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  1. Glove failure in elective thyroid surgery: A prospective randomized study

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    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  2. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

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    Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

    For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

  3. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

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    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  4. Colon and rectal surgery for cancer without mechanical bowel preparation: one-center randomized prospective trial.

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    Scabini, Stefano; Rimini, Edoardo; Romairone, Emanuele; Scordamaglia, Renato; Damiani, Giampiero; Pertile, Davide; Ferrando, Valter

    2010-04-30

    Mechanical bowel preparation is routinely done before colon and rectal surgery, aimed at reducing the risk of postoperative infectious complications. The aim of the study was to assess whether elective colon and rectal surgery can be safely performed without preoperative mechanical bowel preparation. Patients undergoing elective colon and rectal resections with primary anastomosis were prospectively randomized into two groups. Group A had mechanical bowel preparation with polyethylene glycol before surgery, and group B had their surgery without preoperative mechanical bowel preparation. Patients were followed up for 30 days for wound, anastomotic, and intra-abdominal infectious complications. Two hundred forty four patients were included in the study, 120 in group A and 124 in group B. Demographic characteristics, type of surgical procedure and type of anastomosis did not significantly differ between the two groups. There was no difference in the rate of surgical infectious complications between the two groups but the overall infectious complications rate was 20.0% in group A and 11.3% in group B (p .05). Wound infection (p = 0.18), anastomotic leak (p = 0.52), and intra-abdominal abscess (p = 0.36) occurred in 9.2%, 5.8%, and 5.0% versus 4.8%, 4.0%, and 2.4%, respectively. No mechanical bowel preparation seems to be safe also in rectal surgery. These results suggest that elective colon and rectal surgery may be safely performed without mechanical preparation.

  5. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

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    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  6. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial.

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    Bickel, Amitai; Gurevits, Michael; Vamos, Ronny; Ivry, Simon; Eitan, Arieh

    2011-04-01

    To assess the influence of hyperoxygenation on surgical site infection by using the most homogeneous study population. A randomized, prospective, controlled trial. Department of surgery in a government hospital. A total of 210 patients who underwent open surgery for acute appendicitis. In the study group, patients received 80% oxygen during anesthesia, followed by high-flow oxygen for 2 hours in the recovery room. The control group received 30% oxygen, as usual. Open appendectomy via incision in the right lower quadrant of the abdomen. Surgical site infection, mainly assessed by the ASEPSIS (additional treatment, serous discharge, erythema, purulent discharge, separation of deep tissues, isolation of bacteria, and stay in hospital prolonged >14 days) system score. Surgical site infections were recorded in 6 of 107 patients (5.6%) in the study group vs 14 of 103 patients (13.6%) in the control group (P = .04). Significant differences in the ASEPSIS score were also found. The mean hospital stay was longer in the control group (2.92 days) compared with the study group (2.51 days) (P = .01). The use of supplemental oxygen is advantageous in operations for acute appendicitis by reducing surgical site infection rate and hospital stay. clinicaltrials.gov Identifier: NCT01002365.

  7. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

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    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  8. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  9. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

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    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  10. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

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    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  11. Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study

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    Xu C

    2018-04-01

    Full Text Available Can Xu, Mingqing Li, Chenggong Wang, Hui Li, Hua Liu Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, Hunan Province, People’s Republic of China Purpose: Hallux valgus surgery often results in significant postoperative pain. Adequate control of pain is essential for patient satisfaction and improves the outcome of the procedure. This study aimed to investigate the perioperative analgesic effect of a buprenorphine transdermal patch in patients who underwent hallux valgus surgery.Patients and methods: A total of 90 patients were randomly divided into the following three groups based on the perioperative analgesic method: flurbiprofen axetil intravenous injection (Group F, oral celecoxib (Group C, and buprenorphine transdermal delivery system (BTDS (Group BTDS. The pain status, degree of satisfaction, adverse effects, and administration of tramadol hydrochloride for uncontrolled pain were recorded on the night before surgery, postoperative day 1, postoperative day 2, and postoperative day 3.Results: The BTDS could effectively control perioperative pain for patients undergoing ­hallux valgus surgery. The analgesic effect of the BTDS was better than that of oral celecoxib. In addition, statistically significant differences were not observed in the visual analog scale (VAS scores, adverse effects, and rescue analgesia between the patients who received the BTDS and the patients who received the flurbiprofen axetil intravenous injection. However, the degree of patient satisfaction of the BTDS group was significantly higher (P<0.05 than that of the other two groups.Conclusion: The BTDS (a preemptive analgesia regimen could exert an analgesic effect during the perioperative period for patients who had received hallux valgus surgery, and this effect is beneficial for sustaining postoperative physiological and psychological states and promoting functional rehabilitation. Keywords: hallux valgus, buprenorphine transdermal

  12. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

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    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  13. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

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    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  14. A randomized prospective study of oral levofloxacin vs intravenous flomoxef prophylaxis in postoperative infection after endoscopic sinus surgery.

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    Inoshita, Ayako; Yokoi, Hidenori; Matsumoto, Fumihiko; Yao, Toru; Kawano, Kenji; Furukawa, Masayuki; Ikeda, Katsuhisa

    2010-01-01

    The clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with levofloxacin (LVFX) on endoscopic sinus surgery (ESS) was evaluated. Ninety-three patients undergoing ESS were prospectively enrolled in the present study. The patients were randomly divided into 2 groups, LVFX and flomoxef (FMOX). Two hundred milligrams of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days. There were no statistically significant differences between 2 groups in terms of age, sex, systemic complications, surgical procedures, the duration of the operation, the length of hospitalization, the amount of blood loss, body temperature, or the number of white blood cells or C-reactive protein. Although no statistical significance was observed in the bacterial resistance between the two antibiotics, LVFX seems to show a low rate of resistance pattern change as compared to FMOX. The present study demonstrated that no patients treated with LVFX or FMOX were afflicted with postsurgical infection. Oral administration of LVFX is a simple, cost-effective and safe alternative to intravenous prophylaxis in ESS based on clinical efficacy and bacteriological study. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Role of modified ultrfiltration in adult cardic surgery: a prospective randomized control trial

    International Nuclear Information System (INIS)

    Naveed, D.; Khan, R.A.; Malik, A.; Shah, S.Z.A.; Ullah, I.; Hussain, A.

    2016-01-01

    Background: Cardiopulmonary bypass (CPB) is associated with morbidity and mortality. To reduce its adverse effect modified ultrafiltration is being increasingly employed. This study is planned to evaluate the benefits of modified ultrafiltration (MUF) in adult cardiac surgery. Methods: Eighty consecutive patients presenting to adult cardiac surgery as elective case were enrolled. These patients were randomly divided in to two groups. MUF group which received modified ultrafiltration after separation from CPB and control group which did not receive modified ultrafiltration. Postoperative mediastinal and chest drainage in 24 hrs, blood products requirement, reopening, ICU stay, and mortality in 30 days were recorded. These variables were compared between MUF group and control group. Results: Forty patients were randomized to control group and 40 in MUF group. Mean age was 51.15±8.90 in control group as compared to 46.95±13.24 MUF group (p=0.1). Out of 40 patients in control group 7 (17.5 percentage) were female while 11 (27.5 percentage) out of total 40 were female in MUF group. (p=.284). Mean CBP time was 120.62±20.97 in control group versus 117.37±38.78 in MUF group (p=0.64). Post-operative drain output ranged from 330 ml to 1300 ml in control group and 300 ml to 780 ml in MUF group. Mean postoperative drain output 554.25±192.57 in control group versus 439.22±89.59 in MUF group (p=.001). Three (7.5 percentage) out of 40 patients required re-exploration in control group versus 1 (2.5 percentage) in MUF group. (p=.305). Mean ICU stay was 52.80±22.37 hours in control group versus 45.30±21.82 hours in MUF group (p=0.133). Three (7.5 percentage) out of 40 patients died in control group versus 1 (2.5 percentage) in MUF group. (p=0.305). Conclusion: Use of modified ultrafiltration is associated with low postoperative bleeding less requirements of blood and blood products. (author)

  16. Topical sucralfate for pain after oral CO2 laser surgery: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Guo, Chau-Shiang; Chuang, Hui-Ching; Chien, Chih-Yen

    2012-01-01

    The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO(2) laser treatment of oral leukoplakia. In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6. Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed. This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO(2) laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO(2) laser treatment of oral leukoplakia. Copyright © 2012 Elsevier Inc. All rights reserved.

  17. Pharmacological strategies to reduce pruritus during postoperative epidural analgesia after lumbar fusion surgery - a prospective randomized trial in 150 patients

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    Robinson Yohan

    2011-05-01

    Full Text Available Abstract Background Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial. Patients and methods 150 patients (87 women treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B and 74 to ropivacain and oxycodone (group R. Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred. Results The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R. Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p Conclusions Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks.

  18. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

    Science.gov (United States)

    Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

    2016-09-01

    Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

  19. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial

    NARCIS (Netherlands)

    Stevens, Markus F.; Werdehausen, Robert; Golla, Elisabeth; Braun, Sebastian; Hermanns, Henning; Ilg, Ansgar; Willers, Reinhardt; Lipfert, Peter

    2007-01-01

    BACKGROUND: In this prospective, randomized, double-blind trial we investigated the use of stimulating catheters in patients during and after shoulder surgery; functional improvement being the primary outcome measurement. METHODS: After eliciting an adequate muscular twitch at

  20. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

    Science.gov (United States)

    Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

    2012-12-01

    Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

  1. Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial.

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    Ari, Seyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Caca, Ihsan

    2009-08-01

    The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based

  2. Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: a multicenter prospective randomized study

    Science.gov (United States)

    Miyake, Kensaku; Yokoi, Norihiko

    2017-01-01

    Purpose To investigate influences of 3% diquafosol sodium ophthalmic solution (DQS) on ocular surface after cataract surgery and effects on postoperative dry eye. Design This study had two consecutive prospective study phases. The former was an observational study from before cataract surgery to 4 weeks after surgery and the latter was a randomized open-label study from 4 to 8 weeks after surgery. Methods Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms), and Schirmer I test were conducted before surgery and 4 weeks after surgery. Patient demographics and these examination results were used to analyze risk factors to predict postoperative dry eye. In a randomized study, 154 eyes diagnosed with dry eye postoperatively were applied either DQS or artificial tears (AT) six times daily for 4 weeks. The data of the examinations were compared. Results At 4 weeks after surgery, BUT was shortened significantly (P=0.036), fluorescein staining score increased significantly (P=0.012), but total subjective symptom score was significantly improved (Pdry eye was shortened BUT type (53.1%). The dry eye prevalence after surgery decreased (55.7%) compared with before surgery (69.7%). Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye. In a randomized study, BUT was significantly prolonged in the DQS group (P=0.015), but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001). Total subjective symptom score was significantly decreased in the AT group (P<0.001), but not in the DQS group. Conclusion Our study suggests that cataract surgery has harmful effects on tear film stability and ocular surface, and DQS has a capability to improve them. PMID:28360509

  3. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  4. Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: a multicenter prospective randomized study

    Directory of Open Access Journals (Sweden)

    Miyake K

    2017-03-01

    Full Text Available Kensaku Miyake,1 Norihiko Yokoi2 On behalf of Dry Eye After Cataract Surgery Investigational Study Group (DASIS group 1Miyake Eye Hospital, Nagoya, 2Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan Purpose: To investigate influences of 3% diquafosol sodium ophthalmic solution (DQS on ocular surface after cataract surgery and effects on postoperative dry eye. Design: This study had two consecutive prospective study phases. The former was an observational study from before cataract surgery to 4 weeks after surgery and the latter was a randomized open-label study from 4 to 8 weeks after surgery. Methods: Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT, corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms, and Schirmer I test were conducted before surgery and 4 weeks after surgery. Patient demographics and these examination results were used to analyze risk factors to predict postoperative dry eye. In a randomized study, 154 eyes diagnosed with dry eye postoperatively were applied either DQS or artificial tears (AT six times daily for 4 weeks. The data of the examinations were compared. Results: At 4 weeks after surgery, BUT was shortened significantly (P=0.036, fluorescein staining score increased significantly (P=0.012, but total subjective symptom score was significantly improved (P<0.001. The majority of postoperative dry eye was shortened BUT type (53.1%. The dry eye prevalence after surgery decreased (55.7% compared with before surgery (69.7%. Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye. In a randomized study, BUT was significantly prolonged in the DQS group (P=0.015, but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001. Total subjective symptom

  5. Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

    Science.gov (United States)

    Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

    2017-02-01

    Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

  6. Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

    2018-01-01

    A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

  7. Are postoperative intravenous antibiotics necessary after bimaxillary orthognathic surgery? A prospective, randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Tan, S K; Lo, J; Zwahlen, R A

    2011-12-01

    Postoperative antibiotic prophylaxis is often administered intravenously, despite an increased morbidity rate compared with oral application. This study investigates whether a postoperative oral antibiotic regimen is as effective as incorporation of intravenous antibiotics after bimaxillary orthognathic surgery. 42 patients who underwent bimaxillary orthognathic surgery between December 2008 and May 2010 were randomly allocated to 2 placebo-controlled postoperative antibiotic prophylaxis groups. Group 1 received oral amoxicillin 500mg three times daily; group 2 received intravenous ampicillin 1g four times daily, during the first two postoperative days. Both groups subsequently took oral amoxicillin for three more days. Clinically, the infection rate was assessed in both study groups for a period of 6 weeks after the surgery. 9 patients (21.4%) developed infection. No adverse drug event was detected. No significant difference (p=0.45) was detected in the infection rate between group 1 (3/21) and group 2 (6/21). Age, type of surgical procedures, duration of the operative procedure, surgical procedure-related events, blood loss, and blood transfusion were all found not related to infection (p>0.05). Administration of more cost-effective oral antibiotic prophylaxis, which causes less comorbidity, can be considered to be safe in bimaxillary orthognathic surgery with segmentalizations. Copyright © 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  8. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial.

    Science.gov (United States)

    Lee, Won-Suk; Lee, Kwang-Beom; Lim, Soyi; Chang, Young Gin

    2015-09-03

    Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery. In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086). There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group. NCT01752374 , www.clinicaltrials.gov .

  9. Virtual Reality Robotic Surgery Warm-Up Improves Task Performance in a Dry Lab Environment: A Prospective Randomized Controlled Study

    Science.gov (United States)

    Lendvay, Thomas S.; Brand, Timothy C.; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M.

    2014-01-01

    Background Pre-operative simulation “warm-up” has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. Study Design In a two-center randomized trial, fifty-one residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot. Once successfully achieving performance benchmarks, surgeons were randomized to either receive a 3-5 minute VR simulator warm-up or read a leisure book for 10 minutes prior to performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical and cognitive errors. Results Task time (-29.29sec, p=0.001, 95%CI-47.03,-11.56), path length (-79.87mm, p=0.014, 95%CI -144.48,-15.25), and cognitive errors were reduced in the warm-up group compared to the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32, p=0.020, 95%CI 0.06,0.59) were reduced after the dissimilar VR task. When surgeons were stratified by prior robotic and laparoscopic clinical experience, the more experienced surgeons(n=17) demonstrated significant improvements from warm-up in task time (-53.5sec, p=0.001, 95%CI -83.9,-23.0) and economy of motion (0.63mm/sec, p=0.007, 95%CI 0.18,1.09), whereas improvement in these metrics was not statistically significantly appreciated in the less experienced cohort(n=34). Conclusions We observed a significant performance improvement and error reduction rate among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic

  10. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

    Science.gov (United States)

    Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto

    2009-06-01

    Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

  11. Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: a prospective randomized blinded study.

    Science.gov (United States)

    Moser, C; Opitz, I; Zhai, W; Rousson, V; Russi, E W; Weder, W; Lardinois, D

    2008-10-01

    Prolonged air leak is reported in up to 50% of patients after lung volume reduction surgery. The effect of an autologous fibrin sealant on the intensity and duration of air leak and on the time to chest drain removal after lung volume reduction surgery was investigated in a randomized prospective clinical trial. Twenty-five patients underwent bilateral thoracoscopic lung volume reduction surgery. In each patient, an autologous fibrin sealant was applied along the staple lines on one side, whereas no additional measure was taken on the other side. Randomization of treatment was performed at the end of the resection on the first side. Air leak was assessed semiquantitatively by use of a severity score (0 = no leak; 4 = continuous severe leak) by two investigators blinded to the treatment. Mean value of the total severity scores for the first 48 hours postoperative was significantly lower in the treated group (4.7 +/- 7.7) than in the control group (16.0 +/- 10.1) (P drainage were also significantly reduced after application of the sealant (4.5% and 2.8 +/- 1.9 days versus 31.8% and 5.9 +/- 2.9 days) (P = .03 and P drainage.

  12. Acquisition and retention of laparoscopic skills is different comparing conventional laparoscopic and single-incision laparoscopic surgery: a single-centre, prospective randomized study.

    Science.gov (United States)

    Ellis, Scott Michael; Varley, Martin; Howell, Stuart; Trochsler, Markus; Maddern, Guy; Hewett, Peter; Runge, Tina; Mees, Soeren Torge

    2016-08-01

    Training in laparoscopic surgery is important not only to acquire and improve skills but also avoid the loss of acquired abilities. The aim of this single-centre, prospective randomized study was to assess skill acquisition of different laparoscopic techniques and identify the point in time when acquired skills deteriorate and training is needed to maintain these skills. Sixty surgical novices underwent laparoscopic surgery (LS) and single-incision laparoscopic surgery (SILS) baseline training (BT) performing two validated tasks (peg transfer, precision cutting). The novices were randomized into three groups and skills retention testing (RT) followed after 8 (group A), 10 (group B) or 12 (group C) weeks accordingly. Task performance was measured in time with time penalties for insufficient task completion. 92 % of the participants completed the BT and managed to complete the task in the required time frame of proficiency. Univariate and multivariate analyses revealed that SILS (P skills (comparison of BT vs RT) was not identified; however, for SILS a significant deterioration of skills (adjustment of BT and RT values) was demonstrated for all groups (A-C) (P skills more difficult to maintain. Acquired LS skills were maintained for the whole observation period of 12 weeks but SILS skills had begun to deteriorate at 8 weeks. These data show that maintenance of LS and SILS skills is divergent and training curricula need to take these specifics into account.

  13. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    International Nuclear Information System (INIS)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner; Brunner, Thomas B.; Witzigmann, Helmut; Marti, Lukas; Bechstein, Wolf-Otto; Bruns, Christiane; Jungnickel, Henry; Schreiber, Stefan; Grabenbauer, Gerhard G.; Meyer, Thomas; Fietkau, Rainer

    2015-01-01

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [de

  14. The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study

    Directory of Open Access Journals (Sweden)

    Usha Kiran

    2017-01-01

    Full Text Available Introduction: Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. Materials and Methods: A prospective randomized control study was carried out in a single tertiary care center. One hundred and fifty patients undergoing elective coronary artery bypass surgery were enrolled in the study. The patients were randomized in two groups namely, Group 1 (Rajyoga group and Group 2 (Control Group. Anxiety was measured on a visual analog scale 1–10 before the start of Rajyoga training or patient counseling (T1, on the morning of the day of surgery (T2, on the 2nd postoperative day (T3, and on the 5th postoperative day (T4. The serum cortisol level was measured in the morning of the day of surgery (T1, on the 2nd postoperative day (T2 and on the 5th postoperative day (T3, respectively. Results: In the study, it was seen that the anxiety level of the patients before the surgery (T1 and on the day of surgery (T2 were comparable between the two groups. However on the 2nd postoperative day (T3, the patients who underwent Rajyoga training had lower anxiety level in comparison to the control group (3.12 ± 1.45 vs. 6.12 ± 0.14, P < 0.05 and on the 5th postoperative day (T4 it was seen that Rajyoga practice had resulted in significant decline in anxiety level (0.69 ± 1.1 vs. 5.6 ± 1.38, P < 0.05. The serum cortisol level was also favorably modulated by the practice of Rajyoga meditation. Conclusion: Mindbody intervention is found to effective in reducing the anxiety of the patients and modulating the cortisol level in patients undergoing wellknown stressful surgery like coronary artery bypass surgery.

  15. Thoracic paravertebral block versus transversus abdominis plane block in major gynecological surgery: a prospective, randomized, controlled, observer-blinded study

    Directory of Open Access Journals (Sweden)

    Melnikov AL

    2012-10-01

    Full Text Available Andrey L Melnikov,1 Steinar Bjoergo,1 Ulf E Kongsgaard21Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; 2Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital and Medical Faculty, University of Oslo, Oslo, NorwayBackground and objectives: Patients undergoing abdominal surgery often receive an epidural infusion for postoperative analgesia. However, when epidural analgesia is contraindicated or unwanted, the administration of opioids is the usual means used to relieve pain. Various regional analgesia techniques used in conjunction with systemic analgesia have been reported to reduce the cumulative postoperative opioid consumption and opioid-induced side effects. The objective of this trial was to assess the effectiveness of transversus abdominis plane block and paravertebral block in women undergoing major gynecological surgery.Methods: We analyzed 58 patients scheduled for a midline vertical laparatomy due to gynecological cancer. They were all equipped with a patient-controlled postoperative analgesia pump that delivered ketobemidon. In addition, some patients were randomized to receive either a bilateral transversus abdominis plane block (n = 19 or a bilateral paravertebral block at the level of Th10 (n = 19. Both blocks were performed preoperatively as a single injection of bupivacaine.Results: Cumulative ketobemidon consumption, postoperative pain scores at rest and while coughing, and postoperative nausea and vomiting scores were assessed by a blinded observer at 2, 4, 6, 24, and 48 hours postoperatively. Both blocks were associated with significant reductions in opioid consumption and pain scores throughout the study period compared with the control patients. Postoperative nausea and vomiting scores were low in all groups, but during the early postoperative period more control group patients needed antiemetics

  16. A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

    Science.gov (United States)

    Weltert, Luca; Rondinelli, Beatrice; Bello, Ricardo; Falco, Mauro; Bellisario, Alessandro; Maselli, Daniele; Turani, Franco; De Paulis, Ruggero; Pierelli, Luca

    2015-07-01

    We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; pHRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; pHRE (pHRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). In anemic patients (HbHRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events. © 2015 AABB.

  17. Multicenter prospective randomized phase II study of antimicrobial prophylaxis in low-risk patients undergoing colon surgery.

    Science.gov (United States)

    Shimizu, Junzo; Ikeda, Kimimasa; Fukunaga, Mutsumi; Murata, Kohei; Miyamoto, Atsushi; Umeshita, Koji; Kobayashi, Tetsuro; Monden, Morito

    2010-10-01

    Postoperative antimicrobial therapy is generally administered as standard prophylaxis against postoperative infection, despite a lack of sufficient evidence for its usefulness. This study was a phase II study to evaluate the necessity of postoperative antibiotic prophylaxis in patients undergoing a colectomy. Patients received 1 g cefmetazole or flomoxef immediately after anesthetic induction, every 3 h during surgery, and then later once again on the next day. They were randomly assigned to receive either cefmetazole or flomoxef. Ninety-one patients were enrolled in the study. A surgical site infection (SSI) occurred in 7.7% (7/91) of patients. All cases were superficial incisional infections. When comparing the two drugs, SSI occurred in 8.3% (4/48) of patients treated with cefmetazole and in 7.0% (3/43) treated with flomoxef, showing no significant difference (P > 0.99). Antimicrobial prophylaxis was well tolerated when used on the day of a colectomy and once again on the next day.

  18. Local infiltration analgesia in urogenital prolapse surgery: a prospective randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Kristensen, Billy B; Rasmussen, Yvonne H; Agerlin, Marianne

    2011-01-01

    To evaluate the analgesic effect of high-volume infiltration analgesia in urogenital prolapse surgery and provide a detailed description of the infiltration technique.......To evaluate the analgesic effect of high-volume infiltration analgesia in urogenital prolapse surgery and provide a detailed description of the infiltration technique....

  19. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Brunner, Thomas B. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany); Witzigmann, Helmut [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Marti, Lukas [Hospital of Kanton St. Gallen, General Surgery, St. Gallen (Switzerland); Bechstein, Wolf-Otto [University Hospital Frankfurt, Department of Surgery, Frankfurt/Main (Germany); Bruns, Christiane [University Hospital Munich, Department of Surgery - Hospital Campus Grosshadern, Munich (Germany); University Hospital Magdeburg, Department of Surgery, Magdeburg (Germany); Jungnickel, Henry [Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Schreiber, Stefan [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Grabenbauer, Gerhard G. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Hospital Coburg, Department of Radiation Oncology, Coburg (Germany); Meyer, Thomas [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Hospital Ansbach, General Surgery, Ansbach (Germany); Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-09-25

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [German] Mehrere nichtrandomisierte Studien zeigten, dass eine neoadjuvante Therapie das Ueberleben bei Patienten mit Pankreaskarzinom verlaengert. Beim lokal fortgeschrittenen Rektumkarzinom gehoert die

  20. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    Science.gov (United States)

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  1. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine.

    NARCIS (Netherlands)

    Beck, D.E.; Cohen, Z.; Fleshman, J.W.; Kaufman, H.S.; Goor, H. van; Wolff, B.G.

    2003-01-01

    INTRODUCTION: Seprafilm adhesion barrier (Seprafilm) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial

  2. Nasogastric tube versus gastrostomy tube for gastric decompression in abdominal surgery: a prospective, randomized trial comparing patients' tube-related inconvenience.

    Science.gov (United States)

    Hoffmann, S; Koller, M; Plaul, U; Stinner, B; Gerdes, B; Lorenz, W; Rothmund, M

    2001-11-01

    Perioperative decompression of the stomach is still a common procedure and can be achieved using either nasogastric tubes (NTs) or gastrostomy tubes (GTs). While both procedures appear to be equally effective, some authors believe that NTs are less convenient for patients than GTs. However, to date, no reliable prospective data are available on this issue. We conducted a prospective, randomized trial comparing NTs versus GTs with a total of 110 patients undergoing elective colon surgery. The primary outcome measure was the patient's tube-related inconvenience and pain, assessed in a standardized interview on day 2 after surgery and quantified by means of a visual-analog scale (VAS). A questionnaire including the EORTC QLQ-C30 and additional items regarding retrospective tube-related judgements was administered on the day of discharge and 4 weeks after discharge. Secondary endpoints were the therapy-related morbidity and general complications. When patients were asked which of their drainage tubes (all patients had three or four drainage tubes, such as decompression drains, urinary drains, central venous line) was most inconvenient, 43% (CI 33-53%) in the NT group reported that the NT was most inconvenient, while only 4% (CI 1-10%) of the GT patients judged the GT most inconvenient ( Ptube system (day 2 p.o.: 71%, CI 61-80%; 4 weeks p.o.: 66%, CI 56-75%) than did GT patients (day 2 p.o.: 94%, CI 88-98%; 4 weeks p.o.: 91% CI 84-96%); again, these differences were statistically significant ( Ptube system have to weigh up the possibilities of different averse clinical as well as subjective outcomes. It is then preferable to include patients' preferences in the individual decision making process (shared-decision making).

  3. Comparison of the changes in blood glucose level during sedation with midazolam and propofol in implant surgery: a prospective randomized clinical trial.

    Science.gov (United States)

    Kaviani, Nasser; Koosha, Farzad; Shahtusi, Mina

    2014-09-01

    Reducing the patients' stress can prevent, or at least, limit the increase in blood glucose level. The study compares the effect of propofol and midazolam on blood glucose level in the patients undergoing dental implant surgery. The effect of pre-operational stress on blood glucose level during the surgery is also evaluated. This prospective randomized clinical trial recruited 33 patients undergoing dental implant surgery and divided into two groups. Conscious sedation was performed by midazolam in one group and with propofol in another group. The pre-operational stress was scored and the blood glucose level was measured in 4 different stages; before the operation, two minutes after the local anesthetic injection; thirty minutes after the onset of operation and at the end of the operation. The results were analyzed by employing ANOVA and Pearson test. The p Value was adopted 0.05 and the confidence coefficient was assumed 95%. The average levels of the blood glucose in midazolam and propofol group were 93.82 mg/dl and 94 mg/dl before the operation which displayed a meaningful increase of blood glucose level in both groups as the operation went on. The values were 103.76 mg/dl for midazolam and 108.56 mg/dl for the propofol group (pblood glucose level between two groups in the different stages of the operation (p= 0.466). The Pearson correlation coefficient test revealed a higher increase in the blood glucose level in the patients with a higher pre-operational stress score (r= 0.756, pblood glucose level while undergoing an operation. No statistically significant difference was detected between midazolam and propofol.

  4. Two-stage revision surgery with preformed spacers and cementless implants for septic hip arthritis: a prospective, non-randomized cohort study

    Directory of Open Access Journals (Sweden)

    Logoluso Nicola

    2011-05-01

    Full Text Available Abstract Background Outcome data on two-stage revision surgery for deep infection after septic hip arthritis are limited and inconsistent. This study presents the medium-term results of a new, standardized two-stage arthroplasty with preformed hip spacers and cementless implants in a consecutive series of adult patients with septic arthritis of the hip treated according to a same protocol. Methods Nineteen patients (20 hips were enrolled in this prospective, non-randomized cohort study between 2000 and 2008. The first stage comprised femoral head resection, debridement, and insertion of a preformed, commercially available, antibiotic-loaded cement hip spacer. After eradication of infection, a cementless total hip arthroplasty was implanted in the second stage. Patients were assessed for infection recurrence, pain (visual analog scale [VAS] and hip joint function (Harris Hip score. Results The mean time between first diagnosis of infection and revision surgery was 5.8 ± 9.0 months; the average duration of follow up was 56.6 (range, 24 - 104 months; all 20 hips were successfully converted to prosthesis an average 22 ± 5.1 weeks after spacer implantation. Reinfection after total hip joint replacement occurred in 1 patient. The mean VAS pain score improved from 48 (range, 35 - 84 pre-operatively to 18 (range, 0 - 38 prior to spacer removal and to 8 (range, 0 - 15 at the last follow-up assessment after prosthesis implantation. The average Harris Hip score improved from 27.5 before surgery to 61.8 between the two stages to 92.3 at the final follow-up assessment. Conclusions Satisfactory outcomes can be obtained with two-stage revision hip arthroplasty using preformed spacers and cementless implants for prosthetic hip joint infections of various etiologies.

  5. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study.

    Science.gov (United States)

    Lu, Xin; Li, Ying; Yang, Huayu; Sang, Xinting; Zhao, Haitao; Xu, Haifeng; Du, Shunda; Xu, Yiyao; Chi, Tianyi; Zhong, Shouxian; Yu, Kang; Mao, Yilei

    2013-02-01

    The rising of individualized therapy requires nutritional risk screening has become a major topic for each particular disease, yet most of the screenings were for malignancies, less for benign diseases. There is no report on the screening of patients with benign liver tumors postoperatively. We aim to evaluate the nutritional support strategies post operation for benign liver tumors through nutritional risk screening. In this prospective, randomized, controlled study, 95 patients who underwent hepatectomy for benign tumors were divided into two groups. Fifty patients in the control group were given routine permissive underfeeding nutritional supply (75 kJ/kg/d), and 45 patients in the experimental group were given lower energy (42 kJ/kg/d) in accordance of their surgical trauma. Routine blood tests, liver/kidney function were monitored before surgery and at the day 1, 3, 5, 9 after surgery, patients were observed for the time of flatus, complications, length of hospitalization (LOH), nutrition-related costs, and other clinical parameters. This completed study is registered with Clinicaltrials.gov, number NCT01292330. The nutrition-related expenses (494.0±181.0 vs. 1,514.4±348.4 RMB, Pgroup were significantly lower than those in the control group. Meanwhile, the lowered energy supply after the surgeries did not have adverse effects on clinical parameters, complications, and LOH. Patient with benign liver tumors can adopt an even lower postoperative nutritional supply that close to that for mild non-surgical conditions, and lower than the postoperative permissive underfeeding standard.

  6. Local anesthesia with epinephrine is safe and effective for oral surgery in patients with type 2 diabetes mellitus and coronary disease: a prospective randomized study

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    Marcela Alves dos Santos-Paul

    2015-03-01

    Full Text Available OBJECTIVE: To investigate the variations in blood glucose levels, hemodynamic effects and patient anxiety scores during tooth extraction in patients with type 2 diabetes mellitus T2DM and coronary disease under local anesthesia with 2% lidocaine with or without epinephrine. STUDY DESIGN: This is a prospective randomized study of 70 patients with T2DM with coronary disease who underwent oral surgery. The study was double blind with respect to the glycemia measurements. Blood glucose levels were continuously monitored for 24 hours using the MiniMed Continuous Glucose Monitoring System. Patients were randomized into two groups: 35 patients received 5.4 mL of 2% lidocaine, and 35 patients received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. Hemodynamic parameters (blood pressure and heart rate and anxiety levels were also evaluated. RESULTS: There was no difference in blood glucose levels between the groups at each time point evaluated. Surprisingly, both groups demonstrated a significant decrease in blood glucose levels over time. The groups showed no significant differences in hemodynamic and anxiety status parameters. CONCLUSION: The administration of 5.4 mL of 2% lidocaine with epinephrine neither caused hyperglycemia nor had any significant impact on hemodynamic or anxiety parameters. However, lower blood glucose levels were observed. This is the first report using continuous blood glucose monitoring to show the benefits and lack of side effects of local anesthesia with epinephrine in patients with type 2 diabetes mellitus and coronary disease.

  7. The effect of crystalloid versus Low molecular weight colloid solution on post-operative nausea and vomiting after ambulatory gynecological surgery - a prospective randomized trial

    LENUS (Irish Health Repository)

    Hayes, Ivan

    2012-07-31

    AbstractBackgroundIntravenous fluid is recommended in international guidelines to improve patient post-operative symptoms, particularly nausea and vomiting. The optimum fluid regimen has not been established. This prospective, randomized, blinded study was designed to determine if administration of equivolumes of a colloid (hydroxyethyl starch 130\\/0.4) reduced post operative nausea and vomiting in healthy volunteers undergoing ambulatory gynecologic laparoscopy surgery compared to a crystalloid solution (Hartmann’s Solution).Methods120 patients were randomized to receive intravenous colloid (N = 60) or crystalloid (N = 60) intra-operatively. The volume of fluid administered was calculated at 1.5 ml.kg-1 per hour of fasting. Patients were interviewed to assess nausea, vomiting, anti-emetic use, dizziness, sore throat, headache and subjective general well being at 30 minutes and 2, 24 and 48 hours post operatively. Pulmonary function testing was performed on a subgroup.ResultsAt 2 hours the proportion of patients experiencing nausea (38.2 % vs 17.9%, P = 0.03) and the mean nausea score were increased in the colloid compared to crystalloid group respectively (1.49 ± 0.3 vs 0.68 ± 0.2, P = 0.028). The incidence of vomiting and anti-emetic usage was low and did not differ between the groups. Sore throat, dizziness, headache and general well being were not different between the groups. A comparable reduction on post-operative FVC and FEV-1 and PEFR was observed in both groups.ConclusionsIntra-operative administration of colloid increased the incidence of early postoperative nausea and has no advantage over crystalloid for symptom control after gynaecological laparoscopic surgery.

  8. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure

    Directory of Open Access Journals (Sweden)

    Anant Kumar

    2001-01-01

    Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.

  9. Single-Incision Transumbilical Surgery (SITUS) versus Single-Port Laparoscopic Surgery and conventional laparoscopic surgery: a prospective randomized comparative study of performance with novices in a dry laboratory.

    Science.gov (United States)

    Schoenthaler, Martin; Avcil, Tuba; Sevcenco, Sabina; Nagele, Udo; Hermann, Thomas E W; Kuehhas, Franklin E; Shariat, Shahrokh F; Frankenschmidt, Alexander; Wetterauer, Ulrich; Miernik, Arkadiusz

    2015-01-01

    To evaluate the Single-Incision Transumbilical Surgery (SITUS) technique as compared to an established laparoendoscopic single-site surgery (LESS) technique (Single-Port Laparoscopic Surgery, SPLS) and conventional laparoscopy (CLS) in a surgical simulator model. Sixty-three medical students without previous laparoscopic experience were randomly assigned to one of the three groups (SITUS, SPLS and CLS). Subjects were asked to perform five standardized tasks of increasing difficulty adopted from the Fundamentals of Laparoscopic Surgery curriculum. Statistical evaluation included task completion times and accuracy. Overall performances of all tasks (except precision cutting) were significantly faster and of higher accuracy in the CLS and SITUS groups than in the SPLS group (p = 0.004 to p port-assisted LESS technique such as SPLS. The demonstrated advantages of SITUS may be attributed to a preservation of the basic principles of conventional laparoscopy, such as the use of straight instruments and an adequate degree of triangulation.

  10. Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

    Science.gov (United States)

    Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

    2014-03-01

    We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

  11. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results.

    Science.gov (United States)

    Lim, Lyndell L; Morrison, Julie L; Constantinou, Marios; Rogers, Sophie; Sandhu, Sukhpal S; Wickremasinghe, Sanjeewa S; Kawasaki, Ryo; Al-Qureshi, Salmaan

    2016-05-01

    To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME). Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months. Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months. Change in central macular thickness (CMT) and best corrected visual acuity at 6 months. Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group. When administered at the time of cataract surgery in patients with DME, at 6 months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group. © 2016 Royal Australian and New

  12. What is Result: Short-term Medium Chain Triglyceride Diet Effective on
Postoperative Outcome in Lung Cancer Surgery? A Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Na DU

    2016-12-01

    Full Text Available Background and objective It has been proven that medium chain triglyceride (MCT diet was contribute to fast track recovery after surgery in patients with operation. In this study, the benefit of postoperative short term MCT diet support was investigated for non-small cell lung cancer patients who underwent anatomic resection. Methods A prospective study was planned with the approval of our institutional review board. 117 lung cancer patients who underwent anatomic resection in a single medical group between December 2015 and March 2016 were randomized. 62 patients were applied a MCT diet. and 55 patients in the control group who were fed with only normal diet, and the serum albumin levels, anus exhaust time, chest drainage, chest drainage time, the hospitalization time of post operation, average hospital cost were analysed. Results The mean anus exhaust time in MCT group [(27.87±14.38 h] was significantly shorter than that in RDG group [(45.18±8.62 h] (P<0.001; The mean chest tube drainage time in MCT group [(75.40±48.41 h] were less than that in RDG group [(110.64±94.19 h] (P=0.025. The mean chest tube drainage volume in MCT group [395 mL] were less than that in RDG group [590 mL] (P=0.027. The hospitalization time of post operation was (5.26±2.96 d in MCT group against (6.73±3.99 d in RGD group (P=0.030. The serum albumin levels of postoperative in MCT group [(37.26±2.70 g/L] was significantly higher than that in RDG group [(35.92±3.12 g/L] (P=0.023. Conclusion The results of this study demonstrated that postoperative short term MCT diet is beneficial in postoperative gastrointestinal function fast recovered and shorten the hospitalization time in non-small cell lung cancer patients after surgery.

  13. Comparison of multi-modal early oral nutrition for the tolerance of oral nutrition with conventional care after major abdominal surgery: a prospective, randomized, single-blind trial.

    Science.gov (United States)

    Sun, Da-Li; Li, Wei-Ming; Li, Shu-Min; Cen, Yun-Yun; Xu, Qing-Wen; Li, Yi-Jun; Sun, Yan-Bo; Qi, Yu-Xing; Lin, Yue-Ying; Yang, Ting; Lu, Qi-Ping; Xu, Peng-Yuan

    2017-02-10

    Early oral nutrition (EON) has been shown to improve recovery of gastrointestinal function, length of stay and mortality after abdominal surgery; however, early oral nutrition often fails during the first week after surgery. Here, a multi-modal early oral nutrition program is introduced to promote recovery of gastrointestinal function and tolerance of oral nutrition. Consecutive patients scheduled for abdominal surgery were randomized to the multimodal EON group or a group receiving conventional care. The primary endpoint was the time of first defecation. The secondary endpoints were outcomes and the cost-effectiveness ratio in treating infectious complications. The rate of infectious-free patients was regarded as the index of effectiveness. One hundred seven patients were randomly assigned to groups. Baseline characteristics were similar for both groups. In intention-to-treat analysis, the success rate of oral nutrition during the first week after surgery in the multimodal EON group was 44 (83.0%) versus 31 (57.4%) in the conventional care group (P = 0.004). Time to first defecation, time to flatus, recovery time of bowel sounds, and prolonged postoperative ileus were all less in the multimodal EON group (P oral nutrition group (P oral nutrition program was an effective way to improve tolerance of oral nutrition during the first week after surgery, decrease the length of stay and improve cost-effectiveness after abdominal surgery. Registration number: ChiCTR-TRC-14004395 . Registered 15 March 2014.

  14. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial

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    Georgopoulou Stavroula

    2010-02-01

    Full Text Available Abstract Background Cardiac surgery is a major consumer of blood products, and hemodilution increases transfusion requirements during cardiac surgery under CPB. As intraoperative parenteral fluids contribute to hemodilution, we evaluated the hypothesis that intraoperative fluid restriction reduces packed red-cell (PRC use, especially in transfusion-prone adults undergoing elective cardiac surgery. Methods 192 patients were randomly assigned to restrictive (group A, 100 pts, or liberal (group B, 92 pts intraoperative intravenous fluid administration. All operations were conducted by the same team (same surgeon and perfusionist. After anesthesia induction, intravenous fluids were turned off in Group A (fluid restriction patients, who only received fluids if directed by protocol. In contrast, intravenous fluid administration was unrestricted in group B. Transfusion decisions were made by the attending anesthesiologist, based on identical transfusion guidelines for both groups. Results 137 of 192 patients received 289 PRC units in total. Age, sex, weight, height, BMI, BSA, LVEF, CPB duration and surgery duration did not differ between groups. Fluid balance was less positive in Group A. Fewer group A patients (62/100 required transfusion compared to group B (75/92, p Conclusions Our data suggest that fluid restriction reduces intraoperative PRC transfusions without significantly increasing postoperative transfusions in cardiac surgery; this effect is more pronounced in transfusion-prone patients. Trial registration NCT00600704, at the United States National Institutes of Health.

  15. Evaluation of Preemptive Use of Analgesia of The Skin, Before and After Lower Abdominal Surgery: A Prospective, Double-Blind, Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    P Kashefi

    2005-03-01

    Full Text Available Background: Perioperative pain is prevalent and poorly treated. Apart from that it makes the recovery from surgery unpleasent, pain often remains as a residual side effect of surgery, even though the tissue healing is complete. An essential observation is that tissue injury and the resulting nociceptor barrage initiates a cascade of events that can indelibly alter pain perception. Preemptive analgesia is the concept of initiating analgesic therapy before the onset of the noxious stimulus so as to prevent the nociceptor barrage and its consequences. However, anticipated clinical potency of preemptive analgesia, though has firmly grounded in the neurobiology of pain, has not been yet realized. As data accumulates, it has become clear that clinical studies emulating those from the laboratory and designed around a relatively narrow definition of preemptive analgesia have been largely unsupportive of its use. Nevertheless, preemptive analgesic interventions that recognize the intensity, duration, and somatotopic extent of major surgery can help reduce perioperative pain and its longer-term sequelae. surgeons spend a lot of time treating the pain of lower abdominal surgery. Methods: A total number of 48 consecutive patients who were going to undergo elective lower abdominal surgery. Were randomly assigned in two groups of 24 each. In one group the patients received an injection of 0.5 % bupivacaine in the planned skin for incision just before lower abdominal surgery, and in the other group, they received an equal amount of 0.5% bupivacaine after the surgery had been done. Pain was objectified by a numerical visual pain score, in the 24 hours following the lower abdominal surgery. Results: There were no differences in postoperative pain scores on the visual analog scale (VAS: In groups 1and 2, VAS at hour 4 were 6.37±1.13 versus 6.29±1.19; At hour 8 were 5.54 ± 1.17 versus 5.37±1.09; and at hour 12 were 4.5 ± 1.31 versus 4.45 ± 1

  16. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study.

    Science.gov (United States)

    Kim, Kyung Mi; Huh, Jin; Lee, Soo Kyung; Park, Eun Young; Lee, Jung Min; Kim, Hyo Ju

    2017-05-19

    As a drug originally introduced for its anticonvulsant effects, gabapentin has been recently shown to be effective in the treatment of nausea and vomiting in various clinical settings. This study compared the antiemetic efficacy of oral gabapentin, intravenous ramosetron and gabapentin plus ramosetron in patients receiving fentanyl-based patient-controlled analgesia after laparoscopic gynecologic surgery. One hundred and thirty two patients undergoing laparoscopic gynecologic surgery under general anesthesia were allocated randomly into three groups: group G received 300 mg oral gabapentin 1 h before anesthesia, group R received 0.3 mg intravenous ramosetron at the end of surgery, and group GR received a combination of 300 mg oral gabapentin 1 h before anesthesia and 0.3 mg intravenous ramosetron at the end of surgery. Postoperative nausea, retching, vomiting, rescue antiemetic drug use, pain, rescue analgesic requirements and adverse effects were assessed at 0-2, 2-24 and 24-48 h after surgery. Postoperative nausea and vomiting (PONV) was defined as the presence of nausea, retching or vomiting. The incidence of complete response (no PONV and no rescue antiemetics up to 48 h postoperatively) was significantly higher in group GR (26/40, 65%) than group G (16/40, 40%; P = 0.025) and group R (18/44, 41%; P = 0.027), whereas there was no significant difference between group G and group R (P = 0.932). There were no significant between-group differences in the incidence of emetic episodes, use of rescue antiemetics, severe emesis, use of rescue analgesics or any adverse effects. Postoperative pain scores were also similar among groups. The combination with gabapentin and ramosetron is superior to either drug alone for prevention of PONV after laparoscopic gynecologic surgery. ClinicalTrials.gov NCT02617121 , registered November 25, 2015.

