; Yeh, Erlinda; Bodansky, Daniella; Evans, Adam; Kleopoulos, Steven; Maril, Robert; Mathney, Edward; Sanchez, Angela; Tinuoye, Elizabeth; Bateman, Brian; Eng, Kristen; Jiang, Ning; Ladha, Karim; Needleman, Joseph; Chen, Lee-Lynn; Lane, Rondall; Robinowitz, David; Ghushe, Neil; Irshad, Mariam; O'Connor, John; Patel, Samir; Takemoto, Steven; Wallace, Art; Mazzeffi, Michael; Rock, Peter; Wallace, Karin; Zhu, Xiaomao; Chua, Pandora; Mattera, Matthew; Sharar, Rebecca; Thilen, Stephan; Treggiari, Miriam; Morgan, Angela; Sofjan, Iwan; Subramaniam, Kathirvel; Avidan, Michael; Maybrier, Hannah; Muench, Maxwell; Wildes, Troy

    2018-01-01

    The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of

  16. Effective Leadership of Surgical Teams: A Mixed Methods Study of Surgeon Behaviors and Functions.

    Science.gov (United States)

    Stone, Juliana L; Aveling, Emma-Louise; Frean, Molly; Shields, Morgan C; Wright, Cameron; Gino, Francesca; Sundt, Thoralf M; Singer, Sara J

    2017-08-01

    The importance of effective team leadership for achieving surgical excellence is widely accepted, but we understand less about the behaviors that achieve this goal. We studied cardiac surgical teams to identify leadership behaviors that best support surgical teamwork. We observed, surveyed, and interviewed cardiac surgical teams, including 7 surgeons and 116 team members, from September 2013 to April 2015. We documented 1,926 surgeon/team member interactions during 22 cases, coded them by behavior type and valence (ie, positive/negative/neutral), and characterized them by leadership function (conductor, elucidator, delegator, engagement facilitator, tone setter, being human, and safe space maker) to create a novel framework of surgical leadership derived from direct observation. We surveyed nonsurgeon team members about their perceptions of individual surgeon's leadership effectiveness on a 7-point Likert scale and correlated survey measures with individual surgeon profiles created by calculating percentage of behavior types, leader functions, and valence. Surgeon leadership was rated by nonsurgeons from 4.2 to 6.2 (mean, 5.4). Among the 33 types of behaviors observed, most interactions constituted elucidating (24%) and tone setting (20%). Overall, 66% of interactions (range, 43%-84%) were positive and 11% (range, 1%-45%) were negative. The percentage of positive and negative behaviors correlated strongly (r = 0.85 for positive and r = 0.75 for negative, p leadership. Facilitating engagement related most positively (r = 0.80; p = 0.03), and negative forms of elucidating, ie, criticism, related most negatively (r = -0.81; p = 0.03). We identified 7 surgeon leadership functions and related behaviors that impact perceptions of leadership. These observations suggest actionable opportunities to improve team leadership behavior. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Burnout syndrome in surgical oncology and general surgery nurses: a cross-sectional study.

    Science.gov (United States)

    Książek, Ilona; Stefaniak, Tomasz J; Stadnyk, Magdalena; Książek, Janina

    2011-09-01

    The occurrence of burnout syndrome is strongly associated with and modulated by multiple personality and environmental factors. In Poland, nurses experience a discrepancy between the demands, expectations and social status of the position of their profession and low salaries. Such a situation provokes frustration and depression, and further leads to problems of adaptation including burnout syndrome. The aim of this study was to evaluate the occurrence of burnout syndrome among nurses working in general surgery and surgical oncology specialties. The study was designed as a cross-sectional questionnaire survey. It was undertaken in the largest Hospital in the Pomeranian region of Poland. The participants included 60 nurses working in two departments: General Surgery and Surgical Oncology. The study was based upon an anonymous self-test composed of a questionnaire and three psychological measures: Maslach Burnout Inventory (MBI), Psychological Burden Scale and a self-constructed questionnaire on job satisfaction. Intensity of burnout syndrome was significantly higher among oncology nurses than among surgical ones. There was also a strong but not significant trend towards higher Psychological Burden Scale in the group of oncology nurses. The study revealed a high degree of emotional burden and burnout in nurses working in the study hospital suggesting that nurses are at great occupational risk. The findings of the study provide evidence of the potential need to restructure the system and suggest that nurses need more control of their work including a higher degree of involvement in clinical decision-making. Copyright © 2010 Elsevier Ltd. All rights reserved.

  18. The impact of different definitions and reference groups on the prevalence of cognitive impairment: a study in postmenopausal breast cancer patients before the start of adjuvant systemic therapy.

    Science.gov (United States)

    Schilder, Christina M; Seynaeve, Caroline; Linn, Sabine C; Boogerd, Willem; Gundy, Chad M; Beex, Louk V; van Dam, Frits S; Schagen, Sanne B

    2010-04-01

    Several prospective studies into the effects of adjuvant systemic therapy on cognitive functioning suggest that a proportion of breast cancer patients show cognitive deficits already before the start of systemic therapy. Owing to, among others, methodological inconsistency, studies report different rates of this pre-treatment cognitive impairment. We examined the impact of four different criteria of cognitive impairment and two types of reference groups (a study-specific healthy reference group versus published normative data) on the prevalence of cognitive impairment. Two hundred and five postmenopausal breast cancer patients underwent a battery of neuropsychological tests before the start of endocrine therapy, 124 healthy subjects underwent the same tests. Proportions of cognitive impaired patients were calculated for each of four criteria for cognitive impairment, using (1) study-specific healthy controls and (2) published norms of healthy controls as reference groups. The prevalence of cognitive impairment varied greatly with the strictness of the criterion, as expected, but also was dependent on the reference group used. Cognitive impairment, relative to published norms, ranged from 1% for the strictest to 36.6% for the less strict criterion, cognitive impairment relative to study-specific healthy controls, ranged from 13.7 to 45.4% for the same criteria. This study highlights contrasting proportions of cognitive impairment by using different criteria for cognitive impairment and different reference groups. (Dis)advantages of the methods using a criterion for cognitive impairment, and of the use of published norms versus a study-specific reference group are discussed. Copyright 2009 John Wiley & Sons, Ltd.

  19. Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study.

    Science.gov (United States)

    Gligorov, Joseph; Pivot, Xavier B; Jacot, William; Naman, Hervé L; Spaeth, Dominique; Misset, Jean-Louis; Largillier, Rémy; Sautiere, Jean-Loup; de Roquancourt, Anne; Pomel, Christophe; Rouanet, Philippe; Rouzier, Roman; Penault-Llorca, Frederique M

    2015-08-01

    The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER+), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting. A total of 100 patients with ER+, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled. Treatment recommendations, physicians' confidence before and after knowing the Recurrence Score value, and physicians' perception of the assay were recorded. Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37% of patients, predominantly from chemoendocrine to endocrine treatment alone. The proportion of patients recommended chemotherapy decreased from 52% pretest to 25% post-test. Of patients originally recommended chemotherapy, 61% were recommended endocrine treatment alone after receiving the Recurrence Score result. For both pN0 and pN1mi patients, post-test recommendations appeared to follow the Recurrence Score result for low and high values. Physicians' confidence improved significantly. These are the first prospective data on the impact of the Oncotype DX assay on adjuvant treatment decisions in France. Using the assay was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use. These data are consistent with those presented from European and non-European studies. ©AlphaMed Press.

  20. Benefit of adjuvant chemotherapy with or without trastuzumab in pT1ab node-negative human epidermal growth factor receptor 2-positive breast carcinomas: results of a national multi-institutional study.

    Science.gov (United States)

    de Nonneville, Alexandre; Gonçalves, Anthony; Zemmour, Christophe; Classe, Jean M; Cohen, Monique; Lambaudie, Eric; Reyal, Fabien; Scherer, Christophe; Muracciole, Xavier; Colombo, Pierre E; Giard, Sylvia; Rouzier, Roman; Villet, Richard; Chopin, Nicolas; Darai, Emile; Garbay, Jean R; Gimbergues, Pierre; Sabiani, Laura; Coutant, Charles; Sabatier, Renaud; Bertucci, François; Boher, Jean M; Houvenaeghel, Gilles

    2017-04-01

    Benefit of adjuvant trastuzumab-based chemotherapy for node-positive and/or >1 cm human epidermal growth factor receptor 2-positive (HER2+) breast carcinomas has been clearly demonstrated in randomized clinical trials. Yet, evidence that adjuvant chemotherapy with or without trastuzumab is effective in pT1abN0 HER2+ tumors is still limited. The primary objective of this study was to investigate the impact of adjuvant chemotherapy ± trastuzumab on outcome in this subpopulation. A total of 356 cases of pT1abN0M0 HER2 + breast cancers were retrospectively identified from a large cohort of 22,334 patients, including 1248 HER2+ patients who underwent primary surgery at 17 French centers, between December 1994 and January 2014. The primary end point was disease-free survival (DFS). A multivariate Cox model was built, including adjuvant chemotherapy, tumor size, hormone receptor status, and Scarff Bloom Richardson (SBR) grade. A total of 138 cases (39%) were treated with trastuzumab-based chemotherapy, 29 (8%) with chemotherapy alone, and 189 (53%) received neither trastuzumab nor chemotherapy. Adjuvant chemotherapy ± trastuzumab was associated with a significant DFS benefit (3-year 99 vs. 90%, and 5-year 96 vs. 84%, Hazard ratio, HR 0.26 [0.10-0.67]; p = 0.003, logrank test) which was maintained in multivariate analysis (HR 0.19 [0.07-0.52]; p = 0.001). Metastasis-free survival was also increased (HR 0.25 [0.07-0.86]; p = 0.018, logrank test) at 3-year (99 vs. 95%) and 5-year (98 vs. 89%) censoring. Exploratory subgroup analysis found DFS benefit to be significant in hormone receptor-negative, hormone receptor-positive, and pT1b tumors, but not in pT1a tumors. Adjuvant chemotherapy ± trastuzumab is associated with a significantly reduced risk of recurrence in subcentimeter node-negative HER2+ breast cancers. Most of the benefit may be driven by pT1b tumors.

  1. Reducing the risk of surgical site infection: a case controlled study of contamination of theatre clothing.

    Science.gov (United States)

    Sivanandan, Indu; Bowker, Karen E; Bannister, Gordon C; Soar, Jasmeet

    2011-02-01

    Surgical site infections are one of the most important causes of healthcare associated infections (HCAI), accounting for 20% of all HCAIs. Surgical site infections affect 1% of joint replacement operations. This study was designed to assess whether theatre clothing is contaminated more inside or outside the theatre suite. Petri dishes filled with horse blood agar were pressed on theatre clothes at 0, 2, 4, 6 and 8 hours to sample bacterial contamination in 20 doctors whilst working in and outside the theatre suite. The results showed that there was greater bacterial contamination when outside the theatre suite at 2 hours. There were no differences in the amount of contamination at 4, 6 and 8 hours. This study suggests that the level of contamination of theatre clothes is similar both inside and outside the theatre setting.

  2. Prognostic Impact of the Combination of Recurrence Score and Quantitative Estrogen Receptor Expression (ESR1) on Predicting Late Distant Recurrence Risk in Estrogen Receptor-Positive Breast Cancer After 5 Years of Tamoxifen: Results From NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-28 and B-14.

    Science.gov (United States)

    Wolmark, Norman; Mamounas, Eleftherios P; Baehner, Frederick L; Butler, Steven M; Tang, Gong; Jamshidian, Farid; Sing, Amy P; Shak, Steven; Paik, Soonmyung

    2016-07-10

    We determined the utility of the 21-Gene Recurrence Score (RS) in predicting late (> 5 years) distant recurrence (LDR) in stage I and II breast cancer within high and low-ESR1-expressing groups. RS was assessed in chemotherapy/tamoxifen-treated, estrogen receptor (ER) -positive, node-positive National Surgical Adjuvant Breast and Bowel Project B-28 patients and tamoxifen-treated, ER-positive, node-negative B-14 patients. The association of the RS with risk of distant recurrence (DR) 0 to 5 years and those at risk > 5 years was assessed. An ESR1 expression cut point was optimized in B-28 and tested in B-14. Median follow-up was 11.2 years for B-28 and 13.9 years for B-14. Of 1,065 B-28 patients, 36% had low ( 5 to 10 years (log-rank P = .02) regardless of ESR1 expression. An ESR1 expression cut point of 9.1 CT was identified in B-28. It was validated in B-14 patients for whom the RS was associated with DR in years 5 to 15: 6.8% (95% CI, 4.4% to 10.6%) versus 11.2% (95% CI, 6.2% to 19.9%) versus 16.4% (95% CI, 10.2% to 25.7%) for RS < 18, RS 18 to 30, and RS ≥ 31, respectively (log-rank P = .01). For LDR, RS is strongly prognostic in patients with higher quantitative ESR1. Risk of LDR is relatively low for patients with low RS. These results suggest the value of extended tamoxifen therapy merits evaluation in patients with intermediate and high RS with higher ESR1 expression at initial diagnosis. © 2016 by American Society of Clinical Oncology.

  3. Prognostic Impact of the Combination of Recurrence Score and Quantitative Estrogen Receptor Expression (ESR1) on Predicting Late Distant Recurrence Risk in Estrogen Receptor–Positive Breast Cancer After 5 Years of Tamoxifen: Results From NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-28 and B-14

    Science.gov (United States)

    Wolmark, Norman; Baehner, Frederick L.; Butler, Steven M.; Tang, Gong; Jamshidian, Farid; Sing, Amy P.; Shak, Steven; Paik, Soonmyung

    2016-01-01

    Purpose We determined the utility of the 21-Gene Recurrence Score (RS) in predicting late (> 5 years) distant recurrence (LDR) in stage I and II breast cancer within high and low-ESR1–expressing groups. Patients and Methods RS was assessed in chemotherapy/tamoxifen-treated, estrogen receptor (ER) –positive, node-positive National Surgical Adjuvant Breast and Bowel Project B-28 patients and tamoxifen-treated, ER-positive, node-negative B-14 patients. The association of the RS with risk of distant recurrence (DR) 0 to 5 years and those at risk > 5 years was assessed. An ESR1 expression cut point was optimized in B-28 and tested in B-14. Results Median follow-up was 11.2 years for B-28 and 13.9 years for B-14. Of 1,065 B-28 patients, 36% had low ( 5 to 10 years (log-rank P = .02) regardless of ESR1 expression. An ESR1 expression cut point of 9.1 CT was identified in B-28. It was validated in B-14 patients for whom the RS was associated with DR in years 5 to 15: 6.8% (95% CI, 4.4% to 10.6%) versus 11.2% (95% CI, 6.2% to 19.9%) versus 16.4% (95% CI, 10.2% to 25.7%) for RS < 18, RS 18 to 30, and RS ≥ 31, respectively (log-rank P = .01). Conclusion For LDR, RS is strongly prognostic in patients with higher quantitative ESR1. Risk of LDR is relatively low for patients with low RS. These results suggest the value of extended tamoxifen therapy merits evaluation in patients with intermediate and high RS with higher ESR1 expression at initial diagnosis. PMID:27217450

  4. Activity of glycated chitosan and other adjuvants to PDT vaccines

    Science.gov (United States)

    Korbelik, Mladen; Banáth, Judit; Čiplys, Evaldas; Szulc, Zdzislaw; Bielawska, Alicja; Chen, Wei R.

    2015-03-01

    Glycated chitosan (GC), a water soluble galactose-conjugated natural polysaccharide, has proven to be an effective immunoadjuvant for treatment of tumors based on laser thermal therapy. It was also shown to act as adjuvant for tumor therapy with high-intensity ultrasound and in situ photodynamic therapy (PDT). In the present study, GC was examined as potential adjuvant to PDT-generated cancer vaccine. Two other agents, pure calreticulin protein and acid ceramidase inhibitor LCL521, were also tested as prospective adjuvants for use in conjunction with PDT vaccines. Single treatment with GC, included with PDT vaccine cells suspension, improved the therapeutic efficacy when compared to vaccine alone. This attractive prospect of GC application remains to be carefully optimized and mechanistically elucidated. Both calreticulin and LCL521 proved also effective adjuvants when combined with PDT vaccine tumor treatment.

  5. The Effects of Adjuvant Endocrine Treatment on Serum Leptin, Serum Adiponectin and Body Composition in Patients with Breast Cancer: The Izmir Oncology Group (IZOG) Study.

    Science.gov (United States)

    Akyol, Murat; Demir, Leyla; Alacacioglu, Ahmet; Ellidokuz, Hülya; Kucukzeybek, Yuksel; Yildiz, Yasar; Gumus, Zehra; Bayoglu, Vedat; Yildiz, Ibrahim; Salman, Tarık; Varol, Umut; Kucukzeybek, Betul; Demir, Lutfiye; Dirican, Ahmet; Sutcu, Recep; Tarhan, Mustafa Oktay

    2016-01-01

    A limited number of studies have been conducted on the effects of hormonal therapy with tamoxifen (TMX) or aromatase inhibitors (AIs) on plasma levels of leptin and adiponectin, as well as body composition in breast cancer (BC) patients. Therefore, we aimed to analyze the relationship between adipocytokines and body composition as well as the effects of TMX and AIs on plasma adiponectin, leptin, leptin/adiponectin ratio (LAR) and body composition. Patients were treated with either TMX or AI according to their menopausal status after adjuvant radiotherapy. Changes in body composition and serum leptin and adiponectin levels were evaluated. We recorded the type of hormonal therapy, BMI, waist/hip ratio (WHR), leptin and adiponectin levels at study entry, and after 6 and 12 months. From baseline to the 6- and 12-month follow-ups, there were statistically significant increases in WHR (p = 0.003), fat mass (p = 0.041), and serum leptin (p body composition and serum leptin and adiponectin levels were similar in TMX and AI groups. A statistically significant decrease was found in total body water and LAR (p body fat percentage increased, such increases were not statistically significant. A positive correlation was found between baseline BMI and serum leptin levels. This correlation was maintained at 6 and 12 months. The negative correlation found between serum adiponectin levels at baseline and baseline BMI did not last throughout the study. In this study, increased leptin and adiponectin levels and a decreased LAR were found in both AI and TMX groups. These changes might have occurred through both mechanisms of hormonal therapy and body composition changes. Therefore, AIs and TMX may exert their protective effects for BC patients by decreasing LAR rather than affecting leptin or adiponectin alone. © 2015 S. Karger AG, Basel.

  6. "The study on surgical services for the United States": a valid prescription for American surgery?

    Science.gov (United States)

    Hughes, E F; Lewit, E M; Pauly, M V

    1977-01-01

    The overall approach of SOSSUS to the study of surgical services, the interpretation of findings, and policy recommendations are rightly called into question. But singular concern with the consequences of monopolistic control by the profession is no substitute for analysis of the dynamics among demand, production, and supply of surgery. Any delivery system--and many models are feasible--involving consumers, providers, and payers is a market in which multidimensional behavior must be anticipated.

  7. Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage breast cancer.

    Science.gov (United States)

    Martín, Miguel; González-Rivera, Milagros; Morales, Serafín; de la Haba-Rodriguez, Juan; González-Cortijo, Lucía; Manso, Luis; Albanell, Joan; González-Martín, Antonio; González, Sónia; Arcusa, Angels; de la Cruz-Merino, Luis; Rojo, Federico; Vidal, María; Galván, Patricia; Aguirre, Elena; Morales, Cristina; Ferree, Sean; Pompilio, Kristen; Casas, Maribel; Caballero, Rosalía; Goicoechea, Uxue; Carrasco, Eva; Michalopoulos, Steven; Hornberger, John; Prat, Aleix

    2015-06-01

    Improved understanding of risk of recurrence (ROR) is needed to reduce cases of recurrence and more effectively treat breast cancer patients. The purpose of this study was to examine how a gene-expression profile (GEP), identified by Prosigna, influences physician adjuvant treatment selection for early breast cancer (EBC) and the effects of this influence on optimizing adjuvant treatment recommendations in clinical practice. A prospective, observational, multicenter study was carried out in 15 hospitals across Spain. Participating medical oncologists completed pre-assessment, post-assessment, and follow-up questionnaires recording their treatment recommendations and confidence in these recommendations, before and after knowing the patient's ROR. Patients completed questionnaires on decision-making, anxiety, and health status. Between June 2013 and January 2014, 217 patients enrolled and a final 200 were included in the study. Patients were postmenopausal, estrogen receptor positive, human epidermal growth hormone factor negative, and node negative with either stage 1 or stage 2 tumors. After receiving the GEP results, treatment recommendations were changed for 40 patients (20%). The confidence of medical oncologists in their treatment recommendations increased in 41.6% and decreased in 6.5% of total cases. Patients reported lower anxiety after physicians made treatment recommendations based on the GEP results (p anxiety about the selected adjuvant therapy decreased with use of the GEP.

