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Sample records for surgery trials sst

  1. Clinical Trials in Surgery

    African Journals Online (AJOL)

    The ANNALS of AFRICAN SURGERY | www.sskenya.org/journal. The ANNALS of ... by two different experiments on small pox by Lady. Mary Wortley Montagu and ... through their 'animal magnetism' were nothing more than an expensive ...

  2. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  3. NCEP SST Analysis

    Science.gov (United States)

    Organization Search Go Search Polar Go MMAB SST Analysis Main page About MMAB Our Mission Our Personnel EMC Branches Global Climate & Weather Modeling Mesoscale Modeling Marine Modeling and Analysis Contact EMC (RTG_SST_HR) analysis For a regional map, click the desired area in the global SST analysis and anomaly maps

  4. G1SST, 1km blended SST

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — A daily, global Sea Surface Temperature (SST) data set is produced at 1-km (also known as ultra-high resolution) by the JPL ROMS (Regional Ocean Modeling System)...

  5. 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.

  6. Patterns of recurrence after surgery alone versus preoperative chemoradiotherapy and surgery in the CROSS trials.

    Science.gov (United States)

    Oppedijk, Vera; van der Gaast, Ate; van Lanschot, Jan J B; van Hagen, Pieter; van Os, Rob; van Rij, Caroline M; van der Sangen, Maurice J; Beukema, Jannet C; Rütten, Heidi; Spruit, Patty H; Reinders, Janny G; Richel, Dick J; van Berge Henegouwen, Mark I; Hulshof, Maarten C C M

    2014-02-10

    To analyze recurrence patterns in patients with cancer of the esophagus or gastroesophageal junction treated with either preoperative chemoradiotherapy (CRT) plus surgery or surgery alone. Recurrence pattern was analyzed in patients from the previously published CROSS I and II trials in relation to radiation target volumes. CRT consisted of five weekly courses of paclitaxel and carboplatin combined with a concurrent radiation dose of 41.4 Gy in 1.8-Gy fractions to the tumor and pathologic lymph nodes with margin. Of the 422 patients included from 2001 to 2008, 418 were available for analysis. Histology was mostly adenocarcinoma (75%). Of the 374 patients who underwent resection, 86% were allocated to surgery and 92% to CRT plus surgery. On January 1, 2011, after a minimum follow-up of 24 months (median, 45 months), the overall recurrence rate in the surgery arm was 58% versus 35% in the CRT plus surgery arm. Preoperative CRT reduced locoregional recurrence (LRR) from 34% to 14% (P < .001) and peritoneal carcinomatosis from 14% to 4% (P < .001). There was a small but significant effect on hematogenous dissemination in favor of the CRT group (35% v 29%; P = .025). LRR occurred in 5% within the target volume, in 2% in the margins, and in 6% outside the radiation target volume. In 1%, the exact site in relation to the target volume was unclear. Only 1% had an isolated infield recurrence after CRT plus surgery. Preoperative CRT in patients with esophageal cancer reduced LRR and peritoneal carcinomatosis. Recurrence within the radiation target volume occurred in only 5%, mostly combined with outfield failures.

  7. [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.

  8. A randomized trial of laparoscopic versus open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Bonjer, H Jaap; Deijen, Charlotte L; Abis, Gabor A

    2015-01-01

    BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal ar...

  9. 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

  10. NOAA Optimum Interpolation (OI) SST V2

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The optimum interpolation (OI) sea surface temperature (SST) analysis is produced weekly on a one-degree grid. The analysis uses in situ and satellite SST's plus...

  11. 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.

  12. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial

    DEFF Research Database (Denmark)

    Vester-Andersen, Morten; Waldau, Tina; Wetterslev, Jørn

    2013-01-01

    ABSTRACT: BACKGROUND: Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality....... The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.Methods and design: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency...... laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure...

  13. 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 ...

  14. Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials.

    Science.gov (United States)

    Pitak-Arnnop, Poramate; Sader, Robert; Rapidis, Alexander D; Dhanuthai, Kittipong; Bauer, Ute; Herve, Chistian; Hemprich, Alexander

    2010-01-01

    Publication bias (PB) diminishes the full distribution of research, distorts and discredits the scientific record, and thus compromises evidence-based practice. The objective of this study was to analyse published controlled trials with regard to PB in leading oral and maxillofacial surgery (OMS) journals. All controlled trials published in the International Journal of Oral and Maxillofacial Surgery, Journal of Cranio-Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, and British Journal of Oral and Maxillofacial Surgery in 2008 were analysed for a primary outcome, country of authors, sample size, gender of the first author, funding source and location of the study. Of 952 published articles, 53 controlled trials (5.7%) were identified. The OMS journals preferentially published controlled trials with a positive outcome (77.4%) and from high-income countries (73.6%). Single-centred trials (86.8%) with low sample size (njournals should establish measures to eliminate PB to uphold scientific integrity. However, this study was an observation based on the published articles. An analysis of all submitted manuscripts would provide more accurate estimates of PB. Ethical considerations on PB are also discussed.

  15. 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...