  17. Does intravenous ketamine enhance analgesia after arthroscopic shoulder surgery with ultrasound guided single-injection interscalene block?: a randomized, prospective, double-blind trial.

    Science.gov (United States)

    Woo, Jae Hee; Kim, Youn Jin; Baik, Hee Jung; Han, Jong In; Chung, Rack Kyung

    2014-07-01

    Ketamine has anti-inflammatory, analgesic and antihyperalgesic effect and prevents pain associated with wind-up. We investigated whether low doses of ketamine infusion during general anesthesia combined with single-shot interscalene nerve block (SSISB) would potentiate analgesic effect of SSISB. Forty adult patients scheduled for elective arthroscopic shoulder surgery were enrolled and randomized to either the control group or the ketamine group. All patients underwent SSISB and followed by general anesthesia. During an operation, intravenous ketamine was infused to the patients of ketamine group continuously. In control group, patients received normal saline in volumes equivalent to ketamine infusions. Pain score by numeric rating scale was similar between groups at 1, 6, 12, 24, 36, and 48 hr following surgery, which was maintained lower than 3 in both groups. The time to first analgesic request after admission on post-anesthesia care unit was also not significantly different between groups. Intraoperative low dose ketamine did not decrease acute postoperative pain after arthroscopic shoulder surgery with a preincisional ultrasound guided SSISB. The preventive analgesic effect of ketamine could be mitigated by SSISB, which remains one of the most effective methods of pain relief after arthroscopic shoulder surgery.

  18. Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

    Science.gov (United States)

    Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

    2015-09-01

    To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

  19. Intraoperative Low-Dose Ketamine Infusion Reduces Acute Postoperative Pain Following Total Knee Replacement Surgery: A Prospective, Randomized Double-Blind Placebo-Controlled Trial

    International Nuclear Information System (INIS)

    Pelin Cengiz, P.; Gokcinar, D.; Karabeyoglu, I.; Topcu, H.; Cicek, G. S.; Gogus, N.

    2014-01-01

    Objective: To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. Study Design: A randomized, double-blind comparative study. Place and Duration of Study: Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Methodology: Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6.25 g/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Results: Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Conclusion: Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects. (author)

  20. Intraoperative low-dose ketamine infusion reduces acute postoperative pain following total knee replacement surgery: a prospective, randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Cengiz, Pelin; Gokcinar, Derya; Karabeyoglu, Isil; Topcu, Hulya; Cicek, Gizem Selen; Gogus, Nermin

    2014-05-01

    To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. A randomized, double-blind comparative study. Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6 μg/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects.

  1. Comparison of clonidine versus fentanyl as an adjuvant to intrathecal ropivacaine for major lower limb surgeries: A randomized double-blind prospective study

    Directory of Open Access Journals (Sweden)

    Anita R Chhabra

    2013-01-01

    Full Text Available Background: Ropivacaine is a newer local anesthetic, proven to have a better safety margin than bupivacaine and lignocaine. While maintaining this advantage and improving the intraoperative quality of anesthesia, the use of analgesic adjuvants has been proven to be valuable. Aim: To compare the efficacy of clonidine and fentanyl as adjuvants to intrathecal isobaric ropivacaine for major lower limb surgeries. Settings and Designs: Randomized double-blind control trial. Materials and Methods: Seventy patients were randomly divided in two groups. Ropivacaine-Clonidine group (RC received 60 mcg of clonidine with 15 mg of 0.5% isobaric ropivacaine, Ropivacaine Fentanyl group (RF received 25 mcg of fentanyl with 15 mg of 0.5% isobaric ropivacaine intrathecally. The onset and duration of sensory-motor block were recorded. The total analgesia time, sedation score, hemodynamic parameters, and side-effects were noted. Statistical Analysis: SPSS statistical package was used for statistical analysis. Paired and unpaired t-test, analysis of variance and chi-square test were used for statistical calculation. Result: The duration of sensory block in RC (329.42 ± 33.86, RF (226 ± 46.98, and motor block in RC (248.51 ± 55, RF (212.60 ± 43.52 out lasted the duration of surgery (125.61 + 64.46. In clonidine group, there was significant prolongation of sensory block (P < 0.001, motor block (P < 0.01 and the total analgesia time (P < 0.001. Hypotension and bradycardia occurred in 8.6% patients in clonidine group, whereas pruritus was experienced by 8.6% patients in fentanyl group. Conclusion: Ropivacaine when combined with clonidine or fentanyl provided adequate subarachnoid block for major surgeries, wherein clonidine has advantage over fentanyl as it increased the duration of subarachnoid block and prolonged the postoperative analgesia.

  2. Comparison of analgesic efficacy of levobupivacaine, levobupivacaine and clonidine, and levobupivacaine and dexmedetomidine in wound infiltration technique for abdominal surgeries: A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    B Jyothi

    2017-01-01

    Full Text Available Background: This study was designed to evaluate the postoperative analgesic efficacy of levobupivacaine (L alone and its combination with clonidine (C or dexmedetomidine (D in wound infiltration technique for abdominal surgeries. Materials and Methods: After ethical committee approval, a double-blind randomized controlled study was conducted on 90 patients (power of study 80%, physical status American Society of Anesthesiologists Grade I and II, aged 18–60 years scheduled for abdominal surgeries over 1 year duration. A standard general anesthetic technique was used. Patients were randomly allocated into three groups, by computer-generated random number table. Patients received wound infiltration during wound closure. Group L received 29 ml of 0.25% levobupivacaine plus 1 ml 0.9% normal saline, Group LC received 29 ml of 0.25% levobupivacaine with 1 ml (3 mcg/kg clonidine, and Group LD received 29 ml of 0.25% levobupivacaine with 1 ml (2 mcg/kg dexmedetomidine. Postoperative rescue analgesia was provided with injection tramadol. Statistical analysis for duration of analgesia was determined by one-way analysis of variance and side effects by Chi-square test. Results: The total duration of analgesia in LD group was 23.4 h, when compared to LC group 20.9 h and L group 11.65 h (P = 0.0001 with excellent to good quality of analgesia in adjuvant group (P < 0.001 and incidence of minimal side effects such as sedation, nausea, and vomiting. Conclusion: Clonidine and dexmedetomidine were the effective adjuvants to levobupivacaine for single shot wound infiltration analgesic technique; however, dexmedetomidine was found to be superior to clonidine.

  3. Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

    Science.gov (United States)

    Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

    2017-01-23

    Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

  4. Comparison of two doses of heparin on outcome in off-pump coronary artery bypass surgery patients: A prospective randomized control study

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    Murali Chakravarthy

    2017-01-01

    Full Text Available Introduction: While off pump coronary artery bypass surgery is practiced with an intention to reduce the morbidity associated with cardiopulmonary bypass, the resultant ′hypercoagulability′ needs to be addressed. Complications such as cavitary thrombus possibly due to the hyper coagulability after off pump coronary artery bypass surgery have been described. Many clinicians use higher doses of heparin - up to 5 mg/kg in order to thwart this fear. Overall, there appears to be no consensus on the dose of heparin in off pump coronary artery bypass surgeries. Aim of the Study: The aim of the study was understand the differences in outcome of such as transfusion requirement, myocardial ischemia, and morbidity when two different doses were used for systemic heparinization. Methods: Elective patients scheduled for off pump coronary artery bypass surgery were included. Ongoing anti platelet medication was not an exclusion criteria, however, anti platelet medications were ceased about a week prior to surgery when possible. Thoracic epidural anesthesia was administered as an adjunct in patients who qualified for it. By computer generated randomization chart, patients were chosen to receive either 2 or 3 mg/kg of intravenous unfractioned heparin to achieve systemic heparinization with activated clotting time targeted at >240 secs. Intraoperative blood loss, postoperative blood loss, myocardial ischemic episodes, requirement of intraaortic balloon counter pulsation and transfusion requirement were analyzed. Results: Sixty two patients participated in the study. There was one conversion to cardiopulmonary bypass. The groups had comparable ACT at baseline (138.8 vs. 146.64 seconds, P = 0.12; 3 mg/kg group had significantly higher values after heparin, as expected. But after reversal with protamine, ACT and need for additional protamine was similar among the groups. Intraoperative (685.56 ± 241.42 ml vs. 675.15 ± 251.86 ml, P = 0.82 and postoperative

  5. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  6. Preoperative But Not Postoperative Flurbiprofen Axetil Alleviates Remifentanil-induced Hyperalgesia After Laparoscopic Gynecological Surgery: A Prospective, Randomized, Double-blinded, Trial.

    Science.gov (United States)

    Zhang, Linlin; Shu, Ruichen; Zhao, Qi; Li, Yize; Wang, Chunyan; Wang, Haiyun; Yu, Yonghao; Wang, Guolin

    2017-05-01

    Acute remifentanil exposure during intraoperative analgesia might enhance sensitivity to noxious stimuli and nociceptive responses to innocuous irritation. Cyclooxygenase inhibition was demonstrated to attenuate experimental remifentanil-induced hyperalgesia (RIH) in rodents and human volunteers. The study aimed to compare the effects of preoperative and postoperative flurbiprofen axetil (FA) on RIH after surgery. Ninety patients undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive either intravenous placebo before anesthesia induction (Group C); or intravenous FA (1.0 mg/kg) before anesthesia induction (Group F1) or before skin closure (Group F2). Anesthesia consisted off sevoflurane and remifentanil (0.30 μg/kg/min). Postoperative pain was managed by sufentanil titration in the postanesthetic care unit, followed by sufentanil infusion via patient-controlled analgesia. Mechanical pain threshold (primary outcome), pain scores, sufentanil consumption, and side-effects were documented for 24 hours postoperatively. Postoperative pain score in Group F1 was lower than Group C. Time of first postoperative sufentanil titration was prolonged in Group F1 than Group C (P=0.021). Cumulative sufentanil consumption in Group F1 was lower than Group C (P<0.001), with a mean difference of 8.75 (95% confidence interval, 5.21-12.29) μg. Mechanical pain threshold on the dominant inner forearm was more elevated in Group F1 than Group C (P=0.005), with a mean difference of 17.7 (95% confidence interval, 5.4-30.0) g. Normalized hyperalgesia area was decreased in Group F1 compared to Group C (P=0.007). No statistically significant difference was observed between Group F2 and Group C. Preoperative FA reduces postoperative RIH in patients undergoing laparoscopic gynecologic surgery under sevoflurane-remifentanil anesthesia.

  7. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study.

    Science.gov (United States)

    Iyer, Sadasivan Shankar; Bavishi, Harshit; Mohan, Chadalavada Venkataram; Kaur, Navdeep

    2017-01-01

    Anesthesiologists play an important role in postoperative pain management. For analgesia after lower abdominal surgery, epidural analgesia and ultrasound-guided transversus abdominis plane (TAP) block are suitable options. The study aims to compare the analgesic efficacy of both techniques. Seventy-two patients undergoing lower abdominal surgery under spinal anesthesia were randomized to postoperatively receive lumbar epidural catheter (Group E) or ultrasound-guided TAP block (Group T) through intravenous cannulas placed bilaterally. Group E received 10 ml 0.125% bupivacaine stat and 10 ml 8 th hourly for 48 h. Group T received 20 ml 0.125% bupivacaine bilaterally stat and 20 ml bilaterally 8 th hourly for 48 h. Pain at rest and on coughing, total paracetamol and tramadol consumption were recorded. Analgesia at rest was comparable between the groups in the first 16 h. At 24 and 48 h, Group E had significantly better analgesia at rest ( P = 0.001 and 0.004 respectively). Patients in Group E had significantly higher number of patients with nil or mild pain on coughing at all times. Paracetamol consumption was comparable in both groups, but tramadol consumption was significantly higher in Group T at the end of 48 h ( P = 0.001). For lower abdominal surgeries, analgesia provided by intermittent boluses of 0.125% is comparable for first 16 h between epidural and TAP catheters. However, the quality of analgesia provided by the epidural catheter is superior to that provided by TAP catheters beyond that both at rest and on coughing with reduced opioid consumption.

  8. Efficacy of Pectoral Nerve Block Type II for Breast-Conserving Surgery and Sentinel Lymph Node Biopsy: A Prospective Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Doo-Hwan Kim

    2018-01-01

    Full Text Available Objectives. The pectoral nerve block type II (PECS II block is widely used for postoperative analgesia after breast surgery. This study evaluated the analgesic efficacy of PECS II block in patients undergoing breast-conserving surgery (BCS and sentinel lymph node biopsy (SNB. Methods. Patients were randomized to the control group (n=40 and the PECS II group (n=40. An ultrasound-guided PECS II block was performed after induction of anesthesia. The primary outcome measure was opioid consumption, and the secondary outcome was pain at the breast and axillary measured using the Numerical Rating Scale (NRS 24 hours after surgery. Opioid requirement was assessed according to tumor location. Results. Opioid requirement was lower in the PECS II than in the control group (43.8 ± 28.5 µg versus 77.0 ± 41.9 µg, p<0.001. However, the frequency of rescue analgesics did not differ between these groups. Opioid consumption in the PECS II group was significantly lower in patients with tumors in the outer area than that in patients with tumors in the inner area (32.5 ± 23.0 µg versus 58.0 ± 29.3 µg, p=0.007. The axillary NRS was consistently lower through 24 hr in the PECS II group. Conclusion. Although the PECS II block seemed to reduce pain intensity and opioid requirements for 24 h after BCS and SNB, these reductions may not be clinically significant. This trial is registered with Clinical Research Information Service KCT0002509.

  9. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study.

    Science.gov (United States)

    Ryu, Taeha; Kil, Byung Tae; Kim, Jong Hae

    2015-10-01

    Although supraclavicular brachial plexus block (SCBPB) was repopularized by the introduction of ultrasound, its usefulness in shoulder surgery has not been widely reported. The objective of this study was to compare motor and sensory blockades, the incidence of side effects, and intraoperative opioid analgesic requirements between SCBPB and interscalene brachial plexus block (ISBPB) in patients undergoing arthroscopic shoulder surgery. Patients were randomly assigned to 1 of 2 groups (ISBPB group: n = 47; SCBPB group: n = 46). The side effects of the brachial plexus block (Horner's syndrome, hoarseness, and subjective dyspnea), the sensory block score (graded from 0 [no cold sensation] to 100 [intact sensation] using an alcohol swab) for each of the 5 dermatomes (C5-C8 and T1), and the motor block score (graded from 0 [complete paralysis] to 6 [normal muscle force]) for muscle forces corresponding to the radial, ulnar, median, and musculocutaneous nerves were evaluated 20 min after the brachial plexus block. Fentanyl was administered in 50 μg increments when the patients complained of pain that was not relieved by the brachial plexus block. There were no conversions to general anesthesia due to a failed brachial plexus block. The sensory block scores for the C5 to C8 dermatomes were significantly lower in the ISBPB group. However, the percentage of patients who received fentanyl was comparable between the 2 groups (27.7% [ISBPB group] and 30.4% [SCBPB group], P = 0.77). SCBPB produced significantly lower motor block scores for the radial, ulnar, and median nerves than did ISBPB. A significantly higher incidence of Horner's syndrome was observed in the ISBPB group (59.6% [ISBPB group] and 19.6% [SCBPB group], P shoulder surgery under both brachial plexus blocks. However, SCBPB produces a better motor blockade and a lower incidence of Horner's syndrome than ISBPB.

  10. Prospective comparison of breast pain in patients participating in a randomized trial of breast-conserving surgery and tamoxifen with or without radiotherapy

    International Nuclear Information System (INIS)

    Rayan, Gamal; Dawson, Laura A.; Bezjak, Andrea; Lau, Anthea; Fyles, Anthony W.; Yi, Q.-L.; Merante, Pat; Vallis, Katherine A.

    2003-01-01

    Purpose: To determine whether breast pain affects quality of life (QOL) after breast-conserving surgery and tamoxifen (TAM) with or without adjuvant breast radiotherapy (RT). Methods and Materials: A randomized clinical trial was carried out at the Princess Margaret Hospital between 1992 and 2000 to evaluate the need for breast RT in addition to TAM in women ≥50 years treated with breast-conserving surgery for T1-T2N0 breast cancer. A companion study to assess breast pain was carried out during the last 2 years of the randomized clinical trial. The short-form McGill Pain Questionnaire (SF-MPQ), the European Organization for Research and Treatment of Cancer (EORTC) QOL (QLQ-C30) and EORTC breast cancer module (QLQ-BR23) questionnaires were completed by patients within 1 week of randomization in the randomized clinical trial (baseline) and at 3, 6, and 12 months. Results: Eighty-six patients participated in the breast pain study; 41 received RT plus TAM and 45 received TAM alone. The median age was 70 years (range 51-80). The baseline pain and QOL scores were similar for the two groups. No significant difference was found between the two groups for each scale of the QLQ-C30 and QLQ-BR23 questionnaires at 3, 6, or 12 months (p>0.100), except that at 12 months, the score for role function (QLQ-C30) was higher in the RT plus TAM group than in the RT-only group (p=0.02). At 3 months, the difference between the mean scores for the SF-MPQ was 0.553 (p=0.47). At 12 months, the pain scores had decreased in both groups; the difference was 0.199 (p=0.71). The number of breast operations or surgical complications did not correlate with breast pain in either group. Acute RT toxicity scores did not correlate with breast pain or QOL scores at 12 months. Conclusion: These results suggest that breast RT does not significantly contribute to breast pain or adversely impact the QOL up to 12 months after treatment in postmenopausal patients with node-negative breast cancer who take

  11. Time to tracheal extubation after coronary artery surgery with isoflurane, sevoflurane, or target-controlled propofol anesthesia: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Parker, Francis C; Story, David A; Poustie, Stephanie; Liu, Guoming; McNicol, Larry

    2004-10-01

    To determine if anesthesia with sevoflurane or target-controlled propofol reduced the time to tracheal extubation after coronary artery bypass graft surgery compared with isoflurane anesthesia. A 3-arm (isoflurane, sevoflurane, or propofol), randomized, controlled trial with patients and intensive care staff blinded to the drug allocation. A single, tertiary referral hospital affiliated with the University of Melbourne. Three hundred sixty elective coronary artery surgery patients. Patients received either isoflurane (control group, 0.5%-2% end-tidal concentration), sevoflurane (1%-4% end-tidal concentration), or target-controlled infusion of propofol (1-8 microg/mL plasma target concentration) as part of a balanced, standardized anesthetic technique including 15 microg/kg of fentanyl. The primary outcome was time to tracheal extubation. The median time to tracheal extubation for the propofol group was 10.25 hours (interquartile range [IQR] 8.08-12.75), the sevoflurane group 9.17 hours (IQR 6.25-11.25), and the isoflurane group 7.67 hours (IQR 6.25-9.42). Intraoperatively, the propofol group required less vasopressor (p = 0.002) and more vasodilator therapy (nitroglycerin p = 0.01, nitroprusside p = 0.002). There was no difference among the groups in time to intensive care unit discharge. The median time to tracheal extubation was significantly longer for the target-controlled propofol group. A significantly greater number in this group required the use of a vasodilator to control intraoperative hypertension.

  12. A randomized clinical trial to compare the efficacy of submucosal aprotinin injection and intravenous dexamethasone in reducing pain and swelling after third molar surgery: a prospective study.

    Science.gov (United States)

    Arakeri, Gururaj; Rai, Kirthi Kumar; Shivakumar, H R; Jayade, Bhushan

    2013-03-01

    The purpose of this study was to compare two different groups of drugs, aprotinin and dexamethasone for its efficacy in reducing post operative swelling and pain after third molar surgery. Fifty consecutive patients requiring surgical removal of single mandibular third molar (class II position B) under local anesthesia were randomly divided into two groups, each group consisting of 25 patients. One group was administered 8 mg dexamethasone through intravenous route pre-operatively. The other group received 1 ml of Aprotinin through submucosal route in operating area after the onset of local anesthesia. Swelling was assessed by measuring facial contours at baseline and at 1st, 3rd and 7th post-operative days. Pain was measured on the 1st, 3rd and 7th post-operative days using visual analog scale. Based on statistical analysis (paired t test and Wilcoxon's signed ranking test), the results showed statistically significant difference in post operative swelling and pain on 3rd postoperative day in dexamethasone group as compared to aprotinin group. The results of present study showed a similar reduction in the severity of pain and swelling at the aprotinin and dexamethasone sites on 1st and 7th postoperative day. It was also noticed that the aprotinin promoted a greater reduction of swelling and pain on 3rd postoperative day. It appeared that, benefits of aprotinin against the risks of dexamethasone and its efficacy in controlling pain and swelling after third molar surgery makes aprotinin to be a valuable alternative to dexamethasone.

  13. Comparison of New Technology Integrated and Nonintegrated Arterial Filters Used in Cardiopulmonary Bypass Surgery: A Randomized, Prospective, and Single Blind Study

    Directory of Open Access Journals (Sweden)

    Özgür Gürsu

    2013-01-01

    Full Text Available Background. Innovative cardiopulmonary bypass (CPB settings have been developed in order to integrate the concepts of “surface-coating,” “blood-filtration,” and “miniaturization.” Objectives. To compare integrated and nonintegrated arterial line filters in terms of peri- and postoperative clinical variables, inflammatory response, and transfusion needs. Material and Methods. Thirty-six patients who underwent coronary bypass surgery were randomized into integrated (Group In and nonintegrated arterial line filter (Group NIn groups. Arterial blood samples for the assessments of complete hemogram, biochemical screening, interleukin-6, interleukin-2R, and C-reactive protein were analyzed before and after surgery. Need for postoperative dialysis, inotropic therapy and transfusion, in addition to extubation time, total amount of drainage (mL, length of intensive care unit, and hospital stay, and mortality rates was also recorded for each patient. Results. Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn, but need for erythrocyte transfusion was significantly higher in Group NIn. C-reactive protein values did not differ significantly except for postoperative second day's results, which were found significantly lower in Group In than in Group NIn. Conclusion. Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In.

  14. Fosaprepitant versus ondansetron for the prevention of postoperative nausea and vomiting in patients who undergo gynecologic abdominal surgery with patient-controlled epidural analgesia: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Soga, Tomohiro; Kume, Katsuyoshi; Kakuta, Nami; Hamaguchi, Eisuke; Tsutsumi, Rie; Kawanishi, Ryosuke; Fukuta, Kohei; Tanaka, Katsuya; Tsutsumi, Yasuo M

    2015-10-01

    Postoperative nausea and vomiting (PONV) is the most common postoperative complication. The postoperative use of opioids is known to increase the incidence. We compared fosaprepitant, a neurokinin-1 (NK1) receptor antagonist, and ondansetron for their preventive effects on PONV in patients who underwent gynecologic abdominal surgery with patient-controlled epidural analgesia. This prospective, double-blind, randomized study comprised 44 patients who underwent gynecologic abdominal surgery. They were randomly allocated to receive 150 mg intravenous fosaprepitant (n = 24; NKI group) or 4 mg ondansetron (n = 20; ONS group) before anesthesia, which was maintained with volatile anesthetics, remifentanil, fentanyl, and rocuronium. All patients received postoperative fentanyl by patient-controlled epidural anesthesia. The incidence of nausea and vomiting, complete response rate (i.e., no vomiting and no rescue antiemetic use), rescue antiemetic use, nausea score (0-3), and visual analog scale score (VAS 0-10) for pain were recorded at 2, 24, 48, and 72 h after surgery. No (0 %) patient in the NKI group experienced vomiting after surgery; however, 4-6 (20-30 %) of 20 patients in the ONS group experienced vomiting. This difference was significant at 0-24, 0-48, and 0-72 h. During the study period, no significant differences existed between the NK1 and ONS groups in the incidence of PONV, complete response rate, rescue antiemetic use, nausea score, and VAS score for pain. Compared to ondansetron, fosaprepitant more effectively decreased the incidence of vomiting in patients who underwent gynecologic abdominal surgery with patient-controlled epidural analgesia.

  15. Optimal dose of perineural dexmedetomidine for interscalene brachial plexus block to control postoperative pain in patients undergoing arthroscopic shoulder surgery: A prospective, double-blind, randomized controlled study.

    Science.gov (United States)

    Jung, Hong Soo; Seo, Kwon Hui; Kang, Jae Hyuk; Jeong, Jin-Young; Kim, Yong-Shin; Han, Na-Re

    2018-04-01

    Adjuvant perineural dexmedetomidine can be used to prolong the analgesic effect of interscalene brachial plexus block (ISB). We investigated the optimal dose of dexmedetomidine in ISB for postoperative analgesia in patients undergoing arthroscopic shoulder surgery. One hundred patients scheduled for elective shoulder arthroscopic surgery were enrolled in this randomized, double-blind study. Ultrasound-guided ISB was performed before general anesthesia using 22 mL of ropivacaine 0.5% combined with 1, 1.5, or 2 μg/kg of dexmedetomidine (group D1, D2, and D3, respectively) or with normal saline as a control (group R, n = 25 per group). The primary outcome was the duration of analgesia (DOA), numeric pain rating scale (NRS), and consumption of additional analgesics during 36 h after ISB. Secondary outcome included durations of motor and sensory block (DOM and DOS), hemodynamic variables and sedation and dyspnea scores. Ninety-seven patients completed the study. The DOS, DOM, and DOA were significantly longer in the dexmedetomidine groups than in group R. The DOA was significantly longer in group D3 than in groups D1 (P = .026) and D2 (P = .039). The DOA was 808.13 ± 179.97, 1032.60 ± 288.14, 1042.04 ± 188.13, and 1223.96 ± 238.06 min in groups R, D1, D2, and D3, respectively. The NRS score was significantly higher in group R than in the dexmedetomidine groups 12 h after ISB (P surgery (P = .008 and P = .011, respectively). There were no significant differences in consumption of rescue analgesics, sedation, and dyspnea scores between the study groups. Perineural dexmedetomidine 2 μg/kg could be the optimal dose in ISB for arthroscopic shoulder surgery in that it provides an adequate DOA. However, this dose was associated with increased risk of hypotension.

  16. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

    Science.gov (United States)

    Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

    2017-11-01

    To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

  17. A prospective randomized, controlled trial deems a drainage of 300 ml/day safe before removal of the last chest drain after video-assisted thoracoscopic surgery lobectomy.

    Science.gov (United States)

    Xie, Hong-Ya; Xu, Kai; Tang, Jin-Xing; Bian, Wen; Ma, Hai-Tao; Zhao, Jun; Ni, Bin

    2015-08-01

    To study the feasible and safe volume threshold for chest tube removal following video-assisted thoracoscopic surgical lobectomy. One hundred and sixty-eight consecutive patients (18 were excluded) who underwent video-assisted thoracoscopic surgery lobectomy or bilobectomy with two incisions between August 2012 and February 2014 were included. Eligible patients were randomized into three groups: Group A (chest tube was removed at a drainage volume of 150 ml/day or less. n = 49); Group B (chest tube was removed when the drainage volume was less than 300 ml/day. n = 50); Group C (chest tube was removed when the drainage volume was less than 450 ml/day. n = 51). The postoperative care of all patients was consistent. The time of extracting the drainage tube, postoperative hospital stay, postoperative visual analogue scale grades, dosage of analgesic, and the incidence of complications and thoracocentesis were measured. Group B and C had a much shorter drainage time and postoperative hospital stay than Group A (P 0.05). The mean dosage of pethidine hydrochloride was 248.9 ± 33.3 mg in Group B and 226.1 ± 32.7 mg in Group C (P > 0.05). The dosage of pethidine hydrochloride of Group A was significantly higher than that of Group B and C (P 0.05), Group A had a significantly higher total VAS score than Group B and C (P drains among the three groups (P > 0.05). A 300-ml/day volume threshold for chest tube removal after video-assisted thoracoscopic surgery lobectomy is feasible and safe, demonstating more advantages than the 150-ml/day volume threshold. However, a 450-ml/day volume threshold for chest tube removal may increase the risk of thoracentesis compared with the 300- and the 150-ml/day volume threshold. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  18. Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

    Science.gov (United States)

    Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

    2018-04-01

    Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

  19. A randomized prospective analysis of alteration of hemostatic function in patients receiving tranexamic acid and hydroxyethyl starch (130/0.4 undergoing off pump coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Murali Chakravarthy

    2012-01-01

    Full Text Available Postoperative hemorrhagic complications is still one of the major problems in cardiac surgeries. It may be caused by surgical issues, coagulopathy caused by the side effects of the intravenous fluids administered to produce plasma volume expansion such as hydroxyl ethyl starch (HES. In order to thwart this hemorrhagic issue, few agents are available. Fibrinolytic inhibitors like tranexamic acid (TA may be effective modes to promote blood conservation; but the possible complications of thrombosis of coronary artery graft, precludes their generous use in coronary artery bypass graft surgery. The issue is a balance between agents that promote coagulation and those which oppose it. Therefore, in this study we have assessed the effects of concomitant use of HES and TA. Thromboelastogram (TEG was used to assess the effect of the combination of HES and TA. With ethical committee approval and patient′s consent, 100 consecutive patients were recruited for the study. Surgical and anesthetic techniques were standardized. Patients fulfilling our inclusion criteria were randomly allocated into 4 groups of 25 each. The patients in group A received 20 ml/kg of HES (130/0.4, 10 mg/kg of T.A over 30 minutes followed by infusion of 1 mg/kg/hr over the next 12 hrs. The patients in group B received Ringer′s lactate + TA at same dose. The patients in the Group C received 20 ml/kg of HES. Group D patients received RL. Fluid therapy was goal directed. Total blood loss was assessed. Reaction time (r, α angle, maximum amplitude (MA values of TEG were assessed at baseline, 12, 36 hrs. The possible perioperative myocardial infraction (MI was assessed by electrocardiogram (ECG and troponin T values at the baseline, postoperative day 1. Duration on ventilator, length of stay (LOS in the intensive care unit (ICU were also assessed. The demographical profile was similar among the groups. Use of HES increased blood loss significantly (P < 0.05. Concomitant use of TA

  20. A prospective randomized clinical study of the influence of primary closure or dressing on post-operative morbidity after mandibular third molar surgery

    Directory of Open Access Journals (Sweden)

    Peter E Egbor

    2014-01-01

    Full Text Available Objective: The aim of the following study is to determine the effect of primary closure or dressing on post-operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects were divided into two groups of A and B. Group A had total closure (primary closure and Group B had whitehead varnish dressing of the socket. Pain, swelling and trismus were evaluated pre-operatively using visual analogue scale, flexible tape measuring method and inter-incisal distance measurement with Vernier Callipers respectively as well as post-operatively on 1 st , 2 nd , 3 rd , 5 th and 7 th day. Results: The study participants consisted of 27 males and 45 females in a ratio 1:1.7. With a mean age of 24.7 ± 4.9 years (range 19-33 years for Group A and 25.5 ± 4.3 years (range 20-39 years for Group B. Post-operative pain was not significantly affected by the closure techniques (P > 0.05. Dressing was found to significantly reduce the degree of swelling and trismus peaking on the 2 nd day (P = 0.0207 and P = 0.010 respectively. Conclusion: The use of dressing was more effective than primary closure to reduce the degree of swelling and trismus though its effect on post-operative pain reduction was not significant.

  1. Recent advancements and prospects of plastic surgery

    Directory of Open Access Journals (Sweden)

    Xin XING

    2011-09-01

    Full Text Available Objective To summarize the recent advancements and developmental prospects of plastic surgery worldwide,and to describe the future directions,aims,and highlights of Chinese military plastic surgery.Methods Relevant articles published in the last five years were retrieved through a search in PubMed,Medline,and CMCC.A statistical survey was conducted to summarize the achievements obtained by the Chinese military plastic surgery unit in the last five years.Results Considerable progress has been achieved in both clinical treatment and basic research of plastic surgery in the past five years.Its important role in the early treatment of combat injury and trauma has been recognized and emphasized.Chinese military plastic surgery has achieved considerable accomplishments in the last five years,especially in chronic wound repair;mechanism,prevention,and treatment of explosive soft tissue injuries and seawater immersion wounds;and new remedies of maxillofacial traumatic deformity,composite facial tissue allograft,and so on.Conclusions The repair and reconstruction of tissue defect and deformity caused by war injury and trauma will be the future major research direction of military plastic surgery.Research work should focus on tissue engineering,composite tissue allograft,stem cell therapy,mechanism of abnormal scar formation,among others,to solve the clinical problems of destructive facial injuries,extensive thora-abdominal wall defects,chronic ulcer,abnormal scars,and so on.Furthermore,plastic surgeons should fully utilize their special skills and take active part in the early treatment of war injury and trauma.

  2. Off-pump versus On-pump Coronary Artery Surgery - Identification of Fibrinolysis using Rotation Thromboelastography. A Preliminary, Prospective, Randomized Study

    Czech Academy of Sciences Publication Activity Database

    Jareš, M.; Vaněk, T.; Bednář, F.; Malý, Marek; Šnircová, J.; Straka, Z.

    2007-01-01

    Roč. 48, č. 1 (2007), s. 57-67 ISSN 1349-2365 Source of funding: V - iné verejné zdroje Keywords : cardiopulmonary bypass * hemostasis * beating heart surgery * D-dimers * cardiac surgical procedures Subject RIV: FA - Cardiovascular Diseases incl. Cardiotharic Surgery Impact factor: 0.929, year: 2007

  3. Outcome of intraoperative goal-directed therapy using Vigileo/FloTrac in high-risk patients scheduled for major abdominal surgeries: A prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Mohammed A. Elgendy

    2017-07-01

    Conclusion: The applied protocol for intraoperative GDT provided significant reduction of PO morbidities, ICU and hospital LOS but couldn‘t significantly reduce mortality rates in high risk patients scheduled for major abdominal surgeries.

  4. [Present situation and prospect of enhanced recovery after surgery in pancreatic surgery].

    Science.gov (United States)

    Feng, Mengyu; Zhang, Taiping; Zhao, Yupei

    2017-05-25

    Enhanced recovery after surgery is a multimodal perioperative strategy according to the evidence-based medicine and multidisciplinary collaboration, aiming to improve the restoration of functional capacity after surgery by reducing surgical stress, optimal control of pain, early oral diet and early mobilization. Compared with other sub-specialty in general surgery, pancreatic surgery is characterized by complex disease, highly difficult procedure and more postoperative complications. Accordingly, pancreatic surgery shares a slow development in enhanced recovery after surgery. In this review, the feasibility, safety, application progress, prospect and controversy of enhanced recovery after surgery in pancreatic surgery are discussed.

  5. [Prospective randomized study regarding the effect of the preoperative antibiotic and chlorhexidine rinse on wound healing after mandibular third molar surgery].

    Science.gov (United States)

    Kaposvári, István; Körmöczi, Kinga; László, Zsuzsa Beáta; Oberna, Ferenc; Horváth, Ferenc; Joób-Fancsaly, Árpád

    2017-01-01

    The study compares the antibiotic prophylaxis combined with postoperative antibiotic therapy to preoperative chlorhexidine rinse combined with postoperative antibiotic therapy in preventing complications after surgical removal of a mandibular third molar. 71 healthy patients in four groups were enrolled in the study: I. prophylactic dose of 2000 mg of amoxicillin clavulanate, continued with amoxicillin clavulanate postoperatively; II. prophylactic dose of 600 mg of clindamycin, continued with clindamycin postoperatively; III. prophylactic chlorhexidin rinsing, continued randomized amoxicillin clavulanate or clindamycin postoperatively; IV. control, with clindamycin postoperatively. The pain was smaller in the prophylaxis groups. Alveolitis occurred only in the control group: 2 patients. Wound opening occurred in 22,2 % in group IV., 14,2 % in group II, 10 % in group I., 5 % in group III. We consider completing the indicated postoperative antibiotic prescription with antibiotic or antiseptic prophylaxis. Chlorhexidin prophylaxis could have the same positive effect. Orv. Hetil., 2017, 158(1), 13-19.

  6. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

    NARCIS (Netherlands)

    K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

    2004-01-01

    textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

  7. The treatment of soft-tissue sarcomas of the extremities - prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy

    International Nuclear Information System (INIS)

    Rosenberg, S.A.; Tepper, J.; Glatstein, E.

    1982-01-01

    Between May 1975 and April 1981, 43 adult patients with high-grade soft tissue sarcomas of the extremities were prospectively randomized to receive either amputation at or above the joint proximal to the tumor, including all involved muscle groups, or to receive a limb-sparing resection plus adjuvant radiation therapy. The limb-sparing resection group received wide local excision followed by 5000 rads to the entire anatomic area at risk for local spread and 6000 to 7000 rads to the tumor bed. Both randomization groups received postoperative chemotherapy with doxorubicin (maximum cumulative dose 550 mg/m 2 ), cyclophosphamide, and high-dose methotrexate. Twenty-seven patients randomized to receive limb-sparing resection and radiotherapy, and 16 received amputation (randomization was 2:1). There were four local recurrences in the limb-sparing group and none in the amputation group (p 1 = 0.06 generalized Wilcoxon test). However, there were no differences in disease-free survival rates (83% and 88% at five years; p 2 = 0.99) between the limb-sparing group and the amputation treatment groups. Multivariate analysis indicated that the only correlate of local recurrence was the final margin of resection. Patients with positive margins of resection had a higher likelihood of local recurrence compared with those with negative margins (p 1 1 = 0.00008) and overall survival (95% vs. 74%; p 1 = 0.04)

  8. Effects of surgery on ischaemic mitral regurgitation: a prospective multicentre registry (SIMRAM registry)

    DEFF Research Database (Denmark)

    Lancellotti, P.; Donal, E.; Cosyns, B.

    2008-01-01

    at rest. Exercise echocardiography may help identify a subset of patients at higher risk of cardiovascular events by revealing the dynamic component of IMR. METHODS: A large prospective, multicentre, non-randomized registry is designed to evaluate the effects of surgery on IMR at rest and on its dynamic......AIMS: Functional ischaemic mitral regurgitation (IMR) is common in patients with ischaemic left ventricular dysfunction undergoing coronary artery bypass surgery. Although the presence of IMR negatively affects prognosis, the additional benefit of valve repair is debated, particularly with mild IMR...... component at exercise (z). SIMRAM will enrol approximately 550 patients with IMR in up to 17 centres with clinical and exercise follow-up for 1 year. Three sets of outcomes will be prospectively assessed and several hypotheses will be tested including determinants of adverse outcome and progressive left...

  9. [Clinical trials of laparoscopic gastric cancer surgery in South Korea: review and prospect].

    Science.gov (United States)

    Zhu, Chunchao; Zhao, Gang; Cao, Hui

    2018-02-25

    Laparoscopic technology is gradually accepted in gastric cancer surgery, whose efficacy has been demonstrated by some clinical researches. Randomized controlled trials (RCT) are considered as the most important evidence to prove clinical outcomes of laparoscopic surgery for gastric cancer. Korean gastric surgeons have made great contributions to RCT in laparoscopic gastric cancer surgery. KLASS (Korean Laparoscopic Gastrointestinal Surgery Study Group) is one of the most important forerunner and global leader of clinical trials of gastric cancer treatment. KLASS series clinical trials are attracting global attention because of the significant value of surgical treatment for gastric cancer. The RCTs in Korea involve in many aspects of laparoscopic gastrectomy for gastric cancer, including laparoscopy application in early gastric cancer (KLASS-01, KLASS-03 and KLASS-07), advanced gastric cancer (KLASS-02 and KLASS-06), function-preserving gastrectomy (KLASS-04,KLASS-05) and sentinel node navigation surgery (SENORITA trial). In order to share some informations of these RCTs, we review and prospect some important clinical trials of laparoscopic gastric cancer surgery in Korea. With the experience of Korean gastric surgeons, we can make more progress in our own clinical trials of laparoscopic gastric cancer surgery.

  10. Sexual satisfaction following bariatric surgery: A prospective exploratory study.

    Science.gov (United States)

    Ferrer-Márquez, Manuel; Pomares-Callejón, María Ángeles; Fernández-Agis, Inmaculada; Belda-Lozano, Ricardo; Vidaña-Márquez, Elisabet; Soriano-Maldonado, Alberto

    2017-11-01

    Bariatric surgery improves sexual function in obese individuals, although the extent to which sexual satisfaction is improved following surgery is unknown. The aims of this study were 1) to describe sexual satisfaction in severely/morbidly obese men and women candidates for bariatric surgery; 2) to assess the effects of bariatric surgery on sexual satisfaction at 12-months follow-up; and 3) to assess whether weight changes at follow-up following bariatric surgery are associated with changes in sexual satisfaction. We conducted a prospective observational study from February 2011 to June 2014. A total of 44 patients with severe/morbid obesity participated in the study. Sexual satisfaction was assessed (at baseline and 12-months follow-up) through the Index of Sexual Satisfaction (ISS) questionnaire. Of 44 patients who completed the ISS at baseline (mean age 40.3 [SD=9.4] years and BMI 46.9 [SD=6.2] kg/m 2 ), 17 were lost to follow-up. The baseline ISS total scores were 32.0 (SD=20.1) in women and 24.4 (SD=16.0) in men (P>0.05). The proportion of sexually satisfied men and women at baseline was 62.5% and 46.4%, respectively (P=0.360). At follow-up, sexual satisfaction improved significantly in women (average difference 13.7 units; P=0.032) but not in men (average difference 3.6 units; P=0.717). The percentage of women with sexual satisfaction problems was reduced by 33% at follow-up (P=0.038). A relatively large percentage of severely/morbidly obese women and men present clinically significant sexual satisfaction problems before undergoing bariatric surgery. Sexual satisfaction improves significantly 12 months following bariatric surgery, particularly in women. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Immediate postoperative complications in transsphenoidal pituitary surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    Tumul Chowdhury

    2014-01-01

    Full Text Available Background: Considering the important role of pituitary gland in regulating various endocrine axes and its unique anatomical location, various postoperative complications can be anticipated resulting from surgery on pituitary tumors. We examined and categorized the immediate postoperative complications according to various tumor pathologies. Materials and Methods: We carried out a prospective study in 152 consecutive patients and noted various postoperative complications during neurosurgical intensive care unit stay (within 48 hrs of hospital stay in patients undergoing transsphenoidal removal of pituitary tumors. Results: In our series, various groups showed different postoperative complications out of which, cerebrospinal fluid leak was the commonest followed by diabetes insipidus, postoperative nausea and vomiting, and hematoma at operation site. Conclusion: Various immediate postoperative complications can be anticipated in transsphenoidal pituitary surgery even though, it is considered to be relatively safe.

  12. 3D laparoscopic surgery: a prospective clinical trial.

    Science.gov (United States)

    Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

    2018-04-03

    Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

  13. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  14. Prospective Randomized Controlled Comparison of Caudal ...

    African Journals Online (AJOL)

    including 50 consecutive patients in the age group of 1‑10 years, who underwent urogenital surgeries ... The duration of absolute analgesia was defined as the time from caudal injection until the pain score was >2. Motor block was assessed by modified Bromage scale. .... double-blind, phase III, controlled trial comparing.

  15. Haloperidol dose combined with dexamethasone for PONV prophylaxis in high-risk patients undergoing gynecological laparoscopic surgery: a prospective, randomized, double-blind, dose-response and placebo-controlled study.

    Science.gov (United States)

    Joo, Jin; Park, Yong Gyu; Baek, Jungwon; Moon, Young Eun

    2015-07-08

    Low-dose haloperidol is known to be effective for the prevention of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify which dose of haloperidol 1mg or 2mg could be combined with dexamethasone without adverse effects in high-risk patients undergoing gynecological laparoscopic surgery. Female adults (n = 150) with three established PONV risk factors based on Apfel's score were randomized into one of three study groups. At the end of anesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone 5 mg during the induction of anesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanesthesia care unit (PACU). The total incidence of PONV over 24 h was significantly lower in groups H1 (29 %) and H2 (24 %) than in group H0 (54 %; P = 0.003), but there was no significant difference between groups H1 and H2. In the PACU, group H2 had a higher sedation score than groups H1 and H0 (P haloperidol was equally effective as 2 mg in terms of preventing PONV with the less sedative effect. ClinicalTrials.gov ( NCT01639599 ).

  16. [3-dimensional computer animation--a new medium for supporting patient education before surgery. Acceptance and assessment of patients based on a prospective randomized study--picture versus text].