  8. Factors Affecting Adjuvant Therapy in Stage III Pancreatic Cancer—Analysis of the National Cancer Database

    Directory of Open Access Journals (Sweden)

    Mridula Krishnan

    2017-08-01

    Full Text Available Background: Adjuvant therapy after curative resection is associated with survival benefit in stage III pancreatic cancer. We analyzed the factors affecting the outcome of adjuvant therapy in stage III pancreatic cancer and compared overall survival with different modalities of adjuvant treatment. Methods: This is a retrospective study of patients with stage III pancreatic cancer listed in the National Cancer Database (NCDB who were diagnosed between 2004 and 2012. Patients were stratified based on adjuvant therapy they received. Unadjusted Kaplan-Meier and multivariable Cox regression analysis were performed. Results: We analyzed a cohort included 1731 patients who were recipients of adjuvant therapy for stage III pancreatic cancer within the limits of our database. Patients who received adjuvant chemoradiation had the longest postdiagnosis survival time, followed by patients who received adjuvant chemotherapy, and finally patients who received no adjuvant therapy. On multivariate analysis, advancing age and patients with Medicaid had worse survival, whereas Spanish origin and lower Charlson comorbidity score had better survival. Conclusions: Our study is the largest trial using the NCDB addressing the effects of adjuvant therapy specifically in stage III pancreatic cancer. Within the limits of our study, survival benefit with adjuvant therapy was more apparent with longer duration from date of diagnosis.

  9. The challenges of clinical education in a baccalaureate surgical technology students in Iran: a qualitative study.

    Science.gov (United States)

    Zardosht, Roghayeh; Moonaghi, Hossein Karimi; Razavi, Mohammad Etezad; Ahmady, Soleiman

    2018-02-01

    Clinical education is an integral part of the surgical technology curriculum, in which students combine and integrate knowledge, skills, attitudes, values and philosophies of the profession. It is difficult to learn and adapt to different types of skills and roles in the operating room environment. This qualitative study examines the difference between the clinical education of Surgical Technology and other clinical settings, and the challenges faced by students in the field, within the course. This was a qualitative content analysis study conducted in 2016. The participants in this study were 16 baccalaureate surgical technology students of the University for Medical Sciences in Khorasan Razavi province. A semi-structured interview method was run to collect the required data. The sampling was initially purposive, then in the snowball method which continued until data saturation. All interviews were recorded, then transcribed, and analyzed using a continuous comparative method and conventional qualitative content analysis method. From the deep and rich descriptions of the participants, three themes including "stressful environment", "controversy between anticipation of role and reality", and "humiliating experiences" as well as a general theme of "bitter education" were obtained. Students' orientation before attending the operating room, accompanying, supporting, and a full-time attendance of the specialist instructor, strengthening the prerequisite knowledge and skills for the students in this field, teaching ethics, and professional interactions, play an important role in the student's acceptance of the operating room, in the surgery team and the improvement of the quality of clinical education of these students.

  10. Edrecolomab alone or in combination with fluorouracil and folinic acid in the adjuvant treatment of stage III colon cancer: a randomised study

    NARCIS (Netherlands)

    Punt, Cornelis J. A.; Nagy, Attila; Douillard, Jean-Yves; Figer, Arie; Skovsgaard, Torben; Monson, John; Barone, Carlo; Fountzilas, George; Riess, Hanno; Moylan, Eugene; Jones, Delyth; Dethling, Juergen; Colman, Jessica; Coward, Lorna; Macgregor, Stuart

    2002-01-01

    Edrecolomab is a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, which is expressed on epithelial tissues and on various carcinomas. Preliminary data suggested that it might be of use in the adjuvant treatment of patients with resected stage III colon cancer. We did a randomised

  11. Edrecolomab alone or in combination with fluorouracil and folinic acid in the adjuvant treatment of stage III colon cancer: a randomised study.

    NARCIS (Netherlands)

    Punt, C.J.A.; Nagy, A.; Douillard, J.Y.; Figer, A.; Skovsgaard, T.; Monson, J.; Barone, C.; Fountzilas, G.; Riess, H.; Moylan, E.; Jones, D.; Dethling, J.; Colman, J.; Coward, L.; MacGregor, S.

    2002-01-01

    BACKGROUND: Edrecolomab is a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, which is expressed on epithelial tissues and on various carcinomas. Preliminary data suggested that it might be of use in the adjuvant treatment of patients with resected stage III colon cancer. We did a

  12. Concurrent administration of adjuvant chemotherapy and radiotherapy after breast-conserving surgery enhances late toxicities: Long-term results of the ARCOSEIN multicenter randomized study

    International Nuclear Information System (INIS)

    Toledano, Alain; Garaud, Pascal; Serin, Daniel; Fourquet, Alain; Bosset, Jean-Francois; Breteau, Noel; Body, Gilles; Azria, David; Le Floch, Olivier; Calais, Gilles

    2006-01-01

    Purpose: In 1996, a multicenter randomized study was initiated that compared sequential vs. concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) after breast-conserving surgery (ARCOSEIN study). After a median follow-up of 6.7 years (range, 4.3-9 years), we decided to prospectively evaluate the late effects of these 2 strategies. Methods and Materials: A total of 297 patients from the 5 larger participating institutions were asked to report for a follow-up examination. Seventy-two percent (214 patients) were eligible for evaluation of late toxicity. After breast-conserving surgery, patients were treated either with sequential treatment with CT first followed by RT (Arm A) or CT administered concurrently with RT (Arm B). In all patients, CT regimen consisted of mitoxantrone (12 mg/m 2 ), 5-FU (500 mg/m 2 ), and cyclophosphamide (500 mg/m 2 ), 6 cycles (Day 1 to Day 21). Conventional RT was delivered to the whole breast by administration of a 2 Gy per fraction protocol to a total dose of 50 Gy (± boost to the primary tumor bed). The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist, according to the LENT/SOMA scale. Skin pigmentation was also evaluated according to a personal 5-points scoring system (excellent, good, moderate, poor, very poor). Results: Among the 214 evaluable patients, 107 were treated in each arm. The 2 populations were homogeneous for patient, tumor, and treatment characteristics. Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in Arm B. No statistical difference was observed between the 2 arms of the study concerning Grade 2 or higher pain, breast edema, or lymphedema. No deaths were caused by late toxicity. Conclusion: After breast-conserving surgery, the concurrent use of CT with RT is significantly associated with an increase incidence of Grade 2 or greater late side effects

  13. A pilot clinical study of Class III surgical patients facilitated by improved accelerated osteogenic orthodontic treatments.

    Science.gov (United States)

    Wu, JiaQi; Jiang, Jiu-Hui; Xu, Li; Liang, Cheng; Bai, YunYang; Zou, Wei

    2015-07-01

    To evaluate if the improved accelerated osteogenic orthodontics (IAOO) procedure could speed Class III surgical patients' preoperative orthodontic treatment duration and, if yes, to what extent. This study was also designed to determine whether or not an IAOO procedure affects the tooth-moving pattern during extraction space closure. The samples in this study consisted of 24 Class III surgical patients. Twelve skeletal Class III surgery patients served as an experimental group (group 1) and the others as a control group (group 2). Before treatment, the maxillary first premolars were removed. For group 1, after the maxillary dental arch was aligned and leveled (T2), IAOO procedures were performed in the maxillary alveolar bone. Except for this IAOO procedure in group 1, all 24 patients experienced similar combined orthodontic and orthognathic treatment. Study casts of the maxillary dentitions were made before orthodontic treatment (T1) and after extraction space closure (T3). All of the casts were laser scanned, and the amount of movement of the maxillary central incisor, canine, and first molar, as well as arch widths, were digitally measured and analyzed by using the three-dimensional model superimposition method. The time durations T3-T2 were significantly reduced in group 1 by 8.65 ± 2.67 months and for T3-T1 were reduced by 6.39 ± 2.00 months (P teeth movement in the sagittal, vertical, and transverse dimensions between the two groups (P > .05). The IAOO can reduce the surgical orthodontic treatment time for the skeletal Class III surgical patient by more than half a year on average. The IAOO procedures do not save anchorage.

  14. Animal models of surgically manipulated flow velocities to study shear stress-induced atherosclerosis.

    Science.gov (United States)

    Winkel, Leah C; Hoogendoorn, Ayla; Xing, Ruoyu; Wentzel, Jolanda J; Van der Heiden, Kim

    2015-07-01

    Atherosclerosis is a chronic inflammatory disease of the arterial tree that develops at predisposed sites, coinciding with locations that are exposed to low or oscillating shear stress. Manipulating flow velocity, and concomitantly shear stress, has proven adequate to promote endothelial activation and subsequent plaque formation in animals. In this article, we will give an overview of the animal models that have been designed to study the causal relationship between shear stress and atherosclerosis by surgically manipulating blood flow velocity profiles. These surgically manipulated models include arteriovenous fistulas, vascular grafts, arterial ligation, and perivascular devices. We review these models of manipulated blood flow velocity from an engineering and biological perspective, focusing on the shear stress profiles they induce and the vascular pathology that is observed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Comparative study of 2 surgical techniques for castration of guinea pigs (Cavia porcellus).

    Science.gov (United States)

    Guilmette, Josée; Langlois, Isabelle; Hélie, Pierre; El Warrak, Alexander de Oliveira

    2015-10-01

    The objective of this study was to compare 2 surgical approaches (scrotal or abdominal) for castration of guinea pigs and to investigate post-operative infection rates with either technique. Forty-eight guinea pigs were castrated by scrotal or abdominal technique after being randomly assigned to 1 of 2 groups (n = 24). Individuals were either castrated by an experienced exotic animal surgeon (n = 12) or by an experienced small animal surgeon (n = 12). Surgical wounds were evaluated daily before euthanasia for histological evaluation 2 wks after surgery. Post-operative infection rate was significantly higher in the scrotal group than in the abdominal group, with a higher rate for the experienced small animal surgeon. Castration of guinea pigs with the abdominal technique is significantly faster and has a significantly lower post-operative infection rate than the scrotal technique.

  16. Impact of adjuvant chemotherapy for gliomatosis cerebri

    International Nuclear Information System (INIS)

    Kong, Doo-Sik; Nam, Do-Hyun; Kim, Sung Tae; Lee, Jung-Il; Suh, Yeon-Lim; Lim, Do Hoon; Kim, Won Seog; Kwon, Ki-Hoon; Park, Kwan; Kim, Jong Hyun

    2010-01-01

    Gliomatosis cerebri (GC) is characterized by a diffuse infiltration of tumor cells throughout CNS, however, few details are available about the chemotherapeutic effect on GC. The aim of this study was to investigate its clinical course and to determine the efficacy of chemotherapy for GC. Between Jan. 1999 and Dec. 2004, 37 GC patients were diagnosed by biopsy and treated with radiotherapy in a single institution. To determine the efficacy of chemotherapy for GC, we retrospectively reviewed their clinical courses. The study cohort was divided into 2 groups, those with and without receiving post-radiotherapy adjuvant chemotherapy such as temozolomide or nitrosourea-based chemotherapy. Nineteen patients with adjuvant chemotherapy were assigned to the chemotreatment group and 18 with radiotherapy alone were assigned to the control group. Mean survival for chemotreatment group and control group were 24.2 and 13.1 months, respectively (p = 0.045). Time to progression for these groups were 16.0 and 6.0 months, respectively (p = 0.007). Overall review of the clinical course of patients with GC provided that early appearance of new contrast-enhancing lesions within 6 months from the initial diagnosis and higher histological grade were closely associated with poor survival (p < 0.001 and p = 0.008). Adjuvant chemotherapy following radiotherapy could prolong the survival in patients with GC. In addition, newly developed contrast-enhanced lesions on the follow-up MR images indicate the progression of GC

  17. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair - A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Safety and Feasibility.

    Science.gov (United States)

    Greiner, Stefan; Ide, Junji; Van Noort, Arthur; Mochizuki, Yu; Ochi, Hiroshi; Marraffino, Shannon; Sridharan, Sudhakar; Rudicel, Sally; Itoi, Eiji

    2015-08-01

    Recombinant human bone morphogenetic protein-12 (rhBMP-12) has been shown to induce tendon and ligament formation in rats and to improve tendon healing; however, the safety and feasibility of implanting rhBMP-12/absorbable collagen sponge (ACS) in humans are not known. To investigate the safety and feasibility of rhBMP-12 on an ACS as an adjuvant therapy in open rotator cuff repair. Randomized controlled trial; Level of evidence, 2. This study consisted of 20 patients with full-thickness rotator cuff tears. Patients were randomized either to standard of care (SOC) treatment (open rotator cuff repair) or to receive 0.015 mg/mL rhBMP-12/ACS and SOC treatment during their open rotator cuff repair (rhBMP-12/ACS group) at a rate of 1/4 SOC/rhBMP-12/ACS. The feasibility of implanting the product and the safety of the product were evaluated during the 1-year follow-up period. The evaluation involved up to 10 postoperative visits, which included physical examinations, radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans with an emphasis on heterotopic ossification (HO), pharmacokinetics, immunogenicity, laboratory evaluations, and local and systemic adverse events at specified time points. Small amounts of HO were seen on follow-up CT scans in 10 of 16 patients in the rhBMP-12/ACS group and in 2 of 3 patients in the SOC group. HO did not increase at 26 weeks and was not associated with any adverse events or unsatisfactory clinical outcomes. Pharmacokinetics demonstrated that circulating levels of rhBMP-12 were not detectable after administration. Five of 16 patients showed a postoperative immunogenic response but did not show any correlating adverse events. Complete healing of the rotator cuff was observed in 14 of 16 patients; 2 of 16 imaging results could not be analyzed because of artifacts in the rhBMP-12 group on MRI scans. In the SOC group, 1 of 4 patients showed a retear at 12 weeks after surgery. The use of rhBMP-12/ACS has been shown

  18. Effect of surgical staging on 539 patients with borderline ovarian tumors: a Turkish Gynecologic Oncology Group study.

    Science.gov (United States)

    Guvenal, Tevfik; Dursun, Polat; Hasdemir, Pinar S; Hanhan, Merih; Guven, Suleyman; Yetimalar, Hakan; Goksedef, Behice P; Sakarya, Derya K; Doruk, Arzu; Terek, Mustafa C; Saatli, Bahadir; Guzin, Kadir; Corakci, Aydin; Deger, Emek; Celik, Husnu; Cetin, Ahmet; Ozsaran, Aydin; Ozbakkaloglu, Ayşe; Kolusari, Ali; Celik, Cetin; Keles, Refik; Sagir, Fulya G; Dilek, Saffet; Uslu, Turhan; Dikmen, Yilmaz; Altundag, Ozden; Ayhan, Ali

    2013-12-01

    The objectives of this study were to examine demographic and clinicopathologic characteristics and to determine the effects of primary surgery, surgical staging and the extensiveness of staging. In a retrospective Turkish multicenter study, 539 patients, from 14 institutions, with borderline ovarian tumors were investigated. Some of the demographic, clinical and surgical characteristics of the cases were evaluated. The effects of type of surgery, surgical staging; complete or incomplete staging on survival rates were calculated by using Kaplan-Meier method. The median age at diagnosis was 40 years (range 15-84) and 71.1% of patients were premenopausal. The most common histologic types were serous and mucinous. Majority of the staged cases were in Stage IA (73.5%). 242 patients underwent conservative surgery. Recurrence rates were significantly higher in conservative surgery group (8.3% vs. 3%). Of all patients in this study, 294 (54.5%) have undergone surgical staging procedures. Of the patients who underwent surgical staging, 228 (77.6%) had comprehensive staging including lymphadenectomy. Appendectomy was performed on 204 (37.8%) of the patients. The median follow-up time was 36 months (range 1-120 months). Five-year survival rate was 100% and median survival time was 120 months. Surgical staging, lymph node sampling or dissection and appendectomy didn't cause any difference on survival. Comprehensive surgical staging, lymph node sampling or dissection and appendectomy are not beneficial in borderline ovarian tumors surgical management. © 2013.

  19. Impact of External Beam Adjuvant Radiotherapy on Health-Related Quality of Life for Long-Term Survivors of Endometrial Adenocarcinoma: A Population-Based Study

    International Nuclear Information System (INIS)

    Poll-Franse, Lonneke V. van de; Mols, Floortje; Essink-Bot, Marie-Louise; Haartsen, Joke E.; Vingerhoets, Ad J.J.M.; Lybeert, Marnix L.M.; Berg, Hetty A. van den; Coebergh, Jan Willem W.

    2007-01-01

    Purpose: To compare the health-related quality of life (HRQOL) among 5-10-year survivors of Stage I-II endometrial (adeno-)carcinoma (EC) treated with surgery alone or surgery with external beam adjuvant radiotherapy (EBRT) and an age-matched norm population. Methods and Materials: A population-based, cross-sectional survey was conducted by the Eindhoven Cancer Registry. All patients were included who had been diagnosed with EC between 1994 and 1998 (n = 462). Information from the questionnaires returned was linked to data from the Eindhoven Cancer Registry on patient, tumor, and treatment characteristics. Results: Responses were received from 75% of the patients. The analyses were restricted to women with Stage I-II disease at diagnosis, treated with either surgery alone or surgery with adjuvant EBRT, and without recurrent disease or new primary malignancies (n = 264). The patients who had received adjuvant EBRT (n = 80) had had a significantly higher tumor stage and grade at diagnosis (p < 0.0001) and a longer mean time since diagnosis (p = 0.04). Age, number of comorbid diseases, current marital status, nulliparity, education, and occupation were similar for both treatment groups. On multivariate analyses, adjuvant EBRT was independently and negatively associated with the vitality and physical and social well-being scale scores. The HRQOL scores of both treatment groups, however, were similar to those of an age-matched norm population. Conclusion: In general, the HRQOL of EC survivors is good. EC survivors treated with surgery alone had a better HRQOL than women treated with surgery and adjuvant EBRT, although for both groups, the HRQOL was in the range of the norm population

  20. Post-surgical enterococcal meningitis: clinical and epidemiological study of 20 cases.

    Science.gov (United States)

    Guardado, Rodríguez; Asensi, V; Torres, J M; Pérez, F; Blanco, A; Maradona, J A; Cartón, J A

    2006-01-01

    Enterococcal post-surgical meningitis is an uncommon disease. 20 episodes of nosocomial post-surgical enterococcal meningitis diagnosed between 1994 and 2003 were retrospectively studied. During the period of study 20 cases of post-surgical enterococcal meningitis (60% female, mean age 55+/-18 y, range 16-78 y) were reviewed. The mean time between admission at the hospital and surgery was 26 (SD = 15) d (range 7-61 d). The most frequent underlying diseases were: intracerebral haemorrhage (55%), brain neoplasms (25%), head trauma (15%) and hydrocephalus (5%). 11 patients had previously received antibiotic treatment. The isolates identified were Enterococcus faecalis (n = 18) (90%), E. faecium (1) and E. durans (1). 11 patients had polymicrobial infections. The treatment most frequently used was vancomycin alone or with other antibiotics (11). In 5 patients intrathecal vancomycin (20 mg/d) was also added. The mortality rate was not different in intrathecally treated patients. Cerebrospinal fluid (CSF) devices were removed in 8 patients. Four patients died due to the infection. Mortality was significantly associated with lack of removal of the CSF devices (p = 0.04). Enterococcal spp. are a cause of nosocomial meningitis associated with neurosurgical procedures and the presence of neurological devices.