  16. Cataract Surgery Outcomes in Uveitis: The Multicenter Uveitis Steroid Treatment Trial.

    Science.gov (United States)

    Sen, H Nida; Abreu, Francis M; Louis, Thomas A; Sugar, Elizabeth A; Altaweel, Michael M; Elner, Susan G; Holbrook, Janet T; Jabs, Douglas A; Kim, Rosa Y; Kempen, John H

    2016-01-01

    To assess the visual outcomes of cataract surgery in eyes that received fluocinolone acetonide implant or systemic therapy with oral corticosteroids and immunosuppression during the Multicenter Uveitis Steroid Treatment (MUST) Trial. Nested prospective cohort study of patients enrolled in a randomized clinical trial. Patients that underwent cataract surgery during the first 2 years of follow-up in the MUST Trial. Visual outcomes of cataract surgery were evaluated 3, 6, and 9 months after surgery using logarithmic visual acuity charts. Change in visual acuity over time was assessed using a mixed-effects model. Best-corrected visual acuity. After excluding eyes that underwent cataract surgery simultaneously with implant surgery, among the 479 eyes in the MUST Trial, 117 eyes (28 eyes in the systemic, 89 in the implant group) in 82 patients underwent cataract surgery during the first 2 years of follow-up. Overall, visual acuity increased by 23 letters from the preoperative visit to the 3-month visit (95% confidence interval [CI], 17-29 letters; P uveitis onset, and hypotony were associated with worse preoperative visual acuity (P 0.05, test of interaction). After adjusting for other risk factors, there was no significant difference in the improvement in visual acuity between the 2 treatment groups (implant vs. systemic therapy, 2 letters; 95% CI, -10 to 15 letters; P = 0.70). Cataract surgery resulted in substantial, sustained, and similar visual acuity improvement in the eyes of patients with uveitis treated with the fluocinolone acetonide implant or standard systemic therapy. Published by Elsevier Inc.

  17. 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.

  18. 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.

  19. The Challenges of Recruiting Patients into a Sham Surgery Trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer Borbjerg; Lohmander, Stefan; Roos, Ewa M.

    the challenges in recruiting patients into a placebo controlled surgical trial of arthroscopic partial meniscectomy. Materials and Methods Results presented are from an ongoing RCT where patients aged 35-55 with an MRI confirmed degenerative medial meniscus tear were randomized to arthroscopic partial...

  20. The first experiments in SST-1

    Science.gov (United States)

    Pradhan, S.; Khan, Z.; Tanna, V. L.; Sharma, A. N.; Doshi, K. J.; Prasad, U.; Masand, H.; Kumar, Aveg; Patel, K. B.; Bhandarkar, M. K.; Dhongde, J. R.; Shukla, B. K.; Mansuri, I. A.; Varadarajulu, A.; Khristi, Y. S.; Biswas, P.; Gupta, C. N.; Sharma, D. K.; Raval, D. C.; Srinivasan, R.; Pandya, S. P.; Atrey, P. K.; Sharma, P. K.; Patel, P. J.; Patel, H. S.; Santra, P.; Parekh, T. J.; Dhanani, K. R.; Paravastu, Y.; Pathan, F. S.; Chauhan, P. K.; Khan, M. S.; Tank, J. K.; Panchal, P. N.; Panchal, R. N.; Patel, R. J.; George, S.; Semwal, P.; Gupta, P.; Mahesuriya, G. I.; Sonara, D. P.; Jayswal, S. P.; Sharma, M.; Patel, J. C.; Varmora, P. P.; Patel, D. J.; Srikanth, G. L. N.; Christian, D. R.; Garg, A.; Bairagi, N.; Babu, G. R.; Panchal, A. G.; Vora, M. M.; Singh, A. K.; Sharma, R.; Raju, D.; Kulkarni, S. V.; Kumar, M.; Manchanda, R.; Joisa, S.; Tahiliani, K.; Pathak, S. K.; Patel, K. M.; Nimavat, H. D.; Shah, P. R.; Chudasma, H. H.; Raval, T. Y.; Sharma, A. L.; Ojha, A.; Parghi, B. R.; Banaudha, M.; Makwana, A. R.; Chowdhuri, M. B.; Ramaiya, N.; kumar, A.; Raval, J. V.; Gupta, S.; Purohit, S.; Kaur, R.; Adhiya, A. N.; Jha, R.; Kumar, S.; Nagora, U. C.; Siju, V.; Thomas, J.; Chaudhari, V. R.; Patel, K. G.; Ambulkar, K. K.; Dalakoti, S.; Virani, C. G.; Parmar, P. R.; Thakur, A. L.; Das, A.; Bora, D.; the SST-1 Team