    Science.gov (United States)

    Hermann, M

    2002-05-01

    The rigorous implementation of clear preoperative information is mandatory for the patient's understanding, acceptance and written informed consent to all diagnostic and surgical procedures. In the present study, I evaluated whether new media are suitable for conveying basic information to patients; I analysed the merits of computerized animation to illustrate a difficult treatment process, i.e., the progressive steps of a thyroid operation, in comparison to the use of conventional flyers. 3D animation software was employed to illustrate the basic anatomy of the thyroid and the larnyx; the principle of thyroidectomy was explained by visualizing the surgical procedure step by step. Finally, the possible complications that may result from the intraoperative manipulations were also visually explained. Eighty patients entered a prospective randomisation: on the day before surgery, group 1 watched the computer animation, whereas group 2 was given the identical information in a written text (= standard flyer). The evaluation included a questionnaire with scores of 1-5, rating the patients' understanding, subjective and objective knowledge, emotional factors like anxiety and trust, and the willingness to undergo an operation. Understanding of and subjective knowledge about the surgical procedure and possible complications, the degree of trust in professional treatment, the reduction in anxiety and readiness for the operation were significantly better after watching the computer animation than after reading the text. However, active knowledge did not improve significantly. The interest in the preoperative information was high in both groups. The benefit of computer animation was enhanced in a second inquiry; patients who had only read the text had a significant improvement in parameters after an additional exposure to the video animation. Preoperative surgical information can be optimized by presenting the operative procedure via computer animation. Nowadays, several types

  17. Sevoflurane requirement during elective ankle day surgery: the effects of etirocoxib premedication, a prospective randomised study

    Directory of Open Access Journals (Sweden)

    Jakobsson Jan G

    2008-09-01

    Full Text Available Abstract Background Anti-inflammatory drugs, NSAIDs, have become an important part of the pain management in day surgery. The aim of the present study was to evaluate the effect of Coxib premedication on the intra-operative anaesthetic requirements in patients undergoing elective ankle surgery in general anaesthesia. Type of study Prospective, randomized study of the intra-operative anaesthetic-sparing effects of etoricoxib premedication as compared to no NSAID preoperatively. Methods The intra-operative requirement of sevoflurane was studied in forty-four ASA 1–2 patients undergoing elective ankle day surgical in balanced general anaesthesia. Primary study endpoint was end-tidal sevoflurane concentration to maintain Cerebral State Index of 40 – 50 during surgery. Results All anaesthesia and surgery was uneventful, no complications or adverse events were noticed. The mean end-tidal sevoflurane concentration intra-operatively was 1.25 (SD 0.2 and 0.91 (SD 0.2 for the pre and post-operative administered group of patients respectively (p Conclusion Coxib premedication before elective day surgery has an anaesthetic sparing potential.

  18. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

    Science.gov (United States)

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  19. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  20. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  1. Effects of a balanced energy and high protein formula diet (Vegestart complet®) vs. low-calorie regular diet in morbid obese patients prior to bariatric surgery (laparoscopic single anastomosis gastric bypass): a prospective, double-blind randomized study.

    Science.gov (United States)

    Carbajo, M A; Castro, Maria J; Kleinfinger, S; Gómez-Arenas, S; Ortiz-Solórzano, J; Wellman, R; García-Ianza, C; Luque, E

    2010-01-01

    Bariatric surgery is considered the only therapeutic alternative for morbid obesity and its comorbidities. High risks factors are usually linked with this kind of surgery. In order to reduce it, we consider that losing at least 10% of overweight in Morbid Obese (MO) and a minimum of 20% in Super- Obese patients (SO) before surgery, may reduce the morbidity of the procedure. The aim of our study is to demonstrate the effectiveness and tolerance of a balanced energy formula diet at the preoperative stage, comparing it against a low calorie regular diet. We studied 120 patients divided into two groups of 60 each, group A was treated 20 days prior to bariatric surgery with a balanced energy formula diet, based on 200 Kcal every 6 hours for 12 days and group B was treated with a low calorie regular diet with no carbs or fat. The last eight days prior to surgery both groups took only clear liquids. We studied the evolution of weight loss, the BMI, as well as behavior of co-morbidities as systolic blood pressure, diastolic blood pressure, glucose controls and tolerance at the protocol. The study shows that patients undergoing a balanced energy formula diet improved their comorbidities statistically significant in terms of decrease in weight and BMI loss, blood pressure and glucose, compared to the group that was treated before surgery with a low calorie regular diet. Nevertheless both groups improving the weight loss and co-morbidities with better surgical results and facilities. A correct preparation of the Morbid Obese patients prior of surgery can reduce the operative risks improving the results. Our study show that the preoperative treatment with a balanced energy formula diet as were included in our protocol in patients undergoing bariatric surgery improves statistical better their overall conditions, lowers cardiovascular risk and metabolic diseases that the patients with regular diet alone.

  2. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  3. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  4. A randomized controlled trial of cell salvage in routine cardiac surgery.

    Science.gov (United States)

    Klein, Andrew A; Nashef, Samer A M; Sharples, Linda; Bottrill, Fiona; Dyer, Matthew; Armstrong, Johanna; Vuylsteke, Alain

    2008-11-01

    Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics. Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion. There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04). In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this

  5. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

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    Sheetal Oswal

    2014-01-01

    Full Text Available Aims and Objectives: (1 To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2 To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic, Group B (therapeutic, and Group C (no antibiotics. Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

  6. A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

    African Journals Online (AJOL)

    International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

  7. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  8. Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial.

    Science.gov (United States)

    Amaral, M B F; de Ávila, J M S; Abreu, M H G; Mesquita, R A

    2015-11-01

    Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  9. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery

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    Mostafa Sadeghi

    2014-07-01

    Full Text Available BACKGROUND AND OBJECTIVES: Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. METHODS: A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1 g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. RESULTS: There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0 ± 1.4 in fibrinogen group, and 1.3 ± 1.1 in control group. Less postoperative bleeding was observed in the fibrinogen group (477 ± 143 versus 703 ± 179, p = 0.0001. Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p = 0.094. No thrombotic event was observed through 72 h after surgery. CONCLUSION: Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft.

  10. A randomized trial of preoperative oral carbohydrates in abdominal surgery

    OpenAIRE

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Background Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. Methods A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and ...

  11. Preoperative clonidine use in trans-sphenoidal pituitary adenoma surgeries - a randomized controlled trial.

    Science.gov (United States)

    Bajaj, Jitin; Mittal, Radhe Shyam; Sharma, Achal

    2017-02-01

    Pituitary masses are common lesions accounting for about 15-20% of all brain tumours. Oozing blood is an annoyance in microscopic sublabial trans-sphenoidal approach for these masses. There have been many ways of reducing the ooze, having their own pros and cons. To find out the efficacy and safety of clonidine in reducing blood loss in pituitary adenoma surgery through a randomized masked trial. It was a prospective randomized controlled trial done. Total 50 patients of pituitary adenomas were randomized into two groups. Group A (25 patients) was given 200 μg clonidine orally, while Group B (25 patients) was given placebo. Surgeon, anaesthesiologist and patient were blinded for the trial. Sublabial trans-septal trans-sphenoidal approach to sella and excision of mass was performed in each patient. Patients were studied for pre-, intra- and post-operative blood pressure and heart rate, pre- and post-operative imaging findings, intra-operative blood loss, bleeding grading by surgeon, surgeon's satisfaction about condition of specific part and quality of surgical field, operative time and extent of resection. Blood loss during the surgery, operative time and bleeding grading by the surgeon were found significantly less in the clonidine group, while quality of surgical field, condition of the specific part and extent of resection were found significantly better in the clonidine group (p value trans-sphenoidal microscopic pituitary adenoma surgeries.

  12. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study.

    Science.gov (United States)

    Park-Hansen, Jesper; Holme, Susanne J V; Irmukhamedov, Akhmadjon; Carranza, Christian L; Greve, Anders M; Al-Farra, Gina; Riis, Robert G C; Nilsson, Brian; Clausen, Johan S R; Nørskov, Anne S; Kruuse, Christina R; Rostrup, Egill; Dominguez, Helena

    2018-05-23

    Open heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis. One hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions. During a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1-0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1-1.0, p = 0.05). In a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline. LAACS study, clinicaltrials.gov NCT02378116 , March 4th 2015, retrospectively registered.

  13. Analgesia with interfascial continuous wound infiltration after laparoscopic colon surgery: A randomized clinical trial.

    Science.gov (United States)

    Telletxea, S; Gonzalez, J; Portugal, V; Alvarez, R; Aguirre, U; Anton, A; Arizaga, A

    2016-04-01

    For major laparoscopic surgery, as with open surgery, a multimodal analgesia plan can help to control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. We conducted a prospective, randomized, study of patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital from January 2012 to January 2013. Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for pain at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale scores and amount of intravenous morphine used via patient controlled infusion. 92 patients were included in the study, 43 had a wound catheter implanted and 49 did not. Statistically significant differences in morphine consumption were observed between groups throughout the course of the treatment period. The mean total morphine consumption at the end of the study was 5.63±5.02mg among wound catheter patients and 21. 86±17.88mg among control patients (P=.0001). Wound catheter patients had lower pain scale scores than control patients throughout the observation period. No adverse effects associated with the wound catheter technique were observed. The wound catheter group showed lower hospital stays with statistically significant difference (P=.02). In patients undergoing laparoscopic colon surgery, continuous infusion of local anaesthetics through interfascial wound catheters during the first 48h aftersurgery reduced the level of perceived pain and also reduced parenteral morphine consumption with no associated adverse effects and lower hospital stays. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

  14. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial.

    Science.gov (United States)

    Lilot, Marc; Bellon, Amandine; Gueugnon, Marine; Laplace, Marie-Christine; Baffeleuf, Bruno; Hacquard, Pauline; Barthomeuf, Felicie; Parent, Camille; Tran, Thomas; Soubirou, Jean-Luc; Robinson, Philip; Bouvet, Lionel; Vassal, Olivia; Lehot, Jean-Jacques; Piriou, Vincent

    2018-01-27

    An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min -1 m -2 , p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.

  15. Analgesia preemptiva nas cirurgias da coluna lombossacra: estudo prospectivo e randomizado Analgesia preventiva en las cirugías de la columna lumbosacra: estudio prospectivo y aleatorio Preemptive analgesia in lumbosacral spine surgeries: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Augustin Malzac

    2009-06-01

    recibieron alguna sustancia analgésica (control. Veinte y dos en el segundo (B que fueron sometidos a la inyección epidural, 20 minutos antes de la incisión quirúrgica, conteniendo 10 mL de marcaína y morfina. En el tercer grupo, y último (C, con 20 pacientes que fueron inyectados con auxilio de un catéter, en el espacio epidural, las mismas drogas del grupo B, por medio de la incisión antes de cerrar la herida operatoria. Los pacientes fueron examinados durante las primeras 24 horas, con auxilio de la escala verbal de dolor. RESULTADOS: los tres grupos fueron comparados según la edad, sexo, nivel y tiempo quirúrgico. Como los datos no obedecieron a una distribución Gausiana, el test paramétrico de Mann-Whitney fue entonces adoptado para análisis estadístico. De esta forma, los valores de la escala verbal de dolor, en todos los intervalos de tiempo fueron significativamente bajos (pOBJECTIVE: To analyze the efficacy of the preemptive analgesia with a method of epidural analgesic administration before and after the surgical painful stimulation, as comparing them. Its role in postoperative pain relief after lumbosacral spinal surgery, by the posterior approach, has not been fully investigated. METHODS: Sixty two patients who underwent microdiscectomy or microdecompression in a single level of the lumbosacral spine were divided into three groups: 20 patients that had not received any analgesic medication in the first one (A (control; 22 that had been submitted to the epidural injection containing 10 mL of marcaína and morphine 20 minutes before the surgical incision in the second one (B. In the third and last group (C, 20 patients received the same drugs of group B, with the aid of a catheter positioned in the epidural space, through the incision before the closing of the surgical wound. The patients were examined during the first 24 hours, with the use of the verbal scale of pain. RESULTS: The three groups were compared concerning age, sex, level and surgical

  16. [Robotics in general surgery: personal experience, critical analysis and prospectives].

    Science.gov (United States)

    Fracastoro, Gerolamo; Borzellino, Giuseppe; Castelli, Annalisa; Fiorini, Paolo

    2005-01-01

    Today mini invasive surgery has the chance to be enhanced with sophisticated informative systems (Computer Assisted Surgery, CAS) like robotics, tele-mentoring and tele-presence. ZEUS and da Vinci, present in more than 120 Centres in the world, have been used in many fields of surgery and have been tested in some general surgical procedures. Since the end of 2003, we have performed 70 experimental procedures and 24 operations of general surgery with ZEUS robotic system, after having properly trained 3 surgeons and the operating room staff. Apart from the robot set-up, the mean operative time of the robotic operations was similar to the laparoscopic ones; no complications due to robotic technique occurred. The Authors report benefits and disadvantages related to robots' utilization, problems still to be solved and the possibility to make use of them with tele-surgery, training and virtual surgery.

  17. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Day case inguinal hernia surgery in Nigerian children: Prospective ...

    African Journals Online (AJOL)

    required readmission into the hospital. Conclusion: Day case inguinal hernia surgery in children is safe and well accepted by patients and parents alike. Health institutions in which children with inguinal hernias still queue for long periods for space on the operation list need to adopt day case surgery for inguinal hernia in ...

  19. Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update.

    Science.gov (United States)

    Sammour, Tarik; Barazanchi, Ahmed W H; Hill, Andrew G

    2017-02-01

    The aim of this systematic review was to update previous PROSPECT ( http://www.postoppain.org ) review recommendations for the management of pain after excisional haemorrhoidectomy. Randomized studies and reviews published in the English language from July 2006 (end date of last review) to March 2016, assessing analgesic, anaesthetic, and operative interventions pertaining to excisional haemorrhoidectomy in adults, and reporting pain scores, were retrieved from the EMBASE and MEDLINE databases. An additional 464 studies were identified of which 74 met the inclusion criteria. There were 48 randomized controlled trials and 26 reviews. Quantitative analyses were not performed, as there were limited numbers of trials with a sufficiently homogeneous design. Pudendal nerve block, with or without general anaesthesia, is recommended for all patients undergoing haemorrhoidal surgery. Either closed haemorrhoidectomy, or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure. Combinations of analgesics (paracetamol, non-steroidal anti-inflammatory drugs, and opioids), topical lignocaine and glyceryl trinitrate, laxatives, and oral metronidazole are recommended post-operatively. The recommendations are largely based on single intervention, not multimodal intervention, studies.

  20. Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.

    Science.gov (United States)

    Butler, Kristina; Yi, John; Wasson, Megan; Klauschie, Jennifer; Ryan, Debra; Hentz, Joseph; Cornella, Jeffrey; Magtibay, Paul; Kho, Roseanne

    2017-05-01

    After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed. We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery. A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment. Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a

  1. Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery.

    Science.gov (United States)

    Pellegrino, Luciano N; Avanzi, Osmar

    2014-12-01

    Prospective observational study. To assess patient quality of life before and after surgical treatment of adolescent idiopathic scoliosis (AIS) and determine whether an association exists between quality of life and curve magnitude, curve correction, and type of instrumentation. Assessment of AIS surgery outcomes has always been based on analysis of radiographic measurements and postoperative curve correction. However, there is a current trend toward greater emphasis on patient-centered outcomes. Assessment of treatment success on the basis of these outcomes requires prospective use of quality-of-life surveys before and after AIS treatment. Prospective study of 33 patients undergoing surgical treatment of AIS. Mean age was 15.6 years and mean Cobb angle was 70.5 degrees. Patients were randomly allocated into one of 2 instrumentation groups (hybrid and pedicle screws alone), and the Scoliosis Research Society-30 questionnaire (SRS-30) and Short Form-36 Health Survey (SF-36) questionnaires were administered preoperatively and at 3-, 6-, and 12-month follow-up. Statistical testing was performed to determine whether survey scores correlated with Cobb angle, curve correction, or type of instrumentation. SRS-30 and SF-36 scores improved significantly. The greatest changes occurred in the self-image and satisfaction with management domains of the SRS-30 survey. SRS-30 and SF-36 scores showed worsening pain and decreased function at 3-month follow-up, but significant improvement from baseline at 12 months. Total SRS-30 scores were significantly improved at 6- and 12-month follow-up, as were subscores in the general health, vitality, and social functioning domains of SF-36. Curve magnitude, percent curve correction, and type of instrumentation had no significant influence on final SRS-30 and SF-36 scores. Surgical treatment of AIS improved patient quality of life, as shown by significant improvement on all SRS-30 and SF-36 domains. Questionnaire scores did not correlate

  2. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial.

    Science.gov (United States)

    Westerdahl, Elisabeth; Urell, Charlotte; Jonsson, Marcus; Bryngelsson, Ing-Liss; Hedenström, Hans; Emtner, Margareta

    2014-01-01

    Postoperative breathing exercises are recommended to cardiac surgery patients. Instructions concerning how long patients should continue exercises after discharge vary, and the significance of treatment needs to be determined. Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for 2 months following cardiac surgery. The study design was a prospective, single-blinded, parallel-group, randomized trial. Patients performing breathing exercises 2 months after cardiac surgery (n = 159) were compared with a control group (n = 154) performing no breathing exercises after discharge. The intervention consisted of 30 slow deep breaths performed with a positive expiratory pressure device (10-15 cm H2O), 5 times a day, during the first 2 months after surgery. The outcomes were lung function measurements, oxygen saturation, thoracic excursion mobility, subjective perception of breathing and pain, patient-perceived quality of recovery (40-Item Quality of Recovery score), health-related quality of life (36-Item Short Form Health Survey), and self-reported respiratory tract infection/pneumonia and antibiotic treatment. Two months postoperatively, the patients had significantly reduced lung function, with a mean decrease in forced expiratory volume in 1 second to 93 ± 12% (P< .001) of preoperative values. Oxygenation had returned to preoperative values, and 5 of 8 aspects in the 36-Item Short Form Health Survey were improved compared with preoperative values (P< .01). There were no significant differences between the groups in any of the measured outcomes. No significant differences in lung function, subjective perceptions, or quality of life were found between patients performing home-based deep breathing exercises and control patients 2 months after cardiac surgery.

  3. A randomized controlled trial evaluating early versus traditional oral feeding after colorectal surgery

    Directory of Open Access Journals (Sweden)

    Ahmet Dag

    2011-01-01

    Full Text Available OBJECTIVE: This prospective randomized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations. METHODS: A total of 199 patients underwent colorectal surgery and were randomly assigned to early feeding (n = 99 or a regular diet (n = 100. Patients’ characteristics, diagnoses, surgical procedures, comorbidity, bowel movements, defecation, nasogastric tube reinsertion, time of tolerance of solid diet, complications, and length of hospitalization were assessed. RESULTS: The two groups were similar in terms of gender, age, diagnosis, surgical procedures, and comorbidity. In the early feeding group, 85.9% of patients tolerated the early feeding schedule. Bowel movements (1.7±0.89 vs. 3.27±1.3, defecation (3.4±0.77 vs. 4.38±1.18 and time of tolerance of solid diet (2.48±0.85 vs. 4.77±1.81 were significantly earlier in the early feeding group. There was no change between the groups in terms of nasogastric tube reinsertion, overall complication or anastomotic leakage. Hospitalization (5.55±2.35 vs. 9.0±6.5 was shorter in the early feeding group. CONCLUSIONS: The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively. Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions.

  4. Prospective randomized trial compares suction versus water seal for air leaks.

    Science.gov (United States)

    Cerfolio, R J; Bass, C; Katholi, C R

    2001-05-01

    Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

  5. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  6. Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

    Science.gov (United States)

    Persson-Kjerstadius, N; Forsgren, H; Westgren, M

    1999-02-01

    To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

  7. Is there a prospect for hybrid aortic arch surgery?

    Science.gov (United States)

    Bashir, Mohamad; Harky, Amer; Bilal, Haris

    2018-05-16

    The surge of endovascular repair of aortic aneurysm in current modern aortic surgery practice has been the key for surgical management of elective cases of thoracic aortic aneurysms. This has paved way for the combined hybrid approach to be amongst the armamentarium for the management of aortic arch disease. The pivotal understanding of the aortic arch natural history coupled with device technology advancement allowed surgeons insight into delivery of hybrid surgery with acceptable morbidity and mortality results. This review article provides current insights into hybrid technique of aortic arch aneurysm repair and the evidences behind its applicability to arch surgery. It is aimed to highlight the challenges encountered for this innovative approach and correlate its challenges to those that are met by the conventional open aortic arch repair.

  8. PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

    Science.gov (United States)

    Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

    2008-06-01

    To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (PPRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

  9. Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

    Science.gov (United States)

    Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

    2012-02-01

    To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

  10. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  11. Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

    NARCIS (Netherlands)

    Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

    Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

  12. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  13. Timing and approaches in congenital cataract surgery: a four-year, two-layer randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jin-Chao Liu

    2017-12-01

    Full Text Available "AIM: To compare visual prognoses and postoperative adverse events of congenital cataract surgery performed at different times and using different surgical approaches. METHODS: In this prospective, randomized controlled trial, we recruited congenital cataract patients aged 3mo or younger before cataract surgery. Sixty-one eligible patients were randomly assigned to two groups according to surgical timing: a 3-month-old group and a 6-month-old group. Each eye underwent one of three randomly assigned surgical procedures, as follows: surgery A, lens aspiration (I/A; surgery B, lens aspiration with posterior continuous curvilinear capsulorhexis (I/A+PCCC; and surgery C, lens aspiration with posterior continuous curvilinear capsulorhexis and anterior vitrectomy (I/A+PCCC+A-Vit. The long-term best-corrected visual acuity (BCVA and the incidence of complications in the different groups were compared and analyzed. RESULTS: A total of 57 participants (114 eyes with a mean follow-up period of 48.7mo were included in the final analysis. The overall logMAR BCVA in the 6-month-old group was better than that in the 3-month-old group (0.81±0.28 vs 0.96±0.30; P=0.02. The overall logMAR BCVA scores in the surgery B group were lower than the scores in the A and C groups (A: 0.80±0.29, B: 1.02±0.28, and C: 0.84±0.28; P=0.007. A multivariate linear regression revealed no significant relationships between the incidence of complications and long-term BCVA. CONCLUSION: It might be safer and more beneficial for bilateral total congenital cataract patients to undergo surgery at 6mo of age than 3mo. Moreover, with rigorous follow-up and timely intervention, the postoperative complications in these patients are treatable and do not compromise visual outcomes."

  14. Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: A randomized trial

    DEFF Research Database (Denmark)

    Krag Moeller, Lars Bo; Moeller, Charlotte; Thomsen, Sten Grove

    2009-01-01

    . A total of 106 women diagnosed with ectopic pregnancy (EP). Methods. Between March 1997 and September 2000, 1,265 women were diagnosed with EP, 395 (31%) were eligible, 109 (9%) were randomized of whom 106 had an EP. The study was originally powered to a sample size of 422 patients. The women were......Objective. To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery. Design. Prospective, randomized, open multicenter study. Setting. Seven Danish departments of obstetrics and gynecology. Sample...... (n.s.). Conclusions. In women with an EP, who are hemodynamically stable and wishing to preserve their fertility, medical treatment with single dose MTX tends to be equal to treatment with laparoscopic surgery regarding success rate, complications, and subsequent fertility. Although the two treatment...

  15. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2–12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients’ characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  16. Incidence and prognostic factors for postoperative frozen shoulder after shoulder surgery: a prospective cohort study.

    Science.gov (United States)

    Koorevaar, Rinco C T; Van't Riet, Esther; Ipskamp, Marcel; Bulstra, Sjoerd K

    2017-03-01

    Frozen shoulder is a potential complication after shoulder surgery. It is a clinical condition that is often associated with marked disability and can have a profound effect on the patient's quality of life. The incidence, etiology, pathology and prognostic factors of postoperative frozen shoulder after shoulder surgery are not known. The purpose of this explorative study was to determine the incidence of postoperative frozen shoulder after various operative shoulder procedures. A second aim was to identify prognostic factors for postoperative frozen shoulder after shoulder surgery. 505 consecutive patients undergoing elective shoulder surgery were included in this prospective cohort study. Follow-up was 6 months after surgery. A prediction model was developed to identify prognostic factors for postoperative frozen shoulder after shoulder surgery using the TRIPOD guidelines. We nominated five potential predictors: gender, diabetes mellitus, type of physiotherapy, arthroscopic surgery and DASH score. Frozen shoulder was identified in 11% of the patients after shoulder surgery and was more common in females (15%) than in males (8%). Frozen shoulder was encountered after all types of operative procedures. A prediction model based on four variables (diabetes mellitus, specialized shoulder physiotherapy, arthroscopic surgery and DASH score) discriminated reasonably well with an AUC of 0.712. Postoperative frozen shoulder is a serious complication after shoulder surgery, with an incidence of 11%. Four prognostic factors were identified for postoperative frozen shoulder: diabetes mellitus, arthroscopic surgery, specialized shoulder physiotherapy and DASH score. The combination of these four variables provided a prediction rule for postoperative frozen shoulder with reasonable fit. Level II, prospective cohort study.

  17. A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

    Science.gov (United States)

    Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

    2013-08-01

    Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

  18. Minimally invasive glaucoma surgery: current status and future prospects

    Directory of Open Access Journals (Sweden)

    Richter GM

    2016-01-01

    Full Text Available Grace M Richter,1,2 Anne L Coleman11UCLA Stein Eye Institute, Department of Ophthalmology, University of California, Los Angeles, CA, USA; 2USC Eye Institute, Department of Ophthalmology, Keck School of Medicine of University of Southern California, Los Angeles, CA, USAAbstract: Minimally invasive glaucoma surgery aims to provide a medication-sparing, conjunctival-sparing, ab interno approach to intraocular pressure reduction for patients with mild-to-moderate glaucoma that is safer than traditional incisional glaucoma surgery. The current approaches include: increasing trabecular outflow (Trabectome, iStent, Hydrus stent, gonioscopy-assisted transluminal trabeculotomy, excimer laser trabeculotomy; suprachoroidal shunts (Cypass micro-stent; reducing aqueous production (endocyclophotocoagulation; and subconjunctival filtration (XEN gel stent. The data on each surgical procedure for each of these approaches are reviewed in this article, patient selection pearls learned to date are discussed, and expectations for the future are examined. Keywords: MIGS, microincisional glaucoma surgery, trabecular stent, Schlemm’s canal, suprachoroidal shunt, ab interno

  19. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  20. Objective and subjective outcomes of strabismus surgery in Graves' orbitopathy: a prospective multicentre study

    NARCIS (Netherlands)

    Jellema, Hinke Marijke; Saeed, Peerooz; Mombaerts, Ilse; Dolman, Peter J.; Garrity, Jim; Kazim, Mike; Dhrami-Gavazi, Elona; Lyons, Christopher; Nieuwkerk, Pythia; Mourits, Maarten P.

    2017-01-01

    To assess the change and interrelationship of the field of binocular single vision (BSV) and the quality of life (QoL), tested with two different tools, after one or two strabismus surgeries in patients with Graves' orbitopathy (GO). Prospectively, consecutive patients with GO who were scheduled for

  1. Prospective evaluation of psychosocial adaptation to stoma surgery: the role of self-efficacy.

    NARCIS (Netherlands)

    Bekkers, M.J.T.; Knippenberg, F.C.E. van; Borne, H.W. van den; Berge-Henegouwen, G.P. van

    1996-01-01

    Self-efficacy, one's expectations regarding the ability to perform some specific task, was studied prospectively in the adaptation process of stoma patients. One week after surgery, stoma-related self-efficacy was assessed in 59 patients (26 cancer patients and 33 patients with benign diseases) who

  2. Early versus conventional stoma closure following bowel surgery: A randomized controlled trial

    Science.gov (United States)

    Nelson, Thirugnanasambandam; Pranavi, Amuda R.; Sureshkumar, Sathasivam; Sreenath, Gubbi S.; Kate, Vikram

    2018-01-01

    Background/Aim: To compare early stoma closure with conventional stoma closure following defunctioning diversion stoma surgery with respect to the frequency of complications, health-related quality of life (QoL), and length of hospitalization (LoH). Patients and Methods: This study was designed as a prospective parallel-arm randomized controlled trial. Patients who underwent temporary stoma following bowel surgery between February 2014 and November 2015 were included. The rate of complications (medical and surgical) following early and conventional stoma closure was assessed. Health-related QoL and LoH were also measured. Results: One hundred patients were included, with 50 cases in each group. Postoperative complications including laparostoma (6% vs. 2%;P = 0.307), wound infection (32% vs. 18%; P = 0.106), intra-abdominal collection (14% vs. 18%; P = 0.585), anastomotic leak (4%vs. 8%;P = 0.400), and medical complications were comparable (22% vs. 32%;P = 0.257). The length of hospital stay, overall mortality and morbidity (64% vs. 44%; P = 0.05) were similar across the two groups. There was a significant reduction in the cost towards stoma care (96% vs. 2%; P = 0.001) in the early stoma closure group. Patients in the early stoma closure group also had a significantly better QoL. Conclusion: Early stoma closure does not carry an increased risk of postoperative complications, reduces cost towards stoma care, and leads to better a QoL. PMID:29451185

  3. Diathermy vs. scalpel skin incisions in general surgery: double-blind, randomized, clinical trial.

    Science.gov (United States)

    Shamim, Muhammad

    2009-08-01

    This prospective, double-blind, randomized, controlled trial was designed to compare the outcome of diathermy incisions versus scalpel incisions in general surgery. A total of 369 patients who underwent diathermy incision (group A: 185 patients) or scalpel incision (group B: 184 patients) were analyzed. Variables analyzed were: surgical wound classification, length and depth of incision, incision time, duration of operation, incisional blood loss, postoperative pain, duration of hospital stay, duration of healing, and postoperative complications. The inclusion criteria were all patients who underwent elective or emergency general surgery. The exclusion criteria were only cases with incomplete patients' data and patients who were lost to follow-up. This study was conducted at Fatima Hospital-Baqai Medical University and Shamsi Hospital (Karachi), from January 2006 to December 2007. Incision time was significantly longer for patients in group B (p = 0.001). Incisional blood loss also was more for patients in group B (p = 0.000). Pain perception was found to be markedly reduced during the first 48 h in group A (p = 0.000). Total period of hospital stay (p = 0.129) and time for complete wound healing (p = 0.683) were almost the same for both groups. Postoperative complication rate by wound classification did not differ markedly between the two groups (p = 0.002 vs. p = 0.000). Diathermy incision has significant advantages compared with the scalpel because of reduced incision time, less blood loss, & reduced early postoperative pain.

  4. Gut barrier function and systemic endotoxemia after laparotomy or laparoscopic resection for colon cancer: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Mario Schietroma

    2016-01-01

    Full Text Available Purpose: The gut barrier is altered in certain pathologic conditions (shock, trauma, or surgical stress, resulting in bacterial and/or endotoxin translocation from the gut lumen into the systemic circulation. In this prospective randomized study, we investigated the effect of surgery on intestinal permeability (IP and endotoxemia in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach. Patients and Methods: A hundred twenty-three consecutive patients underwent colectomy for colon cancer: 61 cases were open resection (OR and 62 cases were laparoscopic resection (LR. IP was measured preoperatively and at days 1 and 3 after surgery. Serial venous blood sample were taken at 0, 30, 60, 90, 120, and 180 min, and at 12, 24, and 48 h after surgery for endotoxin measurement. Results: IP was significantly increased in the open and closed group at day 1 compared with the preoperative level (P < 0.05, but no difference was found between laparoscopic and open surgery group. The concentration endotoxin systemic increased significantly in the both groups during the course of surgery and returned to baseline levels at the second day. No difference was found between laparoscopic and open surgery. A significant correlation was observed between the maximum systemic endotoxin concentration and IP measured at day 1 in the open group and in the laparoscopic group. Conclusion: An increase in IP, and systemic endotoxemia were observed during the open and laparoscopic resection for colon cancer, without significant statistically difference between the two groups.

  5. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study.

    Science.gov (United States)

    Alolayan, Albraa Badr; Leung, Yiu Yan

    2017-05-01

    To investigate the longitudinal resolution of neurosensory deficit (NSD) and the possible risk factors that might contribute to NSD following mandibular orthognathic procedures. A prospective longitudinal observational study on patients who had mandibular orthognathic procedures was performed. Standardized neurosensory assessments were performed. The 2 years longitudinal resolution and risk factors of NSD including patients' age and gender, specific mandibular procedures and surgeons' experience were analyzed. 66 patients (44 females) with 132 sides of mandibular procedures were enrolled in the study. Surgical procedures included mandibular ramus surgery, anterior mandibular surgery, or the combination of the two. The overall occurrences of subjective NSD improved from 78.8% at postoperative 2 weeks to 13.8% at post-operative 2 years. Combinations of ramus surgery and anterior mandibular surgery increased the risk of NSD at the first three post-operative months (p orthognathic surgery. The occurrence of NSD after mandibular orthognathic procedures reduced progressively within the post-operative 2 years. Combination of mandibular ramus surgery and anterior mandibular surgery increased the risk of NSD in the early post-operative period. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  6. Evaluation of aesthetic and functional outcomes in rhinoplasty surgery: a prospective study.

    Science.gov (United States)

    Sena Esteves, Sara; Gonçalves Ferreira, Miguel; Carvalho Almeida, João; Abrunhosa, José; Almeida E Sousa, Cecília

    Evaluation of surgery outcome measured by patient satisfaction or quality of life is very important, especially in plastic surgery. There is increasing interest in self-reporting outcomes evaluation in plastic surgery. The aim of our study was to determine patient satisfaction in regard to nose appearance and function with the use of a validated questionnaire, before and after rhinoplasty surgery. A prospective study was realized at a tertiary centre. All rhinoplasty surgeries performed in adults between February 2013 and August 2014 were included. Many patients underwent additional nasal surgery such as septoplasty or turbinoplasty. The surgical procedures and patients' characteristics were also recorded. Among 113 patients, 107 completed the questionnaires and the follow-up period. Analysis of pre-operative and post-operative Rhinoplasty Evaluation Outcome showed a significant improvement after 3 and 6 months in functional and aesthetic questions (pprocedures, primary or revision surgery and open versus closed approach. We found that patients with lower literacy degree were more satisfied with the procedure. Rhinoplasty surgery significantly improved patient quality of life regarding nose function and appearance. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  7. A randomized trial of preoperative oral carbohydrates in abdominal surgery.

    Science.gov (United States)

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and control. Visual analogue scale (VAS) scores for seven parameters (thirst, hunger, anxiety, mouth dryness, nausea, weakness and sleep quality) were recorded and compared for two different time periods (up to 24 h postoperatively and from 36 to 48 h postoperatively). The Simplified Acute Physiology Score changes (SAPS)-II between the three groups were also studied. There were 142 patients American Society of Anesthesiology (ASA) I or II enrolled in the study (CR = 71 and CH = 71). There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay (LOS) between the groups. However, in CR patients, the degree of thirst was partially improved by drinking CRLDs (P = 0.027). In CH patients, on the other hand, feelings of thirst, hunger, mouth dryness, nausea and weakness showed significant improvement (P < 0.05). Oral administration of carbohydrate-rich liquid drinks (CRLDs) improves the well-being in patients undergoing CH, but the effect is less evident in patients undergoing CR. No significant improvements were seen in clinical status or in length of hospital stay in either group. ANZCTR.org.au: ACTRN12614000995673 (registered on 16/09/2014).

  8. A randomized clinical trial of continuous aspiration of subglottic secretions in cardiac surgery patients.

    Science.gov (United States)

    Kollef, M H; Skubas, N J; Sundt, T M

    1999-11-01

    To determine whether the application of continuous aspiration of subglottic secretions (CASS) is associated with a decreased incidence of ventilator-associated pneumonia (VAP). Prospective clinical trial. Cardiothoracic ICU (CTICU) of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred forty-three patients undergoing cardiac surgery and requiring mechanical ventilation in the CTICU. Patients were assigned to receive either CASS, using a specially designed endotracheal tube (Hi-Lo Evac; Mallinckrodt Inc; Athlone, Ireland), or routine postoperative medical care without CASS. One hundred sixty patients were assigned to receive CASS, and 183 were assigned to receive routine postoperative medical care without CASS. The two groups were similar at the time of randomization with regard to demographic characteristics, surgical procedures performed, and severity of illness. Risk factors for the development of VAP were also similar during the study period for both treatment groups. VAP was seen in 8 patients (5.0%) receiving CASS and in 15 patients (8. 2%) receiving routine postoperative medical care without CASS (relative risk, 0.61%; 95% confidence interval, 0.27 to 1.40; p = 0. 238). Episodes of VAP occurred statistically later among patients receiving CASS ([mean +/- SD] 5.6 +/- 2.3 days) than among patients who did not receive CASS (2.9 +/- 1.2 days); (p = 0.006). No statistically significant differences for hospital mortality, overall duration of mechanical ventilation, lengths of stay in the hospital or CTICU, or acquired organ system derangements were found between the two treatment groups. No complications related to CASS were observed in the intervention group. Our findings suggest that CASS can be safely administered to patients undergoing cardiac surgery. The occurrence of VAP can be significantly delayed among patients undergoing cardiac surgery using this simple-to-apply technique.

  9. The consent and counselling of patients for cataract surgery: a prospective audit.

    Science.gov (United States)

    Cheung, D; Sandramouli, S

    2005-09-01

    The aims of ideal preoperative informed consent include educating the patient adequately to enable an autonomous decision to be made without causing undue anxiety. We study how the paternalistic and nonpaternalistic approaches meet this ideal. The influence of the new patient consent forms is also assessed. Two cycles of a prospective clinical audit are presented. An assessment of relevant patient knowledge was performed by patient interview. Visual analogue scales were used to quantify patient anxiety. The first cycle, examining a paternalistic approach, demonstrated: 37% of patients understood what a cataract was and 48% understood what surgery involved. 48% misunderstood that cataract surgery was completely risk free. In total, 80% of patients undergoing second eye surgery believed that it was completely risk-free. Average anxiety visual analogue scores (VAS) for cataract surgery were low (2.89). The second cycle, examining the nonpaternalistic approach combined with the implementation of new consent forms showed that, despite more explicit repeated preoperative consent: 39% of patients understood correctly what a cataract was, 28% understood what surgery involved and 43% misunderstood that surgery was completely risk-free. All patients undergoing second eye surgery thought that it was risk-free. The average anxiety VAS for cataract surgery were moderate (5.00). Both paternalistic and non-paternalistic approaches to informed consent are inadequate in meeting the demands of the ideal informed consent. The new patient consent forms appear to have little effect in influencing patient knowledge about their surgery. Patients undergoing second eye surgery often have an overoptimistic view of cataract surgery.

  10. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

  11. Effectiveness of the Surgery Core Clerkship Flipped Classroom: a prospective cohort trial.

    Science.gov (United States)

    Liebert, Cara A; Lin, Dana T; Mazer, Laura M; Bereknyei, Sylvia; Lau, James N

    2016-02-01

    The flipped classroom has been proposed as an alternative curricular approach to traditional didactic lectures but has not been previously applied to a surgery clerkship. A 1-year prospective cohort of students (n = 89) enrolled in the surgery clerkship was taught using a flipped classroom approach. A historical cohort of students (n = 92) taught with a traditional lecture curriculum was used for comparison. Pretest and post-test performance, end-of-clerkship surveys, and National Board of Medical Examiners (NBME) scores were analyzed to assess effectiveness. Mean pretest and post-test scores increased across all modules (P flipped classroom contributed to this increase. Implementation of a flipped classroom in the surgery clerkship is feasible and results in high learner satisfaction, effective knowledge acquisition, and increased career interest in surgery with noninferior NBME performance. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Prospective evaluation of outcome measures in free-flap surgery.

    LENUS (Irish Health Repository)

    Kelly, John L

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +\\/- 29 min) and in those that survived (92 +\\/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival.

  13. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  14. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Raquel Pei Chen Chan

    2009-01-01

    Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

  15. Predicting surgical site infection after spine surgery: a validated model using a prospective surgical registry.

    Science.gov (United States)

    Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

    2014-09-01

    The impact of surgical site infection (SSI) is substantial. Although previous study has determined relative risk and odds ratio (OR) values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of SSI, rather than relative risk or OR values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of SSI after spine surgery. This study performs a multivariate analysis of SSI after spine surgery using a large prospective surgical registry. Using the results of this analysis, this study will then create and validate a predictive model for SSI after spine surgery. The patient sample is from a high-quality surgical registry from our two institutions with prospectively collected, detailed demographic, comorbidity, and complication data. An SSI that required return to the operating room for surgical debridement. Using a prospectively collected surgical registry of more than 1,532 patients with extensive demographic, comorbidity, surgical, and complication details recorded for 2 years after the surgery, we identified several risk factors for SSI after multivariate analysis. Using the beta coefficients from those regression analyses, we created a model to predict the occurrence of SSI after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created a predictive model based on our beta coefficients from our multivariate analysis. The final predictive model for SSI had a receiver-operator curve characteristic of 0.72, considered to be a fair measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting SSI after spine surgery. The value in this model is that it gives

  16. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

    Science.gov (United States)

    Angioli, Roberto; De Cicco Nardone, Carlo; Plotti, Francesco; Cafà, Ester Valentina; Dugo, Nella; Damiani, Patrizio; Ricciardi, Roberto; Linciano, Francesca; Terranova, Corrado

    2014-01-01

    To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. Prospective randomized trial (Canadian Task Force classification I). Major university medical center. Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort. Copyright © 2014. Published by Elsevier Inc.

  17. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

    Directory of Open Access Journals (Sweden)

    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  18. Resistant metatarsus adductus: prospective randomized trial of casting versus orthosis.

    Science.gov (United States)

    Herzenberg, John E; Burghardt, Rolf D

    2014-03-01

    Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding. It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching. Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention. We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus. We prospectively treated 27 infants (43 feet) between the ages 3 and 9 months who failed home stretching treatment. Patients were randomized to either serial plaster casting or Bebax orthoses. Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up. There was no statistical difference between casting and Bebax for the following parameters: age at study entry, length of treatment, number of clinic visits, follow-up, and follow-up maintenance treatments. Both groups showed improvement in footprint and radiographic measurements post-treatment, without worsening of heel valgus. The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group. The Bebax treatment requires more active parental cooperation. A simulated cost analysis of materials and office visit charges, however, revealed that Bebax treatment was significantly less expensive, about half the cost of casting. Because of the cost savings and virtually identical clinical results, we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant. Other considerations include specific insurance plans, which may pay for casts but not orthoses.

  19. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery.

    Science.gov (United States)

    de Jonghe, Jos F M; Kalisvaart, Kees J; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Gool, Willem A

    2007-02-01

    The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip surgery aged 70 and older at risk for delirium. Before surgery, patients were randomized to low-dose prophylactic haloperidol treatment or placebo. Daily assessments were based on patient interviews with the Mini-Mental State Examination and Digit Span test. The Delirium Rating Scale-Revised (DRS-R-98) was used to measure early symptoms during the prodromal phase before the onset of delirium. Data of 66 patients with delirium were compared with those of 35 at-risk patients who did not develop delirium: 14 of 66 patients (21%) had delirium on the day of surgery or early the day after, 32 of 66 (48%) on the second day, 14 of 66 on the third, and six of 66 (9%) on the fourth. The average DRS-R-98 total scores on day -4 to day -1 before delirium were 1.9 for the comparison group patients and 5.0, 4.3, 5.8, and 10.7 for patients with postoperative delirium. Multivariate analysis showed that the early symptoms memory impairments, incoherence, disorientation, and underlying somatic illness predict delirium. Most elderly patients undergoing hip surgery with postoperative delirium already have early symptoms in the prodromal phase of delirium. These findings are potentially useful for screening purposes and for optimizing prevention strategies targeted at reducing the incidence of postoperative delirium.

  20. Health-Related Quality of Life, Cachexia and Overall Survival After Major Upper Abdominal Surgery: A Prospective Cohort Study.

    Science.gov (United States)

    Aahlin, E K; Tranø, G; Johns, N; Horn, A; Søreide, J A; Fearon, K C; Revhaug, A; Lassen, K

    2017-03-01

    Major upper abdominal surgery is often associated with reduced health-related quality of life and reduced survival. Patients with upper abdominal malignancies often suffer from cachexia, represented by preoperative weight loss and sarcopenia (low skeletal muscle mass) and this might affect both health-related quality of life and survival. We aimed to investigate how health-related quality of life is affected by cachexia and how health-related quality of life relates to long-term survival after major upper abdominal surgery. From 2001 to 2006, 447 patients were included in a Norwegian multicenter randomized controlled trial in major upper abdominal surgery. In this study, six years later, these patients were analyzed as a single prospective cohort and survival data were retrieved from the National Population Registry. Cachexia was derived from patient-reported preoperative weight loss and sarcopenia as assessed from computed tomography images taken within three months preoperatively. In the original trial, self-reported health-related quality of life was assessed preoperatively at trial enrollment and eight weeks postoperatively with the health-related quality of life questionnaire Short Form 36. A majority of the patients experienced improved mental health-related quality of life and, to a lesser extent, deteriorated physical health-related quality of life following surgery. There was a significant association between preoperative weight loss and reduced physical health-related quality of life. No association between sarcopenia and health-related quality of life was observed. Overall survival was significantly associated with physical health-related quality of life both pre- and postoperatively, and with postoperative mental health-related quality of life. The association between health-related quality of life and survival was particularly strong for postoperative physical health-related quality of life. Postoperative physical health-related quality of life

  1. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  2. A Randomized Controlled Trial Study in Abdominal Surgery

    African Journals Online (AJOL)

    ADMIN

    , and finally, greatly improved postoperative recovery 5-7. In recent years, FTS has been applied to several surgical diseases including radical prostatectomy 8, cardiac surgery 9, total knee replacement 10, cesarean section11, coronary artery ...