  1. Characteristics of the patients undergoing surgical treatment for pneumothorax: A descriptive study.

    Science.gov (United States)

    Cakmak, Muharrem; Yuksel, Melih; Kandemir, Mehmet Nail

    2016-05-01

    To identify the characteristic features of pneumothorax patients treated surgically. The retrospective study was conducted at Gazi Yasargil Education and Research Hospital Thoracic Surgery Clinic, Diyarbakir, Turkey and comprised records of pneumothorax patients from January 2004 to December 2014. They were divided into two groups as spontaneous and traumatic. Patients who had not undergone any surgical intervention were excluded. Mean age, gender distribution, location of the disease, type of pneumothorax, and treatment method were noted. Among patients with spontaneous pneumothorax, age and months distribution, smoking habits, pneumothorax size, and treatment method were assessed. The effect of gender, location, comorbid disease, smoking, subgroup of disease, and pneumothorax size on surgical procedures were also investigated. The mean age of the 672 patients in the study was 34.5±6.17 years. There were 611(91%) men and 61(9%) women. Disease was on the right side in 360(53.6%) patients, on the left side in 308(45.8%), and bilateral in 4(0.59%). Besides, 523(77.8%) patients had spontaneous, and 149(22.7%) had traumatic pneumothorax. Overall, 561(83.5%) patients had been treated with tube thoracostomy, whereas 111(16.5%) were treated with thoracotomy/thoracoscopic surgery. The presence of comorbid diseases, being primary, and being total or subtotal according to partial were found to create predisposition to thoracotomy/ thoracoscopic surgery (ppneumothorax being total, the presence of comorbid diseases, and the increase in pneumothorax size, thoracotomy or thoracoscopic surgery is preferred.

  2. A randomised phase II study of sialyl-Tn and DETOX-B adjuvant with or without cyclophosphamide pretreatment for the active specific immunotherapy of breast cancer.

    Science.gov (United States)

    Miles, D W; Towlson, K E; Graham, R; Reddish, M; Longenecker, B M; Taylor-Papadimitriou, J; Rubens, R D

    1996-10-01

    Studies in animal models of mouse mammary carcinoma have shown that ovine submaxillary mucin, which carries multiple sialyl-Tn (STn) epitopes, is effective in stimulating an immune response and inhibiting tumour growth. In similar studies using carbohydrate antigens, pretreatment with low-dose cyclophosphamide has been shown to be important in modulating the immune response to antigen possibly by inhibiting suppresser T-cell activity. In a clinical trial assessing the efficacy and toxicity of synthetic STn, patients with metastatic breast cancer were randomised to receive 100 micrograms STn linked to keyhole limpet haemocyanin (KLH) with DETOX-B adjuvant given by subcutaneous injection at weeks 0, 2, 5 and 9 with or without low-dose cyclophosphamide (CTX, 300 mg m-2) pretreatment, 3 days before the start of immunotherapy. Patients with responding or stable disease after the first four injections were eligible to receive STn-KLH at 4 week intervals. The main toxicity noted was the development of subcutaneous granulomata at injection sites. Of 23 patients randomised, 18 received four injections, 5 patients having developed progressive disease during the initial 12 week period. Two minor responses were noted in the 18 patients who received four active specific immunotherapy (ASI) injections and a further five patients had stable disease. Six patients continued ASI at 4 week intervals and a partial response was noted in a patient who had previously had stable disease. All patients developed IgG and IgM responses to sialyl-Tn and levels of IgM antibodies were significantly higher in those patients who were pretreated with CTX. Measurable tumour responses have been recorded following ASI with STn-KLH plus DETOX and the immunomodulatory properties of low-dose CTX have been confirmed.

  3. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study

    International Nuclear Information System (INIS)

    Groot, Stefanie de; Vreeswijk, Maaike PG; Welters, Marij JP; Gravesteijn, Gido; Boei, Jan JWA; Jochems, Anouk; Houtsma, Daniel; Putter, Hein; Hoeven, Jacobus JM van der; Nortier, Johan WR; Pijl, Hanno; Kroep, Judith R

    2015-01-01

    Preclinical evidence shows that short-term fasting (STF) protects healthy cells against side effects of chemotherapy and makes cancer cells more vulnerable to it. This pilot study examines the feasibility of STF and its effects on tolerance of chemotherapy in a homogeneous patient group with early breast cancer (BC). Eligible patients had HER2-negative, stage II/III BC. Women receiving (neo)-adjuvant TAC (docetaxel/doxorubicin/cyclophosphamide) were randomized to fast 24 h before and after commencing chemotherapy, or to eat according to the guidelines for healthy nutrition. Toxicity in the two groups was compared. Chemotherapy-induced DNA damage in peripheral blood mononuclear cells (PBMCs) was quantified by the level of γ-H2AX analyzed by flow cytometry. Thirteen patients were included of whom seven were randomized to the STF arm. STF was well tolerated. Mean erythrocyte- and thrombocyte counts 7 days post-chemotherapy were significantly higher (P = 0.007, 95 % CI 0.106-0.638 and P = 0.00007, 95 % CI 38.7-104, respectively) in the STF group compared to the non-STF group. Non-hematological toxicity did not differ between the groups. Levels of γ-H2AX were significantly increased 30 min post-chemotherapy in CD45 + CD3- cells in non-STF, but not in STF patients. STF during chemotherapy was well tolerated and reduced hematological toxicity of TAC in HER2-negative BC patients. Moreover, STF may reduce a transient increase in, and/or induce a faster recovery of DNA damage in PBMCs after chemotherapy. Larger studies, investigating a longer fasting period, are required to generate more insight into the possible benefits of STF during chemotherapy. ClinicalTrials.gov: NCT01304251, March 2011

  4. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study.

    Science.gov (United States)

    de Groot, Stefanie; Vreeswijk, Maaike P G; Welters, Marij J P; Gravesteijn, Gido; Boei, Jan J W A; Jochems, Anouk; Houtsma, Daniel; Putter, Hein; van der Hoeven, Jacobus J M; Nortier, Johan W R; Pijl, Hanno; Kroep, Judith R

    2015-10-05

    Preclinical evidence shows that short-term fasting (STF) protects healthy cells against side effects of chemotherapy and makes cancer cells more vulnerable to it. This pilot study examines the feasibility of STF and its effects on tolerance of chemotherapy in a homogeneous patient group with early breast cancer (BC). Eligible patients had HER2-negative, stage II/III BC. Women receiving (neo)-adjuvant TAC (docetaxel/doxorubicin/cyclophosphamide) were randomized to fast 24 h before and after commencing chemotherapy, or to eat according to the guidelines for healthy nutrition. Toxicity in the two groups was compared. Chemotherapy-induced DNA damage in peripheral blood mononuclear cells (PBMCs) was quantified by the level of γ-H2AX analyzed by flow cytometry. Thirteen patients were included of whom seven were randomized to the STF arm. STF was well tolerated. Mean erythrocyte- and thrombocyte counts 7 days post-chemotherapy were significantly higher (P = 0.007, 95 % CI 0.106-0.638 and P = 0.00007, 95 % CI 38.7-104, respectively) in the STF group compared to the non-STF group. Non-hematological toxicity did not differ between the groups. Levels of γ-H2AX were significantly increased 30 min post-chemotherapy in CD45 + CD3- cells in non-STF, but not in STF patients. STF during chemotherapy was well tolerated and reduced hematological toxicity of TAC in HER2-negative BC patients. Moreover, STF may reduce a transient increase in, and/or induce a faster recovery of DNA damage in PBMCs after chemotherapy. Larger studies, investigating a longer fasting period, are required to generate more insight into the possible benefits of STF during chemotherapy. ClinicalTrials.gov: NCT01304251 , March 2011.

  5. Unfavorable surgical outcomes in partial epilepsy with secondary bilateral synchrony: Intracranial electroencephalography study.

    Science.gov (United States)

    Sunwoo, Jun-Sang; Byun, Jung-Ick; Moon, Jangsup; Lim, Jung-Ah; Kim, Tae-Joon; Lee, Soon-Tae; Jung, Keun-Hwa; Park, Kyung-Il; Chu, Kon; Kim, Manho; Chung, Chun-Kee; Jung, Ki-Young; Lee, Sang Kun

    2016-05-01

    Secondary bilateral synchrony (SBS) indicates bilaterally synchronous epileptiform discharges arising from a focal cortical origin. The present study aims to investigate SBS in partial epilepsy with regard to surgical outcomes and intracranial EEG findings. We retrospectively reviewed consecutive patients who underwent epilepsy surgery following extraoperative intracranial electroencephalography (EEG) study from 2008 to 2012. The presence of SBS was determined based upon the results of scalp EEG monitoring performed for presurgical evaluations. We reviewed scalp EEG, neuroimaging, intracranial EEG findings, and surgical outcomes in patients with SBS. We found 12 patients with SBS who were surgically treated for intractable partial epilepsy. Nine (75%) patients had lateralized ictal semiology and only two (16.6%) patients showed localized ictal onset in scalp EEG. Brain MRI showed epileptogenic lesion in three (25%) patients. Intracranial EEG demonstrated that ictal onset zone was widespread or non-localized in six (50%) patients. Low-voltage fast activity was the most common ictal onset EEG pattern. Rapid propagation of ictal onset was noted in 10 (83.3%) patients. Eleven patients underwent resective epilepsy surgery and only two patients (18.2%) achieved seizure-freedom (median follow-up 56 months). MRI-visible brain lesions were associated with favorable outcomes (p=0.024). Patients with SBS, compared to frontal lobe epilepsy without SBS, showed lesser localization in ictal onset EEG (p=0.029) and more rapid propagation during evolution of ictal rhythm (p=0.015). The present results suggested that resective surgery for partial epilepsy with SBS should be decided carefully, especially in case of nonlesional epilepsy. Poor localization and rapid spread of ictal onset were prominent in intracranial EEG, which might contribute to incomplete resection of the epileptogenic zone and poor surgical outcomes. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. The clinical outcomes of surgical treatment of noncontiguous spinal tuberculosis: a retrospective study in 23 cases.

    Directory of Open Access Journals (Sweden)

    Jia Huang

    Full Text Available STUDY DESIGN: A retrospective clinical study. OBJECTIVE: To evaluate the clinical efficacy of the surgical treatment of noncontiguous spinal tuberculosis (NSTB, and to discuss its therapeutic strategies. METHODS: We performed a retrospective review of clinical and radiographic data that were prospectively collected on 550 consecutive spinal tubercular patients including 27 patients who were diagnosed and treated as NSTB in our institution from June 2005 to June 2011. Apart from 4 patients being treated conservatively, the remainder received surgery by posterior transforaminal debridement, interbody fusion with instrumentation, posterior instrumentation and anterior debridement with fusion in a single or two-stage operation. The clinical outcomes were evaluated before and after treatment in terms of hematologic and radiographic examinations, bone fusion and neurologic status. The Oswestry Disability Index score was determined before treatment and at the last follow-up visit. RESULTS: 23 patients (15 M/8F, averaged 44.6 ± 14.2 years old (range, 19 to 70 yd, who received surgical treatment, were followed up after surgery for a mean of 52.5 ± 19.5 months (range, 24 to 72 months. The kyphotic angle was changed significantly between pre- and postoperation (P<0.05. The mean amount of correction was 12.6 ± 7.2 degrees, with a small loss of correction at last follow-up. All patients achieved solid bone fusion. No patients with neurological deficit deteriorated postoperatively. Neither mortalities nor any major complications were found. There was a significant difference of Oswestry Disability Index scores between preoperation and the final follow-up. CONCLUSION: The outcomes of follow-up showed that posterior and posterior-anterior surgical treatment methods were both viable surgical options for NSTB. Posterior transforaminal debridement, interbody fusion and posterior instrumentation, as a less invasive technique, was feasible and effective to treat

  7. Surgical volume and conversion rate in laparoscopic hysterectomy: does volume matter? A multicenter retrospective cohort study.

    Science.gov (United States)

    Keurentjes, José H M; Briët, Justine M; de Bock, Geertruida H; Mourits, Marian J E

    2018-02-01

    A multicenter, retrospective, cohort study was conducted in the Netherlands. The aim was to evaluate whether surgical volume of laparoscopic hysterectomies (LHs) performed by proven skilled gynecologists had an impact on the conversion rate from laparoscopy to laparotomy. In 14 hospitals, all LHs performed by 19 proven skilled gynecologists between 2007 and 2010 were included in the analysis. Surgical volume, conversion rate and type of conversion (reactive or strategic) were retrospectively assessed. To estimate the impact of surgical volume on the conversion rate, logistic regressions were performed. These regressions were adjusted for patient's age, Body Mass Index (BMI), ASA classification, previous abdominal surgery and the indication (malignant versus benign) for the LH. During the study period, 19 proven skilled gynecologists performed a total of 1051 LHs. Forty percent of the gynecologists performed over 20 LHs per year (median 17.3, range 5.4-49.5). Conversion to laparotomy occurred in 5.0% of all LHs (53 of 1051); 38 (3.6%) were strategic and 15 (1.4%) were reactive conversions. Performing over 20 LHs per year was significantly associated with a lower overall conversion rate (OR adjusted 0.43, 95% CI 0.24-0.77), a lower strategic conversion rate (OR adjusted 0.32, 95% CI 0.16-0.65), but not with a lower reactive conversion rate (OR adjusted 0.96, 95% CI 0.33-2.79). A higher annual surgical volume of LHs by proven skilled gynecologists is inversely related to the conversion rate to laparotomy, and results in a lower strategic conversion rate.

  8. Adaptation and innovation: a grounded theory study of procedural variation in the academic surgical workplace.

    Science.gov (United States)

    Apramian, Tavis; Watling, Christopher; Lingard, Lorelei; Cristancho, Sayra

    2015-10-01

    Surgical research struggles to describe the relationship between procedural variations in daily practice and traditional conceptualizations of evidence. The problem has resisted simple solutions, in part, because we lack a solid understanding of how surgeons conceptualize and interact around variation, adaptation, innovation, and evidence in daily practice. This grounded theory study aims to describe the social processes that influence how procedural variation is conceptualized in the surgical workplace. Using the constructivist grounded theory methodology, semi-structured interviews with surgeons (n = 19) from four North American academic centres were collected and analysed. Purposive sampling targeted surgeons with experiential knowledge of the role of variations in the workplace. Theoretical sampling was conducted until a theoretical framework representing key processes was conceptually saturated. Surgical procedural variation was influenced by three key processes. Seeking improvement was shaped by having unsolved procedural problems, adapting in the moment, and pursuing personal opportunities. Orienting self and others to variations consisted of sharing stories of variations with others, taking stock of how a variation promoted personal interests, and placing trust in peers. Acting under cultural and material conditions was characterized by being wary, positioning personal image, showing the logic of a variation, and making use of academic resources to do so. Our findings include social processes that influence how adaptations are incubated in surgical practice and mature into innovations. This study offers a language for conceptualizing the sociocultural influences on procedural variations in surgery. Interventions to change how surgeons interact with variations on a day-to-day basis should consider these social processes in their design. © 2015 John Wiley & Sons, Ltd.

  9. Effectiveness of the Thoracic Pedicle Screw Placement Using the Virtual Surgical Training System: A Cadaver Study.

    Science.gov (United States)

    Hou, Yang; Lin, Yanping; Shi, Jiangang; Chen, Huajiang; Yuan, Wen

    2018-03-14

    The virtual simulation surgery has initially exhibited its promising potentials in neurosurgery training. To evaluate effectiveness of the Virtual Surgical Training System (VSTS) on novice residents placing thoracic pedicle screws in a cadaver study. A total of 10 inexperienced residents participated in this study and were randomly assigned to 2 groups. The group using VSTS to learn thoracic pedicle screw fixation was the simulation training (ST) group and the group receiving an introductory teaching session was the control group. Ten fresh adult spine specimens including 6 males and 4 females with a mean age of 58.5 yr (range: 33-72) were collected and randomly allocated to the 2 groups. After exposing anatomic structures of thoracic spine, the bilateral pedicle screw placement of T6-T12 was performed on each cadaver specimen. The postoperative computed tomography scan was performed on each spine specimen, and experienced observers independently reviewed the placement of the pedicle screws to assess the incidence of pedicle breach. The screw penetration rates of the ST group (7.14%) was significantly lower in comparison to the control group (30%, P < .05). Statistically significant difference in acceptable rates of screws also occurred between the ST (100%) and control (92.86%) group (P < .05). In addition, the average screw penetration distance in control group (2.37 mm ± 0.23 mm) was significantly greater than ST group (1.23 mm ± 0.56 mm, P < .05). The virtual reality surgical training of thoracic pedicle screw instrumentation effectively improves surgical performance of novice residents compared to those with traditional teaching method, and can help new beginners to master the surgical technique within shortest period of time.

  10. Learning impairment in honey bees caused by agricultural spray adjuvants.

    Directory of Open Access Journals (Sweden)

    Timothy J Ciarlo

    Full Text Available BACKGROUND: Spray adjuvants are often applied to crops in conjunction with agricultural pesticides in order to boost the efficacy of the active ingredient(s. The adjuvants themselves are largely assumed to be biologically inert and are therefore subject to minimal scrutiny and toxicological testing by regulatory agencies. Honey bees are exposed to a wide array of pesticides as they conduct normal foraging operations, meaning that they are likely exposed to spray adjuvants as well. It was previously unknown whether these agrochemicals have any deleterious effects on honey bee behavior. METHODOLOGY/PRINCIPAL FINDINGS: An improved, automated version of the proboscis extension reflex (PER assay with a high degree of trial-to-trial reproducibility was used to measure the olfactory learning ability of honey bees treated orally with sublethal doses of the most widely used spray adjuvants on almonds in the Central Valley of California. Three different adjuvant classes (nonionic surfactants, crop oil concentrates, and organosilicone surfactants were investigated in this study. Learning was impaired after ingestion of 20 µg organosilicone surfactant, indicating harmful effects on honey bees caused by agrochemicals previously believed to be innocuous. Organosilicones were more active than the nonionic adjuvants, while the crop oil concentrates were inactive. Ingestion was required for the tested adjuvant to have an effect on learning, as exposure via antennal contact only induced no level of impairment. CONCLUSIONS/SIGNIFICANCE: A decrease in percent conditioned response after ingestion of organosilicone surfactants has been demonstrated here for the first time. Olfactory learning is important for foraging honey bees because it allows them to exploit the most productive floral resources in an area at any given time. Impairment of this learning ability may have serious implications for foraging efficiency at the colony level, as well as potentially many

  11. A potent steroid cream is superior to emollients in reducing acute radiation dermatitis in breast cancer patients treated with adjuvant radiotherapy. A randomised study of betamethasone versus two moisturizing creams

    International Nuclear Information System (INIS)

    Ulff, Eva; Maroti, Marianne; Serup, Jörgen; Falkmer, Ursula

    2013-01-01

    Background and purpose: The aim was to investigate whether treatment with potent local steroids can reduce signs and symptoms of acute radiation dermatitis in breast cancer patients undergoing adjuvant radiotherapy (RT) compared to emollient creams. Material and methods: The study was randomised and double-blinded. Patients with breast cancer who had undergone mastectomy or breast-conserving surgery were included when they started adjuvant 3-D planned RT. In all, 104 patients were randomised 2:1:1 to three treatment groups, i.e. betamethasone + Essex® cream, Essex® cream or Canoderm® cream. The patients themselves treated the irradiated area during the radiation period (5 weeks) and two weeks after cessation of RT. Signs of RT dermatitis were measured qualitatively with RTOG clinical scoring and quantitatively by colorimeter. In addition, the patients’ symptoms were recorded as well as the Fitzpatrick skin type. There was a statistically significant difference (p = 0.05) in skin reactions when assessed with RTOG in favour of the group treated with the potent steroid. Patient-related symptoms did not differ between the treatment groups. The effect of the steroid was prominent in three subgroups, i.e. (i) patients treated with ablation of the breast, (ii) patients receiving RT to the armpit and the supraclavicular fossa, and (iii) patients with Fitzpatrick skin type 1. Conclusions: Treatment with betamethasone cream is more efficient than moisturizers for the control of acute RT dermatitis in patients treated with adjuvant RT for breast cancer

  12. Adjuvant radiotherapy for stage I endometrial cancer.

    Science.gov (United States)

    Kong, A; Johnson, N; Cornes, P; Simera, I; Collingwood, M; Williams, C; Kitchener, H

    2007-04-18

    The role of adjuvant radiotherapy (both pelvic external beam radiotherapy and vaginal intracavity brachytherapy) in stage I endometrial cancer following total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH and BSO) remains unclear. To assess the efficacy of adjuvant radiotherapy following surgery for stage I endometrial cancer. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CancerLit, Physician Data Query (PDQ) of National Cancer Institute. Handsearching was also carried out where appropriate. Randomised controlled trials (RCTs) which compared adjuvant radiotherapy versus no radiotherapy following surgery for patients with stage I endometrial cancer were included. Quality of the studies was assessed and data collected using a predefined data collection form. The primary endpoint was overall survival. Secondary endpoints were locoregional recurrence, distant recurrence and endometrial cancer death. Data on quality of life (QOL) and morbidity were also collected. A meta-analysis on included trials was performed using the Cochrane Collaboration Review Manager Software 4.2. The meta-analysis was performed on four trials (1770 patients). The addition of pelvic external beam radiotherapy to surgery reduced locoregional recurrence, a relative risk (RR) of 0.28 (95% confidence interval (CI) 0.17 to 0.44, p ASTEC; Lukka) are awaited. External beam radiotherapy carries a risk of toxicity and should be avoided in stage 1 endometrial cancer patients with no high risk factors.