  3. Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

    Science.gov (United States)

    Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

    2012-05-01

    Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

  4. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barbero, Cristina; Ricci, Davide; Cura Stura, Erik; Pellegrini, Augusto; Marchetto, Giovanni; ElQarra, Suad; Boffini, Massimo; Passera, Roberto; Valentini, Maria Consuelo; Rinaldi, Mauro

    2017-02-21

    Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

  5. Female plastic surgery patients prefer mirror-reversed photographs of themselves: A prospective study.

    Science.gov (United States)

    de Runz, Antoine; Boccara, David; Chaouat, Marc; Locatelli, Katia; Bertheuil, Nicolas; Claudot, Frédérique; Bekara, Farid; Mimoun, Maurice

    2016-01-01

    The use of a patient's image in plastic surgery is common today. Thus, plastic surgeons should master the use of the image and be aware of the implications of the patients' perception of themselves. The mere-exposure effect is a psychological phenomenon in which a person tends to rate things more positively merely because (s)he is familiar with them. Faces are asymmetric, so faces in photos are different from those observed in mirrors. The main objective of this study was to assess whether patients within a plastic surgery population, particularly those undergoing facial aesthetic surgery, preferred standard photographs or mirror-reversed photographs of themselves. A prospective study was conducted in a plastic surgery department, which included women who were admitted to the hospital the day before their procedures. The patients were separated into the following two groups: Group 1 was composed of patients who were undergoing facial aesthetic surgeries, and Group 2 consisted of other patients who presented to the plastic surgery department for surgery. The patients were required to rate their appreciation of their own faces and to choose between standard and mirror-reversed photos of themselves. A total of 214 patients participated. The median age was 47.9 years (interquartile range (IQR): 36.4-60.6), and the median face appreciation was 5 (IQR: 5-7). The preference for the mirror-reversed photograph was significantly different from chance (p < 0.001, binomial (214, 156, 0.5)); 73% of the patients preferred the mirror-reversed photographs. The proportions of patients who preferred the mirror-reversed photograph differed significantly (p = 0.047) between Groups 1 (84%) and 2 (70%). Plastic surgery patients have a significant preference for mirror-reversed photographs of themselves over standard photographs. This preference is even more pronounced among patients who are undergoing facial aesthetic surgery. III. Copyright © 2015 British Association of Plastic

  6. Nationwide prospective audit of pancreatic surgery: design, accuracy, and outcomes of the Dutch Pancreatic Cancer Audit

    NARCIS (Netherlands)

    van Rijssen, L. Bengt; Koerkamp, Bas G.; Zwart, Maurice J.; Bonsing, Bert A.; Bosscha, Koop; van Dam, Ronald M.; van Eijck, Casper H.; Gerhards, Michael F.; van der Harst, Erwin; de Hingh, Ignace H.; de Jong, Koert P.; Kazemier, Geert; Klaase, Joost; van Laarhoven, Cornelis J.; Molenaar, I. Quintus; Patijn, Gijs A.; Rupert, Coen G.; van Santvoort, Hjalmar C.; Scheepers, Joris J.; van der Schelling, George P.; Busch, Olivier R.; Besselink, Marc G.; Bollen, Thomas L.; Bruno, Marco J.; van Tienhoven, Geert-Jan; Norduyn, Arnold; Berry, David P.; Tingstedt, Bobby; Tseng, Jennifer F.; Wolfgang, Christopher L.

    2017-01-01

    Background: Auditing is an important tool to identify practice variation and 'best practices'. The Dutch Pancreatic Cancer Audit is mandatory in all 18 Dutch centers for pancreatic surgery. Methods: Performance indicators and case-mix factors were identified by a PubMed search for randomized

  7. Routine calcium measurement is not necessary after most thyroid surgeries: a prospective clinical study.

    LENUS (Irish Health Repository)

    Quinn, E M

    2010-12-01

    Calcium levels are often measured to diagnose postoperative hypocalcaemia following thyroidectomy. The aims of this study were to (i) prospectively determine the incidence of symptomatic and biochemical hypocalcaemia following thyroidectomy, (ii) to identify if any associations exist between hypocalcaemia, type of surgery, histological diagnosis, specimen size\\/weight and the presence of histological parathyroid tissue and (iii) to evaluate the necessity of routine measurement of calcium levels following all thyroidectomies.

  8. Predicting complication risk in spine surgery: a prospective analysis of a novel risk assessment tool.

    Science.gov (United States)

    Veeravagu, Anand; Li, Amy; Swinney, Christian; Tian, Lu; Moraff, Adrienne; Azad, Tej D; Cheng, Ivan; Alamin, Todd; Hu, Serena S; Anderson, Robert L; Shuer, Lawrence; Desai, Atman; Park, Jon; Olshen, Richard A; Ratliff, John K

    2017-07-01

    OBJECTIVE The ability to assess the risk of adverse events based on known patient factors and comorbidities would provide more effective preoperative risk stratification. Present risk assessment in spine surgery is limited. An adverse event prediction tool was developed to predict the risk of complications after spine surgery and tested on a prospective patient cohort. METHODS The spinal Risk Assessment Tool (RAT), a novel instrument for the assessment of risk for patients undergoing spine surgery that was developed based on an administrative claims database, was prospectively applied to 246 patients undergoing 257 spinal procedures over a 3-month period. Prospectively collected data were used to compare the RAT to the Charlson Comorbidity Index (CCI) and the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator. Study end point was occurrence and type of complication after spine surgery. RESULTS The authors identified 69 patients (73 procedures) who experienced a complication over the prospective study period. Cardiac complications were most common (10.2%). Receiver operating characteristic (ROC) curves were calculated to compare complication outcomes using the different assessment tools. Area under the curve (AUC) analysis showed comparable predictive accuracy between the RAT and the ACS NSQIP calculator (0.670 [95% CI 0.60-0.74] in RAT, 0.669 [95% CI 0.60-0.74] in NSQIP). The CCI was not accurate in predicting complication occurrence (0.55 [95% CI 0.48-0.62]). The RAT produced mean probabilities of 34.6% for patients who had a complication and 24% for patients who did not (p = 0.0003). The generated predicted values were stratified into low, medium, and high rates. For the RAT, the predicted complication rate was 10.1% in the low-risk group (observed rate 12.8%), 21.9% in the medium-risk group (observed 31.8%), and 49.7% in the high-risk group (observed 41.2%). The ACS NSQIP calculator consistently

  9. Early Oral Feeding After Surgery for Upper Gastrointestinal Malignancies: A Prospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Saeed Shoar

    2016-05-01

    Full Text Available Objectives: Poor nutritional status following abdominal surgeries for esophageal and gastric cancers remains a major challenge in postoperative care. Our study aimed to investigate the efficacy of starting early oral feeding (EOF in patients undergoing surgical resection of upper gastrointestinal malignancies. Methods: A total of 180 consecutive patients with a diagnosis of esophageal or gastric malignancies undergoing elective surgical resection between January 2008 and February 2011 were enrolled in this prospective cohort study. Seventy-two patients were assigned to the EOF group, and 108 patients received late oral feeding (LOF. Postoperative endpoints were compared between the two groups. Results: Nasogastric tubes were removed from patients on average 3.3±1.6 days after the surgery in the EOF group and 5.2±2.5 days in the LOF group (p 0.050. Conclusions: EOF is safe following esophageal and gastric cancer surgery and results in faster recovery and hospital discharge.

  10. A Prospective Randomized Clinical Study of the Influence of Primary ...

    African Journals Online (AJOL)

    of closure of the socket after surgical extraction of impacted mandibular third molar. ... mandibular third molar surgery concluded that there was a reduction in .... round bur (carbide no: 8) in a high speed straight hand piece under constant ...

  11. Pain control in laparoscopic gynecologic surgery with/without preoperative (preemptive) parecoxib sodium injection: a randomized study.

    Science.gov (United States)

    Ratchanon, Sarwinee; Phaloprakarn, Chadakarn; Traipak, Khanitta

    2011-10-01

    To determine the effectiveness of preoperative parecoxib sodium injection for pain relief after laparoscopic gynecologic surgery. A prospective double-blind, randomized study was conducted in 268 patients who underwent laparoscopic gynecologic surgery at Vajira Hospital between November 1, 2010 and March 31, 2011. The patients were randomly allocated into two groups to receive either single intravenous 40 mg parecoxib (treatment group; n = 133) or normal saline (control group; n = 135) 30 min before surgery. The degree of postoperative pain was assessed every 2 h in the first 8 h postoperation, then every 4 h until completion of 24 h by using a verbal rating scale. Total consumption of meperidine over a 24-h period and the adverse events relevant to parecoxib sodium were also recorded. Mean pain scores at all measured times in the treatment group were insignificantly lower than those in the control group (p = 0.106). The mean 24-h postoperative meperidine consumption in the treatment group was significantly lower compared to that in the control group (26.3 +/- 28.1 mg and 39.1 +/- 34.6 mg, respectively, p = 0.001). The proportion of patients requiring meperidine in the treatment group was significantly lower than that in the control group (58.6% and 70.3%, respectively, p = 0. 045). No serious adverse events were observed in both groups. Preoperative parecoxib sodium significantly reduced postoperative meperidine requirement and consumption, while insignificantly declined the pain scores. Serious adverse events were not encountered

  12. Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

    Science.gov (United States)

    Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

    2018-05-11

    Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk ( 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

  13. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

    NARCIS (Netherlands)

    K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

    2002-01-01

    textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

  14. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

    Science.gov (United States)

    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  15. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  16. Intrathecal sufentanil versus fentanyl for lower limb surgeries - A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poonam Motiani

    2011-01-01

    Full Text Available Background:To compare the efficacy and safety of intrathecal sufentanil or fentanyl as adjuvants to hyperbaric bupivacaine in patients undergoing major orthopaedic lower limb surgeries in terms of onset and duration of sensory block, motor block and post-operative pain relief. Patients & Methods: Ninety patients were recruited in this Prospective, randomized double blind study to receive either intrathecal sufentanil 5 μg (Group S, fentanyl 25 μg (Group F or normal saline 0.5 ml (Group C as adjuvants to 15 mg of 0.5% hyperbaric bupivacaine. The onset and duration of sensory and motor block were assessed intraoperatively. The pain scores were assessed postoperatively. Duration of complete and effective analgesia was recorded. The incidence of side effects such as nausea, vomiting, pruritus, shivering and PDPH was recorded. Results: The Demographic data, hemodynamic and respiratory parameters were comparable in the three groups. There was a significantly earlier onset and prolonged duration of sensory block in the sufentanil and fentanyl groups. The duration of complete and effective analgesia were also significantly prolonged in the fentanyl and sufentanil groups. Pruritus was noticed in the study groups (Groups S&F. Conclusions: Intrathecal sufentanil (5 μg and fentanyl (25 μg, as adjuvants lead to an earlier onset and prolonged duration of sensory block. The duration of effective analgesia with intrathecal sufentanil and fentanyl as adjuvants to hyperbaric bupivacaine is longer than that of bupivacaine alone.

  17. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery.

    Science.gov (United States)

    Akhtar, Zohaib; Hesler, Brian D; Fiffick, Alexa N; Mascha, Edward J; Sessler, Daniel I; Kurz, Andrea; Ayad, Sabry; Saager, Leif

    2016-09-01

    To test the primary hypothesis that forced-air prewarming improves patient satisfaction after outpatient surgery and to evaluate the effect on core temperature and thermal comfort. Prospective randomized controlled trial. Preoperative area, operating room, and postanesthesia care unit. A total of 115 patients aged 18 to 75 years with American Society of Anesthesiologists status thermal comfort via visual analog scales. Data from 102 patients were included in the final analysis. Prewarming did not significantly reduce redistribution hypothermia, with prewarmed minus not prewarmed core temperature differing by only 0.18°C (95% confidence interval [CI], -0.001 to 0.37) during the initial hour of anesthesia (P=.052). Prewarming increased the mean EVAN-G satisfaction score, although not significantly, with an overall difference (prewarmed minus not prewarmed) of 5.6 (95% CI, -0.9 to 12.2; P=.09). Prewarming increased thermal comfort, with an overall difference of 6.6 mm (95% CI, 1.0-12.9; P=.02). Active prewarming increased thermal comfort but did not significantly reduce redistribution hypothermia or improve postoperative patient satisfaction. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Do we at all need surgery to treat thrombosed external hemorrhoids? Results of a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Ole Gebbensleben

    2009-06-01

    Full Text Available Ole Gebbensleben1, York Hilger2, Henning Rohde31Park-Klinik Berlin-Weissensee, Berlin, Germany; 2Institut für Biostatistik, Freiburg im Breisgau, Germany; 3Praxis für Endoskopie und Proktologie, Berlin, GermanyBackground: It is unknown whether surgery is the gold standard for therapy of thrombosed external hemorrhoids (TEH.Methods: A prospective cohort study of 72 adults with TEH was conducted: no surgery, no sitz baths but gentle dry cleaning with smooth toilet paper after defecation. Follow-up information was collected six months after admission by questionnaire.Results: Despite our strict conservative management policy 62.5% (45/72 of patients (95% confidence interval [CI]: 51.0–74.0 described themselves as “healed” or “ameliorated”, and 61.1% (44/72, 95% CI: 49.6–72.6 found our management policy as “valuable to test” or “impracticable”. 13.9% (10/72, 95% CI: 5.7–22.1 of patients suspected to have recurrences. 4.2% did not know. Twenty-two of the 48 responding patients reported symptoms such as itching (18.8%, soiling (12.5%, pricking (10.4%, or a sore bottom (8.3% once a month (59.1%, 13/22, once a week (27.3%, 6/22, or every day (13.6%, 3/22. Conclusions: The dictum that surgery is the gold standard for therapy for TEH should be checked by randomized controlled trials.Keywords: hemorrhoids, acute hemorrhoidal disease, thrombosed external hemorrhoid, perianal thrombosis, conservative therapy, surgery

  19. Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

    A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

  20. The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

    Science.gov (United States)

    Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

    2011-01-01

    This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

  1. Prevalence of acute neuropathic pain after cancer surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    P N Jain

    2014-01-01

    Full Text Available Background and Aims: Acute neuropathic pain (ANP is an under-recognised and under-diagnosed condition and often difficult to treat. If left untreated, it may further transform into persistent post-operative chronic pain leading to a disability. Aims: This prospective study was undertaken on 300 patients to identify the prevalence of ANP in the post-operative period by using a neuropathic pain detection questionnaire tool. Methods: This is an open-label study in which patients with six different types of cancer surgeries (Thoracic, gastro-intestinal, gynae/urology, bone/soft-tissue, head and neck and breast subgroups-50 each were included for painDETECT questionnaire tool on the 2 nd and 7 th day surgery. Results: This study found a 10% point prevalence of ANP. Analysis showed that 25 patients had ′possible′ ANP, the maximum from urological cancer surgery (6 followed by thoracic surgery (5. Five patients were found to have ′positive′ ANP including 2 groin node dissection, 2 hemipelvectomy and 1 oesophagectomy. Conclusion: Significant relationship between severity of post-operative pain was found with the occurrence of ANP in the post-operative period requiring a special attention to neuropathic pain assessment. Larger studies are required with longer follow-up to identify accurately the true prevalence and causative factors of ANP after surgery.

  2. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Wanscher, Michael Jaeger

    2014-01-01

    BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective...

  3. Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

    Science.gov (United States)

    Carranza, Emmanuel John M.; Laborte, Alice G.

    2015-01-01

    Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

  4. Prospective, randomized comparative study between single-port laparoscopic appendectomy and conventional laparoscopic appendectomy.

    Science.gov (United States)

    Villalobos Mori, Rafael; Escoll Rufino, Jordi; Herrerías González, Fernando; Mias Carballal, M Carmen; Escartin Arias, Alfredo; Olsina Kissler, Jorge Juan

    2014-01-01

    Laparoscopic appendectomy is probably the technique of choice in acute appendicitis. Single port laparoscopic surgery (SILS) has been proposed as an alternative technique. The objective of this study is to compare the safety and efficacy of SILS against conventional laparoscopic appendectomy (LA). From January 2011 to September 2012, 120 patients with acute appendicitis were prospectively randomized; 60 for SILS and 60 for LA. Patients between 15 to 65 years were selected, with onset of symptoms less than 48h. We compared BMI, surgery time, start of oral intake, hospital stay, postoperative pain, pathology and costs. The median age, BMI, sex and time of onset of symptoms to diagnosis were similar. There were no statistically significant differences in the operative time, start of oral intake or hospital stay. There was a significant difference in postoperative pain being higher in SILS (4±1.3) than in LA (3.3±0.5) with a P=.004. Flemonous appendicitis predominated in both groups in a similar percentage. A total of 3 cases with intra-abdominal abscess (SILS 2, LA 1) required readmission and resolved spontaneously with intravenous antibiotic treatment. One case of SILS required assistance by a 5mm trocar in the RLC for drainage placement. The cost was higher in SILS due the single port device. SILS appendectomy is safe, effective and has similar results to LA in selected patients, and although the cost is greater, the long term results will determine the future of this technique. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  5. Is LMWH Sufficient for Anticoagulant Prophylaxis in Bariatric Surgery? Prospective Study.

    Science.gov (United States)

    Moaad, Farraj; Zakhar, Bramnik; Anton, Kvasha; Moner, Merie; Wisam, Sbeit; Safy, Farraj; Igor, Waksman

    2017-09-01

    The objective of this study was to evaluate the coagulation profile by thromboelastography in morbidly obese patients who undergo bariatric surgery. Morbid obesity entails increased risk for thromboembolic events. There is no clear protocol for thromboembolic prophylaxis, regarding timing and length of treatment, in bariatric surgery. Thromboelastography provides data on a coagulation process from creation of the clot until the fibrinolysis. Ninety-three morbidly obese patients were prospectively recruited within a 2-year period. Coagulation profile was measured by thromboelastography before surgery, in the immediate postoperative period, within 3 h from surgery, and in the late postoperative period, within 10-14 days after surgery. Venous thromboembolic prophylaxis was achieved by giving low molecular weight heparin (LMWH), once a day. Of the eligible patients, 67 underwent sleeve gastrectomy while 23 underwent Roux-en-Y gastric bypass. Normal values of coagulation factor function, clotting time, and fibrin function, as measured by R, K, and α (angle), were demonstrated in addition to higher maximal amplitude (MA) values, reflecting increased function of platelets. The average MA value before the surgery was above normal and continued rising consistently in the immediate postoperative as well as in the early postoperative period. Morbidly obese patients have a strong tendency toward thrombosis, as demonstrated by pathologically elevated MA values. Altered coagulation profiles were demonstrated 2 weeks postoperatively; thus, prophylaxis that continued at least for 2 weeks after bariatric surgery should be considered. Since LMW heparin is not sufficient alone as thromboembolic prophylaxis, we recommend adding antiplatelet therapy. Further evaluation of appropriate thromboprophylaxis is warranted.

  6. The efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery. A double blind randomized multicentre trail with venographic assesment

    DEFF Research Database (Denmark)

    Bergkvist, A; Eldor, A; Thorlacius-Ussing, O.

    1997-01-01

    BACKGROUND: Surgery for malignant disease carries a high risk of deep vein thrombosis. The aim of this study was to evaluate the prophylactic effect of a low molecular weight heparin, enoxaparin, 40 mg once daily, beginning 2 h before surgery, compared with that of unfractionated low-dose heparin...... three times daily. METHODS: Patients included were over 40 years of age and undergoing planned elective curative abdominal or pelvic surgery for cancer. The study was designed as a prospective double-blind randomized multicentre trial with participating departments from ten countries. Primary outcome...... severe thrombocytopenia. There were no differences in mortality at either 30 days or 3 months. CONCLUSION: Enoxaparin, 40 mg once daily, is as safe and effective as unfractionated heparin three times daily in preventing venous thromboembolism in patients undergoing major elective surgery for abdominal...

  7. Day case shoulder surgery: satisfactory pain control without regional anaesthesia. A prospective analysis of a perioperative protocol.

    LENUS (Irish Health Repository)

    Daruwalla, Z J

    2009-03-01

    Pain control is an issue which may limit patients\\' acceptance of day case shoulder surgery. This study prospectively examined the outcome of a protocol for day case shoulder surgery to determine if satisfactory pain relief could be achieved without regional anaesthesia.

  8. The efficiency of sucralfate in corrosive esophagitis: a randomized, prospective study.

    Science.gov (United States)

    Gümürdülü, Yüksel; Karakoç, Emre; Kara, Banu; Taşdoğan, Burçak Evren; Parsak, Cem Kaan; Sakman, Gürhan

    2010-03-01

    Ingestion of a chemical agent is a serious problem, and several treatment protocols to prevent stricture formation have been proposed. We conducted a randomized prospective study to evaluate the effectiveness of oral intensive sucralfate plus conventional therapy compared to conventional therapy alone. Fifteen patients with stage 2b and 3 corrosive esophagitis admitted to our gastroenterology, general surgery and intensive care units between 2004 and 2007 were included. Patients were divided into two groups. The patients in the first group (n=8) received intensive sucralfate therapy plus conventional therapy, while the other group (n=7) received only conventional therapy. We performed upper endoscopic procedures on days: 0, 21, 45, 90 and 180 to identify the emergent complications. In the first group, only one patient had stricture formation, allowing passage of a 9.2 mm endoscope and causing no dysphagia, on day 45. There was no progression in the stricture on follow-ups at the 3rd and 6th months. In the second group, 6 patients had stricture formation causing narrowing and dysphagia. Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies with large groups of patients are required to confirm our findings.

  9. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  10. [Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

    Science.gov (United States)

    Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

    2016-02-01

    Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

    Science.gov (United States)

    Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

    2014-05-01

    To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  12. Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

    Science.gov (United States)

    Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

    2015-01-01

    To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (Ptransverse system vs torsional (Ptransverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

  13. A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

    Science.gov (United States)

    Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

    2018-05-01

    Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  14. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  15. The effect of milrinone on induced hypotension in elderly patients during spinal surgery: a randomized controlled trial.

    Science.gov (United States)

    Hwang, Wonjung; Kim, Eunsung

    2014-08-01

    Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery. To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients. Prospective randomized clinical trial. Forty patients, 60 to 70 years old, ASA I-II, who underwent elective lumbar fusion surgery. Intraoperative hemodynamics, blood loss, hourly urine output, and grade of surgical field. All patients were randomized to group M or N. The study drug was infused after perivertebral muscle retraction until complete interbody fusion. In group M, 50 μg/kg/min of milrinone was infused over 10 minutes as a loading dose followed by 0.6 μg/kg/min of milrinone as a continuous dose. In group N, an identical volume of normal saline was infused in the same fashion. This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest, financial or otherwise. During infusion of the study drug, the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was 445.0±226.5 mL in group M and 765.0±339.2 mL in group N (p=.001). Hourly urine output was 1.4±0.6 mL in group M and 0.8±0.2 mL in group N (pmilrinone is useful for induced hypotension in elderly patients during spinal surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Single-Blinded Prospective Implementation of a Preoperative Imaging Checklist for Endoscopic Sinus Surgery.

    Science.gov (United States)

    Error, Marc; Ashby, Shaelene; Orlandi, Richard R; Alt, Jeremiah A

    2018-01-01

    Objective To determine if the introduction of a systematic preoperative sinus computed tomography (CT) checklist improves identification of critical anatomic variations in sinus anatomy among patients undergoing endoscopic sinus surgery. Study Design Single-blinded prospective cohort study. Setting Tertiary care hospital. Subjects and Methods Otolaryngology residents were asked to identify critical surgical sinus anatomy on preoperative CT scans before and after introduction of a systematic approach to reviewing sinus CT scans. The percentage of correctly identified structures was documented and compared with a 2-sample t test. Results A total of 57 scans were reviewed: 28 preimplementation and 29 postimplementation. Implementation of the sinus CT checklist improved identification of critical sinus anatomy from 24% to 84% correct ( P identification of sinus anatomic variants, including those not directly included in the systematic review implemented. Conclusion The implementation of a preoperative endoscopic sinus surgery radiographic checklist improves identification of critical anatomic sinus variations in a training population.

  17. Predictors of red blood cell transfusion after cardiac surgery: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Camila Takao Lopes

    2015-12-01

    Full Text Available Abstract OBJECTIVE To identify predictors of red blood cell transfusion (RBCT after cardiac surgery. METHOD A prospective cohort study performed with 323 adults after cardiac surgery, from April to December of 2013. A data collection instrument was constructed by the researchers containing factors associated with excessive bleeding after cardiac surgery, as found in the literature, for investigation in the immediate postoperative period. The relationship between risk factors and the outcome was assessed by univariate analysis and logistic regression. RESULTS The factors associated with RBCT in the immediate postoperative period included lower height and weight, decreased platelet count, lower hemoglobin level, higher prevalence of platelet count <150x10 3/mm3, lower volume of protamine, longer duration of anesthesia, higher prevalence of intraoperative RBCT, lower body temperature, higher heart rate and higher positive end-expiratory pressure. The independent predictor was weight <66.5Kg. CONCLUSION Factors associated with RBCT in the immediate postoperative period of cardiac surgery were found. The independent predictor was weight.

  18. Hemostatic function to regulate perioperative bleeding in patients undergoing spinal surgery: A prospective observational study.

    Directory of Open Access Journals (Sweden)

    Atsushi Kimura

    Full Text Available Although bleeding is a common complication of surgery, routine laboratory tests have been demonstrated to have a low ability to predict perioperative bleeding. Better understanding of hemostatic function during surgery would lead to identification of high-risk patients for bleeding. Here, we aimed to elucidate hemostatic mechanisms to determine perioperative bleeding. We prospectively enrolled 104 patients undergoing cervical spinal surgery without bleeding diathesis. Blood sampling was performed just before the operation. Volumes of perioperative blood loss were compared with the results of detailed laboratory tests assessing primary hemostasis, secondary hemostasis, and fibrinolysis. Platelet aggregations induced by several agonists correlated with each other, and only two latent factors determined inter-individual difference. Platelet aggregability independently determined perioperative bleeding. We also identified low levels of plasminogen-activator inhibitor-1 (PAI-1 and α2-plasmin inhibitor to be independent risk factors for intraoperative and postoperative bleeding, respectively. Most important independent factor to determine postoperative bleeding was body weight. Of note, obese patients with low levels of PAI-1 became high-risk patients for bleeding during surgery. Our data suggest that bleeding after surgical procedure may be influenced by inter-individual differences of hemostatic function including platelet function and fibrinolysis, even in the patients without bleeding diathesis.

  19. Prospective evaluation of dermatologic surgery complications including patients on multiple antiplatelet and anticoagulant medications.

    Science.gov (United States)

    Bordeaux, Jeremy S; Martires, Kathryn J; Goldberg, Dori; Pattee, Sean F; Fu, Pingfu; Maloney, Mary E

    2011-09-01

    Few prospective studies have evaluated the safety of dermatologic surgery. We sought to determine rates of bleeding, infection, flap and graft necrosis, and dehiscence in outpatient dermatologic surgery, and to examine their relationship to type of repair, anatomic location of repair, antibiotic use, antiplatelet use, or anticoagulant use. Patients presenting to University of Massachusetts Medical School Dermatology Clinic for surgery during a 15-month period were prospectively entered. Medications, procedures, and complications were recorded. Of the 1911 patients, 38% were on one anticoagulant or antiplatelet medication, and 8.0% were on two or more. Risk of hemorrhage was 0.89%. Complex repair (odds ratio [OR] = 5.80), graft repair (OR = 7.58), flap repair (OR = 11.93), and partial repair (OR = 43.13) were more likely to result in bleeding than intermediate repair. Patients on both clopidogrel and warfarin were 40 times more likely to have bleeding complications than all others (P = .03). Risk of infection was 1.3%, but was greater than 3% on the genitalia, scalp, back, and leg. Partial flap necrosis occurred in 1.7% of flaps, and partial graft necrosis occurred in 8.6% of grafts. Partial graft necrosis occurred in 20% of grafts on the scalp and 10% of grafts on the nose. All complications resolved without sequelae. The study was limited to one academic dermatology practice. The rate of complications in dermatologic surgery is low, even when multiple oral anticoagulant and antiplatelet medications are continued, and prophylactic antibiotics are not used. Closure type and use of warfarin or clopidogrel increase bleeding risk. However, these medications should be continued to avoid adverse thrombotic events. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  20. Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

    Science.gov (United States)

    Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

    2008-11-01

    A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

  1. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma.

    LENUS (Irish Health Repository)

    Walsh, T N

    1996-08-15

    Uncontrolled studies suggest that a combination of chemotherapy and radiotherapy improves the survival of patients with esophageal adenocarcinoma. We conducted a prospective, randomized trial comparing surgery alone with combined chemotherapy, radiotherapy, and surgery.

  2. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  3. Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    Background Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. Objective To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. Patients and Method Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time. Results Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021). The maximal loudness of low-frequency (40–300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. Conclusions Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures

  4. Predicting medical complications after spine surgery: a validated model using a prospective surgical registry.

    Science.gov (United States)

    Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

    2014-02-01

    The possibility and likelihood of a postoperative medical complication after spine surgery undoubtedly play a major role in the decision making of the surgeon and patient alike. Although prior study has determined relative risk and odds ratio values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of medical complication, rather than relative risk or odds ratio values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of medical complication during and after spine surgery. Statistical analysis using a prospective surgical spine registry that recorded extensive demographic, surgical, and complication data. Outcomes examined are medical complications that were specifically defined a priori. This analysis is a continuation of statistical analysis of our previously published report. Using a prospectively collected surgical registry of more than 1,476 patients with extensive demographic, comorbidity, surgical, and complication detail recorded for 2 years after surgery, we previously identified several risk factor for medical complications. Using the beta coefficients from those log binomial regression analyses, we created a model to predict the occurrence of medical complication after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created two predictive models: one predicting the occurrence of any medical complication and the other predicting the occurrence of a major medical complication. The final predictive model for any medical complications had a receiver operator curve characteristic of 0.76, considered to be a fair measure. The final predictive model for any major medical complications had

  5. [Evolution of ideas and techniques, and future prospects in epilepsy surgery].

    Science.gov (United States)

    Mathon, B; Bédos-Ulvin, L; Baulac, M; Dupont, S; Navarro, V; Carpentier, A; Cornu, P; Clemenceau, S

    2015-02-01

    The aim of this article was to review and evaluate the published literature related to the outcome of epilepsy surgery, while placing it in an historical perspective, and to describe the future prospects in this field. Temporal lobe surgery achieves seizure freedom in about 70% of cases. Seizure outcome is similar in the pediatric population. Extratemporal resections impart good results to 40% to 60% of patients, with a better prognosis in the case of frontal lobe surgery. Pediatric hemispherotomy leads to seizure control in about 80% of children. Radiosurgery used as a treatment for temporal mesial epilepsy has an outcome quite similar to that obtained with surgical resection, but provides a neuropsychological advantage. Radiosurgery is also effective in 60% of children treated for seizures related to hypothalamic hamartoma. Regarding palliative surgery, callosotomy and multiple subpial transections show satisfactory outcomes in over 60% of cases. Neuromodulation techniques (vagus nerve stimulation and bilateral stimulation of the anterior nucleus of the thalamus) allow a 50% reduction of seizures in half of patients. Transcranial magnetic stimulation combined with electroencephalography seems a promising technique because of its diagnostic, prognostic and therapeutic applications. Transcranial ultrasound stimulation, which can reversibly control neuronal activity, is also under consideration. Concerning neuromodulation, trigeminal nerve stimulation may become an alternative to vagus nerve stimulation; while other targets of deep brain stimulation are being evaluated. Also, the possibility of coupling SEEG seizure focus detection with concomitant laser or radiofrequency focus destruction is under development. Constant evolution of epilepsy surgery has improved patient outcomes over time. Current research and development axes suggest the continuation of this trend and a reduction of the invasiveness of surgical procedures. Copyright © 2014 Elsevier Masson SAS. All

  6. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer.

    Science.gov (United States)

    Liu, Qian; Liu, Yinhua; Xu, Ling; Duan, Xuening; Li, Ting; Qin, Naishan; Kang, Hua; Jiang, Hongchuan; Yang, Deqi; Qu, Xiang; Jiang, Zefei; Yu, Chengze

    2014-01-01

    This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer. The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012. The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group). Enhanced MRI was used to measure breast volume, longest diameter of tumor and tumor volume. The correlations between these measurements and those derived from histopathologic findings were assessed. The relationships between the success rate of breast-conserving surgery and MRI- and pathology-based measurement results were statistically analyzed in the breast-conserving group. The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group. Allocation to these groups was based on clinical indications and patient preferences. The cut-off for concurrence between MRI- and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm. In the total mastectomy group, the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%. Correlation coefficients for MRI and histopathology-based measurements of breast volume, tumor volume and tumor volume/breast volume ratio were r = 0.861, 0.569, and 0.600, respectively (all P surgery were 100% and 88.54%, respectively. There were significant correlations between dynamic enhanced MRI- and histopathology-based measurements of the longest diameter of breast lesions, breast and tumor volumes, and breast volume/tumor volume ratios. Preoperative MRI examination improves the success rate of breast-conserving surgery.

  7. Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

    Science.gov (United States)

    De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

    2017-11-15

    Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

  8. Randomized Controlled Trial of Antiseptic Hand Hygiene Methods in an Outpatient Surgery Clinic.

    Science.gov (United States)

    Therattil, Paul J; Yueh, Janet H; Kordahi, Anthony M; Cherla, Deepa V; Lee, Edward S; Granick, Mark S

    2015-12-01

    Outpatient wound care plays an integral part in any plastic surgery practice. However, compliance with hand hygiene measures has shown to be low, due to skin irritation and lack of time. The objective of this trial was to determine whether single-use, long-acting antiseptics can be as effective as standard multiple-use hand hygiene methods in an outpatient surgical setting. A prospective, randomized controlled trial was performed in the authors' outpatient plastic surgery clinic at Rutgers New Jersey Medical School, Newark, NJ to compare the efficacy of an ethyl alcohol-based sanitizer (Avagard D Instant Hand Aniseptic, 3M Health Care, St. Paul, MN), a benzalkonium chloride-based sanitizer (Soft & Shield, Bioderm Technologies, Inc, Trenton, NJ, distributed by NAPP Technologies, Hackensack, NJ ), and soap and- water handwashing. Subjects included clinic personnel, who were followed throughout the course of a 3-hour clinic session with hourly hand bacterial counts taken. During the course of the trial, 95 subjects completed the clinic session utilizing 1 of the hand hygiene methods (36 ethyl alcohol-based sanitizer, 38 benzalkonium chloride-based sanitizer, and 21 soap-and-water handwashing). There was no difference between hand bacterial counts using the different methods at 4 hourly time points (P greater than 0.05). Hand bacterial counts increased significantly over the 3-hour clinic session with the ethyl alcohol-based sanitizer (9.24 to 21.90 CFU, P less than 0.05), benzalkonium chloride-based sanitizer (6.69 to 21.59 CFU, P less than 0.05), and soap-and-water handwashing (8.43 to 22.75 CFU, P less than 0.05). There does not appear to be any difference in efficacy between single-use, long-acting sanitizer, and standard multiple-use hand hygiene methods. Hand bacterial counts increased significantly over the course of the 3-hour clinic session regardless of the hand hygiene measure used. Hand condition of subjects was improved with the ethyl alcohol

  9. Interscalene plexus block versus general anaesthesia for shoulder surgery: a randomized controlled study.

    Science.gov (United States)

    Lehmann, Lars J; Loosen, Gregor; Weiss, Christel; Schmittner, Marc D

    2015-02-01

    This randomized clinical trial evaluates interscalene brachial plexus block (ISB), general anaesthesia (GA) and the combination of both anaesthetic methods (GA + ISB) in patients undergoing shoulder arthroscopy. From July 2011 until May 2012, 120 patients (male/female), aged 20-80 years, were allocated randomly to receive ISB (10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375%), GA (propofol, sunfentanil, desflurane) or ISB + GA. The primary outcome variable was opioid consumption at the day of surgery. Anaesthesia times were analysed as secondary endpoints. After surgery, 27 of 40 patients with a single ISB bypassed the recovery room (p surgery [GA: n = 25 vs. GA + ISB: n = 10 vs. ISB: n = 10, p = 0.0037]. ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption.

  10. Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study.

    Science.gov (United States)

    Sebastian, Roby; Ratliff, Todd; Winch, Peter D; Tumin, Dmitry; Gomez, Daniel; Tobias, Joseph; Galantowicz, Mark; Naguib, Aymen N

    2017-01-01

    The majority of allogeneic transfusions occur in the perioperative setting, especially during cardiac surgery. In addition to the economic implications, there is emerging evidence that blood transfusion may increase both morbidity and mortality. Acute normovolemic hemodilution (ANH) may limit the need for blood products. The primary objective of this study was to determine if the method of blood collection (syringe or bag) during the ANH process impacted the platelet count and function. The secondary objectives included the need for perioperative blood transfusions during the procedure and in the intensive care unit. In addition, we assessed these outcomes' associations with ANH parameters including the method of collection, time of storage, and volume removed. Data were collected prospectively from 50 patients undergoing cardiac surgery on cardiopulmonary bypass over a 6-month period. Platelet count and function were measured for the ANH blood immediately after collection and again prior to transfusing to the patient at the end of cardiopulmonary bypass. Other data collected included ANH volume, length of storage, and the quantity of all blood products given throughout the perioperative period. No change in platelet count or function was noted regardless of the length of time or collection method for the ANH blood. Twenty-three patients received blood or blood products in the operating room or the intensive care unit, while 27 patients received no blood transfusion during their entire hospitalization. Higher ANH volume (ml·kg -1 ) and longer storage time were associated with a greater need for intraoperative transfusions. Acute normovolemic hemodilution protects the platelets from the untoward effects of cardiopulmonary bypass and offers an important autologous blood product that improves hemostasis at the conclusion of surgery. Platelet count and function are preserved regardless of the method of collection or the length of storage. The volume of ANH removed

  11. Facial nerve injury following surgery for temporomandibular joint ankylosis: A prospective clinical study

    Directory of Open Access Journals (Sweden)

    S Gokkulakrishnan

    2013-01-01

    Full Text Available Objective: The purpose of this prospective study was to evaluate the incidence and degree of facial nerve damage and time taken for its recovery following surgery for temporomandibular joint (TMJ ankylosis. Materials and Methods: A total of 30 subjects with the TMJ ankylosis with or without history of previous surgery were included in this prospective study. House-Brackmann grading system was used to assess the function of the facial nerve post-operatively. Results: Most of the subjects were in the age range of 13-15 years. Eight subjects had bilateral ankylosis and remaining 22 had unilateral ankylosis. Out of 32 joints in which gap arthroplasty was performed, 4 had Grade 1 injury, 14 had Grade 2 injury, 12 had Grade 3, and 2 with the Grade 4 injury 24 h post-operatively. Whereas, out of 6 cases of interpositional arthroplasty 4 had Grade 1 injury and 2 had Grade 4 injury. According to House-Brackmann grading system, at 24 h, 78.9% patients had different grades of facial nerve injury, which gradually improved and came to normal limits within 1-3 months post-operatively. Comparison of change in the Grade of injury at 3 months follow-up as compared to baseline (24 h showed full recovery in all the cases (100% showing a statistically significant difference from baseline (P < 0.001. Conclusion: When proper care is taken during surgery for TMJ ankylosis, permanent facial nerve injury is rare. However, the incidence and degree of temporary nerve injury could be either due to the heavy retraction causing compression and or stretching of nerve fiber resulting in neuropraxia.

  12. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    Science.gov (United States)

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  13. Sinonasal outcomes following endoscopic anterior skull base surgery with nasoseptal flap reconstruction: a prospective study.

    Science.gov (United States)

    Hanson, M; Patel, P M; Betz, C; Olson, S; Panizza, B; Wallwork, B

    2015-07-01

    To assess nasal morbidity resulting from nasoseptal flap use in the repair of skull base defects in endoscopic anterior skull base surgery. Thirty-six patients awaiting endoscopic anterior skull base surgery were prospectively recruited. A nasoseptal flap was used for reconstruction in all cases. Patients were assessed pre-operatively and 90 days post-operatively via the Sino-Nasal Outcome Test 20 questionnaire and visual analogue scales for nasal obstruction, pain, secretions and smell; endoscopic examination findings and mucociliary clearance times were also recorded. Sino-Nasal Outcome Test 20 questionnaire data and visual analogue scale scores for pain, smell and secretions showed no significant differences between pre- and post-operative outcomes, with visual analogue scale scores for nasal obstruction actually showing a significant improvement (p = 0.0007). A significant deterioration for both flap and non-flap sides was demonstrated post-operatively on endoscopic examination (p = 0.002 and p = 0.02 respectively). Whilst elevation of a nasoseptal flap in endoscopic surgery of the anterior skull base engendered significant clinical deterioration on examination post-operatively, quality of life outcomes showed that no such deterioration was subjectively experienced by the patient. In fact, there was significant nasal airway improvement following nasoseptal flap reconstruction.

  14. Circulating histones for predicting prognosis after cardiac surgery: a prospective study.

    Science.gov (United States)

    Gao, Hongxiang; Zhang, Naipu; Lu, Fangfang; Yu, Xindi; Zhu, Limin; Mo, Xi; Wang, Wei

    2016-11-01

    The objective of this study was to assess the perioperative changes in circulating histones and their relationships with other biomarkers and clinical outcomes after cardiac surgery with cardiopulmonary bypass (CPB) in patients. Forty-eight patients with congenital cardiac diseases undergoing corrective procedure with CPB were prospectively enrolled in this study. Circulating histones, N-terminal pro-brain natriuretic peptide (NT-proBNP), procalcitonin (PCT) and C-reactive protein (CRP) were measured preoperatively (T0) and at 0 (T1), 24 (T2), 48 (T3) and 72 (T4) h postoperatively. The relationships between biomarkers and clinical outcomes were analysed. Circulating histones, NT-proBNP, PCT and CRP increased significantly postoperatively, with histones reaching the peak value earliest at T1. Circulating histone levels were higher in patients with adverse events. Receiver operating characteristic curve analysis showed that peak histone levels had a better predictive value for adverse events postoperatively. Peak histone levels correlated with the peak level of NT-proBNP (r = 0.563, P histones reached peak levels faster than NT-proBNP, PCT and CRP. Furthermore, peak histone levels correlated with biomarkers and postoperative clinical outcomes. Circulating histones may be used as a prognostic indicator for patients after cardiac surgery with CPB. ClinicalTrials.gov (ID: NCT02325765). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  15. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium.

    Science.gov (United States)

    Evans, Joanna L; Nadler, Jacob W; Preud'homme, Xavier A; Fang, Eric; Daughtry, Rommie L; Chapman, Joseph B; Attarian, David; Wellman, Samuel; Krystal, Andrew D

    2017-08-01

    Delirium is a common post-operative complication associated with significant costs, morbidity, and mortality. We sought sleep/EEG predictors of delirium present prior to delirium symptoms to facilitate developing and targeting therapies. Continuous EEG data were obtained in 12 patients post-orthopedic surgery from the day of surgery until delirium assessment on post-operative day 2 (POD2). Diminished total sleep time (r=-0.68; pdelirium severity. Patients experiencing delirium slept 2.4h less and took 2h longer to fall asleep. Greater waking EEG delta power (r=0.84; pdelirium severity. Loss of sleep on night1 post-surgery is an early predictor of subsequent delirium. EEG Delta Power alterations in waking and sleep appear to be later indicators of impending delirium. Further work is needed to evaluate reproducibility/generalizability and assess whether sleep loss contributes to causing delirium. This first study to prospectively collect continuous EEG data for an extended period prior to delirium onset identified EEG-derived indices that predict subsequent delirium that could aid in developing and targeting therapies. Copyright © 2017. Published by Elsevier B.V.

  16. A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

    Science.gov (United States)

    Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

    2014-01-01

    Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

  17. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  18. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Conjunctival Goblet Cell Density Following Cataract Surgery With Diclofenac Versus Diclofenac and Rebamipide: A Randomized Trial.

    Science.gov (United States)

    Kato, Kumiko; Miyake, Kensaku; Kondo, Nagako; Asano, Sayaka; Takeda, Junko; Takahashi, Akiko; Takashima, Yuko; Kondo, Mineo

    2017-09-01

    To determine the effects of topical diclofenac or betamethasone with concomitant application of topical rebamipide on the conjunctival goblet cell density in eyes after cataract surgery. Randomized clinical trial. Eighty patients who were scheduled for cataract surgery. Patients were randomized into 4 groups according to the postoperative topical drugs to be given; Group A, diclofenac alone; Group B, diclofenac and rebamipide; Group C, betamethasone alone; and Group D, betamethasone and rebamipide. Impression cytology was performed before and at 1 month after the surgery, and the mean density of goblet cells was determined. The mean (± SD) density of goblet cells before the surgery in Group A was 257.0 ± 188.7 cells/mm 2 , and it decreased significantly to 86.5 ± 76.7 cells/mm 2 at 1 month after the surgery (P = .002). In Group B, the goblet cell density was not statistically different between before (238.5 ± 116.6 cells/mm 2 ) and at 1 month after the surgery (211.3 ± 184.4 cells/mm 2 , P = .55). In Groups C and D, the mean density of goblet cells was decreased at 1 month after the surgery, but the decreases were not significant (P = .11 and P = .52, respectively). After cataract surgery with postoperative topical diclofenac, the conjunctival goblet cell density was significantly reduced, and this reduction was blocked by the concomitant use of topical rebamipide. These results suggest that the concomitant use of topical rebamipide with nonsteroidal anti-inflammatory drugs is beneficial, especially in cases with postoperative dry eyes. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  20. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

    Science.gov (United States)

    Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K

    2016-01-01

    Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were

  1. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Christos Asteriou

    2016-01-01

    Full Text Available Background: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. Patients and Methods: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60 or mini-muscle-sparing thoracotomy (n = 60. The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. Results: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006. Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042. Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560. Conclusion: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected.

  2. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  3. Isolated and combined medial patellofemoral ligament reconstruction in revision surgery for patellofemoral instability: a prospective study.