  13. Collagen gel droplet-embedded culture drug sensitivity test for adjuvant chemotherapy after complete resection of non-small-cell lung cancer.

    Science.gov (United States)

    Inoue, Masayoshi; Maeda, Hajime; Takeuchi, Yukiyasu; Fukuhara, Kenjiro; Shintani, Yasushi; Funakoshi, Yasunobu; Funaki, Soichiro; Nojiri, Takashi; Kusu, Takashi; Kusumoto, Hidenori; Kimura, Toru; Okumura, Meinoshin

    2018-04-01

    We conducted a prospective clinical study to individualize adjuvant chemotherapy after complete resection of non-small-cell lung cancer (NSCLC), based on the drug sensitivity test. Patients with resectable c-stage IB-IIIA NSCLC were registered between 2005 and 2010. We performed the collagen gel droplet-embedded culture drug sensitivity test (CD-DST) on a fresh surgical specimen to assess in vitro chemosensitivity and evaluated the prognostic outcome after adjuvant chemotherapy with carboplatin/paclitaxel based on the CD-DST. Among 92 registered patients, 87 were eligible for inclusion in the analysis. The success rate of CD-DST was 86% and chemosensitivity to carboplatin and/or paclitaxel was evident in 57 (76%) of the 75 patients. Adjuvant chemotherapy was completed in 22 (73%) of 30 patients. The 5-year overall survival rates were 71, 73, and 75% for all, CD-DST success, and chemosensitive patients, respectively. The 5-year disease-free survival and overall survival rates of the chemosensitive patients who completed adjuvant chemotherapy using carboplatin/paclitaxel were 68 and 82%, respectively. The 5-year disease-free survival and overall survival rates of the patients with stage II-IIIA chemosensitive NSCLC were 58 and 75%, respectively. Comparative analyses of the chemosensitive and non-chemosensitive/CD-DST failure groups showed no significant survival difference. CD-DST can be used to evaluate chemosensitivity after lung cancer surgery; however, its clinical efficacy for assessing individualized treatment remains uncertain.

  14. Using Qualitative Comparative Analysis (QCA) of Key Informant Interviews in Health Services Research: Enhancing a Study of Adjuvant Therapy Use in Breast Cancer Care

    Science.gov (United States)

    McAlearney, Ann Scheck; Walker, Daniel; Moss, Alexandra DeNardis; Bickell, Nina A.

    2015-01-01

    Background Qualitative Comparative Analysis (QCA) is a methodology created to address causal complexity in social sciences research by preserving the objectivity of quantitative data analysis without losing detail inherent in qualitative research. However, its use in health services research (HSR) is limited, and questions remain about its application in this context. Objective To explore the strengths and weaknesses of using QCA for HSR. Research Design Using data from semi-structured interviews conducted as part of a multiple case study about adjuvant treatment underuse among underserved breast cancer patients, findings were compared using qualitative approaches with and without QCA to identify strengths, challenges, and opportunities presented by QCA. Subjects Ninety administrative and clinical key informants interviewed across ten NYC area safety net hospitals. Measures Transcribed interviews were coded by three investigators using an iterative and interactive approach. Codes were calibrated for QCA, as well as examined using qualitative analysis without QCA. Results Relative to traditional qualitative analysis, QCA strengths include: (1) addressing causal complexity, (2) results presentation as pathways as opposed to a list, (3) identification of necessary conditions, (4) the option of fuzzy-set calibrations, and (5) QCA-specific parameters of fit that allow researchers to compare outcome pathways. Weaknesses include: (1) few guidelines and examples exist for calibrating interview data, (2) not designed to create predictive models, and (3) unidirectionality. Conclusions Through its presentation of results as pathways, QCA can highlight factors most important for production of an outcome. This strength can yield unique benefits for HSR not available through other methods. PMID:26908085

  15. Does Concurrent Radiochemotherapy Affect Cosmetic Results in the Adjuvant Setting After Breast-Conserving Surgery? Results of the ARCOSEIN Multicenter, Phase III Study: Patients' and Doctors' Views

    International Nuclear Information System (INIS)

    Toledano, Alain H.; Bollet, Marc A.; Fourquet, Alain; Azria, David; Gligorov, Joseph; Garaud, Pascal; Serin, Daniel; Bosset, Jean-Francois; Miny-Buffet, Joelle; Favre, Anne; Le Foch, Olivier; Calais, Gilles

    2007-01-01

    Purpose: To evaluate the cosmetic results of sequential vs. concurrent adjuvant chemotherapy with radiotherapy after breast-conserving surgery for breast cancer, and to compare ratings by patients and physicians. Methods and Materials: From 1996 to 2000, 716 patients with Stage I-II breast cancers were included in a multicenter, Phase III trial (the ARCOSEIN study) comparing, after breast-conserving surgery with axillary dissection, sequential treatment with chemotherapy first followed by radiotherapy vs. chemotherapy administered concurrently with radiotherapy. Cosmetic results with regard to both the overall aspect of the breast and specific changes (color, scar) were evaluated in a total of 214 patients (107 in each arm) by means of questionnaires to both the patient and a physician whose rating was blinded to treatment allocation. Results: Patients' overall satisfaction with cosmesis was not statistically different between the two arms, with approximately 92% with at least satisfactory results (p = 0.72), although differences between the treated and untreated breasts were greater after the concurrent regimen (29% vs. 14% with more than moderate differences; p 0.0015). Physician assessment of overall cosmesis was less favorable, with lower rates of at least satisfactory results in the concurrent arm (60% vs. 85%; p = 0.001). Consequently, the concordance for overall satisfaction with cosmesis between patients and doctors was only fair (κ = 0.62). Conclusion: After breast-conserving surgery, the concurrent use of chemotherapy with radiotherapy is significantly associated with greater differences between the breasts. These differences do not translate into patients' lessened satisfaction with cosmesis

  16. Cost-effectiveness analysis of an 18-week exercise programme for patients with breast and colon cancer undergoing adjuvant chemotherapy: the randomised PACT study.

    Science.gov (United States)

    May, Anne M; Bosch, Marcel J C; Velthuis, Miranda J; van der Wall, Elsken; Steins Bisschop, Charlotte N; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J; de Roos, Marnix A J; Verhaar, Marlies; Ten Bokkel Huinink, Daan; Peeters, Petra H M; de Wit, G Ardine

    2017-03-06

    Meta-analyses show that exercise interventions during cancer treatment reduce cancer-related fatigue. However, little is known about the cost-effectiveness of such interventions. Here we aim to assess the cost-effectiveness of the 18-week physical activity during cancer treatment (PACT) intervention for patients with breast and colon cancer. The PACT trial showed beneficial effects for fatigue and physical fitness. Cost-effectiveness analyses with a 9-month time horizon (18 weeks of intervention and 18 weeks of follow-up) within the randomised controlled multicentre PACT study. Outpatient clinics of 7 hospitals in the Netherlands (1 academic and 6 general hospitals) PARTICIPANTS: 204 patients with breast cancer and 33 with colon cancer undergoing adjuvant treatment including chemotherapy. Supervised 1-hour aerobic and resistance exercise (twice per week for 18 weeks) or usual care. Costs, quality-adjusted life years (QALY) and the incremental cost-effectiveness ratio. For colon cancer, the cost-effectiveness analysis showed beneficial effects of the exercise intervention with incremental costs savings of €4321 and QALY improvements of 0.03. 100% of bootstrap simulations indicated that the intervention is dominant (ie, cheaper and more effective). For breast cancer, the results did not indicate that the exercise intervention was cost-effective. Incremental costs were €2912, and the incremental effect was 0.01 QALY. At a Dutch threshold value of €20 000 per QALY, the probability that the intervention is cost-effective was 2%. Our results suggest that the 18-week exercise programme was cost-effective for colon cancer, but not for breast cancer. ISRCTN43801571. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. Value of adjuvant misonidazole in the definitive irradiation of advanced head and neck squamous cancer: an RTOG pilot study (78-02)

    International Nuclear Information System (INIS)

    Fazekas, J.T.; Goodman, R.L.; McLean, C.J.

    1981-01-01

    This RTOG Phase II trial was instituted to determine the toxicity and potential value of the electron-affinic agent, Misonidazole, adjunctive to definitive radiotherapy of T3 and T4 squamous cancers of the oral cavity, oropharynx, or hypopharynx. The fractionation schema was altered to deliver two separate treatments (250 rad and 210 rad) on each day when Misonidazole was administered, while maintaining relatively ''standard'' fractionation (5 fractions and 1000 rad per week). In order to achieve effective enhancement while minimizing toxicity, Misonidazole doses were limited to 2.5 gm/m 2 once per week, not to exceed 24 gm total cumulative in 6 weeks. The dosage was reduced to 2.0 gm/m 2 /wk after the first 30 patients were entered. Among the 50 patients entered, toxicity was confined to the nervous system, with one-third of the patients experiencing mild or moderate peripheral neuropathies and an equal number developing nausea and/or vomiting following p.o. drug administration. Encephalopathy occurred in 10% of the 30 patients receiving 2.5 mg/m 2 dosage. Serum drug levels and cumulative Misonidazole doses did not correlate well with toxicity or response except in comparison of the ''no response'' to the ''complete response'' categories. Immediate mucosal and skin reactions were not enhanced and unusual late normal tissue effects were not encountered. Complete disappearance of all visible and palpable primary tumor was noted in 67% of the 36 patients who completed the adjuvant sensitizer program. Tumor response and survival did not generally correlate with measured (serum) Misonidazole concentration; recurrence was also independent of these measured levels. These preliminary results seemed sufficiently encouraging to warrant a Phase III (randomized) study, now underway by the RTOG

  18. Improvisation versus guideline concordance in surgical antibiotic prophylaxis: a qualitative study.

    Science.gov (United States)

    Broom, Jennifer; Broom, Alex; Kirby, Emma; Post, Jeffrey J

    2018-05-28

    Surgical antibiotic prophylaxis (SAP) is a common area of antimicrobial misuse. The aim of this study was to explore the social dynamics that influence the use of SAP. 20 surgeons and anaesthetists from a tertiary referral hospital in Australia participated in semi-structured interviews focusing on experiences and perspectives on SAP prescribing. Interview data were analysed using the framework approach. Systematic analysis of the participants' account of the social factors influencing SAP revealed four themes. First, antibiotic prophylaxis is treated as a low priority with the competing demands of the operating theatre environment. Second, whilst guidelines have increased in prominence in recent years, there exists a lack of confidence in their ability to protect the surgeon from responsibility for infectious complications (thus driving SAP over-prescribing). Third, non-concordance prolonged duration of SAP is perceived to be driven by benevolence for the individual patient. Finally, improvisation with novel SAP strategies is reported as ubiquitous, and acknowledged to confer a sense of reassurance to the surgeon despite potential non-concordance with guidelines or clinical efficacy. Surgical-specific concerns have thus far not been meaningfully integrated into antimicrobial stewardship (AMS) programmes, including important dynamics of confidence, trust and mitigating fear of adverse infective events. Surgeons require specific forms of AMS support to enact optimisation, including support for strong collaborative ownership of the surgical risk of infection, and intra-specialty (within surgical specialties) and inter-specialty (between surgery, anaesthetics and infectious diseases) intervention strategies to establish endorsement of and address barriers to guideline implementation.

  19. Diagnosis and surgical approach of popliteal artery entrapment syndrome: a retrospective study

    Directory of Open Access Journals (Sweden)

    Stavros Gourgiotis

    2008-02-01

    Full Text Available Stavros Gourgiotis1, John Aggelakas1, Nikolaos Salemis1, Charalabos Elias2, Charalabos Georgiou11Second Surgical Department, 401 General Army Hospital of Athens, Greece; 2Second Surgical Department, 417 NIMTS Veterans General Hospital of Athens, GreeceBackground: Popliteal artery entrapment syndrome (PAES is a rare but potentially limb threatening peripheral vascular disease occurring predominantly in young adults. This study is a retrospective review of 49 limbs in 38 patients with PAES treated surgically over an 8-year period.Patients and methods: From 1995 to 2002, 38 patients with a mean age of 21 years (range, 18–29 years underwent surgery for PAES at a single institution. The patients’ demographic data and clinical features are recorded. The preoperative diagnosis of PAES was made based on various combinations of investigations including positional stress test, duplex ultrasonography, computed tomography, computed tomographic angiography, and angiography. Results: Nine, 33, and 7 patients had Delaney’s type I, II, and III PAES respectively. The surgical procedures consisted of simple release of the popliteal artery in 33 limbs (67.3%, autogenous saphenous vein (ASV patch angioplasty with or without thromboendarterectomy (TEA in 5 limbs (10.2% and ASV graft interposition or bypass in 11 limbs (22.5%. At a median follow up of 34 months (range, 8–42 months, there were no postoperative complications and all the patients were cured of their symptoms.Conclusions: PAES is an unusual but important cause of peripheral vascular insufficiency especially in young patients. Early diagnosis through a combined approach is necessary for exact diagnosis. Popliteal artery release alone or with vein bypass is the treatment of choice when intervention is indicated for good operative outcome and to prevent limb loss.Keywords: popliteal artery, entrapment syndrome, diagnosis, surgery, treatment

  20. Study of the standard direct costs of various techniques of advanced endoscopy. Comparison with surgical alternatives.

    Science.gov (United States)

    Loras, Carme; Mayor, Vicenç; Fernández-Bañares, Fernando; Esteve, Maria

    2018-03-12

    The complexity of endoscopy has carried out an increase in cost that has a direct effect on the healthcare systems. However, few studies have analyzed the cost of advanced endoscopic procedures (AEP). To carry out a calculation of the standard direct costs of AEP, and to make a financial comparison with their surgical alternatives. Calculation of the standard direct cost in carrying out each procedure. An endoscopist detailed the time, personnel, materials, consumables, recovery room time, stents, pathology and medication used. The cost of surgical procedures was the average cost recorded in the hospital. Thirty-eight AEP were analyzed. The technique showing lowest cost was gastroscopy + APC (€116.57), while that with greatest cost was ERCP with cholangioscopy + stent placement (€5083.65). Some 34.2% of the procedures registered average costs of €1000-2000. In 57% of cases, the endoscopic alternative was 2-5 times more cost-efficient than surgery, in 31% of cases indistinguishable or up to 1.4 times more costly. Standard direct cost of the majority of AEP is reported using a methodology that enables easy application in other centers. For the most part, endoscopic procedures are more cost-efficient than the corresponding surgical procedure. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  1. Acute and long-term survival in chronically critically ill surgical patients: a retrospective observational study.

    Science.gov (United States)

    Hartl, Wolfgang H; Wolf, Hilde; Schneider, Christian P; Küchenhoff, Helmut; Jauch, Karl-Walter

    2007-01-01

    Various cohort studies have shown that acute (short-term) mortality rates in unselected critically ill patients may have improved during the past 15 years. Whether these benefits also affect acute and long-term prognosis in chronically critically ill patients is unclear, as are determinants relevant to prognosis. We conducted a retrospective analysis of data collected from March 1993 to February 2005. A cohort of 390 consecutive surgical patients requiring intensive care therapy for more than 28 days was analyzed. The intensive care unit (ICU) survival rate was 53.6%. Survival rates at one, three and five years were 61.8%, 44.7% and 37.0% among ICU survivors. After adjustment for relevant covariates, acute and long-term survival rates did not differ significantly between 1993 to 1999 and 1999 to 2005 intervals. Acute prognosis was determined by disease severity during ICU stay and by primary diagnosis. However, only the latter was independently associated with long-term prognosis. Advanced age was an independent prognostic determinant of poor short-term and long-term survival. Acute and long-term prognosis in chronically critically ill surgical patients has remained unchanged throughout the past 12 years. After successful surgical intervention and intensive care, long-term outcome is reasonably good and is mainly determined by age and underlying disease.

  2. Development of a minimal saponin vaccine adjuvant based on QS-21

    Science.gov (United States)

    Fernández-Tejada, Alberto; Chea, Eric K.; George, Constantine; Pillarsetty, Nagavarakishore; Gardner, Jeffrey R.; Livingston, Philip O.; Ragupathi, Govind; Lewis, Jason S.; Tan, Derek S.; Gin, David Y.

    2014-07-01

    Adjuvants are materials added to vaccines to enhance the immunological response to an antigen. QS-21 is a natural product adjuvant under investigation in numerous vaccine clinical trials, but its use is constrained by scarcity, toxicity, instability and an enigmatic molecular mechanism of action. Herein we describe the development of a minimal QS-21 analogue that decouples adjuvant activity from toxicity and provides a powerful platform for mechanistic investigations. We found that the entire branched trisaccharide domain of QS-21 is dispensable for adjuvant activity and that the C4-aldehyde substituent, previously proposed to bind covalently to an unknown cellular target, is also not required. Biodistribution studies revealed that active adjuvants were retained preferentially at the injection site and the nearest draining lymph nodes compared with the attenuated variants. Overall, these studies have yielded critical insights into saponin structure-function relationships, provided practical synthetic access to non-toxic adjuvants, and established a platform for detailed mechanistic studies.

  3. EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

    NARCIS (Netherlands)

    DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

    Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

  4. Assessment of communication, professionalism, and surgical skills in an objective structured performance-related examination (OSPRE): a psychometric study.

    Science.gov (United States)

    Ponton-Carss, Alicia; Hutchison, Carol; Violato, Claudio

    2011-10-01

    The purpose of this study was to investigate the reliability and validity of a performance assessment of communication, professionalism, and surgical skills competencies for surgery residents. Fourteen residents from the general surgery program of the University of Calgary were assessed in 7 surgical simulation stations that included communication and professionalism skills. The internal consistency reliability of the checklists and global rating scales combined was adequate for communication (α = .75-.92) and surgical skills (α = .86-.96), but not for professionalism (α = 0). There was evidence of validity as surgical skills performance improved as a function of postgraduate year level but not for the professionalism checklist. Surgical skills and communication correlated in the 2 stations assessed (r = .55 and .57; P communication skills. Further instrument development is required to assess professionalism in a structured examination context. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. The effect of comorbidity on the use of adjuvant chemotherapy and survival from colon cancer: a retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Purdie Gordon

    2009-04-01

    Full Text Available Abstract Background Comorbidity has a well documented detrimental effect on cancer survival. However it is difficult to disentangle the direct effects of comorbidity on survival from indirect effects via the influence of comorbidity on treatment choice. This study aimed to assess the impact of comorbidity on colon cancer patient survival, the effect of comorbidity on treatment choices for these patients, and the impact of this on survival among those with comorbidity. Methods This retrospective cohort study reviewed 589 New Zealanders diagnosed with colon cancer in 1996–2003, followed until the end of 2005. Clinical and outcome data were obtained from clinical records and the national mortality database. Cox proportional hazards and logistic regression models were used to assess the impact of comorbidity on cancer specific and all-cause survival, the effect of comorbidity on chemotherapy recommendations for stage III patients, and the impact of this on survival among those with comorbidity. Results After adjusting for age, sex, ethnicity, area deprivation, smoking, stage, grade and site of disease, higher Charlson comorbidity score was associated with poorer all-cause survival (HR = 2.63 95%CI:1.82–3.81 for Charlson score ≥ 3 compared with 0. Comorbidity count and several individual conditions were significantly related to poorer all-cause survival. A similar, but less marked effect was seen for cancer specific survival. Among patients with stage III colon cancer, those with a Charlson score ≥ 3 compared with 0 were less likely to be offered chemotherapy (19% compared with 84% despite such therapy being associated with around a 60% reduction in excess mortality for both all-cause and cancer specific survival in these patients. Conclusion Comorbidity impacts on colon cancer survival thorough both physiological burden of disease and its impact on treatment choices. Some patients with comorbidity may forego chemotherapy unnecessarily

  6. Dexmedetomidine as an adjuvant for perioperative pain management in adolescents undergoing bariatric surgery: An observational cohort study.

    Science.gov (United States)

    Vaughns, Janelle D; Martin, Celeste; Nelson, Jonathon; Nadler, Evan; Quezado, Zenaide M

    2017-11-01

    The anesthetic management of adolescents undergoing bariatric surgery presents a number of challenges, including increased risk of postoperative opioid-related respiratory depression. These patients could benefit from adjunctive analgesics with opioid-sparring effects to optimize perioperative pain control. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has sedative and analgesic properties with no respiratory depressant effects. To determine the effect of intraoperative dexmedetomidine on opioid requirement and perioperative pain management in obese adolescents undergoing bariatric surgery. An observational study of 26 consecutive patients treated with and without dexmedetomidine during the intraoperative period was conducted. The dexmedetomidine treated patients received a loading dose over 30min and a continuous infusion thereafter. The standard group represented patients who received an institutional standard anesthetic without dexmedetomidine. The primary outcome was total perioperative intravenous morphine equivalent (MEq). We also examined reported pain scores during the perioperative period. While there were no significant differences in age, height and weight category, there were imbalances on race distribution between the two groups. Both groups received similar doses of ketorolac and acetaminophen perioperatively. Overall, during 48h postoperatively, the dexmedetomidine group received significantly less total MEq administration compared with the standard group. Three patients in the dexmedetomidine group required ephedrine to treat an episode of hypotension. These results suggest that the use of dexmedetomidine during bariatric surgery in the morbidly obese adolescent population is associated with decreased opioid utilization during the perioperative period. Future randomized studies will determine the role of dexmedetomidine in the pain management of obese adolescents undergoing bariatric surgery. Therapeutic, Level III. Copyright © 2017

  7. A RANDOMIZED CONTROLLED STUDY OF RISK FACTORS AND ROLE OF PROPHYLACTIC ANTIBIOTICS IN PREVENTION OF SURGICAL SITE INFECTIONS

    Directory of Open Access Journals (Sweden)

    Avijeet Mukherjee, Naveen N

    2015-01-01

    Full Text Available Background and Objectives: Surgical site infection (SSI is the most common nosocomial infection encountered in post operative surgical wards. The use of prophylactic antibiotic in clean elective surgical cases is still a subject of controversy to surgeons. The objective of the study is to identify the need for using prophylactic antibiotics in clean surgeries, prevalence of organisms in patients who are not given prophylactic antibiotics and to study whether the presence of risk factors increase the incidence of surgical site infection. Methodology: The comparative study consists of 100 cases admitted under two groups of 50 each: Group A was given prophylactic antibiotic and Group B didn’t receive any. All surgeries other than clean surgical cases were excluded from the study. Results: Out of 50 patients in group B who were not given prophylactic antibiotic, 2 patients had more than one risk factor for development of SSI and both of them developed SSI. Of the 50 patients who received prophylactic antibiotic, none developed SSI. The rate of infection in group A was nil and in Group B was 4%. Conclusion: Prophylactic antibiotics are not recommended for clean elective surgical cases as there is no statistically significant change in the infection rate seen in patients not receiving prophylactic antibiotic(P=0.4952. Meticulous surgical technique and correcting risk factors prior to surgery is a must for reducing incidence of SSI.

  8. Coma and Stroke Following Surgical Treatment of Unruptured Intracranial Aneurysm: An American College of Surgeons National Surgical Quality Improvement Program Study.

    Science.gov (United States)

    McCutcheon, Brandon A; Kerezoudis, Panagiotis; Porter, Amanda L; Rinaldo, Lorenzo; Murphy, Meghan; Maloney, Patrick; Shepherd, Daniel; Hirshman, Brian R; Carter, Bob S; Lanzino, Giuseppe; Bydon, Mohamad; Meyer, Fredric

    2016-07-01

    A large national surgical registry was used to establish national benchmarks and associated predictors of major neurologic complications (i.e., coma and stroke) after surgical clipping of unruptured intracranial aneurysms. The American College of Surgeons National Surgical Quality Improvement Program data set between 2007 and 2013 was used for this retrospective cohort analysis. Demographic, comorbidity, and operative characteristics associated with the development of a major neurologic complication (i.e., coma or stroke) were elucidated using a backward selection stepwise logistic regression analysis. This model was subsequently used to fit a predictive score for major neurologic complications. Inclusion criteria were met by 662 patients. Of these patients, 57 (8.61%) developed a major neurologic complication (i.e., coma or stroke) within the 30-day postoperative period. On multivariable analysis, operative time (log odds 0.004 per minute; 95% confidence interval [CI], 0.002-0.007), age (log odds 0.05 per year; 95% CI, 0.02-0.08), history of chronic obstructive pulmonary disease (log odds 1.26; 95% CI, 0.43-2.08), and diabetes (log odds 1.15; 95% CI, 0.38-1.91) were associated with an increased odds of major neurologic complications. When patients were categorized according to quartile of a predictive score generated from the multivariable analysis, rates of major neurologic complications were 1.8%, 4.3%, 6.7%, and 21.2%. Using a large, national multi-institutional cohort, this study established representative national benchmarks and a predictive scoring system for major neurologic complications following operative management of unruptured intracranial aneurysms. The model may assist with risk stratification and tailoring of decision making in surgical candidates. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Rates and predictors of consideration for adjuvant radiotherapy among high-risk breast cancer patients: a cohort study.

    Science.gov (United States)

    Krotneva, Stanimira; Reidel, Kristen; Nassif, Mohammed; Trabulsi, Nora; Mayo, Nancy; Tamblyn, Robyn; Meguerditchian, Ari N

    2013-07-01

    Radiotherapy (RT) after breast conserving surgery (BCS) represents the standard for local control of breast cancer (BC). However, variations in practice persist. We aimed to characterize the rate of RT consideration (or referral) after BCS and identify predictors in Quebec, Canada, where universal health insurance is in place. A historical prospective cohort study using the provincial hospital discharge and medical services databases was conducted. All women with incident, non-metastatic BC (stages I-III) undergoing BCS (1998-2005) were identified. Odds ratios (ORs) and 95 % confidence intervals (CIs) for RT consideration were estimated with a generalized estimating equations regression model, adjusting for clustering of patients within physicians. Of the 27,483 women selected, 90 % were considered for RT and 84 % subsequently received it. Relative to women 50-69 years old, younger and older women were less likely to be considered: ORs of 0.82 (95 % CI 0.73-0.93) and 0.10 (0.09-0.12), respectively. Emergency room visits and hospitalizations unrelated to BC were associated with decreased odds of RT consideration: 0.85 (0.76-0.94) and 0.83 (0.71-0.97). Women with regional BC considered for chemotherapy were more likely to be considered for RT: 3.41 (2.83-4.11). RT consideration odds increased by 7 % (OR of 1.07, 95 % CI 1.03-1.10) for every ten additional BCSs performed by the surgeon in the prior year. Social isolation, comorbidities, and greater distance to a referral center lowered the odds. Demographic and clinical patient-related risk factors, health service use, gaps in other aspects of BC management, and surgeon's experience predicted RT consideration.

  10. Evaluation of symptoms of anxiety and depression in women with breast cancer after breast amputation or conservation treated with adjuvant chemotherapy

    Directory of Open Access Journals (Sweden)

    Marzena Kamińska

    2015-02-01

    The level of anxiety and depression among women with breast cancer was influenced by the type of the applied surgical procedure and adjuvant chemotherapy. Demographic variables did not influence the level of anxiety and depression.

  11. Surgical management of breast cancer in China: A 15-year single-center retrospective study of 18,502 patients.

    Science.gov (United States)

    Huang, Nai-Si; Liu, Meng-Ying; Chen, Jia-Jian; Yang, Ben-Long; Xue, Jing-Yan; Quan, Chen-Lian; Mo, Miao; Liu, Guang-Yu; Shen, Zhen-Zhou; Shao, Zhi-Min; Wu, Jiong

    2016-11-01

    The aim of the study was to review the surgical trends in breast cancer treatment in China over the past 15 years and to explore the possible factors related to the choice of surgical modality.The medical records of 18,502 patients with unilateral early stage breast cancer who underwent surgery from January 1999 to December 2013 at our institute were retrospectively reviewed. The utilization of different surgical modalities and the associated clinicopathological factors were analyzed. Furthermore, the prognostic role of surgical modality was also evaluated.The median patient age was 50.0 years. According to the pTNM staging system, 12.5% of the patients were classified as stage 0; 30.2% as stage I; 40.0% as stage II; and 17.3% as stage III. In total, 9.3% of the patients could not be staged. Overall, 67.1% of the breast cancer cases were estrogen receptor (ER) positive. The pattern of breast cancer surgery has changed tremendously over the past 15 years (P Age, TNM staging, and pathological characteristics greatly affected the choice of surgical modality. The 5-year recurrence-free survival (RFS) rates for the mastectomy, BCS, and reconstruction groups were 87.6%, 93.2%, and 91.7%, respectively (P time, stratified by surgical modality and tumor stage. Multivariate Cox-regression analysis revealed that time of treatment, tumor stage, tumor grade, LVI status, and ER status were independent prognostic factors for RFS in our cohort, whereas surgical modality was not.Mastectomy remains the most prevalent surgical modality used to manage early stage breast cancer in China, although the utilization of BCS has increased in the past decade. However, surgical management was not a prognostic factor for RFS. The selection of appropriate patients depended on the assessment of multiple clinicopathological factors, which is essential for making surgical decisions.

  12. Adjuvant chemotherapy versus chemoradiotherapy for small cell lung cancer with lymph node metastasis: a retrospective observational study with use of a national database in Japan

    OpenAIRE

    Urushiyama, Hirokazu; Jo, Taisuke; Yasunaga, Hideo; Yamauchi, Yasuhiro; Matsui, Hiroki; Hasegawa, Wakae; Takeshima, Hideyuki; Hiraishi, Yoshihisa; Mitani, Akihisa; Fushimi, Kiyohide; Nagase, Takahide

    2017-01-01

    Background The optimal postoperative treatment strategy for small cell lung cancer (SCLC) remains unclear, especially in patients with lymph node metastasis. We aimed to compare the outcomes of patients with SCLC and lymph node metastasis treated with postoperative adjuvant chemotherapy or chemoradiotherapy. Methods We retrospectively collected data on patients with postoperative SCLC diagnosed with N1 and N2 lymph node metastasis from the Diagnosis Procedure Combination database in Japan, be...

  13. The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study.

    Science.gov (United States)

    Lesiuk, Teresa

    2015-05-01

    To explore the efficacy of mindfulness-
based music therapy (MBMT) to improve attention and decrease mood distress experienced by women with breast cancer receiving adjuvant chemotherapy. Quantitative, descriptive, longitudinal approach. A comprehensive cancer hospital and a university in southern Florida. 15 women with a diagnosis of breast cancer, stages I-III, receiving adjuvant chemotherapy. Participants individually received MBMT for one hour per week for four weeks. The sessions consisted of varied music activities accompanied by mindfulness attitudes, or mental strategies that enhance moment-to-moment awareness, and weekly homework. Demographic information was collected at baseline. Attention was measured using Conners' Continuous Performance Test II. Mood was measured using the Profile of Mood States-Brief Form. Narrative comments collected from the homework assignments served to reinforce quantitative data. Repeated measures analysis of variance showed that attention improved significantly over time. Although all mood states significantly improved from the beginning to the end of each MBMT session, the mood state of fatigue decreased significantly more than the other mood states. MBMT enhances attention and mood, particularly the mood state of fatigue, in women with breast cancer receiving adjuvant chemotherapy. 
. A preferred music listening and mindfulness exercise may be offered to women with breast cancer who experience attention problems and mood distress.

  14. [3D Virtual Reality Laparoscopic Simulation in Surgical Education - Results of a Pilot Study].

    Science.gov (United States)

    Kneist, W; Huber, T; Paschold, M; Lang, H

    2016-06-01

    The use of three-dimensional imaging in laparoscopy is a growing issue and has led to 3D systems in laparoscopic simulation. Studies on box trainers have shown differing results concerning the benefit of 3D imaging. There are currently no studies analysing 3D imaging in virtual reality laparoscopy (VRL). Five surgical fellows, 10 surgical residents and 29 undergraduate medical students performed abstract and procedural tasks on a VRL simulator using conventional 2D and 3D imaging in a randomised order. No significant differences between the two imaging systems were shown for students or medical professionals. Participants who preferred three-dimensional imaging showed significantly better results in 2D as wells as in 3D imaging. First results on three-dimensional imaging on box trainers showed different results. Some studies resulted in an advantage of 3D imaging for laparoscopic novices. This study did not confirm the superiority of 3D imaging over conventional 2D imaging in a VRL simulator. In the present study on 3D imaging on a VRL simulator there was no significant advantage for 3D imaging compared to conventional 2D imaging. Georg Thieme Verlag KG Stuttgart · New York.

  15. The study of surgical image quality evaluation system by subjective quality factor method

    Science.gov (United States)

    Zhang, Jian J.; Xuan, Jason R.; Yang, Xirong; Yu, Honggang; Koullick, Edouard

    2016-03-01

    GreenLightTM procedure is an effective and economical way of treatment of benign prostate hyperplasia (BPH); there are almost a million of patients treated with GreenLightTM worldwide. During the surgical procedure, the surgeon or physician will rely on the monitoring video system to survey and confirm the surgical progress. There are a few obstructions that could greatly affect the image quality of the monitoring video, like laser glare by the tissue and body fluid, air bubbles and debris generated by tissue evaporation, and bleeding, just to name a few. In order to improve the physician's visual experience of a laser surgical procedure, the system performance parameter related to image quality needs to be well defined. However, since image quality is the integrated set of perceptions of the overall degree of excellence of an image, or in other words, image quality is the perceptually weighted combination of significant attributes (contrast, graininess …) of an image when considered in its marketplace or application, there is no standard definition on overall image or video quality especially for the no-reference case (without a standard chart as reference). In this study, Subjective Quality Factor (SQF) and acutance are used for no-reference image quality evaluation. Basic image quality parameters, like sharpness, color accuracy, size of obstruction and transmission of obstruction, are used as subparameter to define the rating scale for image quality evaluation or comparison. Sample image groups were evaluated by human observers according to the rating scale. Surveys of physician groups were also conducted with lab generated sample videos. The study shows that human subjective perception is a trustworthy way of image quality evaluation. More systematic investigation on the relationship between video quality and image quality of each frame will be conducted as a future study.

  16. Incidence and risk factors for surgically acquired pressure ulcers: a prospective cohort study investigators.

    Science.gov (United States)

    Webster, Joan; Lister, Carolyn; Corry, Jean; Holland, Michelle; Coleman, Kerrie; Marquart, Louise

    2015-01-01

    To assess the incidence of hospital-acquired, surgery-related pressure injury (ulcers) and identify risk factors for these injuries. We used a prospective cohort study to investigate the research question. The study was conducted at a major metropolitan hospital in Brisbane, Australia. Five hundred thirty-four adult patients booked for any surgical procedure expected to last more than 30 minutes were eligible for inclusion. Patients who provided informed consent for study participation were assessed for pressure ulcers, using the European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel Guidelines, before entering the operating room and again in the post-anesthetic care unit (PACU). Research nurses and all PACU nurses were trained in skin assessment and in pressure ulcer staging. Patients were not assessed again after their discharge from the PACU. Seven patients (1.3%) had existing pressure injuries (ulcers) and a further 6 (1.3%) developed a surgery-related pressure ulcer. Risk factors associated with surgery-related pressure injuries were similar to non-surgically related risks and included older age, skin condition, and being admitted from a location other than one's own home. Length of surgery was not associated with pressure ulcer development in this cohort. Perioperative nurses play an important role in identifying existing or new pressure injuries. However, many of these nurses are unfamiliar with pressure ulcer classification, so education in this area is essential. Although the incidence of surgically acquired pressure ulcers was low in this cohort, careful skin inspection before and after surgery provides an opportunity for early treatment and may prevent existing lesions progressing to higher stages.

  17. Adjuvant Chemoradiation Therapy for Pancreatic Adenocarcinoma: Who Really Benefits?

    Science.gov (United States)

    Merchant, Nipun B; Rymer, Jennifer; Koehler, Elizabeth AS; Ayers, G Daniel; Castellanos, Jason; Kooby, David A; Weber, Sharon H; Cho, Clifford S; Schmidt, C Max; Nakeeb, Atilla; Matos, Jesus M; Scoggins, Charles R; Martin, Robert CG; Kim, Hong Jin; Ahmad, Syed A; Chu, Carrie K; McClaine, Rebecca; Bednarski, Brian K; Staley, Charles A; Sharp, Kenneth; Parikh, Alexander A

    2014-01-01

    BACKGROUND The role of adjuvant chemoradiation therapy (CRT) in pancreatic cancer remains controversial. The primary aim of this study was to determine if CRT improved survival in patients with resected pancreatic cancer in a large, multiinstitutional cohort of patients. STUDY DESIGN Patients undergoing resection for pancreatic adenocarcinoma from seven academic medical institutions were included. Exclusion criteria included patients with T4 or M1 disease, R2 resection margin, preoperative therapy, chemotherapy alone, or if adjuvant therapy status was unknown. RESULTS There were 747 patients included in the initial evaluation. Primary analysis was performed between patients that had surgery alone (n = 374) and those receiving adjuvant CRT (n = 299). Median followup time was 12.2 months and 14.5 months for survivors. Median overall survival for patients receiving adjuvant CRT was significantly longer than for those undergoing operation alone (20.0 months versus 14.5 months, p = 0.001). On subset and multivariate analysis, adjuvant CRT demonstrated a significant survival advantage only among patients who had lymph node (LN)-positive disease (hazard ratio 0.477, 95% CI 0.357 to 0.638) and not for LN-negative patients (hazard ratio 0.810, 95% CI 0.556 to 1.181). Disease-free survival in patients with LN-negative disease who received adjuvant CRT was significantly worse than in patients who had surgery alone (14.5 months versus 18.6 months, p = 0.034). CONCLUSIONS This large multiinstitutional study emphasizes the importance of analyzing subsets of patients with pancreas adenocarcinoma who have LN metastasis. Benefit of adjuvant CRT is seen only in patients with LN-positive disease, regardless of resection margin status. CRT in patients with LN-negative disease may contribute to reduced disease-free survival. PMID:19476845

  18. Surgical considerations when reporting MRI studies of soft tissue sarcoma of the limbs

    Energy Technology Data Exchange (ETDEWEB)

    De la Hoz Polo, Marcela [Kings College Hospital, Radiology Department, London, Brixton (United Kingdom); Dick, Elizabeth [St Mary' s Hospital, Imperial College Healthcare NHS Trust, Radiology Department, London (United Kingdom); Bhumbra, Rej [Newham and The Royal London Hospitals, Trauma and Orthopaedic Department, Barts Health Orthopaedic Centre, London, Whitechapel (United Kingdom); Pollock, Rob [Royal National Orthopaedic Hospital, Trauma and Orthopaedic Department, Stanmore (United Kingdom); Sandhu, Ranbir [University Hospitals Birmingham, Radiology Department, Queen Elizabeth Hospital, Birmingham (United Kingdom); Saifuddin, Asif [Royal National Orthopaedic Hospital, Radiology Department, Stanmore (United Kingdom)

    2017-12-15

    Soft tissue sarcomas (STS) are rare tumours that require prompt diagnosis and treatment at a specialist centre. Magnetic resonance imaging (MRI) has become the modality of choice for identification, characterisation, biopsy planning and staging of soft tissue masses. MRI enables both the operating surgeon and patient to be optimally prepared prior to surgery for the likelihood of margin-negative resection and to anticipate possible sacrifice of adjacent structures and consequent loss of function. The aim of this review is to aid the radiologist in performing and reporting MRI studies of soft tissue sarcomas, with particular reference to the requirements of the surgical oncologist. (orig.)