    Science.gov (United States)

    Kohn, Ludwig M; Meidinger, Gebhart; Beitzel, Knut; Banke, Ingo J; Hensler, Daniel; Imhoff, Andreas B; Schöttle, Philip B

    2013-09-01

    Persistent pain and redislocations after surgical treatment of patellofemoral instability are described in up to 40% of patients. However, prospective outcome data about revision surgery are missing. To evaluate the clinical outcome after revision medial patellofemoral ligament (MPFL) reconstruction using isolated and combined procedures, with a follow-up of 24 months. Case series; Level of evidence, 4. Study participants were 42 patients (median age, 22 years; range, 13-46 years) who underwent revision surgery between January 2007 and December 2009 because of persistent patellofemoral instability after a mean of 1.8 previous failed surgical interventions (lateral release, medial imbrication/vastus medialis obliquus distalization, medialization of the tuberosity). An isolated MPFL reconstruction was performed in 15 cases, while a combination procedure was performed in 27 cases. The clinical results were evaluated preoperatively and 24 months postoperatively using the International Knee Documentation Committee (IKDC), Kujala, and Tegner scores as well as a subjective questionnaire. Patellar shift, tilt, and height, as well as level of degeneration, were defined preoperatively and at the latest follow-up on plain radiographs and magnetic resonance imaging. At 24-month follow-up, 87% of the patients were satisfied or very satisfied with the treatment. No apprehension or redislocation was reported at follow-up, and there was a significant decrease in pain during daily activities. There were significant improvements (P instability is a multifactorial problem, revision surgery should be indicated only after a comprehensive examination. The results of this study show that MPFL reconstruction, alone or in combination, seems to be an effective treatment for recurrent patellar dislocations after a failed previous surgery, leading to significant increases in stability and functionality as well as a reduction in pain.

  4. Minimally invasive strabismus surgery versus paralimbal approach: A randomized, parallel design study is minimally invasive strabismus surgery worth the effort?

    Directory of Open Access Journals (Sweden)

    Richa Sharma

    2014-01-01

    Full Text Available Introduction : Minimal access surgery is common in all fields of medicine. We compared a new minimally invasive strabismus surgery (MISS approach with a standard paralimbal strabismus surgery (SPSS approach in terms of post-operative course. Materials and Methods: This parallel design study was done on 28 eyes of 14 patients, in which one eye was randomized to MISS and the other to SPSS. MISS was performed by giving two conjunctival incisions parallel to the horizontal rectus muscles; performing recession or resection below the conjunctival strip so obtained. We compared post-operative redness, congestion, chemosis, foreign body sensation (FBS, and drop intolerance (DI on a graded scale of 0 to 3 on post-operative day 1, at 2-3 weeks, and 6 weeks. In addition, all scores were added to obtain a total inflammatory score (TIS. Statistical Analysis: Inflammatory scores were analyzed using Wilcoxon′s signed rank test. Results: On the first post-operative day, only FBS (P = 0.01 and TIS (P = 0.04 showed significant difference favoring MISS. At 2-3 weeks, redness (P = 0.04, congestion (P = 0.04, FBS (P = 0.02, and TIS (P = 0.04 were significantly less in MISS eye. At 6 weeks, only redness (P = 0.04 and TIS (P = 0.05 were significantly less. Conclusion: MISS is more comfortable in the immediate post-operative period and provides better cosmesis in the intermediate period.

  5. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    Science.gov (United States)

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  6. The Anxiolytic Effect of Aromatherapy on Patients Awaiting Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Cheng-Hua Ni

    2013-01-01

    Full Text Available The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil and control (water vapor conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery.

  7. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  8. Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

    2013-01-01

    Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

  9. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  10. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

  11. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  12. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  13. A prospective study of conservative surgery without radiation therapy in select patients with Stage I breast cancer

    International Nuclear Information System (INIS)

    Lim, May; Bellon, Jennifer R.; Gelman, Rebecca; Silver, Barbara B.A.; Recht, Abram; Schnitt, Stuart J.; Harris, Jay R.

    2006-01-01

    Purpose: The effectiveness of radiation therapy (RT) in reducing local recurrence after breast-conserving surgery (BCS) in unselected patients with early stage invasive breast cancer has been demonstrated in multiple randomized trials. Whether a subset of women can achieve local control without RT is unknown. In 1986, we initiated a prospective one-arm trial of BCS alone for highly selected breast-cancer patients. This report updates those results. Methods and Materials: Eighty-seven (of 90 planned) patients enrolled from 1986 until closure in 1992, when a predefined stopping boundary was crossed. Patients were required to have a unicentric, T1, pathologic node-negative invasive ductal, mucinous, or tubular carcinoma without an extensive intraductal component or lymphatic-vessel invasion. Surgery included local excision with margins of at least 1 cm or a negative re-excision. No RT or systemic therapy was given. Results: Results are available on 81 patients (median follow-up, 86 months). Nineteen patients (23%) had local recurrence (LR) as a first site of failure (average annual LR: 3.5 per 100 patient-years of follow-up). Other sites of first failure included 1 ipsilateral axilla, 2 contralateral breast cancers, and 4 distant metastases. Six patients developed other (nonbreast) malignancies. Nine patients have died, 4 of metastatic breast cancer and 5 of unrelated causes. Conclusions: Even in this highly selected cohort, a substantial risk of local recurrence occurred after BCS alone with margins of 1.0 cm or more. These results suggest that with the possible exception of elderly women with comorbid conditions, radiation therapy after BCS remains standard treatment

  14. Evaluation of hyperglycaemic response to intra-operative dexamethasone administration in patients undergoing elective intracranial surgery: A randomised, prospective study.

    Science.gov (United States)

    Sethi, Rakesh; Naqash, Imtiaz A; Bajwa, Sukhminder Jit Singh; Dutta, Vikas; Ramzan, Altaf Umar; Zahoor, Syed Amir

    2016-01-01

    The glucocorticoid dexamethasone in a bolus dose of 8-10 mg followed by quarterly dose of 4 mg is commonly used during intracranial surgery so as to reduce oedema and vascular permeability. However, the detrimental hyperglycaemic effects of dexamethasone may override its potentially beneficial effects. The present prospective, randomised study aimed at comparing the degree and magnitude of hyperglycaemia induced by prophylactic administration of dexamethasone in patients undergoing elective craniotomy. Sixty American Society of Anaesthesiologist (ASA) grade-I and II patients were randomly assigned to three groups of 20 patients each. Group-I received dexamethasone during surgery for the first time. Group-II received dexamethasone in addition to receiving it pre-operatively, whereas Group-III (control group) patients were administered normal saline as placebo. Baseline blood glucose (BG) was measured in all the three groups before induction of anaesthesia and thereafter after every hour for 4 h and then two-hourly. Besides intra- and intergroup comparison of BG, peak BG concentration was also recorded for each patient. Statistical analysis was carried out with analysis of variance (ANOVA) and Student's t-test and value of P < 0.05 was considered statistically significant. Baseline BG reading were higher and statistically significant in Group-II as compared with Group-I and Group-III (P < 0.05). However, peak BG levels were significantly higher in Group-I than in Group-II and III (P < 0.05). Similarly, the magnitude of change in peak BG was significantly higher in Group-I as compared to Group-II and III (P < 0.05). Peri-operative administration of dexamethasone during neurosurgical procedures can cause significant increase in BG concentration especially in patients who receive dexamethasone intra-operatively only.

  15. Nationwide prospective audit of pancreatic surgery: design, accuracy, and outcomes of the Dutch Pancreatic Cancer Audit.

    Science.gov (United States)

    van Rijssen, L Bengt; Koerkamp, Bas G; Zwart, Maurice J; Bonsing, Bert A; Bosscha, Koop; van Dam, Ronald M; van Eijck, Casper H; Gerhards, Michael F; van der Harst, Erwin; de Hingh, Ignace H; de Jong, Koert P; Kazemier, Geert; Klaase, Joost; van Laarhoven, Cornelis J; Molenaar, I Quintus; Patijn, Gijs A; Rupert, Coen G; van Santvoort, Hjalmar C; Scheepers, Joris J; van der Schelling, George P; Busch, Olivier R; Besselink, Marc G

    2017-10-01

    Auditing is an important tool to identify practice variation and 'best practices'. The Dutch Pancreatic Cancer Audit is mandatory in all 18 Dutch centers for pancreatic surgery. Performance indicators and case-mix factors were identified by a PubMed search for randomized controlled trials (RCT's) and large series in pancreatic surgery. In addition, data dictionaries of two national audits, three institutional databases, and the Dutch national cancer registry were evaluated. Morbidity, mortality, and length of stay were analyzed of all pancreatic resections registered during the first two audit years. Case ascertainment was cross-checked with the Dutch healthcare inspectorate and key-variables validated in all centers. Sixteen RCT's and three large series were found. Sixteen indicators and 20 case-mix factors were included in the audit. During 2014-2015, 1785 pancreatic resections were registered including 1345 pancreatoduodenectomies. Overall in-hospital mortality was 3.6%. Following pancreatoduodenectomy, mortality was 4.1%, Clavien-Dindo grade ≥ III morbidity was 29.9%, median (IQR) length of stay 12 (9-18) days, and readmission rate 16.0%. In total 97.2% of >40,000 variables validated were consistent with the medical charts. The Dutch Pancreatic Cancer Audit, with high quality data, reports good outcomes of pancreatic surgery on a national level. Copyright © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  16. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  17. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  18. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  19. Quality of recovery from anesthesia of patients undergoing balanced or total intravenous general anesthesia. Prospective randomized clinical trial.

    Science.gov (United States)

    Moro, Eduardo Toshiyuki; Leme, Fábio Caetano Oliveira; Noronha, Bernardo Roveda; Saraiva, Gustavo Farinha Pinto; de Matos Leite, Nathália Vianna; Navarro, Laís Helena Camacho

    2016-12-01

    The aim of the present study was to assess the quality of recovery from anesthesia of patients subjected to otorhinolaryngological (ORL) surgery under balanced or total intravenous general anesthesia by means of Quality of Recovery-40 (QoR-40) questionnaire. Prospective randomized clinical trial. The setting is at an operating room, a postoperative recovery area, and a hospital ward. One-hundred thirty American Society of Anesthesiologists physical status I or II patients scheduled to undergo general anesthesia for ORL interventions under remifentanil, in combination with sevoflurane (balanced technique) or propofol (total intravenous anesthesia). Occurrence of nausea, vomiting, body temperature less than 36°C, and length of stay in the postanesthesia care unit were recorded. The QoR-40 was administered by an investigator blind to group allocation 24 hours after surgery. The quality of recovery, as assessed by the score on the QoR-40, was compared between the groups. There is no difference regarding the QoR-40 score among intravenous and inhalation anesthesia groups (190.5 vs 189.5, respectively; P=.33). Similarly, among the 5 dimensions of the QoR-40, the scores were comparable between the groups. Incidence of hypothermia (P=.58), nauseas or vomits (P=.39), and length of surgery (P=.16) were similar among groups. The evaluation of pain intensity (P=.80) and dose of morphine use in the postanesthesia care unit (P=.4) was also comparable between groups. The quality of recovery from anesthesia assessed based on the patients' perception did not differ between the ones subjected to either inhalation or intravenous general anesthesia for ORL surgery based on QoR-40 questionnaire assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Randomized clinical study comparing piezosurgery and conventional rotatory surgery in mandibular cyst enucleation.

    Science.gov (United States)

    Pappalardo, Sabrina; Guarnieri, Renzo

    2014-07-01

    The aim of the present study is to compare piezoelectric surgery to the conventional rotatory surgery in mandibular cyst enucleation, and to determine the 2 method's suitability and the postoperative outcomes. Eighty patients were included in the study. 35 male and 45 female, which showed cystic mandibular lesions, compared with the inferior alveolar nerve or the mental nerve. The patients were randomly divided into two groups. In the test group, cystectomy was performed using conventional rotatory instrumentation (rotatory-group), and in the other one piezoelectric surgery (piezo-group). The swelling was documented 24/48/72 h and 1 week post-surgery and the patients recorded their subjective postoperative pain daily for 7 days using a Visual Analog Scale (VAS). Patients treated with piezoelectric technique have presented a lower VAS, minor swelling and less recovery time compared to the rotatory-group. No lesions of the mandible nerve were detected with piezosurgery whereas surgery with rotary instruments resulted in 8% hypesthesia at least up to one week. The results of this study suggest that piezosurgery may be considered effective in cyst enucleation compared to traditional procedures with burs, since it grants the patients significantly less post-surgical pain and swelling. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  1. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  2. Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

    Science.gov (United States)

    Turchetti, Giuseppe; Pierotti, Francesca; Palla, Ilaria; Manetti, Stefania; Freschi, Cinzia; Ferrari, Vincenzo; Cuschieri, Alfred

    2017-02-01

    Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA). The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches. The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge. The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

  3. Pain Control Following Impacted Third Molar Surgery with Bupivacaine Irrigation of Tooth Socket: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Reza Khorshidi Khiavi

    2010-12-01

    Full Text Available Background and aims. The surgical removal of the lower third molars is a procedure generally followed by side effects such as postoperative pain. The aim of this study was to evaluate the efficacy of socket irrigation with an anesthetic solution in relieving pain following impacted third molar surgery. Materials and methods. Thirty-four patients (17 males and 17 females, aged 18-24 years, with bilateral impacted lower third molars were selected. Both third molars were extracted in one surgical session. Tooth sockets in each patient were rinsed randomly either with 4 mL of 0.5% bupivacaine hydrochloride plain (without vasoconstrictor anesthetic solution or 4 mL of normal saline, used as control. The patients were instructed not to use analgesics as long as possible, and if not, they were instructed to use an analgesic, and record the time. Pain severity was assessed using a visual analogue pain scale (VAPS at 1-, 6-, 12-, and 24-hour intervals post-operatively. Data were analyzed using Pearson’s chi-square test and P <0.05 was considered statistically significant. Results. Post-operative pain difference between the two groups was statistically significant at 1-, 6-, 12- and 24-hour postoperative intervals (P <0.05. Post-operative pain increased in both groups to a maximum 12 hours after surgery with significant improvements after that. Conclusion. Based on the results, the irrigation of surgery site with bupivacaine after third molar surgery significantly reduces post-operative pain.

  4. Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer

    International Nuclear Information System (INIS)

    Ang, K. Kian; Trotti, Andy; Brown, Barry W.; Garden, Adam S.; Foote, Robert L.; Morrison, William H.; Geara, Fady B.; Klotch, Douglas W.; Goepfert, Helmuth; Peters, Lester J.

    2001-01-01

    Purpose: A multi-institutional, prospective, randomized trial was undertaken in patients with advanced head-and-neck squamous cell carcinoma to address (1) the validity of using pathologic risk features, established from a previous study, to determine the need for, and dose of, postoperative radiotherapy (PORT); (2) the impact of accelerating PORT using a concomitant boost schedule; and (3) the importance of the overall combined treatment duration on the treatment outcome. Methods and Materials: Of 288 consecutive patients with advanced disease registered preoperatively, 213 fulfilled the trial criteria and went on to receive therapy predicated on a set of pathologic risk features: no PORT for the low-risk group (n=31); 57.6 Gy during 6.5 weeks for the intermediate-risk group (n=31); and, by random assignment, 63 Gy during 5 weeks (n=76) or 7 weeks (n=75) for the high-risk group. Patients were irradiated with standard techniques appropriate to the site of disease and likely areas of spread. The study end points were locoregional control (LRC), survival, and morbidity. Results: Patients with low or intermediate risks had significantly higher LRC and survival rates than those with high-risk features (p=0.003 and p=0.0001, respectively), despite receiving no PORT or lower dose PORT, respectively. For high-risk patients, a trend toward higher LRC and survival rates was noted when PORT was delivered in 5 rather than 7 weeks. A prolonged interval between surgery and PORT in the 7-week schedule was associated with significantly lower LRC (p=0.03) and survival (p=0.01) rates. Consequently, the cumulative duration of combined therapy had a significant impact on the LRC (p=0.005) and survival (p=0.03) rates. A 2-week reduction in the PORT duration by using the concomitant boost technique did not increase the late treatment toxicity. Conclusions: This Phase III trial established the power of risk assessment using pathologic features in determining the need for, and dose of

  5. Prospective study of use of perioperative antimicrobial therapy in general surgery.

    LENUS (Irish Health Repository)

    Fennessy, Brendan G

    2012-02-03

    BACKGROUND: Perioperative antimicrobial therapy has demonstrated efficacy in reducing the rate of surgical site infections in clinical trials. With the emergence of antibiotic resistance, the risk of reaction, and the inevitable financial repercussions, use of prophylactic antibiotics is not a panacea, and their misuse may have considerable implications. The aim of this study was to assess the use of antibiotics in the perioperative period in both general and vascular surgery procedures. METHODS: A prospective study was undertaken of 131 patients with a mean age of 43 years (range one month-88 years), of whom 68 (51%) were male, who underwent twenty-seven different general or vascular surgery procedures over a four-week period. Each patient was evaluated from the time of antibiotic commencement through their operative procedure until the treatment was discontinued. RESULTS: A total of 73 patients (54%) received ten antibiotics, with 71 (97%) of these uses being prophylactic. Of the 15 appendectomies performed for uncomplicated appendicitis, the mean number of prophylactic antibiotic doses was 5.3 (range 1-12). Where they were documented, written postoperative directives were not adhered to in 18\\/27 prescriptions (66%). CONCLUSION: This study has demonstrated a lack of adherence to guidelines in the perioperative administration of antimicrobial agents. In addition, it calls attention to the economic implications of unnecessary prophylaxis.

  6. Correlates of non-technical skills in surgery: a prospective study.

    Science.gov (United States)

    Gillespie, Brigid M; Harbeck, Emma; Kang, Evelyn; Steel, Catherine; Fairweather, Nicole; Chaboyer, Wendy

    2017-01-30

    Communication and teamwork failures have frequently been identified as the root cause of adverse events and complications in surgery. Few studies have examined contextual factors that influence teams' non-technical skills (NTS) in surgery. The purpose of this prospective study was to identify and describe correlates of NTS. We assessed NTS of teams and professional role at 2 hospitals using the revised 23-item Non-TECHnical Skills (NOTECHS) and its subscales (communication, situational awareness, team skills, leadership and decision-making). Over 6 months, 2 trained observers evaluated teams' NTS using a structured form. Interobserver agreement across hospitals ranged from 86% to 95%. Multiple regression models were developed to describe associations between operative time, team membership, miscommunications, interruptions, and total NOTECHS and subscale scores. We observed 161 surgical procedures across 8 teams. The total amount of explained variance in NOTECHS and its 5 subscales ranged from 14% (adjusted R 2 0.12, p<0.001) to 24% (adjusted R 2 0.22, p<0.001). In all models, inverse relationships between the total number of miscommunications and total number of interruptions and teams' NTS were observed. Miscommunications and interruptions impact on team NTS performance. 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/.

  7. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

    2017-02-01

    Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Comparison of commercial fibrin sealants in facelift surgery: a prospective study

    Directory of Open Access Journals (Sweden)

    Botti G

    2013-11-01

    Full Text Available Giovanni Botti,1 Michele Pascali,2 Chiara Botti,1 Florian Bodog,3 Pietro Gentile,2 Valerio Cervelli2 1Villa Bella Clinic, Salò, 2Department of Plastic and Reconstructive Surgery, University of Rome Tor Vergata, Italy; 3University of Oradea, Oradea, Romania Background: The aim of this study was to compare the effects of two types of fibrin glue in patients undergoing facelift surgery. Methods: A prospective, controlled "right-left side" study was carried out in 20 patients. The two fibrin sealants used were Quixil® and Tissucol®. The two sealants were used at the same time, ie, one on one side of the face and the other on the contralateral side. Comparisons were made with regard to rates of hematoma and seroma, degree of induration, edema, ecchymosis, pain levels, and patient satisfaction. Results: The results were almost equivalent. The only exception was a significant (40 mL hematoma in a patient treated with Quixil. Bleeding was most likely due to a sudden rise in blood pressure during the immediate postoperative period. However, it must be emphasized that, while Tissucol actually seals the undermined area, thus virtually eliminating the dead space, Quixil acts differently, in that its effectiveness in preventing hematoma is linked mainly to its hemostatic effect. Conclusion: The two fibrin sealants used were nearly identical with regard to patient safety and quality of the result. Nevertheless, it is noted that, while Tissucol has both hemostatic and "gluing" effects, Quixil is mainly effective in securing hemostasis. Keywords: facelift surgery, rhytidectomy, fibrin sealants, hematoma

  9. Novel approach of single-port laparoscopic appendectomy as a solo surgery: A prospective cohort study.

    Science.gov (United States)

    Kim, Say-June; Choi, Byung-Jo; Lee, Sang Chul

    2015-09-01

    Recent advances in medical equipment and surgical techniques have enabled solo surgery, wherein a surgeon operates alone without the participation of other surgical members. However, the application of solo surgery in single-port laparoscopic surgery (SPLS) has been rarely reported. Prospectively collected databases of 60 patients who underwent solo-SPLS for appendicitis between March 2013 and June 2014 were retrospectively reviewed. Making a transumbilical incision into the peritoneal cavity was facilitated by using a Lone Star self-retaining retractor. After the establishment of a single port through the umbilicus, we installed a mechanical adjustable camera holder (Endoworld®LAP53 Holding Systems). It was anchored to the operating table rail and firmly held the laparoscope with a possibility to adjust the same as required by the operator. The operative method was identical to the SPLS appendectomy, except for the use of these instruments. The median operation time was 50 min (25-120). None of the patients required open conversion, insertion of an additional port or help of a human assistant. The median length of hospital stay for all patients was 1.0 day (range: 1-3 days). The median dosage of required intravenous analgesics (ketorolac, 0.1 mg/kg of body weight) was 0.0 ampoule (0-4). The median interval to initiation of solid diet was 1 day (1-2). The incidence of postoperative complications was 8.3% (5/60). Our results shows that solo-SPLS appendectomy could be performed without increasing operation time or postoperative complications when performed by a surgeon competent in performing SPLS appendectomy. Copyright © 2015. Published by Elsevier Ltd.

  10. Anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS)? A prospective cohorts' comparison using radiologic and functional outcomes.

    Science.gov (United States)

    Rushton, Paul R P; Grevitt, Michael P; Sell, Philip J

    2015-04-01

    Prospective cohort study. Prospectively compare patient-reported as well as clinical and radiologic outcomes after anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS) in a single center by the same surgeons. Anterior and posterior spinal instrumentation and arthrodesis are both well-established treatments of thoracic AIS. The majority of studies comparing the 2 approaches have focused on radiographic outcomes. There remains a paucity of prospectively gathered patient-reported outcomes comparing surgical approaches. Forty-two consecutive patients with right thoracic AIS were treated in a single center by one of 2 surgeons with either anterior (n=18) or posterior (n=24) approaches and followed up for over 2 years. Radiographic, clinical, and patient-reported outcomes of the Modified Scoliosis Research Society Outcome Instrument were gathered and analyzed by an independent surgeon. Patients reported significant improvements in all areas of the Modified Scoliosis Research Society Outcome Instrument, especially pain and self-image domains. There were no significant differences in the degree of improvement in any domains between the groups. Posterior and anterior surgery corrected rib hump by 53% and 61%, respectively (P=0.4). The Main thoracic curve Cobb angle was corrected from 69 to 26 degrees (62%) by posterior surgery and 61 to 23 degrees (64%) by anterior surgery (P=0.6). Posterior surgery significantly reduced kyphosis and lumbosacral lordosis. Anterior surgery had no overall affect of sagittal alignment but seemed able to correct those hypokyphotic preoperatively. Complications differed and were largely approach-related--intrathoracic in anterior and wound-related in posterior surgery. Patients with right thoracic AIS of differing curve types but otherwise similar preoperatively demonstrated that anterior and posterior surgery are largely equivalent. Patient-reported outcomes are improved similarly by either approach. Both offer

  11. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery

    NARCIS (Netherlands)

    de Jonghe, Jos F. M.; Kalisvaart, Kees J.; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G.; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Goo, Willem A.

    2007-01-01

    OBJECTIVES: The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. METHODS: This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip

  12. Effects of levosimendan on glomerular filtration rate, renal blood flow, and renal oxygenation after cardiac surgery with cardiopulmonary bypass: a randomized placebo-controlled study.

    Science.gov (United States)

    Bragadottir, Gudrun; Redfors, Bengt; Ricksten, Sven-Erik

    2013-10-01

    Acute kidney injury develops in a large proportion of patients after cardiac surgery because of the low cardiac output syndrome. The inodilator levosimendan increases cardiac output after cardiac surgery with cardiopulmonary bypass, but a detailed analysis of its effects on renal perfusion, glomerular filtration, and renal oxygenation in this group of patients is lacking. We therefore evaluated the effects of levosimendan on renal blood flow, glomerular filtration rate, renal oxygen consumption, and renal oxygen demand/supply relationship, i.e., renal oxygen extraction, early after cardiac surgery with cardiopulmonary bypass. Prospective, placebo-controlled, and randomized trial. Cardiothoracic ICU of a tertiary center. Postcardiac surgery patients (n=30). The patients were randomized to receive levosimendan, 0.1 µg/kg/min after a loading dose of 12 µg/kg (n=15), or placebo (n=15). The experimental procedure started 4-6 hours after surgery in the ICU during propofol sedation and mechanical ventilation. Systemic hemodynamic were evaluated by a pulmonary artery thermodilution catheter. Renal blood flow and glomerular filtration rate were measured by the renal vein retrograde thermodilution technique and by renal extraction of Cr-EDTA, respectively. Central venous pressure was kept constant by colloid/crystalloid infusion. Compared to placebo, levosimendan increased cardiac index (22%), stroke volume index (15%), and heart rate (7%) and decreased systemic vascular resistance index (21%), whereas mean arterial pressure was not affected. Levosimendan induced significant increases in renal blood flow (12%, prenal vascular resistance (18%, prenal oxygen consumption, or renal oxygen extraction, compared to placebo. After cardiac surgery with cardiopulmonary bypass, levosimendan induces a vasodilation, preferentially of preglomerular resistance vessels, increasing both renal blood flow and glomerular filtration rate without jeopardizing renal oxygenation. Due to its

  13. Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.

    Science.gov (United States)

    Wichmann, Matthias W; Thul, Paul; Czarnetzki, Hans-Dieter; Morlion, Bart J; Kemen, Matthias; Jauch, Karl-Walter

    2007-03-01

    To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters. Prospective, randomized, double-blind, multicenter trial. University and surgical teaching hospitals. After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol. Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery. No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I. Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.

  14. Sugammadex by ideal body weight versus 20% and 40% corrected weight in bariatric surgery - double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nádia Maria da Conceição Duarte

    Full Text Available Abstract Background and objectives: The weight parameters for use of sugammadex in morbidly obese patients still need to be defined. Methods: A prospective clinical trial was conducted with sixty participants with body mass index ≥ 40 kg.m-2 during bariatric surgery, randomized into three groups: ideal weight (IW, 20% corrected body weight (CW20 and 40% corrected body weight (CW40. All patients received total intravenous anesthesia. Rocuronium was administered at dose of 0.6 mg.kg-1 of Ideal weight for tracheal intubation, followed by infusion of 0.3-0.6 mg.kg-1.h-1. Train of four (TOF was used to monitor depth of blockade. After spontaneous recovery TOF-count 2 at the end of surgery, 2 mg.kg-1 of sugammadex was administered. Primary outcome was neuromuscular blockade reversal time to TOF ≥ 0.9. Secondary outcome was the occurrence of postoperative residual curarization in post-anesthesia recovery room, searching the patient's ability to pass from the surgical bed to the transport, adequacy of oxygenation, respiratory pattern, ability to swallow saliva and clarity of vision. Results: Groups were homogenous in gender, age, total body weight, ideal body weight, body mass index, type and time of surgery. The reversal times (s were (mean ± standard deviation 225.2 ± 81.2, 173.9 ± 86.8 and 174.1 ± 74.9 respectively, in the IW, CW20 and CW40 groups (p = 0.087. Conclusions: No differences were observed between groups with neuromuscular blockade reversal time and frequency of postoperative residual curarization. We concluded that ideal body weight can be used to calculate sugammadex dose to reverse moderate neuromuscular blockade in morbidly obese patients.

  15. Open-Lung Ventilation Improves Clinical Outcomes in Off-Pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Bolzan, Douglas W; Trimer, Renata; Begot, Isis; Nasrala, Mara L S; Forestieri, Patricia; Mendez, Vanessa M F; Arena, Ross; Gomes, Walter J; Guizilini, Solange

    2016-06-01

    To compare pulmonary function, functional capacity, and clinical outcomes among conventional mechanical ventilation (CMV), early open-lung (EOL), and late open-lung (LOL) strategies after off-pump coronary artery bypass surgery (OPCAB). Prospective, randomized, and double-blinded study. Two hospitals of the Federal University of Sao Paulo, Brazil. Ninety-three patients undergoing elective first-time OPCAB. Patients were randomized into 3 groups: CMV (n=31); LOL (n=32) initiated upon intensive care unit (ICU) arrival; EOL (n = 30) initiated after intubation. Spirometry was performed at bedside preoperatively and on postoperative days (PODs) 1, 3, and 5. Partial pressure of arterial oxygen (PaO2) and pulmonary shunt fraction were evaluated presurgically and on POD 1; 6-minute walk test (6MWT) was performed presurgically and on POD 5. Both open-lung groups demonstrated higher forced vital capacity and forced expiratory volume in 1 second on PODs 1, 3 and 5 compared to the CMV group (pLOL groups were compared. Both open-lung strategies were able to promote higher pulmonary function preservation and greater recovery of functional capacity with better clinical outcomes after OPCAB. No difference in outcome was found when comparing initiation of OLS intraoperatively or after ICU arrival. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

    Science.gov (United States)

    Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

    2017-03-01

    Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Efficacy and safety profile of antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, Yi; Dong, Jiasheng; Qiao, Yufei; He, Jinguang; Wang, Tao; Ma, Sunxiang

    2014-01-01

    There is no consensus with regard to antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery. This meta-analysis sought to assess the efficacy and safety of antibiotic prophylaxis and to determine appropriate duration of prophylaxis. An English language literature search was conducted using PubMed and the Cochrane Collaboration for randomized controlled trials (RCTs) that evaluate the use of antibiotic prophylaxis to prevent postoperative surgical site infection (SSI) in patients undergoing clean and clean-contaminated plastic and reconstructive surgery. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were odds ratio (OR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method or the DerSimonian and Laird method. Study quality was critically appraised by 2 reviewers using established criteria. STATA version 12 was used for meta-analyses. Twelve RCTs involving 2395 patients were included, of which 8 trials were considered to be of high methodological quality. Effect of antibiotic prophylaxis in plastic and reconstructive surgery was found favorable over placebo in SSI prevention (13 studies; 2449 participants; OR, 0.53; 95% CI, 0.4-0.7; P plastic surgeries with high-risk factors and clean-contaminated plastic surgeries. Besides, a short-course administration regimen seemed to be of adequate efficacy and safety. High-quality prospective trials on larger scale are needed to further confirm these findings.

  18. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

    Science.gov (United States)

    Hersh, P S; Brint, S F; Maloney, R K; Durrie, D S; Gordon, M; Michelson, M A; Thompson, V M; Berkeley, R B; Schein, O D; Steinert, R F

    1998-08-01

    This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). A randomized, prospective multicenter clinical trial. A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more

  19. Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial.

    Science.gov (United States)

    Alalaf, S K; Jawad, A K; Jawad, R K; Ali, M S; Al Tawil, N G

    2015-12-01

    Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery. To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery. We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE. In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3-36.2), varicose veins (OR 16.8; 95% CI 3.1-76.2), and thrombophilia (OR 39.3; 95% CI 1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin. Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery. © 2015 International Society on Thrombosis and Haemostasis.

  20. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

    Science.gov (United States)

    Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

    2018-04-01

    Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

  1. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    Science.gov (United States)

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  2. Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial.

    Science.gov (United States)

    Unterhofer, Claudia; Freyschlag, Christian F; Thomé, Claudius; Ortler, Martin

    2016-08-01

    Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated. To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH. Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3-6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness. Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow-up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% [95% confidence interval, -38% to 8%]). Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

    Science.gov (United States)

    Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

    2017-03-01

    OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant

  4. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  5. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery.

    Science.gov (United States)

    Cottam, J; Richards, K; Hasted, A; Blackman, A

    2007-11-01

    Actuarial analysis of stoma complications (problematic stomas) is lacking. The objectives of this audit were: to identify the incidence of stoma complications within the UK; to highlight any dissimilarity of incidence from centre to centre; to ascertain if the height of the stoma (distance of stoma lumen from the skin) at the time of fashioning is a predisposing factor to problems; and finally to initiate much needed research. Commencing 1st January 2005, stoma care services nationwide (256) were invited to audit prospectively their next 50 enteric stomas or for a period of 1 year which ever came first. The definition of a problematic stoma being one, which needed one or more accessories to keep the patient clean and dry for a minimum period of 24 h. The incident is to have happened within 3 weeks of surgery. Factors taken into account were: type of stoma, height of stoma within 48 h of surgery; emergency or elective procedure, problem identified, BMI, gender and underlying diagnosis of the patient. The identities of the participating centres are confidential. Of the 256 hospital-based stoma care services within the UK, 93 (36%) participated. A total of 3970 stomas were recorded, of which 1329 (34%) were identified as problematic. Sixty-two centres reported 45-50 stomas with a range of complications 6-96%. The loop ileostomy was found to be the stoma which causes most problems. A stoma of stomas formed, but have significantly fewer problems and there is no significant difference between underlying diagnoses. The stoma height, stoma type and gender of the patient are significant risk factors identified in this audit. The BMI of patient did not affect the outcome. Patients undergoing an emergency procedure are more likely to have a problematic stoma. The significant variation of complications from centre to centre indicates surgical technique as being the key factor in stoma formation and subsequent quality of life for the patient.

  6. Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial.

    Science.gov (United States)

    van Barneveld, Kevin W Y; Smeets, Boudewijn J J; Heesakkers, Fanny F B M; Bosmans, Joanna W A M; Luyer, Misha D; Wasowicz, Dareczka; Bakker, Jaap A; Roos, Arnout N; Rutten, Harm J T; Bouvy, Nicole D; Boelens, Petra G

    2016-06-01

    To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery. Previously, it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients. A preplanned substudy of a previous prospective, randomized, open-label, single-centre study, comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer. Early enteral nutrition reduced postoperative ileus, anastomotic leakage, and hospital stay. Tertiary referral centre for locally advanced and recurrent rectal cancer. A total of 123 patients with locally advanced or recurrent rectal carcinoma requiring major rectal surgery. Patients were randomized (ALEA web-based external randomization) preoperatively into two groups: early enteral nutrition (early enteral nutrition, intervention) by nasojejunal tube (n = 61) or early parenteral nutrition (early parenteral nutrition, control) by jugular vein catheter (n = 62). Eight hours after the surgical procedure artificial nutrition was started in hemodynamically stable patients, stimulating oral intake in both groups. Blood samples were collected to measure plasma glutamine, citrulline, and arginine concentrations using a validated ultra performance liquid chromatography-tandem mass spectrometric method. Baseline concentrations were comparable for both groups. Directly after rectal surgery, a decrease in plasma amino acids was observed. Plasma glutamine concentrations were higher in the parenteral group than in the enteral group on postoperative day 1 (p = 0.027) and day 5 (p = 0.008). Arginine concentrations were also significantly increased in the parenteral group at day 1 (p < 0.001) and day 5 (p = 0.001). Lower plasma glutamine and arginine concentrations were measured in the enteral group, whereas a

  7. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II.

    Science.gov (United States)

    Versyck, Barbara; van Geffen, Geert-Jan; Van Houwe, Patrick

    2017-08-01

    The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. A prospective randomized double blind placebo-controlled study. A secondary hospital. 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection. Patients were randomized to receive either a Pecs block with levobupivacaine 0.25% (n=70) or placebo block with saline (n=70). The pain levels were evaluated by Numeric Rating Scale (NRS) pain scores at 15-minute intervals during the post anesthesia care unit stay time (PACU), at 2-hour intervals for the first 24h on the ward and at 4-hour intervals for the next 24h. Intraoperative and postoperative opioid consumption were recorded during the full stay. Patient satisfaction was evaluated upon discharge using a 10-point scale. Intraoperative sufentanil requirements were comparable for the Pecs and placebo group (8.0±3.5μg and 7.8±3.0μg, P=0.730). Patients in the Pecs group experienced significantly less pain than patients in the control group (P=0.048) during their PACU stay. Furthermore, patients in the Pecs group required significant less postoperative opioids (9.16±10.15mg and 14.97±14.38mg morphine equivalent, P=0.037) and required significant fewer postsurgical opioid administration interventions than patients in the control group (P=0.045). Both patient-groups were very satisfied about their management (9.6±0.6 and 9.1±1.8 on a 10-point scale, P=0.211). The Pecs block reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  9. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial

    Science.gov (United States)

    Arts, Mark P.; Brand, Ronald; Koes, Bart W.

    2009-01-01

    Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent. PMID:19132412

  10. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ljunggren Stefan

    2012-07-01

    Full Text Available Abstract Background Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L rather than to the nutrients. Methods Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine, muscle catabolism (urinary 3-methylhistidine, and wellbeing. Results Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (−48% and was due to an increased insulin response (+51%. Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups. Conclusions Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery. Trial registration Registration number: NCT 01211184 (http://www.clinicaltrials.gov

  11. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial.

    Science.gov (United States)

    Ljunggren, Stefan; Hahn, Robert G

    2012-07-02

    Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients. Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine), muscle catabolism (urinary 3-methylhistidine), and wellbeing. Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (-48%) and was due to an increased insulin response (+51%). Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups. Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery.

  12. Randomized clinical trial of expressive writing on wound healing following bariatric surgery.

    Science.gov (United States)

    Koschwanez, Heidi; Robinson, Hayley; Beban, Grant; MacCormick, Andrew; Hill, Andrew; Windsor, John; Booth, Roger; Jüllig, Mia; Broadbent, Elizabeth

    2017-07-01

    Writing emotionally about upsetting life events (expressive writing) has been shown to speed healing of punch-biopsy wounds compared to writing objectively about daily activities. We aimed to investigate whether a presurgical expressive writing intervention could improve surgical wound healing. Seventy-six patients undergoing elective laparoscopic bariatric surgery were randomized either to write emotionally about traumatic life events (expressive writing) or to write objectively about how they spent their time (daily activities writing) for 20 min a day for 3 consecutive days beginning 2 weeks prior to surgery. A wound drain was inserted into a laparoscopic port site and wound fluid analyzed for proinflammatory cytokines collected over 24 hr postoperatively. Expanded polytetrafluoroethylene tubes were inserted into separate laparoscopic port sites during surgery and removed after 14 days. Tubes were analyzed for hydroxyproline deposition (the primary outcome), a major component of collagen and marker of healing. Fifty-four patients completed the study. Patients who wrote about daily activities had significantly more hydroxyproline than did expressive writing patients, t(34) = -2.43, p = .020, 95% confidence interval [-4.61, -0.41], and higher tumor necrosis factor-alpha, t(29) = -2.42, p = .022, 95% confidence interval [-0.42, -0.04]. Perceived stress significantly reduced in both groups after surgery. Expressive writing prior to bariatric surgery was not effective at increasing hydroxyproline at the wound site 14 days after surgery. However, writing about daily activities did predict such an increase. Future research needs to replicate these findings and investigate generalizability to other surgical groups. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Preoperative antibiotic prophylaxis in orthognathic surgery: a randomized, double-blind, and placebo-controlled clinical study

    NARCIS (Netherlands)

    Zijderveld, S. A.; Smeele, L. E.; Kostense, P. J.; Tuinzing, D. B.

    1999-01-01

    This study evaluated the need for antibiotic prophylaxis in orthognathic surgery. Fifty-four patients (age range, 18 to 40 years) underwent bimaxillary orthognatic surgery. After randomization, a placebo (n = 19), 2,200 mg amoxicillin-clavulanic acid (n = 18), or 1,500 mg cefuroxime (n = 17) was

  14. A systematic review of the quality of randomized controlled trials in head and neck oncology surgery.

    Science.gov (United States)

    Carlton, Daniel A; Kocherginsky, Masha; Langerman, Alexander J

    2015-01-01

    To determine the quality of randomized controlled trials (RCTs) in head and neck surgery in which surgery was a primary intervention. Potential articles were identified in PubMed without publication date restrictions. Articles were scored using the CONSORT checklist and the relationship between the checklist score and whether the first and/or last authors were surgeons was investigated. Differences in the checklist score based on how many surgeons were among the first and last authors of the study were analyzed using the Kruskal-Wallis test. Fisher's exact test was used to examine if there was a significant difference of the reporting of individual items from the checklist between surgeons and nonsurgeons. A nonparametric trend test was used to determine whether there was a difference in the reporting of individual items based on whether there were none, one, or two surgeons among first and last authors. A total of 38 publications satisfied the inclusion criteria. There was a trend toward lower quality for studies in which surgeons were either first, last, or both first and last authors compared to studies that were first-authored and last-authored by nonsurgeons (P = 0.068). Nonsurgeons were more likely to report on critical elements regarding hypothesis, sample size determination, randomization, and eligibility of centers (P = 0.023-0.058). The quality of RCTs in head and neck surgery is poor. Improved training in conducting and reporting clinical research is needed in otolaryngology residencies. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  15. Can evidence change the rate of back surgery? A randomized trial of community-based education.

    Science.gov (United States)

    Goldberg, H I; Deyo, R A; Taylor, V M; Cheadle, A D; Conrad, D A; Loeser, J D; Heagerty, P J; Diehr, P

    2001-01-01

    Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences. To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery. A randomized, controlled trial. Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults). Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators. The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period. Quarterly observations of surgical rates. After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01). We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities.

  16. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

    DEFF Research Database (Denmark)

    Andersson, J; Angenete, E; Gellerstedt, M

    2013-01-01

    Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.......Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

  17. Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study

    Directory of Open Access Journals (Sweden)

    Daniele Bernardeschi

    2015-01-01

    Full Text Available Objective. To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. Material and Methods. Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance. Results. All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study. Conclusion. The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications.

  18. Assessing the Risk of Occult Cancer and 30-day Morbidity in Women Undergoing Risk-reducing Surgery: A Prospective Experience.

    Science.gov (United States)

    Bogani, Giorgio; Tagliabue, Elena; Signorelli, Mauro; Chiappa, Valentina; Carcangiu, Maria Luisa; Paolini, Biagio; Casarin, Jvan; Scaffa, Cono; Gennaro, Massimiliano; Martinelli, Fabio; Borghi, Chiara; Ditto, Antonino; Lorusso, Domenica; Raspagliesi, Francesco

    To investigate the incidence and predictive factors of 30-day surgery-related morbidity and occult precancerous and cancerous conditions for women undergoing risk-reducing surgery. A prospective study (Canadian Task Force classification II-1). A gynecologic oncology referral center. Breast-related cancer antigen (BRCA) mutation carriers and BRCAX patients (those with a significant family history of breast and ovarian cancer). Minimally invasive risk-reduction surgery. Overall, 85 women underwent risk-reducing surgery: 30 (35%) and 55 (65%) had hysterectomy plus bilateral salpingo-oophorectomy (BSO) and BSO alone, respectively. Overall, in 6 (7%) patients, the final pathology revealed unexpected cancer: 3 early-stage ovarian/fallopian tube cancers, 2 advanced-stage ovarian cancers (stage IIIA and IIIB), and 1 serous endometrial carcinoma. Additionally, 3 (3.6%) patients had incidental finding of serous tubal intraepithelial carcinoma. Four (4.7%) postoperative complications within 30 days from surgery were registered, including fever (n = 3) and postoperative ileus (n = 1); no severe (grade 3 or more) complications were observed. All complications were managed conservatively. The presence of occult cancer was the only factor predicting the development of postoperative complications (p = .02). Minimally invasive risk-reducing surgery is a safe and effective strategy to manage BRCA mutation carriers. Patients should benefit from an appropriate counseling about the high prevalence of undiagnosed cancers observed at the time of surgery. Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.

  19. A randomized-clinical trial examining a neoprene abdominal binder in gynecologic surgery patients

    Science.gov (United States)

    Szender, J.B.; Hall, K.L.; Kost, E.R.

    2016-01-01

    Summary Purpose of Investigation Pain control and early ambulation are two important postoperative goals. Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications. In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use, pain, and ambulation in the first day after surgery. Materials and Methods The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery. Demographic data and surgical characteristics were collected. Outcome variables included morphine use, pain score, time to ambulation, and number of ambulations. Results A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300%, 260%, and 240% in patients with vertical incisions, age over 50 years, and complex surgeries, respectively. Morphine use and pain scores were not significantly different. Conclusion The binder increased ambulations in the subset of patients at the highest risk for postoperative complications: elderly, cancer patients, and vertical incisions. Routine use of the binder may benefit particularly high-risk gynecologic surgical patients. PMID:25864252

  20. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial.