  19. Surgical lighting

    NARCIS (Netherlands)

    Knulst, A.J.

    2017-01-01

    The surgical light is an important tool for surgeons to create and maintain good visibility on the surgical task. Chapter 1 gives background to the field of (surgical) lighting and related terminology. Although the surgical light has been developed strongly since its introduction a long time ago,

  20. Reasons for family involvement in elective surgical decision-making in Taiwan: a qualitative study.

    Science.gov (United States)

    Lin, Mei-Ling; Huang, Chuen-Teng; Chen, Ching-Huey

    2017-07-01

    To inquire into the reasons for family involvement in adult patients' surgical decision-making processes from the point of view of the patients' family. Making a patient the centre of medical decision-making is essential for respecting individual's autonomy. However, in a Chinese society, family members are often deeply involved in a patient's medical decision-making. Although family involvement has long been viewed as an aspect of the Chinese culture, empirical evidence of the reasons for family involvement in medical decision-making has been lacking. A qualitative study. In order to record and examine reasons for family involvement in adult patients' surgical decision-making, 12 different family members of 12 elective surgery patients were interviewed for collecting and analysing data. Three major reasons for family involvement emerged from the data analyses: (1) to share responsibility; (2) to ensure the correctness of medical information; and (3) to safeguard the patient's well-being. These findings also reveal that culture is not the only reason for family involvement. Making decision to undergo a surgery is a tough and stressful process for a patient. Family may provide the patient with timely psychological support to assist the patient to communicate with his or her physician(s) and other medical personnel to ensure their rights. It is also found that due to the imbalanced doctor-patient power relationship, a patient may be unable, unwilling to, or even dare not, tell the whole truth about his or her illness or feelings to the medical personnel. Thus, a patient would expect his or her family to undertake such a mission during the informed consent and decision-making processes. The results of this study may provide medical professionals with relevant insights into family involvement in adult patients' surgical decision-making. © 2016 John Wiley & Sons Ltd.

  1. The risk of headache attributed to surgical treatment of intracranial aneurysms: a cohort study.

    Science.gov (United States)

    Magalhães, João E; Azevedo-Filho, Hildo R C; Rocha-Filho, Pedro A S

    2013-01-01

    The aim of this study was to assess the risk of headache in patients undergoing surgical treatment of intracranial aneurysms. The risk of the post-craniotomy headache has never been studied. Patients with intracranial aneurysm, who were consecutively admitted to the Hospital da Restauração, Brazil, from May 2009 to October 2010, were interviewed before they underwent surgical or non-surgical treatment of the aneurysms. The patients were followed for 4 months after intervention. The International Headache Society criteria for post-craniotomy headache were used after surgery and adapted for headache after embolization (maximum intensity of pain on the same side of the aneurysm). We also used the Headache Impact Test, the Hospital Anxiety and Depression Scale, and the Epworth Sleepiness Scale. Of 101 patients enrolled, 53 patients underwent craniotomy and 48 patients embolization. The surgery group was younger and had fewer women. The incidence of headache was 28/51 cases (54.9%) after surgery and 12/47 cases (25.5%) after embolization (relative risk = 2.15; 95% confidence interval [CI] 1.24-3.72). The incidence of persistent headache was not different between the 2 groups. The only risk factor for headache after the intervention was craniotomy (odds ratio = 2.6; 95% CI 1.1-6.7) and for persistent headache was anxiety prior to treatment (odds ratio = 8.5; 95% CI 1.7-42.3). The headache after treatment was not associated with the risk of anxiety or depression after the intervention. Patients who underwent craniotomy had an increased risk of headache after treatment of intracranial aneurysms. The incidence of persistent headache after 3 months was higher among patients who had anxiety before the intervention. © 2013 American Headache Society.

  2. Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study

    OpenAIRE

    Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry

    2014-01-01

    Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight speci...

  3. Surgical and postmortem pathology studies: contribution for the investigation of temporal lobe epilepsy.

    Science.gov (United States)

    Caboclo, Luís Otávio Sales Ferreira; Neves, Rafael Scarpa; Jardim, Anaclara Prada; Hamad, Ana Paula Andrade; Centeno, Ricardo Silva; Lancellotti, Carmen Lucia Penteado; Scorza, Carla Alessandra; Cavalheiro, Esper Abrão; Yacubian, Elza Márcia Targas; Sakamoto, Américo Ceiki

    2012-12-01

    Pathology studies in epilepsy patients bring useful information for comprehending the physiopathology of various forms of epilepsy, as well as aspects related to response to treatment and long-term prognosis. These studies are usually restricted to surgical specimens obtained from patients with refractory focal epilepsies. Therefore, most of them pertain to temporal lobe epilepsy (TLE) with mesial temporal sclerosis (MTS) and malformations of cortical development (MCD), thus providing information of a selected group of patients and restricted regions of the brain. Postmortem whole brain studies are rarely performed in epilepsy patients, however they may provide extensive information on brain pathology, allowing the analysis of areas beyond the putative epileptogenic zone. In this article, we reviewed pathology studies performed in epilepsy patients with emphasis on neuropathological findings in TLE with MTS and MCD. Furthermore, we reviewed data from postmortem studies and discussed the importance of performing these studies in epilepsy populations.

  4. Surgical and postmortem pathology studies: contribution for the investigation of temporal lobe epilepsy

    Directory of Open Access Journals (Sweden)

    Luís Otávio Sales Ferreira Caboclo

    2012-12-01

    Full Text Available Pathology studies in epilepsy patients bring useful information for comprehending the physiopathology of various forms of epilepsy, as well as aspects related to response to treatment and long-term prognosis. These studies are usually restricted to surgical specimens obtained from patients with refractory focal epilepsies. Therefore, most of them pertain to temporal lobe epilepsy (TLE with mesial temporal sclerosis (MTS and malformations of cortical development (MCD, thus providing information of a selected group of patients and restricted regions of the brain. Postmortem whole brain studies are rarely performed in epilepsy patients, however they may provide extensive information on brain pathology, allowing the analysis of areas beyond the putative epileptogenic zone. In this article, we reviewed pathology studies performed in epilepsy patients with emphasis on neuropathological findings in TLE with MTS and MCD. Furthermore, we reviewed data from postmortem studies and discussed the importance of performing these studies in epilepsy populations.

  5. Phase 1/2 Study of the Addition of Cisplatin to Adjuvant Chemotherapy With Image Guided High-Precision Radiation Therapy for Completely Resected Gastric Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Goody, Rebecca B. [Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); MacKay, Helen [Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Pitcher, Bethany [Department of Biostatistics, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Oza, Amit; Siu, Lillian L. [Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Kim, John; Wong, Rebecca K.S. [Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Chen, Eric [Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Swallow, Carol [Department of Surgical Oncology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario (Canada); Knox, Jennifer [Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Kassam, Zahra [Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Department of Radiation Oncology, Stronach Regional Cancer Centre, Newmarket, Ontario (Canada); Cummings, Bernard [Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Feld, Ron; Hedley, David; Liu, Geoffrey; Krzyzanowska, Monika K. [Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Dinniwell, Robert; Brade, Anthony M.; Dawson, Laura A. [Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Pintilie, Melania [Department of Biostatistics, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); and others

    2016-12-01

    Purpose: Locoregional recurrence is common after surgery for gastric cancer. Adjuvant therapy improves outcomes but with toxicity. This phase 1/2 study investigated infusional 5-fluorouracil (5-FU) in combination with biweekly cisplatin delivered concurrently with image guided high-precision radiation therapy. Methods and Materials: Eligible patients had completely resected stage IB to IV (Union for International Cancer Control TNM 6th edition) nonmetastatic gastric adenocarcinoma. Treatment constituted 12 weeks of infusional 5-FU (200 mg/m{sup 2}/day) with cisplatin added in a standard 3 + 3 dose escalation protocol (0, 20, 30, and 40 mg/m{sup 2}) during weeks 1, 3, 5, and 7, and an additional week 9 dose in the final cohort. Radiation therapy (45 Gy in 25 fractions) was delivered during weeks 3 to 7. Maximum tolerated dose (MTD) was determined in phase 1 and confirmed in phase 2. Results: Among the 55 patients (median age, 54 years; range 28-77 years; 55% male), the median follow-up time was 3.0 years (range, 0.3-5.3 years). Five patients in phase 1 experienced dose-limiting toxicity, and MTD was determined as 4 cycles of 40 mg/m{sup 2} cisplatin. Twenty-seven patients were treated at MTD. Acute grade 3 to 4 toxicity rate was 37.0% at MTD and 29.1% across all dose levels. No treatment-related deaths occurred. Fourteen patients experienced recurrent disease. The 2-year overall survival (OS) and relapse-free survival were 85% and 74%, respectively. Median OS has not been reached. Quality of life (QOL) was impaired during treatment, but most scores recovered by 4 weeks. Conclusion: Cisplatin can be safely delivered with 5-FU–based chemoradiation therapy. Acute toxicity was acceptable, and patient-reported QOL showed the regimen was tolerable. Outcomes are encouraging and justify further study of this regimen.

  6. Prevalence of Untreated Surgical Conditions in Rural Rwanda: A Population-Based Cross-sectional Study in Burera District.

    Science.gov (United States)

    Maine, Rebecca G; Linden, Allison F; Riviello, Robert; Kamanzi, Emmanuel; Mody, Gita N; Ntakiyiruta, Georges; Kansayisa, Grace; Ntaganda, Edmond; Niyonkuru, Francine; Mubiligi, Joel M; Mpunga, Tharcisse; Meara, John G; Hedt-Gauthier, Bethany L

    2017-12-20

    In low- and middle-income countries, community-level surgical epidemiology is largely undefined. Accurate community-level surgical epidemiology is necessary for surgical health systems planning. To determine the prevalence of surgical conditions in Burera District, Northern Province, Rwanda. A cross-sectional study with a 2-stage cluster sample design (at village and household level) was carried out in Burera District in March and May 2012. A team of surgeons randomly sampled 30 villages with probability proportionate to village population size, then sampled 23 households within each village. All available household members were examined. The presence of 10 index surgical conditions (injuries/wounds, hernias/hydroceles, breast masses, neck masses, obstetric fistulas, undescended testes, hypospadias, hydrocephalus, cleft lip/palate, and clubfoot) was determined by physical examination. Prevalence was estimated overall and for each condition. Multivariable logistic regression was performed to identify factors associated with surgical conditions, accounting for the complex survey design. Of the 2165 examined individuals, 1215 (56.2%) were female. The prevalence of any surgical condition among all examined individuals was 12% (95% CI, 9.2-14.9%). Half of conditions were hernias/hydroceles (49.6%), and 44% were injuries/wounds. In multivariable analysis, children 5 years or younger had twice the odds of having a surgical condition compared with married individuals 21 to 35 years of age (reference group) (odds ratio [OR], 2.2; 95% CI, 1.26-4.04; P = .01). The oldest group, people older than 50 years, also had twice the odds of having a surgical condition compared with the reference group (married, aged >50 years: OR, 2.3; 95% CI, 1.28-4.23; P = .01; unmarried, aged >50 years: OR, 2.38; 95% CI, 1.02-5.52; P = .06). Unmarried individuals 21 to 35 years of age and unmarried individuals aged 36 to 50 years had higher odds of a surgical condition compared with the

  7. Association between adjuvant regional radiotherapy and cognitive function in breast cancer patients treated with conservation therapy

    International Nuclear Information System (INIS)

    Shibayama, Osamu; Yoshiuchi, Kazuhiro; Inagaki, Masatoshi; Matsuoka, Yutaka; Yoshikawa, Eisho; Sugawara, Yuriko; Akechi, Tatsuo; Wada, Noriaki; Imoto, Shigeru; Murakami, Koji; Ogawa, Asao; Akabayashi, Akira; Uchitomi, Yosuke

    2014-01-01

    Although protracted cognitive impairment has been reported to occur after radiotherapy even when such therapy is not directed to brain areas, the mechanism remains unclear. This study investigated whether breast cancer patients exposed to local radiotherapy showed lower cognitive function mediated by higher plasma interleukin (IL)-6 levels than those unexposed. We performed the Wechsler Memory Scale-Revised (WMS-R) and measured plasma IL-6 levels for 105 breast cancer surgical patients within 1 year after the initial therapy. The group differences in each of the indices of WMS-R were investigated between cancer patients exposed to adjuvant regional radiotherapy (n = 51) and those unexposed (n = 54) using analysis of covariance. We further investigated a mediation effect by plasma IL-6 levels on the relationship between radiotherapy and the indices of WMS-R using the bootstrapping method. The radiotherapy group showed significantly lower Immediate Verbal Memory Index and Delayed Recall Index (P = 0.001, P = 0.008, respectively). Radiotherapy exerted an indirect effect on the lower Delayed Recall Index of WMS-R through elevation of plasma IL-6 levels (bootstrap 95% confidence interval = −2.6626 to −0.0402). This study showed that breast cancer patients exposed to adjuvant regional radiotherapy in conservation therapy might have cognitive impairment even several months after their treatment. The relationship between the therapy and the cognitive impairment could be partially mediated by elevation of plasma IL-6 levels

  8. Conventional external irradiation alone as adjuvant treatment in resectable pancreatic cancer

    International Nuclear Information System (INIS)

    Bosset, J.F.; Pavy, J.J.; Gillet, M.; Mantuon, G.; Pelissier, E.; Schraub, S.

    1992-01-01

    Between 1/85 and 1/90, 14 consecutive patients were entered into a prospective study of conventional adjuvant post-operative external beam radiotherapy after complete resection for a pancreatic adeno-carcinoma. The surgical procedure was a Whipple resection in 9 patients, a distal pancrea-tectomy in 1 patient. There were 3 T 1b , 8 T 2 and 3 T 3 tumors (UICC 1987); nodal involvement was present in 5 cases. The radiotherapy was delivered using a 4-field box technique with a 23 x MV photon beam. All patients received a total dose of 54 Gy to the tumor bed. The mean treated volume was 900 cm 3 . Acute toxicities consisted mainly of weight loss (mean: 2 kg). Two patients had a grade 2 diarrhea and 2 patients a grade 2 gastritis. Late effects were minimal and only observed in 2 patients. The overall loco-regional recurrence (LR) rate was 50%. The median disease-free survival was 12 months, and the median survival was 23 months. This post-operative conventional radiotherapy treatment gives results that are comparable to the results of GITSG-adjuvant study using a combination of split-course radiotherapy and 5-fluorouracil (5-FU). (author). 46 refs.; 1 fig.; 1 tab

  9. Surgical outcomes of robot-assisted rectal cancer surgery using the da Vinci Surgical System: a multi-center pilot Phase II study.

    Science.gov (United States)

    Tsukamoto, Shunsuke; Nishizawa, Yuji; Ochiai, Hiroki; Tsukada, Yuichiro; Sasaki, Takeshi; Shida, Dai; Ito, Masaaki; Kanemitsu, Yukihide

    2017-12-01

    We conducted a multi-center pilot Phase II study to examine the safety of robotic rectal cancer surgery performed using the da Vinci Surgical System during the introduction period of robotic rectal surgery at two institutes based on surgical outcomes. This study was conducted with a prospective, multi-center, single-arm, open-label design to assess the safety and feasibility of robotic surgery for rectal cancer (da Vinci Surgical System). The primary endpoint was the rate of adverse events during and after robotic surgery. The secondary endpoint was the completion rate of robotic surgery. Between April 2014 and July 2016, 50 patients were enrolled in this study. Of these, 10 (20%) had rectosigmoid cancer, 17 (34%) had upper rectal cancer, and 23 (46%) had lower rectal cancer; six underwent high anterior resection, 32 underwent low anterior resection, 11 underwent intersphincteric resection, and one underwent abdominoperineal resection. Pathological stages were Stage 0 in 1 patient, Stage I in 28 patients, Stage II in 7 patients and Stage III in 14 patients. Pathologically complete resection was achieved in all patients. There was no intraoperative organ damage or postoperative mortality. Eight (16%) patients developed complications of all grades, of which 2 (4%) were Grade 3 or higher, including anastomotic leakage (2%) and conversion to open surgery (2%). The present study demonstrates the feasibility and safety of robotic rectal cancer surgery, as reflected by low morbidity and low conversion rates, during the introduction period. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  10. Treatment patterns of adjuvant interferon-α2b for high-risk melanoma: a retrospective study of the Grupo Español Multidisciplinar de Melanoma - Prima study.

    Science.gov (United States)

    Espinosa, Enrique; Soriano, Virtudes; Malvehy, Josep; Berrocal, Alfonso; Martínez de Prado, Purificación; Quindós, María; Soria, Ainara; Márquez-Rodas, Iván; Palacio, Isabel; Cerezuela, Pablo; López-Vivanco, Guillermo; Alonso, Lorenzo; Samaniego, Elia; Ballesteros, Ana; Puértolas, Teresa; Díaz-Beveridge, Rodrigo; de la Cruz-Merino, Luis; López Castro, Rafael; López López, Rafael; Stevinson, Kendall; Del Barrio, Patricia; Tornamira, Maria V; Guillém, Vicente; Martín-Algarra, Salvador

    2016-06-01

    Adjuvant interferon-α2b (IFN-α2b) has been studied extensively in clinical trials, but there have been few studies of real-world use. The aim of this study is to describe the IFN-α2b real-world patterns in patients with high-risk melanoma in Spain. This was a retrospective and multicentre chart review study of an unselected cohort of patients with melanoma at high risk for relapse (stage IIB/IIC/III) treated with IFN-α2b. Patterns were assessed in terms of dose and compliance to planned treatment. A survival analysis was carried out for the full population and according to Kirkwood scheme compliance and the presence of ulceration. Of 327 patients treated with IFN-α2b, 318 received a high-dose regimen following the standard Kirkwood scheme; thus, patterns are described for this regimen. A total of 121 (38%) and 88 (28%) patients had at least one dose reduction during the induction and maintenance phases, respectively. Dose delay was required in fewer than 10% of patients. A total of 78, 40 and 38% of the patients completed the induction phase, maintenance phase and completed treatment, respectively. The median progression-free and overall survival for the full population were 3.2 and 10.5 years, respectively. There were no differences in progression-free survival and overall survival according to Kirkwood scheme compliance and the presence of ulceration. The most frequent adverse events were neutropenia (31%) and fatigue (30%). High-dose IFN-α2b is the most frequently used regimen in Spain as an adjuvant systemic treatment for high-risk melanoma. Despite poor compliance, in this retrospective study, IFN-α2b treatment provided a benefit consistent with that described previously.

  11. Improved survival with early adjuvant chemotherapy after colonic resection for stage III colonic cancer

    DEFF Research Database (Denmark)

    Klein, Mads; Azaquoun, Najah; Jensen, Benny Vittrup

    2015-01-01

    . Data on patients with stage III colonic cancer operated between January 1, 2005 and August 31, 2012 were retrieved. Perioperative variables, surgical modality, and time to adjuvant therapy (8 weeks) were evaluated and Cox regression was performed to identify factors influencing survival...

  12. Music as an adjuvant therapy in control of pain and symptoms in hospitalized adults: a systematic review.

    Science.gov (United States)

    Cole, Linda C; LoBiondo-Wood, Geri

    2014-03-01

    The objective of this review is to evaluate the evidence regarding the use of music as an adjuvant therapy for pain control in hospitalized adults. The search terms music, music therapy, pain, adults, inpatient, and hospitalized were used to search the Cochrane Library, Cinahl, Medline, Natural Standard, and Scopus databases from January 2005 to March 2011. (A systematic review conducted by the Cochrane Collaboration has extensively covered the time frame from 1966 to 2004.) Seventeen randomized controlled trials met criteria for review and inclusion. Seven of the research studies were conducted with surgical patients, three with medical patients, one with medical-surgical patients, four with intensive care patients, and two with pregnant patients. The combined findings of these studies provide support for the use of music as an adjuvant approach to pain control in hospitalized adults. The use of music is safe, inexpensive, and an independent nursing function that can be easily incorporated into the routine care of patients. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  13. Comparative assessment of surgeons' task performance and surgical ergonomics associated with conventional and modified flank positions: a simulation study.