    Science.gov (United States)

    Qazi, Nahida; Bhat, Wasim Mohammad; Iqbal, Malik Zaffar; Wani, Anisur Rehman; Gurcoo, Showkat A; Rasool, Sahir

    2017-01-01

    Ultrasound-guided transversus abdominis plane (TAP) block is done as a part of multimodal analgesia for pain relief after abdominal surgeries. This prospective randomized, double-blind, placebo-controlled trial was conducted to evaluate the postoperative analgesic efficacy of bilateral TAP block in patients undergoing midline colorectal surgeries using ropivacaine. Eighty patients scheduled for elective colorectal surgeries involving midline abdominal wall incision under general anesthesia were enrolled in this prospective randomized controlled trial. Group A received TAP block with 20 ml of 0.2% ropivacaine on either side of the abdominal wall, and Group B received 20 ml of normal saline. The time to request for rescue analgesia, total analgesic consumption in 24 h, and satisfaction with the anesthetic technique were assessed. The mean visual analog scale scores at rest and on coughing were higher in control group ( P > 0.05). Time (min) to request for the first rescue analgesia was prolonged in study group compared to control group ( P consumption in 24 h postoperatively was significantly high in control group ( P 0.05). The level of satisfaction concerning postoperative pain control/anesthetic technique was higher in study group ( P < 0.001). TAP block produces effective and prolonged postoperative analgesia in patients undergoing midline colorectal surgery. It is a technically simple block to perform with a high margin of safety. It produces a considerable reduction in mean intravenous postoperative tramadol requirements, reduction in postoperative pain scores, and increased time to first request for further analgesia, both at rest and on movement.

  1. A prospective study on the risk of glove fingertip contamination during draping in joint replacement surgery.

    Science.gov (United States)

    Makki, D; Deierl, K; Pandit, A; Trakru, S

    2014-09-01

    The aim of this prospective study was to investigate the risk of contamination of surgical gloves during preparation and draping in joint replacement surgery. During 46 hip and knee replacement procedures, the gloves of orthopaedic consultants (n=5) and registrars (n=3) were assessed for contamination immediately after draping by impression of gloved fingers on blood agar. Contamination was evaluated by the surgeon's grade, the type of procedure, the role of the assistant and the dominance of the hand. A total of 125 pairs of top gloves were examined (79 pairs from registrars and 46 pairs from consultants). Bacterial contamination was isolated on 19 pairs (15.2%) (16 pairs from registrars and 3 pairs from consultants, p=0.04). Coagulase negative staphylococci were the main isolates and contamination was considered low in all cases (1-5 colonies). Contamination was seen more on the dominant hand (16 gloves from dominant hands and 6 from non-dominant hands, p=0.04), on the index finger and thumb. More contaminated gloves were seen in hip arthroplasty procedures (16 pairs from total hip replacements vs 3 pairs from total knee replacements, p=0.02). Contamination of glove fingertips during draping in joint replacement procedures is more likely to occur among junior surgeons, in hip rather than knee arthroplasty procedures and on the dominant hand. It is therefore essential that surgeons of different grades replace gloves used in draping to avoid exposing patients to the risk of infection.

  2. Prospective assessment of positioning-related pain in robotic urologic surgery.

    Science.gov (United States)

    Ginsburg, Kevin B; Pape, Kelsey; Heilbronn, Chase; Levin, Michael; Cher, Michael L

    2018-03-01

    This was a prospective study to assess positioning-related pain in 20 awake volunteers in the dorsal lithotomy (DL) and lateral decubitus (LD) positions. Each volunteer was put through the series of discrete, sequential steps used to achieve a final position; each step had two options. The Wong-Baker scale (WB) was used to rate pain for each option and the preferred option and ad lib comments were recorded. We found that awake volunteers could clearly and immediately distinguish differences in pain levels between position options. For the DL position, volunteers favored having the arms slightly flexed and pronated as opposed to being straight and supinated reflected by statistically less painful WB scores and option preference. Volunteers preferred having the neck flexed as opposed to being flat. For the LD position, volunteers reported statistically lower pain scores and preference for a foam roll for axilla support as opposed to a rolled blanket, the table flexed without the kidney rest as opposed to a raised kidney rest, and the over arm board as oppose to stacked blankets for contralateral arm support. Ad lib comments from the volunteers supported the above findings. To our knowledge, ours is the first study to demonstrate objective preferences for variations in surgical positioning using awake volunteers. This exercise with awake volunteers resulted in immediate changes in positioning for real robotic surgery patients in our practice.

  3. The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

    Directory of Open Access Journals (Sweden)

    Coburn Mark

    2012-09-01

    Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

  4. Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749)

    International Nuclear Information System (INIS)

    Tachezy, Michael; Yekebas, Emre; Gebauer, Florian; Petersen, Cordula; Arnold, Dirk; Trepel, Martin; Wegscheider, Karl; Schafhausen, Phillipe; Bockhorn, Maximilian; Izbicki, Jakob Robert

    2014-01-01

    Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially “curative” R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n = 205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial. For the first time, the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner. The results of the study have the potential to change substantially the treatment regimen of pancreas cancer. Clinical Trial gov:http://www.clinicaltrials.gov/show/NCT01900327; Clinical Trial gov:http://drks-neu.uniklinik-freiburg.de/drks w eb/navigate.do?navigationId; Clinical Trial gov

  5. Multi-modal-analgesia for pain management after Hallux Valgus surgery: a prospective randomised study on the effect of ankle block

    Directory of Open Access Journals (Sweden)

    Rolf Christer

    2007-12-01

    Full Text Available Abstract Background Pain and emesis are the two major complaints after day case surgery. Local anaesthesia has become an important part of optimizing intra and post-operative pain treatment, but is sometimes not entirely sufficient. The aim of the present study was to study the effect of adding an ankle block to a multi-modal analgesic approach on the first 24-hour-need for rescue analgesia in patients undergoing elective Hallux Valgus surgery. Type of study Prospective, randomized patient-blind study comparing ankle block with levo-bupivacaine, lidocaine and Saline placebo control. Methods Ninety patients were studied comparing ankle block (15 cc using levo-bupivacaine 2.5 mg/ml, lidocaine 10 mg/ml or placebo (saline on day-case elective Hallux Valgus surgery, supported by general anaesthesia in all cases. Primary study endpoint was number of patient's requiring oral analgesics during the first 24 post-operative hours. Results Ankle block had no effect on need for rescue analgesia and pain ratings during the 1st 24 postoperative hours, there was no difference seen between placebo and any of the two active local anaesthesia studied. The only differences seen was that both lidocaine and levo-bupivacaine reduced the intra-operative need for anaesthetic (sevoflurane and that levo-bupivacaine patients had a lower need as compared to the lidocaine patients for oral analgesics during the afternoon of surgery. Conclusion Adding a single shot ankle block to a multi-modal pain management strategy reduces the need for intra-operative anaesthesia but has no major impact of need of rescue analgesics or pain during the first 24-hour after surgery.

  6. Fast track multi-discipline treatment (FTMDT trial versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Zhou Jiao-Jiao

    2011-11-01

    Full Text Available Abstract Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547

  7. Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

    Science.gov (United States)

    Kwon, Brian K; Curt, Armin; Belanger, Lise M; Bernardo, Arlene; Chan, Donna; Markez, John A; Gorelik, Stephen; Slobogean, Gerard P; Umedaly, Hamed; Giffin, Mitch; Nikolakis, Michael A; Street, John; Boyd, Michael C; Paquette, Scott; Fisher, Charles G; Dvorak, Marcel F

    2009-03-01

    Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive drainage was 28.1 +/- 2.8 mm Hg, which was not statistically higher than the peak intraoperative ITP (p = 0.15). The

  8. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  9. Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

    NARCIS (Netherlands)

    Fockens, P.; Cohen, L.; Edmundowicz, S.A.; Binmoeller, K.; Rothstein, R.I.; Smith, D.; Lin, E.; Nickl, N.; Overholt, B.; Kahrilas, P.J.; Vakil, N.; Abdel Aziz Hassan, A.M.; Lehman, G.A.

    2010-01-01

    This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). A prospective, randomized, sham-controlled, single-blinded,

  10. Computed tomography prospective study of pleural-pulmonary changes after abdominal surgery : assessment of associated risk factors

    International Nuclear Information System (INIS)

    Rossi, Luis Antonio; Bromberg, Sansom Henrique

    2005-01-01

    Postoperative pleural-pulmonary changes (PPC) are very common following elective abdominal surgery, resolving without clinical manifestations in most patients. The incidence and risk factors associated are unknown. Objective: to determine the incidence of PPC and possible association with risk factors using computerized tomography (CT). Material and method: thirty seven patients submitted to elective abdominal surgery were prospectively analyzed using CT performed in the preoperative period and 48 hours after surgery. The PPC was scored from 0 to III. The risk factors evaluated were: age, sex, obesity, smoking history, alcoholism, comorbid conditions, cancer, ASA classification, duration of surgery, surgical incision type and number of days of hospitalization. Results: Pleura effusion was detected by CT in 70.3% (26/37) of the patients and pulmonary atelectasis in 75.5% (28/37). Grade I and II PPC was found in 59.5% (22/37) of the patients and grade III in 21.6% (8/37). Two (5.4%) of these patients developed serious pulmonary complications whereas one patient died. Surgery due to cancer, class ASA >2, longitudinal incision and > 15 cm showed statistical significance and were associated with pleural effusion. The hospitalization was over 2.4 longer for patients with PPC. Conclusion: PPC is frequently seen in patients submitted to abdominal surgery. The use of the CT for the detection of pulmonary atelectasis and pleural effusion proved to be effective. Most cases of PPC are self-limited, resolving without symptoms. (author)

  11. The impact of cataract surgery on visual functioning, vision-related disability and psychological distress: a randomized controlled trial.

    Science.gov (United States)

    Walker, Janine G; Anstey, Kaarin J; Hennessy, Michael P; Lord, Stephen R; von Sanden, Chwee

    2006-11-01

    Determine whether there are changes in visual functioning, vision-related disability, health status and mood after cataract surgery. 45 adults (mean age = 73.7 years) with bilateral cataract needing surgery for the first eye were recruited from public ophthalmology clinics. The Visual Functioning-14 survey assessed visual disability. Minimal angle of resolution tested visual acuity, and the Melbourne Edge Test examined contrast sensitivity. Demographic, psychological, health and medication use variables were examined. Participants were randomized to either an intervention or control arm. Controls were assessed on two occasions at a 3-month interval before having surgery. The intervention group was assessed 1-2 weeks before surgery and then reassessed 3 months after surgery. Visual functioning improved for those who had cataract surgery with better visual acuity in the better (P = 0.010) and worse (P = 0.028) eye compared with controls. The intervention group reported fewer difficulties with overall vision-related disability (P = 0.0001), reading (P = 0.004) and instrumental activities of daily living (P = 0.010) post-surgery compared with controls. People with improved depression scores (P = 0.048) after surgery had less difficulty with reading compared with those with unchanged or worsened depression scores. Cataract surgery did not improve health status. First eye cataract surgery is effective in improving outcomes in visual functioning and disability. Improved mood after surgery was related to less vision-related disability compared with unchanged or worse depression.

  12. A randomized, double-blind, placebo-controlled trial of oral pregabalin for relief of shoulder pain after laparoscopic gynecologic surgery.

    Science.gov (United States)

    Nutthachote, Pattiya; Sirayapiwat, Porntip; Wisawasukmongchol, Wirach; Charuluxananan, Somrat

    2014-01-01

    To investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery. Prospective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). Tertiary referral center, university hospital. Fifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013. Women in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses, and women in the control group received an identical capsule and the same dosage of placebo. Visual analog scale (VAS) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome. Postoperative analgesics used and drug-related adverse events were also monitored. Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours, compared with the placebo group (median, 23.14 [range, 13.67-32.61] vs. 37.22 [27.75-46.64]; p = .04), and required less analgesic (p = .01). There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups (p = .56). Perioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

  13. Training With Curved Laparoscopic Instruments in Single-Port Setting Improves Performance Using Straight Instruments: A Prospective Randomized Simulation Study.

    Science.gov (United States)

    Lukovich, Peter; Sionov, Valery Ben; Kakucs, Timea

    2016-01-01

    Lately single-port surgery is becoming a widespread procedure, but it is more difficult than conventional laparoscopy owing to the lack of triangulation. Although, these operations are also possible with standard laparoscopic instruments, curved instruments are being developed. The aims of the study were to identify the effect of training on a box trainer in single-port setting on the quality of acquired skills, and transferred with the straight and curved instruments for the basic laparoscopic tasks, and highlight the importance of a special laparoscopic training curriculum. A prospective study on a box trainer in single-port setting was conducted using 2 groups. Each group performed 2 tasks on the box trainer in single-port setting. Group-S used conventional straight laparoscopic instruments, and Group-C used curved laparoscopic instruments. Learning curves were obtained by daily measurements recorded in 7-day sessions. On the last day, the 2 groups changed instruments between each other. 1st Department of Surgery, Semmelweis University of Medicine from Budapest, Hungary, a university teaching hospital. In all, 20 fifth-year medical students were randomized into 2 groups. None of them had any laparoscopic or endoscopic experience. Participation was voluntary. Although Group-S performed all tasks significantly faster than Group-C on the first day, the difference proved to be nonsignificant on the last day. All participants achieved significantly shorter task completion time on the last day than on the first day, regardless of the instrument they used. Group-S showed improvement of 63.5%, and Group-C 69.0% improvement by the end of the session. After swapping the instruments, Group-S reached significantly higher task completion time with curved instruments, whereas Group-C showed further progression of 8.9% with straight instruments. Training with curved instruments in a single-port setting allows for a better acquisition of skills in a shorter period. For this

  14. Corneal power, thickness, and stiffness: results of a prospective randomized controlled trial of PRK and LASIK for myopia.

    Science.gov (United States)

    Hjortdal, Jesper Ø; Møller-Pedersen, Torben; Ivarsen, Anders; Ehlers, Niels

    2005-01-01

    To compare the short-, medium-, and long-term changes in corneal optical power and corneal aberrations, central corneal thickness, and corneal "stiffness" assessed by pneumotonometry readings in patients having laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) for myopia. Department of Ophthalmology, Arhus University Hospital, Arhus, Denmark. One eye of each of 45 patients with myopia ranging from -6.00 to -8.00 diopters (D) (spherical equivalent spectacle refraction [SER]) was randomized to LASIK (n=25; mean SER -7.12 D +/- 0.57 [SD]) or PRK (n=20; mean SER -6.91 +/- 0.57 D). Data were collected prospectively before and 1, 3, 6, 12, and 36 months after surgery. Measurements included corneal topography (TMS-1, Tomey), corneal thickness (ultrasound pachymetry), and apparent intraocular pressure (IOP) (pneumotonometry). Retreatments were not performed during the first year, and retreated eyes were excluded from the 3-year follow-up. Changes in corneal power and aberrations, thickness, and apparent IOP were calculated in a pair-wise manner for 3 time periods: short term (preoperative to 1 month after surgery), medium term (1 to 12 months after surgery), and long term (1 to 3 years after surgery). In the short term, corneal power decreased equally in LASIK and PRK eyes. Spherical aberrations and coma-like aberrations increased equally, while corneal thickness decreased significantly less in LASIK eyes than in PRK eyes. The apparent IOP decreased more in LASIK eyes than in PRK eyes. In the medium term, corneal power increased significantly in both groups. Spherical aberrations decreased significantly in PRK eyes but not in LASIK eyes. From 1 to 12 months, corneal thickness increased more in PRK eyes than in LASIK eyes. During this period, the apparent IOP increased significantly in LASIK eyes. In the long term, corneal power and corneal aberrations did not change significantly in either group. Corneal thickness increased slightly but

  15. The course of language functions after temporal lobe epilepsy surgery: a prospective study.

    Science.gov (United States)

    Giovagnoli, A R; Parente, A; Didato, G; Manfredi, V; Deleo, F; Tringali, G; Villani, F

    2016-12-01

    Anterior temporal lobectomy (ATL) within the language-dominant hemisphere can impair naming. This prospective study examined the pre-operative to post-operative course of different language components, clarifying which changes are relevant within the short-term and long-term outcome of language. Patients with drug-resistant temporal lobe epilepsy (TLE) were evaluated using the Token, Boston Naming and Word Fluency tests assessing sentence comprehension and word-finding on visual, semantic or phonemic cues. A total of 106 patients were evaluated before and 6 months, 1 and 2 years after ATL; 60 patients were also evaluated after 5 years and 38 controls were assessed at baseline. Seizure outcome was comparable between the left and right TLE patients. Before surgery, naming and word fluency were impaired in the left and right TLE patients, whereas sentence comprehension was normal. After left or right ATL, word fluency progressively improved, naming showed early worsening and late improvement after left ATL and progressive improvement after right ATL, and sentence comprehension did not change. At the 5-year follow-up, naming improvement was clinically significant in 31% and 71% of the left and right TLE patients, respectively. Pre-operative naming, ATL laterality, schooling, and post-operative seizure frequency and number of antiepileptic drugs predicted post-operative naming. Pre-operative word fluency and schooling predicted post-operative word fluency. Left or right TLE can impair word-finding but not sentence comprehension. After ATL, word-finding may improve for a long time, depending on TLE laterality, seizure control and mental reserve. These findings may clarify prognosis prior to treatment. © 2016 EAN.

  16. The Prevalence of Ostomy-related Complications 1 Year After Ostomy Surgery: A Prospective, Descriptive, Clinical Study.

    Science.gov (United States)

    Carlsson, Eva; Fingren, Jeanette; Hallén, Anne-Marie; Petersén, Charlotta; Lindholm, Elisabet

    2016-10-01

    Despite advancements in the creation and care of stomas, ostomy and peristomal skin complications are common immediately following surgery as well as in the months and years thereafter. A prospective study to determine the prevalence of ostomy and peristomal skin complications and the influence of ostomy configuration on such complications was conducted 1 year after ostomy surgery among all patients at a university hospital in Sweden. All participants received regular (10 to 14 days post discharge, 6 weeks, 3 months, 6 months, and 1 year post surgery) ostomy follow-up care by a wound ostomy continence (WOC) nurse. All consecutive elective and emergency patients who had undergone surgery to create a colostomy (end colostomy), end ileostomy, or loop ileostomy were eligible to participate. Patients who were reoperated during their first year post-surgery, patients with a urostomy, and patients with double ostomies were excluded from the study. Patient data collected included age, gender, diagnosis, elective or emergency surgery, open or laparoscopic surgical procedure, presence of a colorectal surgeon specialist at surgery, type of ostomy (colostomy, end ileostomy, loop ileostomy), preoperative ostomy siting, counseling, body mass index, American Society of Anesthesiologists classification, and radiation and/or chemotherapy status. Ostomies were evaluated by 4 WOC nurses as to stoma configuration, convexity use, patient self-sufficiency in stoma care, and complications. All 207 patients (53% women) who were eligible agreed to participate in the study. Patient median age was 70 years (range 19-94); 74% underwent elective surgery. Main diagnoses were colorectal cancer (62%) and inflammatory bowel disease (19%). Ostomy types were: colostomy (71%), end ileostomy (26%), and loop ileostomy (3%). One or more complications occurred in 35% of the patients (27% ostomy complications, 11% peristomal skin complications). A colostomy hernia was the most common surgical complication

  17. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

    Science.gov (United States)

    Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

    2018-03-01

    OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but

  18. [Factors involved in the development of vasoplegia after cardiac surgery with extracorporeal circulation. A prospective observational study].

    Science.gov (United States)

    Durán Bruce, M; Gomar Sancho, C; Holguera, J C; Muliterno Español, E

    2014-05-01

    The incidence and risk factors for vasoplegia in the early postoperative period and at 24h are investigated in patients subjected to cardiopulmonary bypass surgery. Vasoplegia following cardiac surgery with cardiopulmonary bypass is associated with a high morbimortality. The risk factors described emerged from retrospective, non-controlled studies. Observational prospective study of 188 consecutive patients subjected to cardiac surgery with cardiopulmonary bypass in a single hospital between November 2011 and May 2012. Emergency surgery or complex procedures were excluded. Vasoplegia was assessed during the immediate postoperative period, and at 24h after surgery, and was defined as a mean arterial pressure below 50mmHg, and the need for a noradrenaline perfusion of more than 0.08μg/kg/min, monitored by cardiac output and systemic vascular resistances. The anaesthetic and cardiopulmonary bypass protocols, as well as haemodynamic management, were the same in all patients. Almost half (48%) of patients had vasoplegia in the immediate postoperative period, and 34% at 24h. Risk factors for immediate vasoplegia development were preoperative use of angiotensin converting enzyme inhibitor drugs, a mean arterial pressure<50mmHg immediately after beginning cardiopulmonary bypass, duration of aortic clamping as well as the cardiopulmonary bypass, and minimum temperature in cardiopulmonary bypass. Vasoplegia at 24h after surgery was correlated to preoperative angiotensin converting enzyme inhibitor drug treatment and cardiopulmonary bypass duration. The incidence of vasoplegia after cardiac surgery with cardiopulmonary bypass is high during the first 24 postoperative hours. Preoperative treatment with angiotensin converting enzyme inhibitor and the mean arterial pressure at the beginning of cardiopulmonary bypass are the more easily controllable risk factors. In patients arriving to surgery with those drugs, treatment or prevention of vasoplejia should be planned. Copyright

  19. Prospective randomized trial of sclerotherapy vs standard treatment for epistaxis due to hereditary hemorrhagic telangiectasia.

    Science.gov (United States)

    Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan

    2015-05-01

    Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.

  20. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2017-06-01

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

  1. Impact of Early Valve Surgery on Outcome of Staphylococcus aureus Prosthetic Valve Infective Endocarditis: Analysis in the International Collaboration of Endocarditis–Prospective Cohort Study

    OpenAIRE

    Chirouze, Catherine; Alla, François; Fowler, Vance G.; Sexton, Daniel J.; Corey, G. Ralph; Chu, Vivian H.; Wang, Andrew; Erpelding, Marie-Line; Durante-Mangoni, Emanuele; Fernández-Hidalgo, Nuria; Giannitsioti, Efthymia; Hannan, Margaret M.; Lejko-Zupanc, Tatjana; Miró, José M.; Muñoz, Patricia

    2014-01-01

    Using appropriate analytical methods to examine data from the International Collaboration on Endocarditis–Prospective Cohort Study, we found that early valve surgery was not associated with reduced 1-year mortality in Staphylococcus aureus prosthetic valve infective endocarditis.

  2. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    Science.gov (United States)

    Duara, Rajnish; Misra, Manoranjan; Bhuyan, Ritwick Raj; Sarma, P. Sankara; Jayakumar, Karunakaran

    2008-01-01

    Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1) cases where residual pump blood was used and (2) controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained. PMID:20041077

  3. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    Directory of Open Access Journals (Sweden)

    Duara Rajnish

    2008-01-01

    Full Text Available Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1 cases where residual pump blood was used and (2 controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1 st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained.

  4. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  5. Dexmedetomidine in a surgically inserted catheter for transversus abdominis plane block in donor hepatectomy: A prospective randomized controlled study.

    Science.gov (United States)

    Aboelela, Mohamed Adel; Kandeel, Al-Refaey; Elsayed, Usama; Elmorshedi, Mohamed; Elsarraf, Waleed; Elsayed, Eman; Elgawalby, Ahmed; Sultan, Ahmed Mohamed; Wahab, Mohamed Abdel; Yassen, Amr

    2018-01-01

    Transversus abdominis plane (TAP) block is a promising technique for analgesia after abdominal surgery. This prospective, randomized controlled trial assessed the effect of adding dexmedetomidine to bupivacaine in TAP block for donor hepatectomy. We hypothesized that this would improve postoperative morphine consumption and reduce analgesia related complication and inflammation. A total of 50 donor hepatectomy were enrolled in this study. Patients divided into two equal groups according to drugs used for TAP block. Group (B) received 20 ml of bupivacaine hydrochloride 0.25%, Group (BD) received 20 ml of bupivacaine hydrochloride 0.25% and 0.3 μg/kg dexmedetomidine, on both sides at the end of surgery and every 8 h for 48 h at right side only through inserted catheter. Primary outcome objective was morphine consumption at first 72 h. Secondary outcome objectives were morphine requirement, numbers of intake, time to first intake, pain score numerical analog scale (NAS), postoperative analgesia related complications, recovery of intestinal motility, and inflammatory markers. Data were analyzed, rescue morphine analgesia was significantly lower in (BD) group compared with (B) groups as considering total morphine consumption (B 4 ± 1.9, BD 1.5 ± 0.5, P = 0.03), numbers of morphine intake ( P = 0.04), morphine requirement ( P = 0.03), and first time of analgesia intake ( P = 0.04). NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03). Adding dexmedetomidine improved gut motility, first oral intake without detectable anti-inflammatory effect. Adding dexmedetomidine to bupivacine in a surgically inserted catheter for TAP block in donor hepatectomy reduced morphine consumption without detectable anti-inflammatory effect.

  6. Tamoxifen added to radiotherapy and surgery for the treatment of ductal carcinoma in situ of the breast: A meta-analysis of 2 randomized trials

    International Nuclear Information System (INIS)

    Petrelli, Fausto; Barni, Sandro

    2011-01-01

    Background: Surgical excision with adequate margins is the treatment of choice for ductal, in situ carcinoma of the breast (DCIS). The addition of radiotherapy (RT) halved local in situ and invasive recurrence. The purpose of our meta-analysis is to evaluate the reduction in recurrence (in situ or invasive) with the addition of tamoxifen (T), in particular in patients with DCIS treated with surgery + RT. Patients and methods: The eligible studies (NSABP-B24 and UK ANZ DCIS trials) included prospective, randomized, controlled trials in which the addition of T had been compared with surgery + RT without T in women with DCIS of the breast. Relative risks (RRs) with 95% confidence intervals (CIs) were calculated for both in situ and invasive recurrence (local and controlateral). Results: Tamoxifen does not reduce breast cancer-specific or overall mortality when added to loco-regional therapy for DCIS of the breast (surgery plus or minus RT). Tamoxifen reduces overall breast cancer recurrence by 29% in all patients and by 33% in those treated with both surgery and RT. Only ipsilateral invasive (RR 0.61 [95% CI 0.41, 0.92]; p = 0.02) and controlateral in situ relapses (RR 0.40 [95% CI 0.16, 0.96]; p = 0.04) are significantly lowered when T is added to RT. Tamoxifen seems to exert a local synergistic effect with RT. Both young and older women ( 50 years) achieve some benefit from the addition of T (RR 0.6 and 0.74, respectively). Conclusion: The addition of T to surgery and RT for DCIS of the breast reduces the risk of local invasive and controlateral in situ relapses, but not the survival. The benefit is independent of age. In conclusion, surgery associated with RT and T is the treatment of choice for patients with (estrogen-receptor positive) DCIS of the breast.

  7. Harmonic scalpel versus electrocautery in breast reduction surgery: a randomized controlled trial.

    Science.gov (United States)

    Burdette, Todd E; Kerrigan, Carolyn L; Homa, Karen; Homa, Karen A

    2011-10-01

    The authors hypothesized that the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) might outperform electrocautery in bilateral breast reduction surgery, possibly resulting in (1) shorter operative times, (2) lower postoperative fluid drainage rates, and (3) reduced postoperative pain scores. Thirty-one patients were evaluated in a matched-pair design, with random (blinded) assignment of one side to the Harmonic Scalpel, with the other side defaulting to electrocautery. Main outcome measures were: (1) resection/hemostasis time, (2) drainage volume, and (3) postoperative pain. The authors also compared the learning curves, operative time versus specimen weights, complications, and costs for the devices. There was a statistically significant (but not clinically significant) difference between the median times for the Harmonic Scalpel (33 minutes) and electrocautery (31 minutes) (p=0.02). There was no statistical difference in drainage scores, and pain scores were equivalent. The analysis of specimen weight versus resection/hemostasis time showed no correlation. There were more complications on the breasts reduced with the Harmonic device, but due to the small sample size, the complication results were not statistically significant. Start-up costs for the devices were comparable, but the per-procedure cost for the Harmonic device was considerably higher. The Harmonic Scalpel is roughly equivalent to electrocautery in breast reduction surgery in terms of resection/hemostasis time, serous drainage, and postoperative pain. Though the Harmonic device may be excellent for other surgical procedures, its high cost suggests that surgeons and institutions can confidently forgo its use in breast reduction surgery. Therapeutic, II.

  8. Effect of Preoperative Warm-up Exercise Before Laparoscopic Gynecological Surgery: A Randomized Trial.

    Science.gov (United States)

    Polterauer, Stephan; Husslein, Heinrich; Kranawetter, Marlene; Schwameis, Richard; Reinthaller, Alexander; Heinze, Georg; Grimm, Christoph

    2016-01-01

    Laparoscopic surgical procedures require a high level of cognitive and psychomotoric skills. Thus, effective training methods to acquire an adequate level of expertise are crucial. The aim of this study was to investigate the effect of preoperative warm up training on surgeon׳s performance during gynecologic laparoscopic surgery. In this randomized controlled trial, surgeons performed a preoperative warm up training using a virtual reality simulator before laparoscopic unilateral salpingo-oophorectomy. Serving as their own controls, each subject performed 2 pairs of laparoscopic cases, each pair consisting of 1 case with and 1 without warm up before surgery. Surgeries were videotaped and psychomotoric skills were rated using objective structured assessment of technical skills (OSATS) and the generic error rating tool by a masked observer. Perioperative complications were assessed. Statistical analysis was performed using a mixed model, and mean OSATS scores were compared between both the groups. In total, data of 10 surgeons and 17 surgeries were available for analysis. No differences between educational level and surgical experiences were observed between the groups. Mean standard error psychomotoric and task-specific OSATS scores of 19.8 (1.7) and 3.7 (0.2) were observed in the warm up group compared with 18.6 (1.7) and 3.8 (0.2) in the no warm up group, respectively (p = 0.51 and p = 0.29). Using generic error rating tool, the total number of errors was 8.75 (2.15) in the warm up group compared with 10.8 (2.18) in the no warm-up group (p = 0.53). Perioperative complications and operating time did not differ between both the groups. The present study suggests that warm-up before laparoscopic salpingo-oophorectomy does not increase psychomotoric skills during surgery. Moreover, it does not influence operating time and complication rates. (Medical University of Vienna-IRB approval number, 1072/2011, ClinicalTrials.gov number, NCT01712607). Copyright © 2016

  9. Effect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.

    Science.gov (United States)

    Trabelsi, W; Ben Gabsia, A; Lebbi, A; Sammoud, W; Labbène, I; Kchelfi, S; Ferjani, M

    2017-02-01

    To evaluate the effect of warming bupivacaine 0.5% on ultrasound-guided axillary brachial plexus block. Prospective, randomized, double-blind. Eighty patients undergoing elective or emergency surgery beyond the distal third of the upper limb were divided into two groups of 40 patients: the warm group received 15mL bupivacaine 0.5% heated to 37°C; the cold group received 15mL 0.5% bupivacaine stored for at least 24hours in the lower compartment of a refrigerator at 13-15°C. Onset and duration of sensory and motor blocks were evaluated every 5minutes for 40minutes. Postoperative pain was evaluated at 1, 3, 6, 12 and 24hours. Effective analgesia time was recorded as the interval between anesthetic injection and the first analgesia requirement (VAS>30mm). Time to onset of sensory and motor block was significantly shorter in the warm group, and mean duration of sensory and motor block and of postoperative analgesia significantly longer. Warming bupivacaine 0.5% to 37°C accelerated onset of sensory and motor block and extended action duration. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  10. A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

    Science.gov (United States)

    Koch, Colleen G; Sessler, Daniel I; Mascha, Edward J; Sabik, Joseph F; Li, Liang; Duncan, Andra I; Zimmerman, Nicole M; Blackstone, Eugene H

    2017-10-01

    Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  11. A prospective comparison of postoperative pain and quality of life in robotic assisted vs conventional laparoscopic gynecologic surgery.

    Science.gov (United States)

    Zechmeister, Jenna R; Pua, Tarah L; Boyd, Leslie R; Blank, Stephanie V; Curtin, John P; Pothuri, Bhavana

    2015-02-01

    We sought to compare robotic vs laparoscopic surgery in regards to patient reported postoperative pain and quality of life. This was a prospective study of patients who presented for treatment of a new gynecologic disease requiring minimally invasive surgical intervention. All subjects were asked to take the validated Brief Pain Inventory-Short Form at 3 time points to assess pain and its effect on quality of life. Statistical analyses were performed using Pearson x(2) and Student's t test. One hundred eleven were included in the analysis of which 56 patients underwent robotic assisted surgery and 55 patients underwent laparoscopic surgery. There was no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. There was a statistically significant difference found at the delayed postoperative period when evaluating interference of sleep, favoring laparoscopy (ROB 2.0 vs LSC 1.0; P = .03). There were no differences found between the robotic and laparoscopic groups of patients receiving narcotics (56 vs 53, P = .24, respectively), route of administration of narcotics (47 vs 45, P > .99, respectively), or administration of nonsteroidal antiinflammatory medications (27 vs 21, P = .33, respectively). Our results demonstrate no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. Furthermore, pain did not appear to interfere consistently with any daily activity of living. Interference of sleep needs to be further evaluated after controlling for bilateral salpingo-oophorectomy. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. A prospective clinical study evaluating the development of bowel wall edema during laparoscopic and open visceral surgery.

    Science.gov (United States)

    Marjanovic, Goran; Kuvendziska, Jasmina; Holzner, Philipp Anton; Glatz, Torben; Sick, Olivia; Seifert, Gabriel; Kulemann, Birte; Küsters, Simon; Fink, Jodok; Timme, Sylvia; Hopt, Ulrich Theodor; Wellner, Ulrich; Keck, Tobias; Karcz, Wojciech Konrad

    2014-12-01

    To examine bowel wall edema development in laparoscopic and open major visceral surgery. In a prospective study, 47 consecutively operated patients with gastric and pancreatic resections were included. Twenty-seven patients were operated in a conventional open procedure (open group) and 20 in a laparoscopic fashion (lap group). In all procedures, a small jejunal segment was resected during standard preparation, of which we measured the dry-wet ratio. Furthermore, HE staining was performed for measuring of bowel wall thickness and edema assessment. Mean value (±std) of dry-wet ratio was significantly lower in the open than in the lap group (0.169 ± 0.017 versus 0.179 ± 0.015; p = 0.03) with the same amount of fluid administration in both groups and a longer infusion interval during laparoscopic surgery. Subgroup analyses (only pancreatic resections) still showed similar results. Histologic examination depicted a significantly larger bowel wall thickness in the open group. Laparoscopic surgery does not seem to lead to the bowel wall edema observed to occur in open surgery regardless of the degree of intravenous fluid administration, thus supporting its use even in major visceral surgery.

  13. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

  14. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  15. Effects of daikenchuto, a Japanese herb, on intestinal motility after total gastrectomy: a prospective randomized trial.

    Science.gov (United States)

    Akamaru, Yusuke; Takahashi, Tsuyoshi; Nishida, Toshirou; Omori, Takeshi; Nishikawa, Kazuhiro; Mikata, Shoki; Yamamura, Noriyuki; Miyazaki, Satoru; Noro, Hiroshi; Takiguchi, Shuji; Mori, Masaki; Doki, Yuichiro

    2015-03-01

    This study aimed to assess the efficacy of daikenchuto (DKT), a commonly prescribed, traditional Japanese herbal medicine, on postoperative intestinal dysfunction after gastric cancer surgery. Patients with gastric cancer scheduled for a total gastrectomy were randomly assigned before surgery to receive either no treatment (n = 40; control group) or DKT (7.5 g/day, t.i.d.) for 3 months (n = 41) postoperatively. We examined gastrointestinal motility, stool attributes, the quantity of bowel gas, the quality of life, and the incidence of postoperative ileus. During the hospital stay, significant differences were observed between the DKT group and controls in the number of stools per day (1.1 ± 0.6 vs 0.8 ± 0.4, respectively; P = 0.037) and stool consistencies (Bristol scale ratings were 3.7 ± 0.8 vs 3.1 ± 0.8, respectively; P = 0.041). The DKT group showed significant reductions in gas volume scores, calculated from abdominal radiographs, at 7 days, 1 month, and 3 months after surgery. The groups did not show significant differences in quality of life scores (based on the Gastrointestinal Symptom Rating Scale) or in the incidence of postoperative ileus. DKT improved bowel movements, stool properties, and bowel gas. These results suggested that DKT promoted early postoperative bowel functions after total gastrectomy.

  16. Prospective randomized assessment of single versus double-gloving for general surgical procedures.

    Science.gov (United States)

    Na'aya, H U; Madziga, A G; Eni, U E

    2009-01-01

    There is increased tendency towards double-gloving by general surgeons in our practice, due probably to awareness of the risk of contamination with blood or other body fluids during surgery. The aim of the study was to compare the relative frequency of glove puncture in single-glove versus double glove sets in general surgical procedures, and to determine if duration of surgery affects perforation rate. Surgeons at random do single or double gloves at their discretion, for general surgical procedures. All the gloves used by the surgeons were assessed immediately after surgery for perforation. A total of 1120 gloves were tested, of which 880 were double-glove sets and 240 single-glove sets. There was no significant difference in the overall perforation rate between single and double glove sets (18.3% versus 20%). However, only 2.3% had perforations in both the outer and inner gloves in the double glove group. Therefore, there was significantly greater risk for blood-skin exposure in the single glove sets (p < 0.01). The perforation rate was also significantly greater during procedures lasting an hour or more compared to those lasting less than an hour (p < 0.01). Double-gloving reduces the risk of blood-skin contamination in all general surgical procedures, and especially so in procedures lasting an hour or more.

  17. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  18. The effect of colorectal surgery in female sexual function, body image, self-esteem and general health: a prospective study.

    Science.gov (United States)

    da Silva, Giovanna M; Hull, Tracy; Roberts, Patricia L; Ruiz, Dan E; Wexner, Steven D; Weiss, Eric G; Nogueras, Juan J; Daniel, Norma; Bast, Jane; Hammel, Jeff; Sands, Dana

    2008-08-01

    To evaluate women's sexual function, self-esteem, body image, and health-related quality of life after colorectal surgery. Current literature lacks prospective studies that evaluate female sexuality/quality of life after colorectal surgery using validated instruments. Sexual function, self-esteem, body image, and general health of female patients undergoing colorectal surgery were evaluated preoperatively, at 6 and 12 months after surgery, using the Female Sexual Function Index, Rosenberg Self-Esteem scale, Body Image scale and SF-36, respectively. Ninety-three women with a mean age of 43.0 +/- 11.6 years old were enrolled in the study. Fifty-seven (61.3%) patients underwent pelvic and 36 (38.7%) underwent abdominal procedures. There was a significant deterioration in overall sexual function at 6 months after surgery, with a partial recovery at 12 months (P = 0.02). Self-esteem did not change significantly after surgery. Body image improved, with slight changes at 6 months and significant improvement at 12 months, compared with baseline (P = 0.05). Similarly, mental status improved over time with significant improvement at 12 months, with values superior than baseline (P = 0.007). Physical recovery was significantly better than baseline in the first 6 months after surgery with no significant further improvement between 6 and 12 months. Overall, there were no differences between patients who had abdominal procedures and those who underwent pelvic dissection, except that patients from the former group had faster physical recovery than patients in the latter (P = 0.031). When asked about the importance of discussing sexual issues, 81.4% of the woman stated it to be extremely or somewhat important. Surgical treatment of colorectal diseases leads to improvement in global quality of life. There is, however, a significant decline in sexual function postoperatively. Preoperative counseling is desired by most of the patients.

  19. Predictors for the need of surgery in antenatally detected hydronephrosis due to UPJ obstruction--a prospective multivariate analysis.

    Science.gov (United States)

    Arora, S; Yadav, P; Kumar, M; Singh, S Kumar; Sureka, S Kumar; Mittal, V; Ansari, M S

    2015-10-01

    Disagreement exists over the ability of different diagnostic tests to define obstruction, indications and timing of surgery and which patients will benefit from surgical intervention in antenatal hydronephrosis (ANH) due to ureteropelvic junction obstruction (UPJO). We try to find a way to predict which patients of ANH due to UPJO will eventually need surgery during conservative management. Prospective single centre study involving 122 renal units at a referral centre in India. Patients on conservative management were followed using a standard protocol and operated for pre-defined indications defining failure of conservative management. Patients who underwent surgery were compared with the non-operated group in terms of sex, side, baseline grade of hydronephrosis, maximum anterioposterior diameter on first postnatal ultrasound and differential renal function on first renal scan. A total of 109 renal units qualified for conservative management. Of those, 23.9% required operative intervention during follow-up. Median time to failure of conservative management was 37 weeks. The median follow-up of non-operated cases was 54 months. Univariate analysis revealed that society of fetal urology (SFU) grade of hydronephrosis, anteroposterior diameter (APD), cortical thickness (CT), and pre-operative differential renal function (DRF) had a significant association with surgery (P hydronephrosis were not. Receiver operating curve analysis showed that an APD of 24.3 mm could predict the need for surgery, with a sensitivity of 73.1% and a specificity of 88.0%. APD and DRF are the predictive factors for surgery. We stop short of recommending surgery only on the basis of APD. Instead we recommend that efforts be made to improve the specificity of this criterion, or by using APD in perspective with the differential renal function. We can reduce the burden of investigations in those with APD 24 mm can be more comprehensively monitored. Copyright © 2015 Journal of Pediatric Urology

  20. Hybrid surgery-radiosurgery therapy for metastatic epidural spinal cord compression: A prospective evaluation using patient-reported outcomes.

    Science.gov (United States)

    Barzilai, Ori; Amato, Mary-Kate; McLaughlin, Lily; Reiner, Anne S; Ogilvie, Shahiba Q; Lis, Eric; Yamada, Yoshiya; Bilsky, Mark H; Laufer, Ilya

    2018-05-01

    Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain ( P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity ( P < .001), along with decreased symptom interference ( P < .001). Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

  1. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lee, Jae-Hoo; Park, In; Hyun, Hwan-Sub; Shin, Sang-Jin

    2018-01-20

    To compare the clinical effects of radiofrequency (RF)-based microtenotomy and arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon in patients with recalcitrant lateral epicondylitis through a prospective randomized controlled study. A total of 46 patients were randomly assigned to receive arthroscopic release (group A, 24 patients) or RF-based microtenotomy (group B, 22 patients). The visual analog scale (VAS) score for pain, flexion-extension arc, operation time, Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), Mayo Elbow Performance Score (MEPS), and grip power of groups A and B were compared during the recovery phases for up to 2 postoperative years. Both groups showed statistically significant functional improvement compared with their preoperative grip strength and DASH, VAS, and MEPS scores at 2 years after surgery (P lateral epicondylitis provided clinical outcomes comparable with those from arthroscopic release of ECRB tendon during the recovery phase. RF-based microtenotomy is considered as one of the surgical procedures for treating recalcitrant lateral epicondylitis, with the advantages of reliable elbow functional restoration and significantly shorter operation time. Level I, prospective randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  2. A prospective randomized study of operative treatment for noncomminuted humeral shaft fractures: conventional open plating versus minimal invasive plate osteosynthesis.

    Science.gov (United States)

    Kim, Ji Wan; Oh, Chang-Wug; Byun, Young-Soo; Kim, Jung Jae; Park, Ki Chul

    2015-04-01

    To compare the clinical and radiologic results of conventional open plating (COP) and minimally invasive plate osteosynthesis (MIPO) in the treatment of noncomminuted humeral shaft fractures. Randomized prospective study. Five level 1 trauma centers. Sixty-eight consecutive patients were randomized into 2 study groups: those treated by COP (COP group; n = 32) and those treated by MIPO (MIPO group; n = 36). Simple humeral shaft fractures (AO/OTA classification types A and B) were reduced by open reduction or closed reduction and fixed with a narrow 4.5/5.0 locking compression plate, metaphyseal locking compression plate, or proximal humeral internal locking system plate to the anterior lateral aspect of the humerus. Fracture healing time, operative time, radiation exposure time, and intraoperative nerve injury. To assess shoulder and elbow function, we used the University of California, Los Angeles (UCLA) scoring system and the Mayo elbow performance index, including the range of motion and pain. Radiographic measurements included fracture alignment, delayed union, and nonunion. Thirty-one fractures (97%) healed in the COP group within 16 weeks, whereas 36 fractures (100%) were healed in the MIPO group by 15 weeks. No significant difference was observed in the operative time or complication rates. In both groups, all fractures achieved union without malunion and with excellent functional outcomes by definition of the Mayo elbow performance index and UCLA scoring system. This study confirmed a high overall rate of union and excellent functional outcomes in both MIPO and COP groups. MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and the surgeon is experienced in the technique. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  3. Adjuvant therapy in stage I and stage II epithelial ovarian cancer. Results of two prospective randomized trials

    International Nuclear Information System (INIS)

    Young, R.C.; Walton, L.A.; Ellenberg, S.S.; Homesley, H.D.; Wilbanks, G.D.; Decker, D.G.; Miller, A.; Park, R.; Major, F. Jr.

    1990-01-01

    About a third of patients with ovarian cancer present with localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials of adjuvant therapy in patients with localized ovarian carcinoma. All patients underwent surgical resection plus comprehensive staging and, 18 months later, surgical re-exploration. In the first trial, 81 patients with well-differentiated or moderately well differentiated cancers confined to the ovaries (Stages Iai and Ibi) were assigned to receive either no chemotherapy or melphalan (0.2 mg per kilogram of body weight per day for five days, repeated every four to six weeks for up to 12 cycles). After a median follow-up of more than six years, there were no significant differences between the patients given no chemotherapy and those treated with melphalan with respect to either five-year disease-free survival or overall survival. In the second trial, 141 patients with poorly differentiated Stage I tumors or with cancer outside the ovaries but limited to the pelvis (Stage II) were randomly assigned to treatment with either melphalan (in the same regimen as above) or a single intraperitoneal dose of 32P (15 mCi) at the time of surgery. In this trial (median follow-up, greater than 6 years) the outcomes for the two treatment groups were similar with respect to five-year disease-free survival (80 percent in both groups) and overall survival (81 percent with melphalan vs. 78 percent with 32P; P = 0.48). We conclude that in patients with localized ovarian cancer, comprehensive staging at the time of surgical resection can serve to identify those patients (as defined by the first trial) who can be followed without adjuvant chemotherapy

  4. Prospective Randomized Evaluation of Intraoperative Application of Autologous Platelet-Rich Plasma on Surgical Site Infection or Delayed Wound Healing.