    Science.gov (United States)

    Fan, Yu; Kong, Gaiqing; Meng, Yisen; Tan, Shutao; Wei, Kunlin; Zhang, Qian; Jin, Jie

    2014-11-01

    Flank position is extensively used in retroperitoneoscopic urological practice. Most surgeons follow the patients' position in open approaches. However, surgical ergonomics of the conventional position in the retroperitoneoscopic surgery is poor. We introduce a modified position and evaluated task performance and surgical ergonomics of both positions with simulated surgical tasks. Twenty-one novice surgeons were recruited to perform four tasks: bead transfer, ring transfer, continuous suturing, and cutting a circle. The conventional position was simulated by setting an endo-surgical simulator parallel to the long axis of a surgical desk. The modified position was simulated by rotating the simulator 30° with respect to the long axis of the desk. The outcome measurements include task performance measures, kinematic measures for body alignment, surface electromyography, relative loading between feet, and subjective ratings of fatigue. We observed significant improvements in both task performance and surgical ergonomics parameters under the modified position. For all four tasks, subjects finished tasks faster with higher accuracy (p ergonomics part: (1) The angle between the upper body and the head was decreased by 7.4 ± 1.7°; (2) The EMG amplitude collected from shoulders and left lumber was significantly lower (p ergonomics. With a simulated surgery, we demonstrated that our modified position could significantly improve task performance and surgical ergonomics. Further studies are still warranted to validate these benefits for both patients and surgeons.

  14. Surgical revascularization versus amputation for peripheral vascular disease in dialysis patients: a cohort study

    Directory of Open Access Journals (Sweden)

    Ramkumar Nirupama

    2005-03-01

    Full Text Available Abstract Background Surgical treatment of peripheral vascular disease (PVD in dialysis patients is controversial. Methods We examined the post-operative morbidity and mortality of surgical revascularization or amputation for PVD in a retrospective analysis of United States Renal Data System. Propensity scores for undergoing amputation were derived from a multivariable logistic regression model of amputation. Results Of the Medicare patients initiated on dialysis from Jan 1, 1995 to Dec 31, 1999, patients underwent surgical revascularization (n = 1,896 or amputation (n = 2,046 in the first 6 months following initiation of dialysis were studied. In the logistic regression model, compared to claudication, presence of gangrene had a strong association with amputation [odds ratio (OR 19.0, 95% CI (confidence interval 13.86–25.95]. The odds of dying within 30 days and within1 year were higher (30 day OR: 1.85, 95% CI: 1.45–2.36; 1 yr OR: 1.46, 95% CI: 1.25–1.71 in the amputation group in logistic regression model adjusted for propensity scores and other baseline factors. Amputation was associated with increased odds of death in patients with low likelihood of amputation (rd percentile of propensity score and moderate likelihood of amputation (33rd to 66th percentile but not in high likelihood group (>66th percentile. The number of hospital days in the amputation and revascularization groups was not different. Conclusion Amputation might be associated with higher mortality in dialysis patients. Where feasible, revascularization might be preferable over amputation in dialysis patients.

  15. Scar endometrioma following obstetric surgical incisions: retrospective study on 33 cases and review of the literature

    Directory of Open Access Journals (Sweden)

    Guilherme Karam Corrêa Leite

    Full Text Available CONTEXT AND OBJECTIVE: The incidence of scar endometrioma ranges from 0.03 to 3.5%. Certain factors relating to knowledge of the clinical history of the disease make correct diagnosis and treatment difficult. The aim here was to identify the clinical pattern of the disease and show surgical results. The literature on this topic was reviewed. DESIGN AND SETTING: Retrospective descriptive study at Hospital Municipal Maternidade - Escola Dr. Mário de Moraes Altenfelder Silva. METHODS: Data from the medical records of patients with preoperative diagnoses of scar endometrioma who underwent operations between 2001 and 2007 were surveyed and reviewed. The postoperative diagnosis came from histopathological analysis. The main information surveyed was age, obstetric antecedents, symptoms, tumor location, size and palpation, duration of complaint, diagnosis and treatment. All patients underwent tumor excision with a safety margin. RESULTS: There were 33 patients, of mean age 30.1 ± 5.0 years (range: 18-41 years. The total incidence was 0.11%: 0.29% in cesarean sections and 0.01% in vaginal deliveries. Twenty-nine tumors (87.9% were located in cesarean scars, two (6.0% in episiotomy scars and two (6.0% in the umbilical region. The main symptom was localized cyclical pain (66.7%, of mean duration 30.5 months (± 23. Surgical treatment was successful in all cases. CONCLUSION: This is an uncommon disease. The most important diagnostic characteristic is coincidence of painful symptoms with menstruation. Patients undergoing cesarean section are at greatest risk: relative risk of 27.37 (P < 0.01. The surgical treatment of choice is excision of the endometrioma with a safety margin.

  16. Phase 1/2a study of the malaria vaccine candidate apical membrane antigen-1 (AMA-1 administered in adjuvant system AS01B or AS02A.

    Directory of Open Access Journals (Sweden)

    Michele D Spring

    Full Text Available This Phase 1/2a study evaluated the safety, immunogenicity, and efficacy of an experimental malaria vaccine comprised of the recombinant Plasmodium falciparum protein apical membrane antigen-1 (AMA-1 representing the 3D7 allele formulated with either the AS01B or AS02A Adjuvant Systems.After a preliminary safety evaluation of low dose AMA-1/AS01B (10 microg/0.5 mL in 5 adults, 30 malaria-naïve adults were randomly allocated to receive full dose (50 microg/0.5 mL of AMA-1/AS01B (n = 15 or AMA-1/AS02A (n = 15, followed by a malaria challenge. All vaccinations were administered intramuscularly on a 0-, 1-, 2-month schedule. All volunteers experienced transient injection site erythema, swelling and pain. Two weeks post-third vaccination, anti-AMA-1 Geometric Mean Antibody Concentrations (GMCs with 95% Confidence Intervals (CIs were high: low dose AMA-1/AS01B 196 microg/mL (103-371 microg/mL, full dose AMA-1/AS01B 279 microg/mL (210-369 microg/mL and full dose AMA-1/AS02A 216 microg/mL (169-276 microg/mL with no significant difference among the 3 groups. The three vaccine formulations elicited equivalent functional antibody responses, as measured by growth inhibition assay (GIA, against homologous but not against heterologous (FVO parasites as well as demonstrable interferon-gamma (IFN-gamma responses. To assess efficacy, volunteers were challenged with P. falciparum-infected mosquitoes, and all became parasitemic, with no significant difference in the prepatent period by either light microscopy or quantitative polymerase chain reaction (qPCR. However, a small but significant reduction of parasitemia in the AMA-1/AS02A group was seen with a statistical model employing qPCR measurements.All three vaccine formulations were found to be safe and highly immunogenic. These immune responses did not translate into significant vaccine efficacy in malaria-naïve adults employing a primary sporozoite challenge model, but encouragingly, estimation of parasite

  17. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study.

    Science.gov (United States)

    George, Daniel J; Martini, Jean-François; Staehler, Michael; Motzer, Robert J; Magheli, Ahmed; Escudier, Bernard; Gerletti, Paola; Li, Sherry; Casey, Michelle; Laguerre, Brigitte; Pandha, Hardev S; Pantuck, Allan J; Patel, Anup; Lechuga, Maria J; Ravaud, Alain

    2018-04-01

    Purpose: Adjuvant sunitinib therapy compared with placebo prolonged disease-free survival (DFS) in patients with locoregional high-risk renal cell carcinoma (RCC) in the S-TRAC trial (ClinicalTrials.gov number NCT00375674). A prospectively designed exploratory analysis of tissue biomarkers was conducted to identify predictors of treatment benefit. Experimental Design: Tissue blocks were used for immunohistochemistry (IHC) staining of programmed cell death ligand 1 (PD-L1), CD4, CD8, and CD68. DFS was compared between < versus ≥ median IHC parameter using the Kaplan-Meier method. For biomarkers with predictive potential, receiver operating characteristics curves were generated. Results: Baseline characteristics were similar in patients with ( n = 191) and without ( n = 419) IHC analysis. Among patients with IHC, longer DFS was observed in patients with tumor CD8 + T-cell density ≥ versus < median [median (95% CI), not reached (6.83-not reached) versus 3.47 years (1.73-not reached); hazard ratio (HR) 0.40 (95% CI, 0.20-0.81); P = 0.009] treated with sunitinib ( n = 101), but not with placebo ( n = 90). The sensitivity and specificity for CD8 + T-cell density in predicting DFS were 0.604 and 0.658, respectively. Shorter DFS was observed in placebo-treated patients with PD-L1 + versus PD-L1 - tumors (HR 1.75; P = 0.103). Among all patients with PD-L1 + tumors, DFS was numerically longer with sunitinib versus placebo (HR 0.58; P = 0.175). Conclusions: Greater CD8 + T-cell density in tumor tissue was associated with longer DFS with sunitinib but not placebo, suggesting predictive treatment effect utility. Further independent cohort validation studies are warranted. The prognostic value of PD-L1 expression in primary tumors from patients with high-risk nonmetastatic RCC should also be further explored. Clin Cancer Res; 24(7); 1554-61. ©2018 AACR . ©2018 American Association for Cancer Research.

  18. Cost study of dermal substitutes and topical negative pressure in the surgical treatment of burns.

    Science.gov (United States)

    Hop, M Jenda; Bloemen, Monica C T; van Baar, Margriet E; Nieuwenhuis, Marianne K; van Zuijlen, Paul P M; Polinder, Suzanne; Middelkoop, Esther

    2014-05-01

    A recently performed randomised controlled trial investigated the clinical effectiveness of dermal substitutes (DS) and split skin grafts (SSG) in combination with topical negative pressure (TNP) in the surgical treatment of burn wounds. In the current study, medical and non-medical costs were investigated, to comprehensively assess the benefits of this new treatment. The primary outcome was mean total costs of the four treatment strategies: SSG with or without DS, and with or without TNP. Costs were studied from a societal perspective. Findings were evaluated in light of the clinical effects on scar elasticity. Eighty-six patients were included. Twelve months post-operatively, highest elasticity was measured in scars treated with DS and TNP (p=0.027). The initial cost price of treatment with DS and TNP was €2912 compared to treatment with SSG alone €1703 (ptreatment contributed maximal 7% to the total costs and total costs varied widely within and between groups, but were not significantly different. Therefore, in the selection of the most optimal type of surgical intervention, cost considerations should not play an important role. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  19. Effects of pharmaceutical counselling on antimicrobial use in surgical wards: intervention study with historical control group.

    Science.gov (United States)

    Grill, Eva; Weber, Alexandra; Lohmann, Stefanie; Vetter-Kerkhoff, Cornelia; Strobl, Ralf; Jauch, Karl-Walter

    2011-07-01

    The objective of this study was to assess the impact of pharmaceutical consulting on the quality of antimicrobial use in a surgical hospital department in a prospective controlled intervention study. Patients receiving pharmaceutical intervention (intervention group, IG, n = 317) were compared with a historical control group (control group, CG, n = 321). During the control period, antimicrobial use was monitored without intervention. During the subsequent intervention period, a clinical pharmacist reviewed the prescriptions and gave advice on medication. Intervention reduced the length of antimicrobial courses (IG = 10 days, CG = 11 days, incidence rate ratio for i.v. versus o.p. = 0.88, 95% confidence interval 0.84 to 0.93) and shortened i.v. administration (IG = 8 days, CG = 10 days, hazard rate = 1.76 in favour of switch from i.v. to p.o., 95% confidence interval 1.23 to 2.52). Intervention also helped to avoid useless combination therapy and reduced total costs for antimicrobials. A clinical pharmacist who reviews prescriptions can promote an increase in efficiency, for example, by shortening the course of treatment. Counselling by ward-based clinical pharmacists was shown to be effective to streamline antimicrobial therapy in surgical units and to increase drug safety. Copyright © 2011 John Wiley & Sons, Ltd.

  20. Utilization of two different surgical techniques in gingival recession treatment: A comparative study

    Directory of Open Access Journals (Sweden)

    Bajić Miljan

    2014-01-01

    Full Text Available Introduction. Gingival recession is a displacement of gingival margin apically to cementenamel junction. Objective. The aim of this study was to compare the results achieved with two different surgical procedures used in gingival recession treatment. Methods. Ten patients with bilateral buccal recession on maxillary canines or premolars were included in the study. Professional teeth cleaning was performed before surgery. Recession on the experimental side was treated with connective tissue graft in combination with coronally advanced, split thickness flap (tunnel technique. Control side recession was treated with connective tissue graft in combination with trapezoidal coronally advanced, full thickness flap. Coin toss was used for side decision. The following parameters were evaluated before surgery and 6 months post-op: Vertical Recession Dimension, Clinical Attachment Level, Apico-coronal width of the keratinized tissue, Healing index (Laundry, RES index, and Patient evaluation of esthetic results. Student’s t-test was used for statistical analysis. Results. Six months after surgery, mean root coverage was 91.5±14.1% and 90.1±14.6% on the experimental and on the control side, respectively. RES index, Healing index (Laundry and Patient Subjective evaluation of esthetic results showed significantly better results (p≤0.05. Conclusion. Both surgical procedures produce highly successful clinical results based on evaluated parameters, but this tunnel technique provides significantly better esthetic results. [Projekat Ministarstva nauke Republike Srbije, br. III 41008: Interakcija etiopatogenetskih mehanizama parodontopatije i periimplantitisa sa sistemskim bolestima današnjice

  1. [A cadaveric study of a new capsulorrhaphy for the surgical treatment of hallux valgus].

    Science.gov (United States)

    Orozco-Villaseñor, S L; Monzó-Planella, M; Martín-Oliva, X; Vázquez-Escamilla, J; Mayagoitia-Vázquez, J J; Frías-Chimal, J E

    2017-01-01

    There are many surgical options for the treatment of hallux valgus in combination with capsular repairs for the correction of hallux valgus. This report corresponds to a descriptive study where a new capsulorrhaphy technique in hallux valgus is proposed. Six dissections were performed on cadavers with hallux valgus deformity using the following surgical technique: medial approach on the first toe longitudinally, dissecting by planes and locating the metatarsophalangeal joint capsule; it was incised longitudinally. The capsule was separated and an exostectomy of the first metatarsal head was done, the edges were regularized and a release of the abductor hallucis was performed. Later, the capsular remnant was resected and repaired. Six cadaveric feet with hallux valgus were studied, five with mild deformity, one with moderate deformity, one foot with the 2nd finger on supraductus. Many capsular repairs have been reported in the literature, including «L», triangular, «V-Y», rectangular, with satisfactory results, along with osteotomy of the first metatarsal. In this report, a new capsular repair was described. Applying this new capsular repair, we reduced the metatarsophalangeal and intermetatarsal angles and achieved a capsular closure with suitable tension; the metatarsophalangeal joint mobility was preserved.

  2. A cross sectional study of surgical training among United Kingdom general practitioners with specialist interests in surgery.

    Science.gov (United States)

    Ferguson, H J M; Fitzgerald, J E F; Reilly, J; Beamish, A J; Gokani, V J

    2015-04-08

    Increasing numbers of minor surgical procedures are being performed in the community. In the UK, general practitioners (family medicine physicians) with a specialist interest (GPwSI) in surgery frequently undertake them. This shift has caused decreases in available cases for junior surgeons to gain and consolidate operative skills. This study evaluated GPwSI's case-load, procedural training and perceptions of offering formalised operative training experience to surgical trainees. Prospective, questionnaire-based cross-sectional study. A novel, 13-item, self-administered questionnaire was distributed to members of the Association of Surgeons in Primary Care (ASPC). A total 113 of 120 ASPC members completed the questionnaire, representing a 94% response rate. Respondents were general practitioners practising or intending to practice surgery in the community. Respondents performed a mean of 38 (range 5-150) surgical procedures per month in primary care. 37% (42/113) of respondents had previously been awarded Membership or Fellowship of a Surgical Royal College; 22% (25/113) had completed a surgical certificate or diploma or undertaken a course of less than 1 year duration. 41% (46/113) had no formal British surgical qualifications. All respondents believed that surgical training in primary care could be valuable for surgical trainees, and the majority (71/113, 63%) felt that both general practice and surgical trainees could benefit equally from such training. There is a significant volume of surgical procedures being undertaken in the community by general practitioners, with the capacity and appetite for training of prospective surgeons in this setting, providing appropriate standards are achieved and maintained, commensurate with current standards in secondary care. Surgical experience and training of GPwSI's in surgery is highly varied, and does not yet benefit from the quality assurance secondary care surgical training in the UK undergoes. The Royal Colleges of

  3. [Effect of compliance with an antibiotic prophylaxis protocol in surgical site infections in appendectomies. Prospective cohort study].

    Science.gov (United States)

    Sánchez-Santana, Tomás; Del-Moral-Luque, Juan Antonio; Gil-Yonte, Pablo; Bañuelos-Andrío, Luis; Durán-Poveda, Manuel; Rodríguez-Caravaca, Gil

    Antibiotic prophylaxis is the most suitable tool for preventing surgical site infection. This study assessed compliance with antibiotic prophylaxis in surgery for acute appendicitis, and the effect of this compliance on surgical site infection. Prospective cohort study to evaluate compliance with antibiotic prophylaxis protocol in appendectomies. An assessment was made of the level of compliance with prophylaxis, as well as the causes of non-compliance. The incidence of surgical site infection was studied after a maximum incubation period of 30 days. The relative risk adjusted with a logistic regression model was used to assess the effect of non-compliance of prophylaxis on surgical site infection. The study included a total of 930 patients. Antibiotic prophylaxis was indicated in all patients, and administered in 71.3% of cases, with an overall protocol compliance of 86.1%. The principal cause of non-compliance was time of initiation. Cumulative incidence of surgical site infection was 4.6%. No relationship was found between inadequate prophylaxis compliance and infection (relative risk=0.5; 95% CI: 0.1-1.9) (P>.05). Compliance of antibiotic prophylaxis was high, but could be improved. No relationship was found between prophylaxis compliance and surgical site infection rate. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  4. Use of chemical and biological adjuvants to achieve the optimum application of radiological techniques

    International Nuclear Information System (INIS)

    Azab, K.S.

    2010-01-01

    Nowadays, the optimization and attainment of maximum guarantee are representing the real challenge for the nuclear technology exercise. The Adjuvant techniques might be considered one of the available tactics for the developing, reducing risk and facilitating secure clearing of nuclear waste in the field of radiation technology applications. The history describes the belief that an adjuvant is required for immunity because the immune system evolved to respond to dangerous situations such as infections, and the presence of an adjuvant is the mechanism used to identify these situations. In immunology, an adjuvant is an agent that may stimulate the immune system and increase the response to a vaccine, without having any specific antigenic effect. Adjuvants are coming increasingly into focus for vaccine developers since many novel split and subunit vaccines are insufficiently immunogenic on their own. Among the used today are alum (aluminum hydroxide) and Glycosyl ceramides. It is worth mentioning that manufacturers already had produced thousands of different adjuvants, for both industrial and agricultural purposes. Today, the agricultural and horticultural industries are being overwhelmed by adjuvant choices. Complete Freunds adjuvant is the adjuvant used in animal research studies of basic and applied immunology. (author)

  5. Efficacy of systemic adjuvant therapies administered to dogs after excision of oral malignant melanomas: 151 cases (2001-2012).

    Science.gov (United States)

    Boston, Sarah E; Lu, Xiaomin; Culp, William T N; Montinaro, Vincenzo; Romanelli, Giorgio; Dudley, Robert M; Liptak, Julius M; Mestrinho, Lisa A; Buracco, Paolo

    2014-08-15

    To determine prognostic factors for and compare outcome among dogs with oral malignant melanoma following excision with or without various systemic adjuvant therapies. Retrospective case series. 151 dogs with naturally occurring oral malignant melanomas treated by excision with or without adjuvant therapies from 2001 to 2012. Case accrual was solicited from Veterinary Society of Surgical Oncology members via an email list service. Information collected from case records included signalment, tumor staging, tumor characteristics, type of surgical excision, histologic diagnosis, adjuvant therapy, and survival time. The overall median survival time was 346 days. Results of multivariate analysis indicated that tumor size, patient age, and intralesional excision (vs marginal, wide, or radical excision) were considered poor prognostic indicators. All other demographic and clinical variables were not significantly associated with survival time after adjusting for the aforementioned 3 variables. A clear survival benefit was not evident with any systemic adjuvant therapy, including vaccination against melanoma or chemotherapy; however, the number of dogs in each treatment group was small. Ninety-eight dogs received no postoperative adjuvant therapy, and there was no difference in survival time between dogs that did (335 days) and did not (352 days) receive systemic adjuvant therapy. For dogs with oral malignant melanoma, increasing tumor size and age were negative prognostic factors. Complete excision of all macroscopic tumor burden improved survival time. Long-term survival was possible following surgery alone. Although systemic adjuvant therapy was not found to improve survival time, this could have been due to type II error.

  6. Investigation of the current situation of massive blood transfusion in different surgical departments: a large multicenter study in China

    OpenAIRE

    Sun, Yang; Jin, Zhan-Kui; Xu, Cui-Xiang; Dang, Qian-Li; Zhang, Li-Jie; Chen, Hong-Nan; Song, Yao-Jun; Yang, Jiang-Cun

    2015-01-01

    Objective: This study aims to learn about the current situation of surgical massive blood transfusion of different surgical departments in China’s Tertiary hospitals, which could provide the basis for the formulation of guidelines on massive blood transfusion. Method: A multicenter retrospective research on the application status of blood constituents during massive blood transfusion was conducted and a comparative analyses of survival and length of hospitalization in patients from different ...

  7. A case study on the design of a modular surgical instrument for removing metastases using engineering design tools

    OpenAIRE

    Preca, George; Farrugia, Philip; Casha, Aaron; International Conference on Engineering and Product Design Education

    2014-01-01

    Metastatic cancer is a form of cancer stemming from a primary tumour that propagates to different organs and/or to different sites within the same organ. Studies have indicated that the chances of survival improve upon surgical removal of metastases. The overall goal of this research was to develop a modular surgical instrument that would be easy to use and manipulate and hence facilitate resection of metastases. This research forms part of a final year project carried out by a mechanical eng...

  8. Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

    Science.gov (United States)

    Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

    2016-06-01

    The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

  9. THE STUDY OF RESULTS OF SURGICAL TREATMENT OF PATIENTS WITH VERTEBRAL-SPINAL TRAUMA

    Directory of Open Access Journals (Sweden)

    B. Sh. Minasov

    2010-01-01

    Full Text Available A study of the efficacy of medical rehabilitation of 170 patients with spinal-cord injury through the application of modern rehabilitation and surgical technologies was conducted. Patients of I (control group received standard set of conservative treatment and rehabilitation. Patients of II (main group the rehabilitation was supplemented with therapeutic exercises with the use of loop complex «Hope» and the rate of adaptation to the stress of hypoxia in the late period of injury. Patient of III (control group surgical treatment and the conventional range of rehabilitation were performed. Patients of IV (main group the rehabilitation was completed with early activation using espandernogo complex «Hope» and the rate of adaptation to the stress of hypoxia in the late period of injury. It is proved that the developed complex rehabilitation of patients with spinal-cord injury using an early stable functional osteosynthesis with the minimum extent necessary, the use of complex «Hope» can improve the functional results at the expense of early motor activation, preventing the formation of contractures and muscle atrophy. The use of adaptation to the stress of hypoxia in the late period of vertebro-spinal cord injury improves overall health, reduces the severity of autonomic reactions, emotional stress, can cut pain syndromes.

  10. Vocal Fold Vibration Following Surgical Intervention in Three Vocal Pathologies: A Preliminary Study.

    Science.gov (United States)

    Chen, Wenli; Woo, Peak; Murry, Thomas

    2017-09-01

    High-speed videoendoscopy captures the cycle-to-cycle vibratory motion of each individual vocal fold in normal and severely disordered phonation. Therefore, it provides a direct method to examine the specific vibratory changes following vocal fold surgery. The purpose of this study was to examine the vocal fold vibratory pattern changes in the surgically treated pathologic vocal fold and the contralateral vocal fold in three vocal pathologies: vocal polyp (n = 3), paresis or paralysis (n = 3), and scar (n = 3). Digital kymography was used to extract high-speed kymographic vocal fold images at the mid-membranous region of the vocal fold. Spectral analysis was subsequently applied to the digital kymography to quantify the cycle-to-cycle movements of each vocal fold, expressed as a spectrum. Surgical modification resulted in significantly improved spectral power of the treated pathologic vocal fold. Furthermore, the contralateral vocal fold also presented with improved spectral power irrespective of vocal pathology. In comparison with normal vocal fold spectrum, postsurgical vocal fold vibrations continued to demonstrate decreased vibratory amplitude in both vocal folds. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  11. Risk Factors and Surgical Refinements of Postresective Mandibular Reconstruction: A Retrospective Study

    Directory of Open Access Journals (Sweden)

    Akiko Sakakibara

    2014-01-01

    Full Text Available Background. Postresective mandibular reconstruction is common in cases of oral and mandibular tumors. However, complications such as infection, plate exposure, or plate fracture can occur. We identified several significant risk factors of complications after reconstructive surgery and compared the effectiveness of different surgical techniques for reducing the incidence of complications. Methods. This study is a retrospective analysis of 28 oromandibular cancer cases that required reconstructive surgery between January 1999 and December 2011 at Kobe University Graduate School of Medicine in Japan. All cases were classified using Hashikawa’s CAT and Eichner’s classification methods. Then, we determined whether these classifications and different treatment or surgical methods were significantly related to complications. Results. Complications after mandibular reconstruction occurred in 10/28 patients (36%. Specifically, five patients had plate fractures, four had plate exposures, and one had an infection. Radiation therapy and closure without any flaps were significantly related to infection or plate exposure. The wrap-around technique of securing reconstruction plates was used in 14 cases, whereas the run-through technique was used in two cases. Conclusions. The success of mandibular reconstruction depends on both mechanical and biological factors, such as the location of defects, presence of occlusions, and the amount of vascularization of the flap.

  12. Surgical pathology report defects: a College of American Pathologists Q-Probes study of 73 institutions.

    Science.gov (United States)

    Volmar, Keith E; Idowu, Michael O; Hunt, Jennifer L; Souers, Rhona J; Meier, Frederick A; Nakhleh, Raouf E

    2014-05-01

    The rate of surgical pathology report defects is an indicator of quality and it affects clinician satisfaction. To establish benchmarks for defect rates and defect fractions through a large, multi-institutional prospective application of standard taxonomy. Participants in a 2011 Q-Probes study of the College of American Pathologists prospectively reviewed all surgical pathology reports that underwent changes to correct defects and reported details regarding the defects. Seventy-three institutions reported 1688 report defects discovered in 360,218 accessioned cases, for an aggregate defect rate of 4.7 per 1000 cases. Median institutional defect rate was 5.7 per 1000 (10th to 90th percentile range, 13.5-0.9). Defect rates were higher in institutions with a pathology training program (8.5 versus 5.0 per 1000, P = .01) and when a set percentage of cases were reviewed after sign-out (median, 6.7 versus 3.8 per 1000, P = .10). Defect types were as follows: 14.6% misinterpretations, 13.3% misidentifications, 13.7% specimen defects, and 58.4% other report defects. Overall, defects were most often detected by pathologists (47.4%), followed by clinicians (22.0%). Misinterpretations and specimen defects were most often detected by pathologists (73.5% and 82.7% respectively, P benchmarking data on report defects and defect fractions using standardized taxonomy.

  13. New therapeutical strategies in adjuvant treatment of stage I B and II A cervical cancer after Wertheim-Mergs radical hysterectomy

    International Nuclear Information System (INIS)

    Ivanov, S.

    2003-01-01

    Patients after Wertheim-Mergs radical hysterectomy of stage I B and II A cervical cancer with positive lymph nodes and unfavourable prognostic factors are usually given adjuvant radiotherapy. The aim of our study was to research retrospectively and to analyse the survival of patients after radical hysterectomy and postoperative radiotherapy. Prognostic factors, survival rate failures of treatment and the way of recurrence were evaluated for 420 patients in I B and II A stage for the period of 1990-2003. All patients were radically operated and underwent an adjuvant radiotherapy, 25 of them received adjuvant chemotherapy. Positive lymph nodes were found in 24.52%. All patients having positive for metastases lymph nodes and those with negative lymph nodes but unfavorable prognostic factors received adjuvant radiotherapy (RT). The 5 years survival rate was 63% for the patients with positive lymph nodes and 89% for those with negative lymph nodes. The level of recurrence was 14% for patients with negative and 35% for those with positive lymph nodes. There were 39 pelvic and 41 distant recurrences, but the behavior was different between patients with negative lymph nodes (32 pelvic and 12 distant recurrences) and with positive ones (7 pelvic and 29 distant recurrences). The updated 5 years survival was 24% for patients with pelvic recurrences and 6% for the patients with distant ones. Our therapy strategy for patients with negative lymph nodes who have distant recurrences involves an adjuvant chemotherapy. All patients with negative lymph nodes but positive parametric and positive surgical margins receive postsurgical radiotherapy or an intensive follow up. (author)

  14. Patterns of Local Recurrence and Dose Fractionation of Adjuvant Radiation Therapy in 462 Patients With Soft Tissue Sarcoma of Extremity and Trunk Wall

    Energy Technology Data Exchange (ETDEWEB)

    Jebsen, Nina L., E-mail: nina.louise.jebsen@helse-bergen.no [Department of Clinical Medicine, Faculty of Medicine and Dentistry, University of Bergen, Bergen (Norway); Department of Oncology, Haukeland University Hospital, Bergen (Norway); Engellau, Jacob [Department of Oncology, Skåne University Hospital, Lund (Sweden); Engström, Katarina [Department of Oncology, Sahlgrenska University Hospital, Gothenburg (Sweden); Bauer, Henrik C. [Department of Molecular Medicine and Surgery, Section for Orthopaedics and Sports Medicine, Karolinska University Hospital, Karolinska Institute, Stockholm (Sweden); Monge, Odd R. [Department of Oncology, Haukeland University Hospital, Bergen (Norway); Muren, Ludvig P. [Department of Physics and Technology, University of Bergen, Bergen (Norway); Department of Medical Physics, Aarhus University and Aarhus University Hospital, Aarhus (Denmark); Eide, Geir E. [Centre for Clinical Research, Haukeland University Hospital, Bergen (Norway); Department of Public Health and Primary Health Care, University of Bergen, Bergen (Norway); Trovik, Clement S. [Department of Clinical Medicine, Faculty of Medicine and Dentistry, University of Bergen, Bergen (Norway); Department of Oncology, Haukeland University Hospital, Bergen (Norway); Bruland, Øyvind S. [Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo (Norway); Institute of Clinical Medicine, University of Oslo, Oslo (Norway)

    2013-08-01

    Purpose: To study the impact of dose fractionation of adjuvant radiation therapy (RT) on local recurrence (LR) and the relation of LR to radiation fields. Methods and Materials: LR rates were analyzed in 462 adult patients with soft tissue sarcoma who underwent surgical excision and adjuvant RT at five Scandinavian sarcoma centers from 1998 to 2009. Medical records were reviewed for dose fractionation parameters and to determine the location of the LR relative to the radiation portals. Results: Fifty-five of 462 patients developed a LR (11.9%). Negative prognostic factors included intralesional surgical margin (hazard ratio [HR]: 7.83, 95% confidence interval [CI]: 3.08-20.0), high malignancy grade (HR: 5.82, 95% CI: 1.31-25.8), age at diagnosis (HR per 10 years: 1.27, 95% CI: 1.03-1.56), and malignant peripheral nerve sheath tumor histological subtype (HR: 6.66, 95% CI: 2.56-17.3). RT dose was tailored to margin status. No correlation between RT dose and LR rate was found in multiple Cox regression analysis. The majority (65%) of LRs occurred within the primary RT volume. Conclusions: No significant dose–response effect of adjuvant RT was demonstrated. Interestingly, patients given 45-Gy accelerated RT (1.8 Gy twice daily/2.5 weeks) had the best local outcome. A total dose of 50 Gy in 25 fractions seemed adequate following wide margin surgery. The risk of LR was associated with histopathologic subtype, which should be included in the treatment algorithm of adjuvant RT in soft tissue sarcoma.

  15. Patterns of Local Recurrence and Dose Fractionation of Adjuvant Radiation Therapy in 462 Patients With Soft Tissue Sarcoma of Extremity and Trunk Wall

    International Nuclear Information System (INIS)

    Jebsen, Nina L.; Engellau, Jacob; Engström, Katarina; Bauer, Henrik C.; Monge, Odd R.; Muren, Ludvig P.; Eide, Geir E.; Trovik, Clement S.; Bruland, Øyvind S.

    2013-01-01

    Purpose: To study the impact of dose fractionation of adjuvant radiation therapy (RT) on local recurrence (LR) and the relation of LR to radiation fields. Methods and Materials: LR rates were analyzed in 462 adult patients with soft tissue sarcoma who underwent surgical excision and adjuvant RT at five Scandinavian sarcoma centers from 1998 to 2009. Medical records were reviewed for dose fractionation parameters and to determine the location of the LR relative to the radiation portals. Results: Fifty-five of 462 patients developed a LR (11.9%). Negative prognostic factors included intralesional surgical margin (hazard ratio [HR]: 7.83, 95% confidence interval [CI]: 3.08-20.0), high malignancy grade (HR: 5.82, 95% CI: 1.31-25.8), age at diagnosis (HR per 10 years: 1.27, 95% CI: 1.03-1.56), and malignant peripheral nerve sheath tumor histological subtype (HR: 6.66, 95% CI: 2.56-17.3). RT dose was tailored to margin status. No correlation between RT dose and LR rate was found in multiple Cox regression analysis. The majority (65%) of LRs occurred within the primary RT volume. Conclusions: No significant dose–response effect of adjuvant RT was demonstrated. Interestingly, patients given 45-Gy accelerated RT (1.8 Gy twice daily/2.5 weeks) had the best local outcome. A total dose of 50 Gy in 25 fractions seemed adequate following wide margin surgery. The risk of LR was associated with histopathologic subtype, which should be included in the treatment algorithm of adjuvant RT in soft tissue sarcoma

  16. Who Benefits From Adjuvant Radiation Therapy for Gastric Cancer? A Meta-Analysis

    International Nuclear Information System (INIS)

    Ohri, Nitin; Garg, Madhur K.; Aparo, Santiago; Kaubisch, Andreas; Tome, Wolfgang; Kennedy, Timothy J.; Kalnicki, Shalom; Guha, Chandan

    2013-01-01

    Purpose: Large randomized trials have demonstrated significant survival benefits with the use of adjuvant chemotherapy or chemoradiation therapy for gastric cancer. The importance of adjuvant radiation therapy (RT) remains unclear. We performed an up-to-date meta-analysis of randomized trials testing the use of RT for resectable gastric cancer. Methods and Materials: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for randomized trials testing adjuvant (including neoadjuvant) RT for resectable gastric cancer. Hazard ratios describing the impact of adjuvant RT on overall survival (OS) and disease-free survival (DFS) were extracted directly from the original studies or calculated from survival curves. Pooled estimates were obtained using the inverse variance method. Subgroup analyses were performed to determine whether the efficacy of RT varies with chemotherapy use, RT timing, geographic region, type of nodal dissection performed, or lymph node status. Results: Thirteen studies met all inclusion criteria and were used for this analysis. Adjuvant RT was associated with a significant improvement in both OS (HR = 0.78, 95% CI: 0.70-0.86, P<.001) and DFS (HR = 0.71, 95% CI: 0.63-0.80, P<.001). In the 5 studies that tested adjuvant chemoradiation therapy against adjuvant chemotherapy, similar effects were seen for OS (HR = 0.83, 95% CI: 0.67-1.03, P=.087) and DFS (HR = 0.77, 95% CI: 0.91-0.65, P=.002). Available data did not reveal any subgroup of patients that does not benefit from adjuvant RT. Conclusion: In randomized trials for resectable gastric cancer, adjuvant RT provides an approximately 20% improvement in both DFS and OS. Available data do not reveal a subgroup of patients that does not benefit from adjuvant RT. Further study is required to optimize the implementation of adjuvant RT for gastric cancer with regard to patient selection and integration with systemic therapy

  17. A Comparative Study of Surgical Training in South East Asia, Australia and The United Kingdom

    Directory of Open Access Journals (Sweden)

    Siew Kheong Lum

    2009-07-01

    Conclusion: Quality of training can be improved by changing to a curriculum and competency based model, utilization of continuous assessment methods, reducing service requirements and better compensation for trainers. Southeast Asia has the potential to provide centres of excellence for surgical training. Surgical educators in SEA will find useful information in this paper to improve their programs which will hopefully evolve into a common core curriculum and enable cross border exchange of surgical trainees in SEA for broader exposure.

  18. Combined-modality treatment in advanced oral squamous cell carcinoma. Primary surgery followed by adjuvant concomitant radiochemotherapy

    International Nuclear Information System (INIS)

    Kreppel, Matthias; Dreiseidler, Timo; Zoeller, Joachim E.; Scheer, Martin; Drebber, Uta; Eich, Hans-Theodor; Mueller, Rolf-Peter

    2011-01-01

    The efficacy of adjuvant radiochemotherapy (RCT) in patients with advanced stage head and neck carcinoma has been proven in prospective randomized trials. However, these trials focused on different head and neck sites. Specific analyses for treatment effects in squamous cell carcinoma of the oral cavity (OSCC) are missing. We evaluated our experiences with adjuvant concomitant RCT in advanced OSCC to compare the results with other treatment schemes using adjuvant RCT. A total of 183 patients with OSCC of UICC stages II-IVb were reviewed retrospectively. All patients were treated with radical surgery followed by adjuvant, conventional fractionated concomitant RCT using carboplatin. Overall survival was plotted by Kaplan-Meier analysis. Prognostic factors were identified through univariate and multivariate analysis. Univariate analysis showed a significant impact of T, N, and UICC stage, histopathologic grading, surgical margins, extracapsular spread (ECS), and lymphangiosis carcinomatosa on overall survival (Table 3). Patients with stage IVa had a higher 5-year overall survival rate (42.8%) than patients with stage IVb (25.0%) (Figure 1). The differences were significant in multivariate analysis (p = 0.033) (Table 4). Adjuvant concomitant RCT is an effective treatment in patients with advanced stage OSCC. However, it remains unclear, which patients should be treated with adjuvant RCT. For patients with stage IVb, adjuvant RCT yields poor results. Prospective randomized trials are needed to confirm which patients should be treated with adjuvant RCT. (orig.)

  19. STUDY ON SURGICAL SITE INFECTIONS CAUSED BY ESBL PRODUCING GRAM NEGATIVE BACTERIA

    Directory of Open Access Journals (Sweden)

    Rambabu

    2015-09-01

    Full Text Available Surgical site infections have been a major problem, because of the emergence of drug resistant bacteria, in particular B - lactamase producing bacteria. Extended spectrum beta lactamase producing gram negative organisms pose a great challenge in treatment o f SSI present study is aimed at determining multiple drug resistance in gram negative bacteria & to find out ESBL producers, in correlation with treatment outcome. A total of 120 wound infected cases were studied. Staphylococcus aureus was predominant bact erium - 20.Among gram negative bacteria, Pseudomonas species is predominant (14 followed by Escherichia coli (13 , Klebsiella species (12 , Proteus (9 Citrobacter (4 Providencia (2 & Acinetobacter species (2 . Out of 56 gramnegative bacteria isolated, 20 were i dentified as ESBL producers, which was statistically significant. Delay in wound healing correlated with infection by ESBL producers, which alarms the need of abstinence from antibiotic abuse

  20. Cognitive function after adjuvant treatment for early breast cancer

    DEFF Research Database (Denmark)

    Debess, Jeanne; Riis, Jens Østergaard; Engebjerg, Malene Cramer

    2010-01-01

    The purpose of this study was to examine cognitive function in patients with early breast cancer before and after adjuvant chemotherapy or 6 months of tamoxifen. We performed a population-based study in the county of North Jutland, Denmark, including 120 women aged ... chemotherapy with seven cycles of cyclophosphamide, epirubicin and fluoruracil or adjuvant tamoxifen for 6 months for early breast cancer from 2004 to 2006. They were compared with an aged-matched group of 208 women without previous cancer selected randomly from the same population. Data were collected before...... themselves as impaired at 6 months. Our results do not support that adjuvant