    Science.gov (United States)

    SanGiovanni, Thomas P; Kiebzak, Gary M

    2016-05-01

    Prevention of surgical site infections and the reduction of wound-related complication rates have become increasingly emphasized by hospital task groups and government agencies given the degree of economic burden it places on the health care system. Platelet-rich plasma (PRP) contains growth factors and other biomolecules that promote endogenous microbicidal activity. We hypothesized that PRP would help prevent postoperative infection and delayed wound healing (DWH). We randomized patients having foot or ankle surgery to the treatment group receiving intraoperative PRP (applied to operative field) and platelet-poor plasma at closing (PPP, on the sutured skin) or the control group (no PRP/PPP). The incidence of deep surgical site infection and DWH (collectively called endpoints) was compared between groups (n = 250/group). PRP had a mean 5.3-fold platelet concentration compared to whole blood, with concentrated white blood cells. Mean age (±SD) of patients was 52 years (±15), 65% were women. Minor and major operative procedures were included. Patients were followed for 60 days. Seventy controls had PRP prepared for assay of growth factors. Procedure mix, ASA scores, mean operative times, and comorbidity mix were similar between groups. The primary result was no difference in number of endpoints between groups: 19 patients in the PRP group (7.6%) versus 18 controls (7.2%). Endpoints were deep surgical site infections in 2 PRP/PPP patients and 1 control, and DWH in 17 PRP/PPP patients and 17 controls. Analysis of PRP samples revealed a large variation in growth factor concentrations between patients. Intraoperative application of PRP/PPP did not reduce the incidence of postoperative infection or DWH. Growth factor profiles varied greatly between patients, suggesting that the potentially therapeutic treatment delivered was not consistent from patient-to-patient. Level I, prospective randomized trial. © The Author(s) 2015.

  5. A prospective qualitative study on patients' perceptions of endoscopic endonasal transsphenoidal surgery.

    Science.gov (United States)

    Edem, Idara J; Banton, Beverly; Bernstein, Mark; Lwu, Shelly; Vescan, Allan; Gentilli, Fred; Zadeh, Gelareh

    2013-02-01

    Endoscopic transsphenoidal surgery has been shown to be a safe and effective treatment option for patients with pituitary tumours, but no study has explored patients' perceptions before and after this surgery. The authors in this study aim to explore patients' perceptions on endoscopic transsphenoidal surgery. Using qualitative research methodology, two semi-structured interviews were conducted with 30 participants who were adults aged > 18 undergoing endoscopic transsphenoidal surgery for the resection of a pituitary tumour between December 2008 and June 2011. The interviews were audiotaped and transcribed. The resulting data was analyzed using a modified thematic analysis. Seven overarching themes were identified: (1) Patients had a positive surgical experience; (2) patients were satisfied with the results of the procedure; (3) patients were initially surprised that neurosurgery could be performed endonasally; (4) patients expected a cure and to feel better after the surgery; (5) many patients feared that something might go wrong during the surgery; (6) patients were psychologically prepared for the surgery; (7) most patients reported receiving adequate pre-op and post-op information. This is the first qualitative study reporting on patients' perceptions before and after an endoscopic endonasal transsphenoidal pituitary surgery, which is increasingly used as a standard surgical approach for patients with pituitary tumours. Patients report a positive perception and general satisfaction with the endoscopic transsphenoidal surgical experience. However, there is still room for improvement in post-surgical care. Overall, patients' perceptions can help improve the delivery of comprehensive care to future patients undergoing pituitary tumour surgery.

  6. Prospective comparison of sinonasal outcomes after microscopic sublabial or endoscopic endonasal transsphenoidal surgery for nonfunctioning pituitary adenomas.

    Science.gov (United States)

    Pledger, Carrie L; Elzoghby, Mohamed A; Oldfield, Edward H; Payne, Spencer C; Jane, John A

    2016-08-01

    OBJECT Both endoscopic and microscopic transsphenoidal approaches are accepted techniques for the resection of pituitary adenomas. Although studies have explored patient outcomes for each technique individually, none have prospectively compared sinonasal and quality of life outcomes in a concurrent series of patients at the same institution, as has been done in the present study. METHODS Patients with nonfunctioning adenomas undergoing transsphenoidal surgery were assessed for sinonasal function, quality of life, and pain using the Sino-Nasal Outcome Test-20 (SNOT-20), the short form of the Nasal Obstruction Symptom Evaluation (NOSE) instrument, the SF-36, and a headache scale. Eighty-two patients undergoing either endoscopic (47 patients) or microscopic (35 patients) surgery were surveyed preoperatively and at 24-48 hours, 2 weeks, 4 weeks, 8 weeks, and 1 year after surgery. RESULTS Patients who underwent endoscopic and microscopic transsphenoidal surgery experienced a similar recovery pattern, showing an initial increase in symptoms during the first 2 weeks, followed by a return to baseline by 4 weeks and improvement beyond baseline functioning by 8 weeks. Patients who underwent endoscopic surgery experienced better sinonasal outcomes at 24-48 hours (SNOT total p = 0.015, SNOT rhinologic subscale [ssRhino] p surgery, no significant differences in sinonasal outcomes were observed between the 2 groups. Headache scales at 1 year improved in all dimensions except duration for both groups (total result 73%, p = 0.004; severity 46%, p surgery, both groups experienced significant improvements in mental health (13%, p = 0.005) and vitality (15%, p = 0.037). By 1 year after surgery, patients improved significantly in mental health (14%, p = 0.03), role physical (14%, p = 0.036), social functioning (16%, p = 0.009), vitality (22%, p = 0.002), and SF-36 total (10%, p = 0.024) as compared with preoperative measures. There were no significant differences at any time point

  7. Intraoperative adverse events can be compensated by technical performance in neonates and infants after cardiac surgery: a prospective study.

    Science.gov (United States)

    Nathan, Meena; Karamichalis, John M; Liu, Hua; del Nido, Pedro; Pigula, Frank; Thiagarajan, Ravi; Bacha, Emile A

    2011-11-01

    Our objective was to define the relationship between surgical technical performance score, intraoperative adverse events, and major postoperative adverse events in complex pediatric cardiac repairs. Infants younger than 6 months were prospectively followed up until discharge from the hospital. Technical performance scores were graded as optimal, adequate, or inadequate based on discharge echocardiograms and need for reintervention after initial surgery. Case complexity was determined by Risk Adjustment in Congenital Heart Surgery (RACHS-1) category, and preoperative illness severity was assessed by Pediatric Risk of Mortality (PRISM) III score. Intraoperative adverse events were prospectively monitored. Outcomes were analyzed using nonparametric methods and a logistic regression model. A total of 166 patients (RACHS 4-6 [49%]), neonates [50%]) were observed. Sixty-one (37%) had at least 1 intraoperative adverse event, and 47 (28.3%) had at least 1 major postoperative adverse event. There was no correlation between intraoperative adverse events and RACHS, preoperative PRISM III, technical performance score, or postoperative adverse events on multivariate analysis. For the entire cohort, better technical performance score resulted in lower postoperative adverse events, lower postoperative PRISM, and lower length of stay and ventilation time (P events, including surgical revisions, provided technical performance score is at least adequate. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  8. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  9. Prospective Randomized Study of the Effect of Music on the Efficiency of Surgical Closures.

    Science.gov (United States)

    Lies, Shelby R; Zhang, Andrew Y

    2015-09-01

    Music is commonly played in operating theaters. Some surgeons believe music reduces stress and operative time, while others think music is a distraction and should be avoided. There is limited published evidence evaluating the effects of music on surgical performance. The goal of this study is to evaluate the effect of music on simple wound closure. Plastic surgery residents were asked to perform layered closures on pigs' feet with and without their preferred music playing. Simple randomization was used to assign residents to the music playing first or music playing second group. The time to complete the repair was measured and repairs were graded by blinded faculty. Results were analyzed to determine significant differences in time to complete the task and quality of repair. Participants were retested in a second session with music played in the opposite order to evaluate consistency. Listening to preferred music decreased repair time by 8% for all plastic surgery residents (p = 0.009). Subgroup analysis demonstrated even more significant improvement in speed for senior residents (PGY 4-6), resulting in a 10% decrease in repair time (p = 0.006). The quality of repair was also better in the music group, at 3.3 versus 3.1 (p = 0.047). Retesting revealed results remained significant whether music was played first or second. Playing preferred music made plastic surgery residents faster in completing wound closure with a 10% improvement in senior residents. Music also improved quality of repair as judged by blinded faculty. Our study showed that music improves efficiency of wound closure, which may translate to healthcare cost savings. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  10. Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial.

    Science.gov (United States)

    Romanò, Carlo L; Monti, Lorenzo; Logoluso, Nicola; Romanò, Delia; Drago, Lorenzo

    2015-11-01

    The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation. Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0-4) vs. 1.9 ± 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. II.

  11. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nguyen, Lee S; Merzoug, Messaouda; Estagnasie, Philippe; Brusset, Alain; Law Koune, Jean-Dominique; Aubert, Stephane; Waldmann, Thierry; Grinda, Jean-Michel; Gibert, Hadrien; Squara, Pierre

    2017-12-02

    Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during

  12. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

    Science.gov (United States)

    Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

    2013-12-01

    Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

  13. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  14. ORGAN-SPARING SURGERY FOR RECTAL CANCER: EVOLUTION, CURRENT TRENDS, AND PROSPECTS

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    R. I. Tamrazov

    2013-01-01

    Full Text Available The article describes the main stages of the development of sphincter-saving surgery for rectal cancer. An historical look at this issue from the standpoint of research of past years in our country and abroad, as well as analysis of current sphincter-preserving surgery and future directions in this area.

  15. Perioperative dexketoprofen or lornoxicam administration for pain management after major orthopedic surgery: a randomized, controlled study.

    Science.gov (United States)

    Sivrikoz, Nükhet; Koltka, Kemalettin; Güresti, Ece; Büget, Mehmet; Sentürk, Mert; Özyalçın, Süleyman

    2014-01-01

    Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for multimodal postoperative pain management. The purpose of this study was to evaluate the postoperative pain relief and opioid-sparing effects of dexketoprofen and lornoxicam after major orthopedic surgery. After obtaining ethical committee approval and informed consent, 120 patients undergoing elective hip or knee replacement under general anesthesia were randomized to receive two intravenous injections of 50 mg dexketoprofen (GD), 8 mg lornoxicam (GL) or saline as placebo (GP) intravenously. Postoperatively, patient-controlled analgesia (PCA) morphine was started as a 0.01 mg.kg-1 bolus dose, with lockout time of 10 minutes without continuous infusion. Pain assessment was made using the Visual Analogue Scale (VAS) at rest or during movement at postoperative 1, 2, 4, 6, 8, 12, and 24 hours. The three groups were similar in terms of age, gender, American Society of Anesthesiologists (ASA) class, number of patients who underwent hip or knee surgery, weight, height, and operation duration. Patients in GD and GL demonstrated significantly reduced pain scores at rest and active motion compared to GP, with lower scores in the dexketoprofen group. Patients in GD and GL used significantly less morphine in the postoperative period compared to GP. The total morphine consumption of patients in GD was lower than in GL. Intravenous application of 50 mg dexketoprofen twice a day and 8 mg lornoxicam twice a day improved analgesia and decreased morphine consumption following major orthopedic surgery. When the two active drugs were compared, it was found that dexketoprofen was superior to lornoxicam in terms of analgesic efficacy and opioid consumption.

  16. Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials

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    Fabiano Timbó Barbosa

    Full Text Available CONTEXT AND OBJECTIVE: Taking the outcome of mortality into consideration, there is controversy about the beneficial effects of neuraxial anesthesia for orthopedic surgery. The aim of this study was to compare the effectiveness and safety of neuraxial anesthesia versus general anesthesia for orthopedic surgery. DESIGN AND SETTING: Systematic review at Universidade Federal de Alagoas. METHODS: We searched the Cochrane Central Register of Controlled Trials (Issue 10, 2012, PubMed (1966 to November 2012, Lilacs (1982 to November 2012, SciELO, EMBASE (1974 to November 2012 and reference lists of the studies included. Only randomized controlled trials were included. RESULTS: Out of 5,032 titles and abstracts, 17 studies were included. There were no statistically significant differences in mortality (risk difference, RD: -0.01; 95% confidence interval, CI: -0.04 to 0.01; n = 1903, stroke (RD: 0.02; 95% CI: -0.04 to 0.08; n = 259, myocardial infarction (RD: -0.01; 95% CI: -0.04 to 0.02; n = 291, length of hospitalization (mean difference, -0.05; 95% CI: -0.69 to 0.58; n = 870, postoperative cognitive dysfunction (RD: 0.00; 95% CI: -0.04 to 0.05; n = 479 or pneumonia (odds ratio, 0.61; 95% CI: 0.25 to 1.49; n = 167. CONCLUSION: So far, the evidence available from the studies included is insufficient to prove that neuraxial anesthesia is more effective and safer than general anesthesia for orthopedic surgery. However, this systematic review does not rule out clinically important differences with regard to mortality, stroke, myocardial infarction, length of hospitalization, postoperative cognitive dysfunction or pneumonia.

  17. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

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    Shiv Akshat

    2014-01-01

    Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.

  18. [Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled clinical trial].

    Science.gov (United States)

    Orozco, H; Sifuentes Osornio, J; Prado, E; Takahashi, T; López Graniel, C M; Anaya, E; Canto, J

    1993-01-01

    The aim of this study was to analyze the efficacy in prophylaxis during biliary tract and gallbladder surgery with amoxicillin/clavulanate and to compare it with the combination of cephalothin and clindamycin. A randomized nonblinded clinical trial with a blind independent observer. Tertiary-care center. Forty-two patients were included. All had undergone biliary tract and/or gallbladder surgery. They were divided in two groups: 22 in group A (cephalothin and clindamycin), and 20 in group B (amoxicillin/clavulanate). Patients from group A were intravenously treated with three doses of cephalothin (2 g at anesthetic induction and two additional doses of 1 g at six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amoxicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). In group A six wound infections were recorded, one of them with secondary bacteremia. In group B we did not record any infection (Fisher p clindamycin.

  19. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery.

    Science.gov (United States)

    Westermann, Lauren B; Crisp, Catrina C; Oakley, Susan H; Mazloomdoost, Donna; Kleeman, Steven D; Benbouajili, Janine M; Ghodsi, Vivian; Pauls, Rachel N

    2016-01-01

    Placement of vaginal packing after pelvic reconstructive surgery is common; however, little evidence exists to support the practice. Furthermore, patients have reported discomfort from the packs. We describe pain and satisfaction in women treated with and without vaginal packing. This institutional review board-approved randomized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs. The primary outcome was visual analog scales (VASs) for pain on postoperative day 1. Allocation to "packing" ("P") or "no-packing" ("NP") arms occurred intraoperatively at the end of surgery. Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal. Visual analog scale scores for pain, satisfaction, and bother attributable to packing were recorded before discharge. All packing and perineal pads were weighed to calculate a "postoperative vaginal blood loss." Perioperative data were collected from the hospital record. Our sample size estimation required 74 subjects. Ninety-three women were enrolled. After exclusions, 77 were randomized (P, 37; NP, 40). No differences were found in surgical information, hemoglobin levels, or narcotic use between groups. However, "postoperative vaginal blood loss" was greater in packed subjects (P discharge (P, 35.0 vs NP, 40.0; P = 0.43] were not significantly different between treatment arms. Likewise, VAS scores for satisfaction before removal of packing (P, 81.0 vs NP, 90.0; P = 0.08] and before discharge (P, 90.0 vs NP, 90.5; P = 0.60] were not significantly different. Packed patients noted lower nursing verbal pain scores (P = 0.04) and used less ketorolac (P = 0.01). Bother from packing was low overall. Although there was no difference based on VAS, women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women. Vaginal packing may provide benefit and can remain part of the surgical practice.

  20. Electrophysiological evaluation of phrenic nerve injury during cardiac surgery – a prospective, controlled, clinical study

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    Ege Turan

    2004-01-01

    Full Text Available Abstract Background According to some reports, left hemidiaphragmatic paralysis due to phrenic nerve injury may occur following cardiac surgery. The purpose of this study was to document the effects on phrenic nerve injury of whole body hypothermia, use of ice-slush around the heart and mammary artery harvesting. Methods Electrophysiology of phrenic nerves was studied bilaterally in 78 subjects before and three weeks after cardiac or peripheral vascular surgery. In 49 patients, coronary artery bypass grafting (CABG and heart valve replacement with moderate hypothermic (mean 28°C cardiopulmonary bypass (CPB were performed. In the other 29, CABG with beating heart was performed, or, in several cases, peripheral vascular surgery with normothermia. Results In all patients, measurements of bilateral phrenic nerve function were within normal limits before surgery. Three weeks after surgery, left phrenic nerve function was absent in five patients in the CPB and hypothermia group (3 in CABG and 2 in valve replacement. No phrenic nerve dysfunction was observed after surgery in the CABG with beating heart (no CPB or the peripheral vascular groups. Except in the five patients with left phrenic nerve paralysis, mean phrenic nerve conduction latency time (ms and amplitude (mV did not differ statistically before and after surgery in either group (p > 0.05. Conclusions Our results indicate that CPB with hypothermia and local ice-slush application around the heart play a role in phrenic nerve injury following cardiac surgery. Furthermore, phrenic nerve injury during cardiac surgery occurred in 10.2 % of our patients (CABG with CPB plus valve surgery.

  1. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    Science.gov (United States)

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

  2. A prospective, randomized study addressing the need for physical simulation following virtual simulation

    International Nuclear Information System (INIS)

    Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

    1997-01-01

    Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

  3. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  4. A Prospective Study of the Conservative Management of Asymptomatic Preoperative and Postoperative Gallbladder Disease in Bariatric Surgery.

    Science.gov (United States)

    Pineda, Omar; Maydón, Hernán G; Amado, Mónica; Sepúlveda, Elisa M; Guilbert, Lizbeth; Espinosa, Omar; Zerrweck, Carlos

    2017-01-01

    Bariatric surgery is the most effective therapy for weight loss in patients with morbid obesity. One of the most common long-term complications includes cholelithiasis. There is not a clear consensus in how to treat an asymptomatic gallbladder disease before and after bariatric surgery. Prospective study with every patient submitted to bariatric surgery from 2012 to 2014. The gallbladder status was assessed with an ultrasound before and after surgery (12 months), and a conservative management was conducted for patients with asymptomatic disease (preoperative and de novo); the need for delayed cholecystectomy was reported. Secondarily, an analysis of weight loss (%EWL) and gallbladder status was performed. Two-hundred and two bariatric surgeries were performed. The global incidence of preoperative gallbladder disease was 34.3 %, with 14.2 % presenting sludge, 20.1 % asymptomatic gallstones, and 2.3 % symptomatic gallstones. The final analysis was based on 146 patients; female sex comprised 81.1 % of cases with a mean age of 38.5 years. After 12 months, de novo gallbladder disease was observed in 21.2 %. The overall rate of cholecystectomy because of symptomatic disease after 12 months was 3.4 % (2 % developed acute cholecystitis). There were no differences in %EWL between patients with de novo gallbladder disease and those without. Conservative management of asymptomatic gallbladder disease in candidates to bariatric surgery is safe and can be offered in every case, based on the low percentage of patients requiring further cholecystectomy after 12 months. Also, a conservative management can be offered to patients developing de novo sludge/cholelithiasis without related symptoms.

  5. Factors associated to post-operative nausea and vomiting following oral and maxillofacial surgery: a prospective study.

    Science.gov (United States)

    Albuquerque, Assis Filipe Medeiros; Queiroz, Salomão Israel Monteiro Lourenço; Germano, Adriano Rocha; da Silva, José Sandro Pereira

    2017-03-01

    This study aims to address and assess possible factors associated with nausea and vomiting (NV) following oral and maxillofacial surgery. A prospective study was carried out in the period from December 2013 to January 2016 targeting all attended cases in that period. For statistical analysis, Pearson chi-square and Fisher tests were used to verify association and ANOVA and Student's t tests to test for significant difference, p was defined as ≤0.05. The sample group consisted of 207 patients with an average age of 33.56 years (±13.23), and 70.5% of subjects were male. Calculations based on the predictive model showed that a female patient with prior history of nausea and vomiting who used opioids and had intra-oral surgical access would have a 96% chance of experiencing a nausea and vomiting episode. Other factors like age, being overweight, anesthesia, surgery duration, and duration of hospital stay also contribute so that these aspects must be paid careful attention prior to surgery to ensure a suitably orientated treatment that will avoid disturbances caused by post-operative nausea and vomiting. The occurrence of post-operative nausea and vomiting after oral and maxillofacial surgery was found to be more higher incidence associated to female patients who used opioids, who had a prior history of NV, whose surgery involved intra-oral access, who were in the second or third decades of their lives, who have above average weight, and who have long anesthesia when undergoing surgery, resulting in a long hospital stays.

  6. A PROSPECTIVE OBSERVATIONAL STUDY REGARDING PREVALENCE OF DRY EYE DISEASE IN POST-OPERATIVE CATARACT SURGERY PATIENTS OF 140 CASES.

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    S. Srinivasan

    2017-02-01

    Full Text Available BACKGROUND Dry eye disease is one of the most common ocular surface disorder with large number of studies carried out in various countries estimate the prevalence of dry eye disease to be between 5-34%. The prevalence of dry eye increases with age. As per Breaver Dam study regarding dry eye the prevalence of DED 13.3%. Dry eye was apparently higher in women than men. Studies have shown that cataract surgery worsen dry eye symptoms in patients with preexisting dry eye symptoms as well as without preexisting DES, mostly dry eye symptoms last for two months of post cataract surgery period. MATERIALS AND METHODS The prospective observational study was conducted in Department of Ophthalmology, Government Vellore Medical College and Hospital, Vellore. The total number of cataract surgery performed cases were 140 in number. The study period was four months, conducted in tertiary eye center. The Cataract patients were preoperatively at normal tear secretions. Post cataract surgery period from first POD, one week POD, four weeks, six weeks, two months and three months POD examined by slit lamp, Schirmer's test I, TBUT and corneal sensitivity test were performed. RESULTS Our study revealed that increased prevalence in female sex with increased age group range from 51-70 years showed post cataract surgery period dryness of eye. The ratio of Post cataract surgery DED in male and female is 13:29. This shows increased female sex prevalence of postoperative DED. In our study, the prevalence of post cataract surgery dry eye disease was 30%. CONCLUSION 73% cataract surgeries is now clear corneal cataract surgery and this procedure cuts a large part of corneal nerves. The nerve essential for tear production gets disturbed leading to dryness and hence decreased visual function. The corneal nerves are important in self-regulation of tears since they provide the sensation in the feedback loop that signals tear production. When the functions of the nerves get blocked

  7. Effects of preventive surgery for unruptured intracranial aneurysms on attention, executive function, learning and memory: a prospective cohort study.

    Science.gov (United States)

    Chung, Joonho; Seok, Jeong-Ho; Kwon, Min A; Kim, Yong Bae; Joo, Jin-Yang; Hong, Chang-Ki

    2016-01-01

    We prospectively evaluated the effects of preventive surgery for unruptured intracranial aneurysms on attention, executive function, learning and memory. Between March 2012 and June 2013, 56 patients were recruited for this study. Fifty-one patients met the inclusion criteria and were enrolled. Inclusion criteria were as follows: (1) age ≤65 years and (2) planned microsurgery or endovascular surgery for unruptured intracranial aneurysm. Exclusion criteria were as follows: (1) preoperative intelligence quotient attention), WCT (executive function) and VLT (learning and memory) scores did not change significantly between the pre- and postoperative evaluations. The ACCPT, WCT, total VLT scores (verbal learning) and delayed VLT scores (memory) did not differ significantly between patients undergoing microsurgery and those undergoing endovascular surgery. However, ACCPT, WCT and delayed VLT scores decreased postoperatively in patients with leukoaraiosis on preoperative FLAIR images (OR 9.899, p = 0.041; OR 11.421, p = 0.006; OR 2.952, p = 0.024, respectively). Preventive surgery for unruptured intracranial aneurysms did not affect attention, executive function, learning or memory. However, patients with leukoaraiosis on FLAIR images might be prone to deficits in attention, executive function and memory postoperatively, whereas learning might not be affected.

  8. Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

    Science.gov (United States)

    Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

    2002-05-01

    Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

  9. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  10. Randomized study of preoperative radiation and surgery or irradiation alone in the treatment of Stage IB and IIA carcinoma of the uterine cervix

    International Nuclear Information System (INIS)

    Perez, C.A.; Camel, H.M.; Kao, M.S.; Askin, F.

    1980-01-01

    A prospective randomized study in selected patients with Stage IB and IIA carcinoma of the uterine cervix was carried out. Patients were randomized to be treated with 1) irradiation alone consisting of 1000 rad whole pelvis, additional 4000 rads to the parametria with a step wedge midline block, and two intracavitary insertions for 7500 mgh; and 2) irradiation and surgery, consisting of 2000 rad whole pelvis irradiation, one intracavitary insertion for 5000 to 6000 mgh followed in two to six weeks later by a radical hysterectomy with pelvic lymphadenectomy. The five-year, tumor-free actuarial survival for Stage IB patients treated with radiation was 87% and with preoperative radiation and surgery 82%. In Stage IIA, the actuarial five-year survival NED was 57% for the irradiation alone group and 71% for the patients treated with preoperative radiation and radical hysterectomy. Major complications of therapy were slightly higher in the patients trated with radiation alone (9.4%, consisting of one recto-vaginal fistula and one vesico-vaginal fistula and a combined recto-vesico-vaginal fistula in another patient). In the preoperative radiation group, only two ureteral strictures (4.1%) were noted. The present study shows no significant difference in therapeutic results or morbidity for invasive carcinoma of the uterine cervix Stage IB or IIA treated with irradiation alone or combined with a radical hysterectomy

  11. Effect of Mechanical Ventilation Mode Type on Intra- and Postoperative Blood Loss in Patients Undergoing Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Kang, Woon-Seok; Oh, Chung-Sik; Kwon, Won-Kyoung; Rhee, Ka Young; Lee, Yun Gu; Kim, Tae-Hoon; Lee, Suk Ha; Kim, Seong-Hyop

    2016-07-01

    The aim of study was to evaluate the effect of mechanical ventilation mode type, pressure-controlled ventilation (PCV), or volume-controlled ventilation (VCV) on intra- and postoperative surgical bleeding in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. This was a prospective, randomized, single-blinded, and parallel study that included 56 patients undergoing PLIF and who were mechanically ventilated using PCV or VCV. A permuted block randomization was used with a computer-generated list. The hemodynamic and respiratory parameters were measured after anesthesia induction in supine position, 5 min after patients were changed from supine to prone position, at the time of skin closure, and 5 min after the patients were changed from prone to supine position. The amount of intraoperative surgical bleeding, fluid administration, urine output, and transfusion requirement were measured at the end of surgery. The amount of postoperative bleeding and transfusion requirement were recorded every 24 h for 72 h. The primary outcome was the amount of intraoperative surgical bleeding, and 56 patients were analyzed. The amount of intraoperative surgical bleeding was significantly less in the PCV group than that in the VCV group (median, 253.0 [interquartile range, 179.0 to 316.5] ml in PCV group vs. 382.5 [328.0 to 489.5] ml in VCV group; P patients undergoing PLIF, which may be related to lower intraoperative peak inspiratory pressure.

  12. Gynecomastia Surgery-Impact on Life Quality: A Prospective Case-Control Study.

    Science.gov (United States)

    Kasielska-Trojan, Anna; Antoszewski, Bogusław

    2017-03-01

    To evaluate the results of surgical treatment of gynecomastia in the context of quality of life and satisfaction after the surgery. Fifty male patients (mean age, 25.1 years [SD = 8 years]) who underwent surgery for gynecomastia and completed both (preoperative and postoperative) stages of the study were included in the analysis. The quality-of-life evaluation instrument was The Short Form-36 Health Survey Questionnaire. Additionally, we used a short questionnaire including 2 questions about patient satisfaction with gynecomastia surgery. The overall change in life satisfaction after gynecomastia surgery was 1 point on Likert scale (sign test, P gynecomastia surgery scored significantly higher than before the procedure in all Short Form-36 Health Survey Questionnaire domains as well as in 2 main scales Psychical and Physical Health. The changes were especially visible for the domain social functioning and a scale Psychical Health (P Gynecomastia surgery significantly improved men's life quality in all aspects and especially in the social aspect and psychical health. This indicates that adult men with gynecomastia are a specific group of patients, in which surgery may result in life quality improvement even over the average scores.

  13. Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

    Science.gov (United States)

    Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

    2016-05-01

    Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

  14. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  15. Goal directed fluid therapy decreases postoperative morbidity but not mortality in major non-cardiac surgery: a meta-analysis and trial sequential analysis of randomized controlled trials.

    Science.gov (United States)

    Som, Anirban; Maitra, Souvik; Bhattacharjee, Sulagna; Baidya, Dalim K

    2017-02-01

    Optimum perioperative fluid administration may improve postoperative outcome after major surgery. This meta-analysis and systematic review has been aimed to determine the effect of dynamic goal directed fluid therapy (GDFT) on postoperative morbidity and mortality in non-cardiac surgical patients. Meta-analysis of published prospective randomized controlled trials where GDFT based on non-invasive flow based hemodynamic measurement has been compared with a standard care. Data from 41 prospective randomized trials have been included in this study. Use of GDFT in major surgical patients does not decrease postoperative hospital/30-day mortality (OR 0.70, 95 % CI 0.46-1.08, p = 0.11) length of post-operative hospital stay (SMD -0.14; 95 % CI -0.28, 0.00; p = 0.05) and length of ICU stay (SMD -0.12; 95 % CI -0.28, 0.04; p = 0.14). However, number of patients having at least one postoperative complication is significantly lower with use of GDFT (OR 0.57; 95 % CI 0.43, 0.75; p infection (p = 0.002) and postoperative hypotension (p = 0.04) are also decreased with used of GDFT as opposed to a standard care. Though patients who received GDFT were infused more colloid (p infection, abdominal complications and postoperative hypotension is reduced.

  16. Expert opinion on laparoscopic surgery for colorectal cancer parallels evidence from a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Guillaume Martel

    Full Text Available This study sought to synthesize survival outcomes from trials of laparoscopic and open colorectal cancer surgery, and to determine whether expert acceptance of this technology in the literature has parallel cumulative survival evidence.A systematic review of randomized trials was conducted. The primary outcome was survival, and meta-analysis of time-to-event data was conducted. Expert opinion in the literature (published reviews, guidelines, and textbook chapters on the acceptability of laparoscopic colorectal cancer was graded using a 7-point scale. Pooled survival data were correlated in time with accumulating expert opinion scores.A total of 5,800 citations were screened. Of these, 39 publications pertaining to 23 individual trials were retained. As well, 414 reviews were included (28 guidelines, 30 textbook chapters, 20 systematic reviews, 336 narrative reviews. In total, 5,782 patients were randomized to laparoscopic (n = 3,031 and open (n = 2,751 colorectal surgery. Survival data were presented in 16 publications. Laparoscopic surgery was not inferior to open surgery in terms of overall survival (HR = 0.94, 95% CI 0.80, 1.09. Expert opinion in the literature pertaining to the oncologic acceptability of laparoscopic surgery for colon cancer correlated most closely with the publication of large RCTs in 2002-2004. Although increasingly accepted since 2006, laparoscopic surgery for rectal cancer remained controversial.Laparoscopic surgery for colon cancer is non-inferior to open surgery in terms of overall survival, and has been so since 2004. The majority expert opinion in the literature has considered these two techniques to be equivalent since 2002-2004. Laparoscopic surgery for rectal cancer has been increasingly accepted since 2006, but remains controversial. Knowledge translation efforts in this field appear to have paralleled the accumulation of clinical trial evidence.

  17. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    Science.gov (United States)

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  18. 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.

  19. [Incidence of postoperative venous thromboembolism after thoracic surgery and its characteristic: a single center, prospective cohort study].

    Science.gov (United States)

    Song, C F; Li, H; Tian, B; Chen, S; Miao, J B; Fu, Y L; You, B; Chen, Q R; Li, T; Hu, X X; Zhang, W Q; Hu, B

    2018-04-01

    Objective: To evaluate the incidence of postoperative venous thromboembolism (VTE) after thoracic surgery and its characteristic. Methods: This was a single-center, prospective cohort study. Patients undergoing major thoracic surgeries between July 2016 and March 2017 at Department of Thoracic Surgery, Beijing Chaoyang Hospital Affiliated to Capital Medical University were enrolled in this study. Besides the routine examination, all patients were screened for deep venous thrombosis (DVT) by using noninvasive duplex lower-extremity ultrasonography after surgery. CT pulmonary angiography (CTPA) was carried out if patients had one of the following conditions including typical symptoms of PE, high Caprini score (>9 points) or new diagnosed postoperative DVT. Caprini risk assessment model was used to detect high risk patients. No patients received any prophylaxis of VTE before surgery. Further data was analyzed for identifying the incidence of postoperative VTE. The t -test, χ 2 test or Wilcoxon rank-sum test was used to analyze the quantitative data and classification data, respectively. Results: Totally 345 patients who undergoing major thoracic surgery were enrolled in this study including 145 benign diseases and 200 malignant diseases.There were 207 male and 138 female, aging from 15 to 85 years. Surgery procedures included 285 lung surgeries, 27 esophagectomies, 22 mediastinal surgeries and 11 other procedures. The overall incidence of VTE was 13.9% (48 of 345) after major thoracic surgery including 39 patients with newly diagnosed DVT (81.2%), 1 patient with PE (2.1%) and 8 patients with DVT+ PE (16.7%). The median time of VTE detected was 4.5 days postoperative. There were 89.6% (43/48) VTE cases diagnosed in 1 week. The incidence of VTE was 9.0% in patients with benign diseases, while 17.5% in malignant diseases (χ 2 =5.112, P patients with pulmonary diseases was 12.6%, among that, in patients with lung cancer and benign lung diseases was 16.4% and 7.5 % (χ 2

  20. The effect of perhexiline on myocardial protection during coronary artery surgery: a two-centre, randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Drury, Nigel E; Howell, Neil J; Calvert, Melanie J; Weber, Ralf J M; Senanayake, Eshan L; Lewis, Michael E; Hyde, Jonathan A J; Green, David H; Mascaro, Jorge G; Wilson, Ian C; Graham, Timothy R; Rooney, Stephen J; Viant, Mark R; Freemantle, Nick; Frenneaux, Michael P; Pagano, Domenico

    2015-03-01

    Perhexiline is thought to modulate metabolism by inhibiting mitochondrial carnitine palmitoyltransferase-1, reducing fatty acid uptake and increasing carbohydrate utilization. This study assessed whether preoperative perhexiline improves markers of myocardial protection in patients undergoing coronary artery bypass graft surgery and analysed its effect on the myocardial metabolome. In a prospective, randomized, double-blind, placebo-controlled trial, patients at two centres were randomized to receive either oral perhexiline or placebo for at least 5 days prior to surgery. The primary outcome was a low cardiac output episode in the first 6 h. All pre-specified analyses were conducted according to the intention-to-treat principle with a statistical power of 90% to detect a relative risk of 0.5 and a conventional one-sided α-value of 0.025. A subset of pre-ischaemic left ventricular biopsies was analysed using mass spectrometry-based metabolomics. Over a 3-year period, 286 patients were randomized, received the intervention and were included in the analysis. The incidence rate of a low cardiac output episode in the perhexiline arm was 36.7% (51/139) vs 34.7% (51/147) in the control arm [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.56-1.50, P = 0.74]. Perhexiline was associated with a reduction in the cardiac index at 6 h [difference in means 0.19, 95% CI 0.07-0.31, P = 0.001] and an increase in inotropic support in the first 12 h (OR 0.55, 95% CI 0.34-0.89, P = 0.015). There were no significant differences in myocardial injury with troponin-T or electrocardiogram, reoperation, renal dysfunction or length of stay. No difference in the preischaemic left ventricular metabolism was identified between groups on metabolomics analysis. Preoperative perhexiline does not improve myocardial protection in patients undergoing coronary surgery and in fact reduced perioperative cardiac output, increasing the need for inotropic support. Perhexiline has no significant effect

  1. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    Science.gov (United States)

    Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

    2016-07-01

    Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Wound complications and clinical results of electrocautery versus a scalpel to create a cutaneous flap in thyroidectomy: a prospective randomized trial.

    Science.gov (United States)

    Uludag, Mehmet; Yetkin, Gurkan; Ozel, Alper; Ozguven, M Banu Yilmaz; Yener, Senay; Isgor, Adnan

    2011-08-01

    The use of electrocautery for tissue dissection is becoming increasingly popular, despite the associated risk of poor wound healing and excessive scarring. We conducted this study to compare the wound complications and early and late clinical results resulting from electrocautery versus the scalpel to create a cutaneous flap during thyroidectomy. The subjects of this study were 100 patients, randomized prospectively to either a scalpel group (group S, n = 50) or an electrocautery group (group E, n = 50). Thickness of tissue damage, postoperative thickness of the flap, discomfort in the neck 7 days after surgery, and hypoesthesia and paresthesia in the neck 3 months after surgery were significantly higher in group E than in group S. There were no significant differences in overall postoperative wound complications, postoperative pain, satisfaction with the cosmetic result, or overall outcome of the operation between the groups. Although the incidence of seroma was higher in group E (20%) than in group S (8%), the difference was not significant. Although electrocautery was associated with increased histological tissue damage, postoperative flap edema, discomfort, and other complications in the early stage, the clinical and cosmetic results of flaps made using electrocautery or a scalpel were similar and satisfactory 6 months after surgery.

  3. Renal effects of dexmedetomidine during coronary artery bypass surgery: a randomized placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Scheinin Harry

    2011-05-01

    Full Text Available Abstract Background Dexmedetomidine, an alpha2-adrenoceptor agonist, has been evaluated as an adjunct to anesthesia and for the delivery of sedation and perioperative hemodynamic stability. It provokes dose-dependent and centrally-mediated sympatholysis. Coronary artery bypass grafting (CABG with extracorporeal circulation is a stressful procedure increasing sympathetic nervous system activity which could attenuate renal function due the interrelation of sympathetic nervous system, hemodynamics and renal function. We tested the hypothesis that dexmetomidine would improve kidney function in patients undergoing elective CABG during the first two postoperative days. Methods This was a double-blind, randomized, parallel-group study. Patients with normal renal function and scheduled for elective CABG were randomized to placebo or to infusion of dexmedetomidine to achieve a pseudo steady-state plasma concentration of 0.60 ng/ml. The infusion was started after anesthesia induction and continued until 4 h after surgery. The primary endpoint was creatinine clearance. Other variables included urinary creatinine and output, fractional sodium and potassium excretion, urinary potassium, sodium and glucose, serum and urinary osmolality and plasma catecholamine concentrations. The data were analyzed with repeated-measures ANOVA or Cochran-Mantel-Haenszel test. Results Sixty-six of 87 randomized patients were evaluable for analysis. No significant between-group differences were recorded for any indices of renal function except for a mean 74% increase in urinary output with dexmedetomidine in the first 4 h after insertion of a urinary catheter (p Conclusions Use of intravenous dexmedetomidine did not alter renal function in this cohort of relatively low-risk elective CABG patients but was associated with an increase in urinary output. This study was carried out in 1994-1997 and was thus not registered.

  4. Duration of antimicrobial prophylaxis in patients undergoing hepatectomy: a prospective randomized controlled trial using flomoxef.

    Science.gov (United States)

    Togo, Shinji; Tanaka, Kuniya; Matsuo, Kenichi; Nagano, Yasuhiko; Ueda, Michio; Morioka, Daisuke; Endo, Itaru; Shimada, Hiroshi

    2007-05-01

    Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized, only a few randomized controlled studies on the duration of administration after hepatectomy have been performed. We investigated the duration of antimicrobial prophylaxis after hepatectomy. The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department. The patients were randomly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days (89 patients) or 5 days (91 patients), including the operation day. The presence or absence of systemic inflammatory response syndrome (SIRS) and infections was investigated. No significant differences were noted in patient background between the two groups. Infections occurred in seven and six patients in the 2 day and 5 day treatment groups (7.9% and 6.6%), respectively, showing no significant difference between the two groups. No significant difference was noted when the cases were divided into surgical site infections and remote infections. The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery. The risk factors in patients who developed infections were blood loss, operation time and the complication of biliary fistula. Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy. However, when SIRS is positive on post-operative day 2, and induction of liver failure is of concern, it may be safer to continue antimicrobial drug administration until SIRS is eliminated.

  5. Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

    Science.gov (United States)

    Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

    1989-08-01

    In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

  6. Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate

    DEFF Research Database (Denmark)

    Sønksen, Jens; Barber, Neil J; Speakman, Mark J

    2015-01-01

    BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral...... lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial...... at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation...

  7. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  8. Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial

    NARCIS (Netherlands)

    de Gast-Bakker, D. H.; de Wilde, R. B. P.; Hazekamp, M. G.; Sojak, V.; Zwaginga, J. J.; Wolterbeek, R.; de Jonge, E.; Gesink-van der Veer, B. J.

    2013-01-01

    To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. Randomized controlled trial. Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. One hundred seven

  9. Do authors report surgical expertise in open spine surgery related randomized controlled trials? A systematic review on quality of reporting

    NARCIS (Netherlands)

    van Oldenrijk, Jakob; van Berkel, Youri; Kerkhoffs, Gino M. M. J.; Bhandari, Mohit; Poolman, Rudolf W.

    2013-01-01

    A systematic review of published trials in orthopedic spine literature. To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) between 2005 and 2010 with special focus on the reporting of surgical skill or expertise. In technically demanding procedures such

  10. [Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].

    Science.gov (United States)

    Chiari, Paolo; Giorgi, Sabina; Ugolini, Daniela; Montanari, Morena; Giudanella, Pietro; Gramantieri, Antonella; Collesi, Franca; Pau, Michelina; Smaldone, Maddalena; Matarasso, Maddalena; Mazzini, Cinzia; Russo, Francesca; Gazineo, Domenica; Fontana, Mirella; Taddia, Patrizia

    2012-01-01

    Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients. The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores. To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre. The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery. Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant. The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.

  11. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II)

    DEFF Research Database (Denmark)

    Andersson, J; Abis, G; Gellerstedt, M

    2014-01-01

    BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed...... laparoscopic and open approaches. An improvement in sexual dysfunction was seen in the first year, but some male sexual problems persisted. Before operation 64·5 per cent of men in the laparoscopic group and 55·6 per cent in the open group reported some degree of erectile dysfunction. This increased to 81...... radiotherapy, did not change these results. CONCLUSION: Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this. REGISTRATION NUMBER: NCT0029779 (http://www.clinicaltrials.gov)....

  12. Changes in retinal nerve fiber layer thickness after spinal surgery in the prone position: a prospective study

    Directory of Open Access Journals (Sweden)

    Baran Gencer

    2015-02-01

    Full Text Available BACKGROUND AND OBJECTIVES: Changes in ocular perfusion play an important role in the pathogenesis of ischemic optic neuropathy. Ocular perfusion pressure is equal to mean arterial pressure minus intraocular pressure. The aim of this study was to evaluate the changes in the intraocular pressure and the retinal nerve fiber layer thickness in patients undergoing spinal surgery in the prone position. METHODS: This prospective study included 30 patients undergoing spinal surgery. Retinal nerve fiber layer thickness were measured one day before and after the surgery by using optical coherence tomography. Intraocular pressure was measured by tonopen six times at different position and time-duration: supine position (baseline; 10 min after intubation (Supine 1; 10 (Prone 1, 60 (Prone 2, 120 (Prone 3 min after prone position; and just after postoperative supine position (Supine 2. RESULTS: Our study involved 10 male and 20 female patients with the median age of 57 years. When postoperative retinal nerve fiber layer thickness measurements were compared with preoperative values, a statistically significant thinning was observed in inferior and nasal quadrants (p = 0.009 and p = 0.003, respectively. We observed a statistically significant intraocular pressure decrease in Supine 1 and an increase in both Prone 2 and Prone 3 when compared to the baseline. Mean arterial pressure and ocular perfusion pressure were found to be significantly lower in Prone 1, Prone 2 and Prone 3, when compared with the baseline. CONCLUSIONS: Our study has shown increase in intraocular pressure during spinal surgery in prone position. A statistically significant retinal nerve fiber layer thickness thinning was seen in inferior and nasal quadrants one day after the spinal surgery.

  13. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  14. Employment status and sick-leave following obesity surgery: a five-year prospective cohort study.

    Science.gov (United States)

    Andersen, John Roger; Hernæs, Ulrikke J V; Hufthammer, Karl Ove; Våge, Villy

    2015-01-01

    Background. Severe obesity is a risk factor for lower participation in paid work, but whether employment increases and sick leave decreases after obesity surgery is not well documented. Methods. We assessed 224 Norwegian patients with severe obesity (mean age: 40; mean BMI: 49; 61% female) regarding employment status (working versus not working) and the number of days of sick leave during the preceding 12 months, before and five years after obesity surgery (75% follow-up rate). Logistic regression analysis was used to study preoperative predictors of employment status after surgery. Results. There were no change in the employment rate over time (54% versus 58%), but the number of days of sick leave per year was significantly reduced, from a mean of 63 to a mean of 26, and from a median of 36 to a median of 4. Most of this change was attributable to patients with zero days of sick leave, which increased from 25% to 41%. Being female, older, having low education level, receiving disability pension and not being employed before obesity surgery were important risk factors for not being employed after obesity surgery. The type of obesity surgery, BMI and marital status were not useful predictors. Conclusions. Our findings suggest that undergoing obesity surgery is not associated with a higher rate of employment, although it may reduce the number of days of sick leave. Additional interventions are likely needed to influence the employment status of these patients. The significant preoperative predictors of not being employed in this study provide suggestions for further research.

  15. Employment status and sick-leave following obesity surgery: a five-year prospective cohort study

    Directory of Open Access Journals (Sweden)

    John Roger Andersen

    2015-09-01

    Full Text Available Background. Severe obesity is a risk factor for lower participation in paid work, but whether employment increases and sick leave decreases after obesity surgery is not well documented.Methods. We assessed 224 Norwegian patients with severe obesity (mean age: 40; mean BMI: 49; 61% female regarding employment status (working versus not working and the number of days of sick leave during the preceding 12 months, before and five years after obesity surgery (75% follow-up rate. Logistic regression analysis was used to study preoperative predictors of employment status after surgery.Results. There were no change in the employment rate over time (54% versus 58%, but the number of days of sick leave per year was significantly reduced, from a mean of 63 to a mean of 26, and from a median of 36 to a median of 4. Most of this change was attributable to patients with zero days of sick leave, which increased from 25% to 41%. Being female, older, having low education level, receiving disability pension and not being employed before obesity surgery were important risk factors for not being employed after obesity surgery. The type of obesity surgery, BMI and marital status were not useful predictors.Conclusions. Our findings suggest that undergoing obesity surgery is not associated with a higher rate of employment, although it may reduce the number of days of sick leave. Additional interventions are likely needed to influence the employment status of these patients. The significant preoperative predictors of not being employed in this study provide suggestions for further research.

  16. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

    DEFF Research Database (Denmark)

    Vester-Andersen, M; Waldau, T; Wetterslev, J

    2015-01-01

    BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care...... ward within 24 h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. RESULTS: In total, 286 patients were included in the modified intention-to-treat analysis. The trial...... was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate. Eleven (7·6 per cent) of 144 patients assigned to intermediate care and 12 (8·5 per cent) of 142 patients assigned to ward care died within 30 days of surgery (odds ratio 0·91, 95 per cent c.i. 0·38 to 2...

  17. Perioperative Alanyl-Glutamine-Supplemented Parenteral Nutrition in Chronic Radiation Enteritis Patients With Surgical Intestinal Obstruction: A Prospective, Randomized, Controlled Study.

    Science.gov (United States)

    Yao, Danhua; Zheng, Lei; Wang, Jian; Guo, Mingxiao; Yin, Jianyi; Li, Yousheng

    2016-04-01

    A prospective, randomized, controlled study was performed to evaluate the effects of perioperative alanyl-glutamine-supplemented parenteral nutrition (PN) support on the immunologic function, intestinal permeability, and nutrition status of surgical patients with chronic radiation enteritis (CRE)-induced intestinal obstruction. Patients who received 0.4 g/kg/d alanyl-glutamine and isonitrogenous PN were assigned to an alanyl-glutamine-supplemented PN (Gln-PN) group and a control group, respectively. Serum levels of alanine aminotransferase and glutamine, body fat mass (FM), immunologic function, and intestinal permeability were measured before and after surgery. Serum glutamine levels of the Gln-PN group significantly exceeded that of the control group (P nutrition state and intestinal motility of surgical patients with CRE-induced intestinal obstruction. © 2015 American Society for Parenteral and Enteral Nutrition.

  18. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial

    International Nuclear Information System (INIS)

    Xiaobin, Feng; Shuguang, Wang; Ping, Bie; Jiahong, Dong; Shuguo, Zheng; Jian, Zhou; Yudong, Qiu; Lijian, Liang; Kuansheng, Ma; Xiaowu, Li; Feng, Xia; Dong, Yi

    2012-01-01

    Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery.

  19. A Prospective Randomized Peri- and Post-Operative Comparison of the Minimally Invasive Anterolateral Approach Versus the Lateral Approach

    Science.gov (United States)

    Landgraeber, Stefan; Quitmann, Henning; Güth, Sebastian; Haversath, Marcel; Kowalczyk, Wojciech; Kecskeméthy, Andrés; Heep, Hansjörg; Jäger, Marcus

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and McMaster Universities Osteoarthritis Index and Harris Hip score (HHS) were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045). But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study. PMID:24191179

  20. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    Directory of Open Access Journals (Sweden)

    Stefan Landgraeber

    2013-07-01

    Full Text Available There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS or a conventional lateral approach (CON. We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36 or CON (n=39 approach. The Western Ontario\tand\tMcMaster\tUniversities Osteoarthritis Index and Harris Hip score (HHS were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045. But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study.

  1. Effect of Continuous Motion Parameter Feedback on Laparoscopic Simulation Training: A Prospective Randomized Controlled Trial on Skill Acquisition and Retention.

    Science.gov (United States)

    Buescher, Julian Frederik; Mehdorn, Anne-Sophie; Neumann, Philipp-Alexander; Becker, Felix; Eichelmann, Ann-Kathrin; Pankratius, Ulrich; Bahde, Ralf; Foell, Daniel; Senninger, Norbert; Rijcken, Emile

    To investigate the effect of motion parameter feedback on laparoscopic basic skill acquisition and retention during a standardized box training curriculum. A Lap-X Hybrid laparoscopic simulator was designed to provide individual and continuous motion parameter feedback in a dry box trainer setting. In a prospective controlled trial, surgical novices were randomized into 2 groups (regular box group, n = 18, and Hybrid group, n = 18) to undergo an identical 5-day training program. In each group, 7 standardized tasks on laparoscopic basic skills were completed twice a day on 4 consecutive days in fixed pairs. Additionally, each participant performed a simulated standard laparoscopic cholecystectomy before (day 1) and after training (day 5) on a LAP Mentor II virtual reality (VR) trainer, allowing an independent control of skill progress in both groups. A follow-up assessment of skill retention was performed after 6 weeks with repetition of both the box tasks and VR cholecystectomy. Muenster University Hospital Training Center, Muenster, Germany. Medical students without previous surgical experience. Laparoscopic skills in both groups improved significantly during the training period, measured by the overall task performance time. The 6 week follow-up showed comparable skill retention in both groups. Evaluation of the VR cholecystectomies demonstrated significant decrease of operation time (p Simulation training on both trainers enables reliable acquisition of laparoscopic basic skills. Furthermore, individual and continuous motion feedback improves laparoscopic skill enhancement significantly in several aspects. Thus, training systems with feedback of motion parameters should be considered to achieve long-term improvement of motion economy among surgical trainees. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  2. A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2015-01-01

    For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  3. Early career choices and successful career progression in surgery in the UK: prospective cohort studies

    Directory of Open Access Journals (Sweden)

    Richards Jennifer MJ

    2010-11-01

    Full Text Available Abstract Background Changes to the structure of medical training worldwide require doctors to decide on their career specialty at an increasingly early stage after graduation. We studied trends in career choices for surgery, and the eventual career destinations, of UK graduates who declared an early preference for surgery. Methods Postal questionnaires were sent, at regular time intervals after qualification, to all medical qualifiers from all UK medical schools in selected qualification years between 1974 and 2005. They were sent in the first year after qualification, at year three and five years after qualification, and at longer time intervals thereafter. Results Responses were received from 27 749 of 38 280 doctors (73% at year one, 23 468 of 33151 (71% at year three, and 17 689 of 24 870 (71% at year five. Early career preferences showed that surgery has become more popular over the past two decades. Looking forward from early career choice, 60% of respondents (64% of men, 48% of women with a first preference for a surgical specialty at year one eventually worked in surgery (p Conclusions Surgery is a popular specialty choice in the UK. The great majority of doctors who progressed in a surgical career made an early and definitive decision to do so.

  4. Transient Exacerbation of Nasal Symptoms following Endoscopic Transsphenoidal Surgery for Pituitary Tumors: A Prospective Study.

    Science.gov (United States)

    Davies, Benjamin M; Tirr, Erica; Wang, Yi Yuen; Gnanalingham, Kanna K

    2017-06-01

    Object  Endoscopic transsphenoidal surgery is the commonest approach to pituitary tumors. One disadvantage of this approach is the development of early postoperative nasal symptoms. Our aim was to clarify the peak onset of these symptoms and their temporal evolution. Methods  The General Nasal Patient Inventory (GNPI) was administered to 56 patients undergoing endoscopic transsphenoidal surgery for pituitary tumors preoperatively and at 1 day, 3 days, 2 weeks, 3 months, and 6 to 12 months postoperatively. Most patients underwent surgery for pituitary adenomas ( N  = 49; 88%) and through a uninostril approach ( N  = 55; 98%). Total GNPI (0-135) and scores for the 45 individual components were compared. Results  GNPI scores peaked at 1 to 3 days postoperatively, with rapid reduction to baseline by 2 weeks and below baseline by 6 to 12 months postsurgery ( p  surgery ( p  transsphenoidal pituitary surgery is common, but transient, more so in the functioning subgroup. Nasal symptoms improve below baseline by 6 to 12 months, without the need for specific long-term postoperative interventions in the vast majority of patients.

  5. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery.

    Science.gov (United States)

    Leurcharusmee, Prangmalee; Elgueta, Maria Francisca; Tiyaprasertkul, Worakamol; Sotthisopha, Thitipan; Samerchua, Artid; Gordon, Aida; Aliste, Julian; Finlayson, Roderick J; Tran, De Q H

    2017-06-01

    This two-centre randomized trial compared costoclavicular and paracoracoid ultrasound-guided infraclavicular brachial plexus block in patients undergoing upper limb surgery. We hypothesized that both techniques would result in similar onset times and designed the study as an equivalence trial. Ninety patients undergoing upper limb surgery at or distal to the elbow were randomly allocated to receive a costoclavicular (n = 45) or paracoracoid (n = 45) ultrasound-guided infraclavicular brachial plexus block. Both groups received a 35-mL mixture of 1% lidocaine-0.25% bupivacaine with epinephrine 5 µg·mL -1 . In the costoclavicular group, local anesthetic was injected into the costoclavicular space in the middle of the three cords of the brachial plexus. In the paracoracoid group, local anesthetic was deposited dorsal to the axillary artery in the lateral infraclavicular fossa. A blinded observer recorded the block onset time (primary endpoint), success rate (i.e., surgical anesthesia), block-related pain scores, as well as the incidence of hemidiaphragmatic paralysis. Performance time and the number of needle passes were also recorded during the performance of the block. The total anesthesia-related time was defined as the sum of the performance and onset times. The mean (SD) onset times were comparable between the costoclavicular and paracoracoid groups [16.0 (7.5) min vs 16.8 (6.2) min, respectively; mean difference, 0.8; 95% confidence interval, -2.3 to 3.8; P = 0.61]. Furthermore, no intergroup differences were found in terms of performance time (P = 0.09), total anesthesia-related time (P = 0.90), surgical anesthesia (P > 0.99), and hemidiaphragmatic paralysis (P > 0.99). The paracoracoid technique required marginally fewer median [interquartile range] needle passes than the costoclavicular technique (2 [1-4] vs 2 [1-6], respectively; P = 0.048); however, procedural pain was comparable between the two study groups. Costoclavicular and paracoracoid ultrasound

  6. Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

    Science.gov (United States)

    Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

    2016-11-03

    The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  7. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    International Nuclear Information System (INIS)

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-01-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

  8. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  9. Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

    Science.gov (United States)

    Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

    2010-01-01

    To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

  10. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  11. Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

    Science.gov (United States)

    Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

    2012-02-01

    The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

  12. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Improving Prospective Memory in Persons With Parkinson Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    Foster, Erin R; McDaniel, Mark A; Rendell, Peter G

    2017-05-01

    Prospective memory (PM) is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause PM deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions (IIs) is an encoding strategy that may improve PM in this population. To determine the effect of IIs on PM performance in PD. This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (n = 62) performed a computerized PM test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either IIs or a rehearsal (RR) encoding strategy. PM performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared with time-based cues. In addition, IIs resulted in a larger effect than RR for the nonrepeated tasks. Strategies that support full encoding of PM cues and actions can improve PM performance among people with PD, particularly for tasks with cues that are readily available in the environment. IIs may be more effective than RR for nonrepeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage PM impairment could improve function and quality of life and significantly affect clinical care for people with PD.

  14. Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

    Science.gov (United States)

    Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

    2012-01-01

    This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

  15. Higher Dose of Dexamethasone Does Not Further Reduce Facial Swelling After Orthognathic Surgery: A Randomized Controlled Trial Using 3-Dimensional Photogrammetry.

    Science.gov (United States)

    Lin, Hsiu Hsia; Kim, Sun-Goo; Kim, Hye-Young; Niu, Lien-Shin; Lo, Lun-Jou

    2017-03-01

    The objective of this prospective, double-blind, randomized clinical trial was to compare the effect of 2 dexamethasone dosages on reducing facial swelling after orthognathic surgery through 3-dimensional (3D) photogrammetry. Patients were classified into group 1 (control group) and group 2 (study group), depending on the administered dexamethasone dosage (5 and 15 mg, respectively). Three-dimensional images were recorded at 5 time points: preoperative (T0) and postoperative at 48 ± 6 hours (T1), 1 week (T2), 1 month (T3), and 6 months (T4). A preliminary study was performed on 5 patients, in whom 3D images were captured at 24, 36, 48, and 60 hours postoperatively to record serial changes in facial swelling. Facial swelling at T1, T2, and T3 and the reduction in swelling at T2 and T3 compared with that at the baseline (T4) were calculated. Possible complications, namely, adrenal suppression, wound dehiscence, wound infection, and postoperative nausea and vomiting were evaluated. In total, 68 patients were enrolled, of whom 25 patients in group 1 and 31 patients in group 2 were eligible for final evaluation. No significant differences were found between the 2 groups at any period. On average, the swelling subsided by 86% at 1 month after the orthognathic surgery. Facial swelling peaked approximately 48 hours after the surgery. The incidence of nausea and vomiting did not differ significantly between the groups. The effect of 5 and 15 mg of dexamethasone on facial swelling reduction as well as on nausea and vomiting after orthognathic surgery was not significantly different.

  16. A modified fast-track program for pancreatic surgery: a prospective single-center experience.

    Science.gov (United States)

    di Sebastiano, Pierluigi; Festa, Leonardina; De Bonis, Antonio; Ciuffreda, Andrea; Valvano, Maria Rosa; Andriulli, Angelo; di Mola, F Francesco

    2011-03-01

    The objective of this study is to evaluate the impact of a fast-track protocol in a high-volume center for patients with pancreatic disorders. The concept of fast-track surgery allowing accelerated postoperative recovery is accepted in colorectal surgery, but efficacy data are only preliminary for patients undergoing major pancreatic surgery. We aimed to evaluate the impact of a modified fast-track protocol in a high-volume center for patients with pancreatic disorders. Between February 2005 and January 2010, 145 subjects had resective pancreatic surgery and were enrolled in the program. Essential features of the program were no preanaesthetic medication, upper and lower air-warming device, avoidance of excessive i.v. fluids perioperatively, effective control of pain, early reinstitution of oral feeding, and immediate mobilization and restoration of bowel function following surgery. Outcome measures were postoperative complications such as pancreatic fistula, delayed gastric emptying, biliary leak, intra-abdominal abscess, post-pancreatectomy hemorrhage, acute pancreatitis, wound infection, 30-day mortality, postoperative hospital stay, and readmission rates. On average, patients were discharged on postoperative day 10 (range 6-69), with a 30-day readmission rate of 6.2%. Percentage of patients with at least one complication was 38.6%. Pancreatic anastomotic leakage occurred in seven of 101 pancreatico-jejunostomies, and biliary leak in three of 109 biliary jejunostomies. Postoperative hemorrhage occurred in ten (6.9%) patients and wound infection in nine (6.2%) cases. In-hospital mortality was 2.7%. Fast-track parameters, such as normal food and first stool, correlated significantly with early discharge (jaundice, and resumption of normal diet by the 5th postoperative day were independent factors of early discharge. Fast-track programs are feasible, easy, and also applicable for patients undergoing a major surgery such as pancreatic resection.

  17. The advantages of carbon dioxide laser applications in paediatric oral surgery. A prospective cohort study.

    Science.gov (United States)

    Hanna, R; Parker, S

    2016-11-01

    The aim of this study is to evaluate and demonstrate the advantages of the carbon dioxide laser in paediatric oral surgery patients in terms of less post-operative complications, healing without scaring, functional benefits, positive patient perception and acceptance of the treatment. One hundred fit and healthy paediatric patients (aged 4-15 years) were recruited to undergo laser surgery for different soft tissue conditions. The outcome of these laser treatments was examined. The Wong-Baker Faces Pain Rating Scale was employed to evaluate the pain before, immediately after laser treatment in the clinic and 1 day after post-operatively at home. Post-operative complications and patients' perception and satisfaction were self-reported during a review telephone call the day after treatment. The patients were reviewed 2 weeks after surgery. Laser parameter was 1.62 W, measured by power meter, continuous wave mode with 50 % emission cycle. The beam spot size at the target tissue was 0.8 mm. The pain score pre-operative, during and immediately after laser treatment was rated 0. Whilst the pain score 1 day after surgery was rated between 0 and 2, the healing time was measured over 2 weeks. None of the patients reported post-operative complications after surgery. Patients' perception and acceptance were rated very good. Laser dentistry is a promising field in modern minimally invasive dentistry, which enables provision of better care for children and adolescents. In this cohort study, the use of the carbon dioxide laser therapy offers a desirable, acceptable and minimally invasive technique in the surgical management of soft tissues in paediatric oral surgery with minimal post-operative complications.

  18. Predictors, Prognosis, and Management of New Clinically Important Atrial Fibrillation After Noncardiac Surgery: A Prospective Cohort Study.

    Science.gov (United States)

    Alonso-Coello, Pablo; Cook, Deborah; Xu, Shou Chun; Sigamani, Alben; Berwanger, Otavio; Sivakumaran, Soori; Yang, Homer; Xavier, Denis; Martinez, Luz Ximena; Ibarra, Pedro; Rao-Melacini, Purnima; Pogue, Janice; Zarnke, Kelly; Paniagua, Pilar; Ostrander, Jack; Yusuf, Salim; Devereaux, P J

    2017-07-01

    Despite the frequency of new clinically important atrial fibrillation (AF) after noncardiac surgery and its increased association with the risk of stroke at 30 days, there are limited data informing their prediction, association with outcomes, and management. We used the data from the PeriOperative ISchemic Evaluation trial to determine, in patients undergoing noncardiac surgery, the association of new clinically important AF with 30-day outcomes, and to assess management of these patients. We also aimed to derive a clinical prediction rule for new clinically important AF in this population. We defined new clinically important AF as new AF that resulted in symptoms or required treatment. We recorded an electrocardiogram 6 to 12 hours postoperatively and on the 1st, 2nd, and 30th days after surgery. A total of 211 (2.5% [8351 patients]; 95% confidence interval, 2.2%-2.9%) patients developed new clinically important AF within 30 days of randomization (8140 did not develop new AF). AF was independently associated with an increased length of hospital stay by 6.0 days (95% confidence interval, 3.5-8.5 days) and vascular complications (eg, stroke or congestive heart failure). The usage of an oral anticoagulant at the time of hospital discharge among patients with new AF and a CHADS2 score of 0, 1, 2, 3, and ≥4 was 6.9%, 10.2%, 23.0%, 9.4%, and 33.3%, respectively. Two independent predictors of patients developing new clinically important AF were identified (ie, age and surgery). The prediction rule included the following factors and assigned weights: age ≥85 years (4 points), age 75 to 84 years (3 points), age 65 to 74 years (2 points), intrathoracic surgery (3 points), major vascular surgery (2 points), and intra-abdominal surgery (1 point). The incidence of new AF based on scores of 0 to 1, 2, 3 to 4, and 5 to 6 was 0.5%, 1.0%, 3.1%, and 5.3%, respectively. Age and surgery are independent predictors of new clinically important AF in the perioperative setting. A

  19. Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

    Science.gov (United States)

    Parilla, B V; McDermott, T M

    1998-01-01

    The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

  20. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

    Science.gov (United States)

    Edwards, Janet P; Kelly, Elizabeth J; Lin, Yongtao; Lenders, Taryn; Ghali, William A; Graham, Andrew J

    2012-06-01

    Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

  1. Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial.

    Science.gov (United States)

    Phillips, C; Kim, S H; Tucker, M; Turvey, T A

    2010-08-01

    Assess the long-term effect of sensory retraining exercises, age, gender, type of surgery, and pre-surgical psychological distress on patients' perception of the interference related to altered sensation 2 years after orthognathic surgery. A total of 186 subjects with a developmental dentofacial disharmony were enrolled in a multicenter randomized clinical trial: one center was a community-based practice and the other a university-based center. Subjects were randomly allocated to two groups: standard of care mouth opening exercises after BSSO or a progressive series of sensory retraining facial exercises in addition to the opening exercises. At 1, 3, 6, 12, and 24 months after surgery, subjects scored unusual feelings on the face, numbness, and loss of lip sensitivity from 'no problem (1)' to 'serious problem (7)'. A marginal proportional odds model was fit for each of the ordinal outcomes. Up to 2 years after surgery, the opening exercise only group had a higher likelihood of reporting interference in daily activities related to numbness and loss of lip sensitivity than the sensory retraining exercise group. The difference between the two groups was relatively constant. Older subjects and those with elevated psychological distress before surgery reported higher burdens related to unusual facial feelings, numbness, and loss of lip sensitivity (p pre-surgical counseling regarding the impact on daily life of persistent altered sensation following a mandibular osteotomy.

  2. Early complication detection after colorectal surgery (CONDOR): study protocol for a prospective clinical diagnostic study

    NARCIS (Netherlands)

    Kornmann, Verena; van Ramshorst, Bert; van Dieren, Susan; van Geloven, Nanette; Boermeester, Marja; Boerma, Djamila

    2016-01-01

    Anastomotic leakage is one of the most feared complications following colorectal surgery with a high morbidity and mortality rate. Multiple risk factors have been identified, but leakage still occurs. Early detection is crucial in order to reduce morbidity and mortality. The aim of this study is to

  3. Incidence and prognostic factors for postoperative frozen shoulder after shoulder surgery : a prospective cohort study

    NARCIS (Netherlands)

    Koorevaar, Rinco C. T.; van't Riet, Esther; Ipskamp, Marcel; Bulstra, Sjoerd K.

    Frozen shoulder is a potential complication after shoulder surgery. It is a clinical condition that is often associated with marked disability and can have a profound effect on the patient's quality of life. The incidence, etiology, pathology and prognostic factors of postoperative frozen shoulder

  4. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    Science.gov (United States)

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

  5. Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

    Science.gov (United States)

    2017-08-01

    Virtual Reality Simulation Curriculum GEARS - Global Evaluative Assessment of Robotic Skills Surgical Education 6 of 41 3. ACCOMPLISHMENTS: What... especially at UW and UMN. A formal budget modification request will be forthcoming in Year 3 to detail these 13 of 41 expenditure changes once we

  6. Perioperative management of vitamin K antagonists in patients with low thromboembolic risk undergoing elective surgery: A prospective experience.

    Science.gov (United States)

    Becerra, Ana Florencia; Cornavaca, María Teresita; Revigliono, José Ignacio; Contreras, Alejandro; Albertini, Ricardo; Tabares, Aldo Hugo

    2017-10-11

    To quantify thromboembolic and bleeding events in patients with low thromboembolic risk, who were chronically receiving vitamin K antagonists and undergoing elective surgery. A descriptive, prospective, single-center study was conducted between December 2010 and July 2014. Patients aged over 18 years old, chronically anticoagulated with vitamin K antagonists and admitted for elective surgery were included in the study. We excluded patients with a creatinine clearance120kg, heparin-induced thrombocytopenia, pregnant women, carriers of an epidural catheter for analgesia, patients who underwent unscheduled surgery and high thromboembolic risk-patients. Vitamin K antagonists were discontinued 5 days prior to the procedure without administering anticoagulant enoxaparin. The NIR was measured 24h before the procedure. A single dose of 3mg of vitamin K was administered in cases of a NIR>1.5. Vitamin K antagonists was resumed according to the surgical bleeding risk. Events were registered between 5 days prior to the procedure until 30 days after it. A total of 75 procedures were included in the study. Fifty-six patients (74.7%) received vitamin K antagonists for atrial fibrillation, 15 suffered from venous thromboembolism (20%) and 4 had mechanical heart valves (5.3%). Twenty-six patients (34.5%) underwent high-bleeding risk surgeries and 49 (65.5%) underwent low risk procedures. No thromboembolic event was recorded. Four bleeding events (5.3%) were reported, 3 of which were considered major bleeding events (2 fatal). Suspending vitamin K antagonists with no bridging therapy performed in patients with a low thromboembolic risk does not expose such patients to a significant risk of embolic events. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  7. Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Implant Surgery: A 12-month Randomized Clinical Trial.

    Science.gov (United States)

    Nader, Nabih; Aboulhosn, Maissa; Berberi, Antoine; Manal, Cordahi; Younes, Ronald

    2016-01-01

    The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at second-stage surgery (control group). A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the

  8. Weight loss after bariatric surgery and periodontal changes: a 12-month prospective study.

    Science.gov (United States)

    Sales-Peres, Silvia Helena de Carvalho; Sales-Peres, Matheus de Carvalho; Ceneviva, Reginaldo; Bernabé, Eduardo

    2017-04-01

    Several longitudinal studies have explored the association of obesity and weight gain with periodontal disease. However, the effect of weight loss on periodontal tissues remains unclear. To explore whether weight loss after bariatric surgery was associated with changes in periodontal measures over 12 months. Two public hospitals in São Paulo, Brazil. We used data from 110 morbidly obese patients (body mass index [BMI]>40 kg/m 2 or≥35 kg/m 2 with co-morbid conditions) who underwent bariatric surgery between April 2011 and March 2013. Data on demographic factors, BMI, smoking habits, and glucose levels were extracted from medical records preoperatively and after 6 and 12 months postsurgery. A full-mouth periodontal examination was conducted by trained examiners to assess probing pocket depth, clinical attachment loss, and bleeding on probing (BOP) at baseline and 6 and 12 months after surgery. Data were analyzed using linear mixed-effects models. BMI was not significantly related to the proportion of sites with BOP at baseline, but it was negatively associated with the rate of change in the proportion of sites with BOP. The greater the BMI loss, the higher the proportion of sites with BOP, particularly 6 months after surgery. However, BMI was not associated with baseline probing pocket depth and clinical attachment loss or rates of changes in these periodontal outcomes. The findings suggest that weight loss was associated with increased gingival bleeding, showing a peak at 6 months after bariatric surgery. Periodontal pocketing and attachment loss remained unchanged during the study period. Copyright © 2017. Published by Elsevier Inc.

  9. Trajectory of sleep disturbances in patients undergoing lung cancer surgery: a prospective study.

    Science.gov (United States)

    Halle, Ingrid Helene; Westgaard, Therese Krystad; Wahba, Alexander; Oksholm, Trine; Rustøen, Tone; Gjeilo, Kari Hanne

    2017-08-01

    Patients with lung cancer report sleep difficulties to be frequent and bothersome symptoms. This study describes the trajectory of sleep from before and up to 12 months after surgery for lung cancer. Further, it investigates possible associations between sleep disturbance, demographic and clinical characteristics before surgery. This study is part of a longitudinal multicentre study. Sleep disturbance was measured by The General Sleep Disturbance Scale (GSDS) that investigates frequencies of sleep difficulties (21 items) and a total sum score ≥43 indicates a clinically meaningful level of sleep disturbance (score range 0-147). Linear mixed models were used to study changes in sleep from baseline to 1, 5, 9 and 12 months after surgery. The percentage of patients (n = 264) reporting sleep disturbances was 60.9% at baseline, 68.5% at Month 1, 55.4% at Month 5, 51.3% at Month 9 and 49.7% at Month 12. The increase to and decrease from Month 1 was the only significant alteration in the occurrence of sleep disturbance. The patients reported most problems within the subscales sleep quantity, early awakenings and sleep quality. Factors associated with sleep disturbance were lower age, use of pain medication and psychotropic medication and higher comorbidity score. Lung cancer patients sleep poorly, before as well as after surgery. There is a need to address sleeping disturbance routinely in clinical practice and screening for sleeping problems is indicated. Further studies are warranted concerning factors that contribute to sleep disturbance and how they best can be treated. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  10. Immediate loading versus immediate provisionalization of maxillary single-tooth replacements: a prospective randomized study with BioComp implants

    NARCIS (Netherlands)

    Lindeboom, Jerome A.; Frenken, Joost W.; Dubois, Leander; Frank, Michael; Abbink, Ingmar; Kroon, Frans H.

    2006-01-01

    PURPOSE: The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar

  11. 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

  12. Advantages of Arthroscopic Rotator Cuff Repair With a Transosseous Suture Technique: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Randelli, Pietro; Stoppani, Carlo Alberto; Zaolino, Carlo; Menon, Alessandra; Randelli, Filippo; Cabitza, Paolo

    2017-07-01

    Rotator cuff tear is a common finding in patients with painful, poorly functioning shoulders. The surgical management of this disorder has improved greatly and can now be fully arthroscopic. To evaluate clinical and radiological results of arthroscopic rotator cuff repair using 2 different techniques: single-row anchor fixation versus transosseous hardware-free suture repair. Randomized controlled trial; Level of evidence, 1. Sixty-nine patients with rotator cuff tears were enrolled: 35 patients were operated with metal anchors and 34 with standardized transosseous repair. The patients were clinically evaluated before surgery, during the 28 days after surgery, and at least 1 year after the operation by the use of validated rating scores (Constant score, QuickDASH, and numerical rating scale [NRS]). Final follow-up was obtained at more than 3 years by a QuickDASH evaluation to detect any difference from the previous follow-up. During the follow-up, rotator cuff integrity was determined through magnetic resonance imaging and was classified according to the 5 Sugaya categories. Patients operated with the transosseous technique had significantly less pain, especially from the 15th postoperative day: In the third week, the mean NRS value for the anchor group was 3.00 while that for transosseous group was 2.46 ( P = .02); in the fourth week, the values were 2.44 and 1.76, respectively ( P rotator cuff repair integrity, based on Sugaya magnetic resonance imaging classification, no significant difference was found between the 2 techniques in terms of retear rate ( P = .81). No significant differences were found between the 2 arthroscopic repair techniques in terms of functional and radiological results. However, postoperative pain decreased more quickly after the transosseous procedure, which therefore emerges as a possible improvement in the surgical repair of the rotator cuff. Registration: NCT01815177 ( ClinicalTrials.gov identifier).

  13. A prospective randomized study assessing optimal method for teaching vascular anastomoses.

    Science.gov (United States)

    Schwartz, Samuel; de Virgilio, Michael; Chisum, Patrick; Heslin, Andrew; Zein, Alyssar; McDermott, Meilu; Kaji, Amy; Yaghoubian, Arezou; de Virgilio, Christian

    2014-07-01

    Laboratory skills training is now required for general surgery residents. The optimal method of teaching vascular anastomosis (VA) is not well defined. Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting. Residents were shown an instructional video on how to perform a VA using a standardized model (cadaver saphenous vein and porcine aorta). Each resident then performed a baseline VA. Sixteen first- and second-year surgical residents were then randomized to 2 VA teaching sessions that consisted of either 1) group teaching (GT, 8 residents in a room with 1 faculty instructor circulating) or 2) one-on-one teaching (1-on-1, faculty member focused on individual resident). After each of these sessions, residents performed a standardized VA. The anastomoses were video recorded. Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion. Outcome measures included total errors, total time, global rating scale, and an anastomosis-specific end-product evaluation (leak and passage of coronary dilator). Overall, significant decreases in total errors (21 to 15, P=0.001) and time to complete anastomoses (42 to 38 min, P=0.02) and an increase in global rating scales (7 to 11, P=0.003) were noted in both groups from baseline after 2 VA teaching session. The 1-on-1 group demonstrated significantly greater improvement in terms of reduced anastomotic time (30 vs. 42 min, P=0.007) and in reduction of errors (13 vs. 19 errors, P=0.09) than the GT group. The high-fidelity VA model is a useful tool for junior general surgery residents. Both GT and 1-on-1 groups demonstrated significant improvement in total errors and time after only 2 sessions. Greater improvement was noted using the 1-on-1 model. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Psychological impact of third molar surgery: a 1-month prospective study

    NARCIS (Netherlands)

    de Jongh, Ad; van Wijk, Arjen J.; Lindeboom, Jerome A.

    2011-01-01

    To prospectively examine the psychological impact of surgical third molar removal, and to identify possible psychological risk factors for the development of dental anxiety and symptoms of psychological trauma. Patients (N = 71) scheduled for surgical mandibular third molar removal were assessed

  15. Effects of oral carbohydrate with amino acid solution on the metabolic status of patients in the preoperative period: a randomized, prospective clinical trial.

    Science.gov (United States)

    Tsutsumi, Rie; Kakuta, Nami; Kadota, Takako; Oyama, Takuro; Kume, Katsuyoshi; Hamaguchi, Eisuke; Niki, Noriko; Tanaka, Katsuya; Tsutsumi, Yasuo M

    2016-10-01

    Enhanced recovery after surgery is increasingly desired nowadays, and preoperative nutrient intake may be beneficial for this purpose. In this study, we investigated whether the intake of preoperative carbohydrate with amino acid (ONS) solution can improve starvation status and lipid catabolism before the induction of anesthesia. This randomized, prospective clinical trial included 24 patients who were divided into two groups before surgery under general anesthesia: a control group, comprising patients who fasted after their last meal the day before surgery (permitted to drink only water), and an ONS group, comprising patients who consumed ONS solution 2 h before surgery. Biochemical markers, the respiratory quotient, and psychosomatic scores were assessed at the initiation of anesthesia. Compared with the control group, the ONS group showed significantly lower serum free fatty acid levels [control group: 828 (729, 1004) µEq/L, ONS group: 479 (408, 610) µEq/L, P = 0.0002, median (25th, 75th percentile)] and total ketone bodies [control group: 119 (68, 440) µmol/L, ONS group: 40 [27, 64] µmol/L, P = 0.037]. In addition, analysis using the Visual Analog Scale showed higher preoperative scores for anxiety, hunger, and thirst for the control group, with no differences in any other measure of subjective well-being between groups. The results of this study suggest that preoperative ONS intake improves lipid catabolism and starvation status before the induction of anesthesia. Furthermore, it can provide better preoperative mental health compared with complete fasting.

  16. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

    Science.gov (United States)

    Kjeken, Ingvild; Eide, Ruth Else Mehl; Klokkeide, Åse; Matre, Karin Hoegh; Olsen, Monika; Mowinckel, Petter; Andreassen, Øyvor; Darre, Siri; Nossum, Randi

    2016-11-15

    In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted. This multicentre randomized controlled trial aims to address the following questions: Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA? What are patients' motivation and reasons for wanting CMC1-surgery? Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery? Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA? Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function? Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery? Is OT more cost-effective than surgery in the management of CMC1-OA? All persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n = 180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and

  17. Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months-a prospective cohort study.

    Science.gov (United States)

    Nickel, Felix; Schmidt, Lukas; Bruckner, Thomas; Büchler, Markus W; Müller-Stich, Beat-Peter; Fischer, Lars

    2017-02-01

    It has been proven that bariatric surgery affects weight loss. Patients with morbid obesity have a significantly lower quality of life (QOL) and body image compared with the general population. To evaluate QOL, body image, and general self-efficacy (GSE) in patients with morbid obesity undergoing bariatric surgery within clinical parameters. Monocentric, prospective, longitudinal cohort study. Patients completed the short form 36 (SF-36) for QOL, body image questionnaire, and GSE scale 3 times: before surgery and within 6 months and 24 months after surgery. Influence of gender, age, and type of procedure, either laparoscopic sleeve gastrectomy (SG) or laparoscopic Roux-en-Y gastric bypass, were analyzed. Thirty patients completed the questionnaires before and within 6 and 24 months after surgery. SF-36 physical summary score improved significantly from 34.3±11.0 before surgery to 46.0±10.4 within 6 months (Psurgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (Psurgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (Pbariatric surgery. Improvements were independent of gender, age, and type of operation. Mental QOL was influenced by body image and GSE. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  18. YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

    Science.gov (United States)

    Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

    2011-03-01

    To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

  19. Reasons for Cancellation of Cases on the Day of Surgery-A Prospective Study

    Directory of Open Access Journals (Sweden)

    Rakesh Garg

    2009-01-01

    We believe that many of the on-the-day surgery cancellations of elective surgery were potentially avoidable. We observed that cancellations due to lack of theatre time were not only a scheduling problem but were mainly caused by surgeons underestimating the timeneeded for the operation. The requirement of the instruments necessary for scheduled surgical listshould be discussed a day prior to planned OR list and arranged. The non-availability of the surgeon should be informed in time so that another case is substituted in that slot. All patients who have met PACU discharge criteria must be discharged promptly to prevent delay in shifting out of the operated patient. Day care patients should be counseled adequately to report on time. Computerized scheduling should be utilized to create a realistic elective schedule. Audit should be carried out at regular intervals to find out the effective functioning of the operation theatre.

  20. Randomized clinical trial of new intravenous lipid (SMOFlipid 20%) versus medium-chain triglycerides/long-chain triglycerides in adult patients undergoing gastrointestinal surgery.

    Science.gov (United States)

    Wu, Ming-Hsun; Wang, Ming-Yang; Yang, Chin-Yao; Kuo, Min-Liang; Lin, Ming-Tsan

    2014-09-01

    SMOFlipid 20% is intravenous lipid emulsion (ILE) containing long-chain triglycerides (LCT), medium-chain triglycerides (MCT), olive oil, and fish oil as a mixed emulsion containing α-tocopherol. The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT. In this prospective study, 40 patients were randomized to SMOFlipid 20% or MCT/LCT (Lipovenoes 20%) group. Clinical and biochemistry data were collected. Inflammatory markers (CRP, IL-6, IL-10, TNF-α, TGF-β1) and oxidative stress (ROS and superoxide) were measured. Thirty-five patients (17 males and 18 females) with a mean age of 57 years completed the study. The patients' demographic characteristics (age, gender, height, body weight, and BMI) were similar without significant differences between groups. The increment of triglyceride on day 6 from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group. Inflammatory markers, as well as superoxide radical and total oxygen radical were not different between groups. Despite the comparable effect on inflammatory response, because of its well-balanced fatty acid pattern, relatively low n-6:n-3 ratio, and high vitamin E content, SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery. © 2013 American Society for Parenteral and Enteral Nutrition.

  1. The effect of morphine added to bupivacaine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia following lower abdominal cancer surgery, a randomized controlled study.

    Science.gov (United States)

    El Sherif, Fatma Adel; Mohamed, Sahar Abdel-Baky; Kamal, Shereen Mamdouh

    2017-06-01

    Transversus abdominis plane (TAP) block used for management of surgical abdominal pain by injecting local anesthetics into the plane between the internal oblique and transversus abdominis muscles. We aimed to explore the effect of adding morphine to bupivacaine in ultrasound guided TAP-block in patients undergoing lower abdominal cancer surgery. Randomized, double-blind, prospective study. Clinical trial identifier: NCT02566096. Academic medical center. Sixty patients were enrolled in this study after ethical committee approval. Patients divided into 2 groups (30 each): Bupivacaine group (GB): given ultrasound guided TAP-block 20ml 0.5% bupivacaine diluted in 20ml saline; Morphine group (GM): given ultrasound guided TAP-block with 20ml 0.5% bupivacaine+10mg morphine sulphate diluted in 20ml saline. Patients were observed for total morphine consumption, time for first request of rescue analgesia, sedation scores, hemodynamics and side effects for 24h postoperatively. Morphine added to bupivacaine in TAP block compared to bupivacaine alone reduced total morphine consumption (5.33±1.28mg) (10.70±3.09mg) respectively (p0.05). Addition of morphine to bupivacaine in TAP block is effective method for pain management in patients undergoing major abdominal cancer surgery without serious side effects. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Randomized study of control of the primary tumor and survival using preoperative radiation, radiation alone, or surgery alone in head and beck carcinomas

    International Nuclear Information System (INIS)

    Hintz, B.; Charyulu, K.; Chandler, J.R.; Sudarsanam, A.; Garciga, C.

    1979-01-01

    Fifty-five selected patients with previously untreated squamous cell carcinoma of the head and neck regions were studied in a randomized, prospective manner. The three treatment categories were primary radiation (Gp R), primary surgery (Gp S), and preoperative radiation of 4000 rads in four weeks (Gp R/S). The local control rates for the 44 evaluable patients with a two-year minimum followup were 24%, 39%, and 43%, respectively. Further treatment attempts in patients failing initial therapy yielded local control rates of 35%, 39%, and 43% for Gp R, Gp S, and Gp R/S, respectively. None of the local control rates nor the corresponding survival curves were significantly different at P < 0.10. However, the group sizes were sufficiently small that true differences might not have been detected. Postoperative complications were higher in the primary radiation failures subsequently operated upon compared to the primary surgery group (P = 0.07). A table is included in which the types of postoperative complications are listed and enumerated according to treatment regime

  3. The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial

    Science.gov (United States)

    Wiwatwongwana, D; Vichitvejpaisal, P; Thaikruea, L; Klaphajone, J; Tantong, A; Wiwatwongwana, A

    2016-01-01

    Purpose To investigate the anxiolytic effects of binaural beat embedded audio in patients undergoing cataract surgery under local anesthesia. Methods This prospective RCT included 141 patients undergoing cataract surgery under local anesthesia. The patients were randomized into three groups; the Binaural beat music group (BB), the plain music intervention group (MI), and a control group (ear phones with no music). Blood pressure (BP) and heart rate were measured on admission, at the beginning of and 20 min after the start of the operation. Peri-operative anxiety level was assessed using the State-Trait Anxiety Inventory questionnaire (STAI). Results The BB and MI groups comprised 44 patients each and the control group 47. Patients in the MI group and BB group showed significant reduction of STAI state scores after music intervention compared with the control group (Pbinaural beat, was proven to decrease anxiety level and lower systolic BP. Patients who received binaural beat audio showed additional decrease in heart rate. Binaural beat embedded musical intervention may have benefit over musical intervention alone in decreasing operative anxiety. PMID:27740618

  4. The incidence of ureteral obstruction secondary to aorto-femoral bypass surgery. A prospective study

    DEFF Research Database (Denmark)

    Henriksen, L O; Mejdahl, Steen; Petersen, F

    1988-01-01

    Hydronephrosis is reported to be an infrequent complication of aorto-femoral bypass operations. To define the true incidence of this complication, renography (131I-Hippuran) and renal scintigraphy (99 Technetium) were performed both pre- and postoperatively on 56 asymptomatic patients following...... successful aortic reconstruction. No patient developed signs of ureteral obstruction. It is concluded that hydronephrosis is a rare complication to aorto-femoral bypass surgery and postoperative control is only indicated in patients with symptoms from the urinary tract....

  5. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Staehr Anne K

    2012-07-01

    Full Text Available Abstract Background A high perioperative inspiratory oxygen fraction (FiO2 may reduce the frequency of surgical site infection. Perioperative atelectasis is caused by absorption, compression and reduced function of surfactant. It is well accepted, that ventilation with 100% oxygen for only a few minutes is associated with significant formation of atelectasis. However, it is still not clear if a longer period of 80% oxygen results in more atelectasis compared to a low FiO2. Our aim was to assess if a high FiO2 is associated with impaired oxygenation and decreased pulmonary functional residual capacity (FRC. Methods Thirty-five patients scheduled for laparotomy for ovarian cancer were randomized to receive either 30% oxygen (n = 15 or 80% oxygen (n = 20 during and for 2 h after surgery. The oxygenation index (PaO2/FiO2 was measured every 30 min during anesthesia and 90 min after extubation. FRC was measured the day before surgery and 2 h after extubation by a rebreathing method using the inert gas SF6. Results Five min after intubation, the median PaO2/FiO2 was 69 kPa [53-71] in the 30%-group vs. 60 kPa [47-69] in the 80%-group (P = 0.25. At the end of anesthesia, the PaO2/FiO2 was 58 kPa [40-70] vs. 57 kPa [46-67] in the 30%- and 80%-group, respectively (P = 0.10. The median FRC was 1993 mL [1610-2240] vs. 1875 mL [1545-2048] at baseline and 1615 mL [1375-2318] vs. 1633 mL [1343-1948] postoperatively in the 30%- and 80%-group, respectively (P = 0.70. Conclusion We found no significant difference in oxygenation index or functional residual capacity between patients given 80% and 30% oxygen for a period of approximately 5 hours. Trial registration ClinicalTrials.gov Identifier: NCT00637936.

  6. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial

    Directory of Open Access Journals (Sweden)

    Ashish Ganjare

    2013-01-01

    Full Text Available Background: Postoperative nausea and vomiting (PONV are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine 3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron. Methods: This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO 2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis. Results: The demographics were similar in both groups. The incidence of significant QTc prolongation was signi