    2015-10-01

    A steady state superconducting tokamak (SST-1) has been commissioned after the successful experimental and engineering validations of its critical sub-systems. During the ‘engineering validation phase’ of SST-1; the cryostat was demonstrated to be leak-tight in all operational scenarios, 80 K thermal shields were demonstrated to be uniformly cooled without regions of ‘thermal runaway and hot spots’, the superconducting toroidal field magnets were demonstrated to be cooled to their nominal operational conditions and charged up to 1.5 T of the field at the major radius. The engineering validations further demonstrated the assembled SST-1 machine shell to be a graded, stress-strain optimized and distributed thermo-mechanical device, apart from the integrated vacuum vessel being validated to be UHV compatible etc. Subsequently, ‘field error components’ in SST-1 were measured to be acceptable towards plasma discharges. A successful breakdown in SST-1 was obtained in SST-1 in June 2013 assisted with electron cyclotron pre-ionization in the second harmonic mode, thus marking the ‘first plasma’ in SST-1 and the arrival of SST-1 into the league of contemporary steady state devices. Subsequent to the first plasma, successful repeatable plasma start-ups with E ˜ 0.4 V m-1, and plasma current in excess of 70 kA for 400 ms assisted with electron cyclotron heating pre-ionization at a field of 1.5 T have so far been achieved in SST-1. Lengthening the plasma pulse duration with lower hybrid current drive, confinement and transport in SST-1 plasmas and magnetohydrodynamic activities typical to large aspect ratio SST-1 discharges are presently being investigated in SST-1. In parallel, SST-1 has uniquely demonstrated reliable cryo-stable high field operation of superconducting TF magnets in the two-phase cooling mode, operation of vapour-cooled current leads with cold gas instead of liquid helium and an order less dc joint resistance in superconducting magnet winding

  1. Sensitive study of the climatological SST by using ATSR global SST data sets

    Science.gov (United States)

    Xue, Yong; Lawrence, Sean P.; Llewellyn-Jones, David T.

    1995-12-01

    Climatological sea surface temperature (SST) is an initial step for global climate processing monitoring. A comparison has been made by using Oberhuber's SST data set and two years monthly averaged SST from ATSR thermal band data to force the OGCM. In the eastern Pacific Ocean, these make only a small difference to model SST. In the western Pacific Ocean, the use of Oberhuber's data set gives higher climatological SST than that using ATSR data. The SSTs were also simulated for 1992 using climatological SSTs from two years monthly averaged ATSR data and Oberhuber data. The forcing with SST from ATSR data was found to give better SST simulation than that from Oberhuber's data. Our study has confirmed that ATSR can provide accurate monthly averaged global SST for global climate processing monitoring.

  2. 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.

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

    NARCIS (Netherlands)

    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

  4. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  5. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer.

    Science.gov (United States)

    Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G

    2007-08-20

    We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

  6. 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

  7. Gas Fuelling System for SST-1Tokamak

    Science.gov (United States)

    Dhanani, Kalpesh; Raval, D. C.; Khan, Ziauddin; Semwal, Pratibha; George, Siju; Paravastu, Yuvakiran; Thankey, Prashant; Khan, M. S.; Pradhan, Subrata

    2017-04-01

    SST-1 Tokamak, the first Indian Steady-state Superconducting experimental device is at present under operation in the Institute for Plasma Research. For plasma break down & initiation, piezoelectric valve based gas feed system is implemented as a primary requirement due to its precise control, easy handling, low construction and maintenance cost and its flexibility in the selection of the working gas. Hydrogen gas feeding with piezoelectric valve is used in the SST-1 plasma experiments. The piezoelectric valves used in SST-1 are remotely driven by a PXI based platform and are calibrated before each SST-1 plasma operation with precise control. This paper will present the technical development and the results of the gas fuelling system of SST-1.

  8. Tissue engineering and surgery: from translational studies to human trials

    Directory of Open Access Journals (Sweden)

    Vranckx Jan Jeroen

    2017-06-01

    Full Text Available Tissue engineering was introduced as an innovative and promising field in the mid-1980s. The capacity of cells to migrate and proliferate in growth-inducing medium induced great expectancies on generating custom-shaped bioconstructs for tissue regeneration. Tissue engineering represents a unique multidisciplinary translational forum where the principles of biomaterial engineering, the molecular biology of cells and genes, and the clinical sciences of reconstruction would interact intensively through the combined efforts of scientists, engineers, and clinicians. The anticipated possibilities of cell engineering, matrix development, and growth factor therapies are extensive and would largely expand our clinical reconstructive armamentarium. Application of proangiogenic proteins may stimulate wound repair, restore avascular wound beds, or reverse hypoxia in flaps. Autologous cells procured from biopsies may generate an ‘autologous’ dermal and epidermal laminated cover on extensive burn wounds. Three-dimensional printing may generate ‘custom-made’ preshaped scaffolds – shaped as a nose, an ear, or a mandible – in which these cells can be seeded. The paucity of optimal donor tissues may be solved with off-the-shelf tissues using tissue engineering strategies. However, despite the expectations, the speed of translation of in vitro tissue engineering sciences into clinical reality is very slow due to the intrinsic complexity of human tissues. This review focuses on the transition from translational protocols towards current clinical applications of tissue engineering strategies in surgery.

  9. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO).

    Science.gov (United States)

    Liu, Tianyu; Congdon, Nathan; Yan, Xixi; Jin, Ling; Wu, Ying; Friedman, David; He, Mingguang

    2012-08-13

    To evaluate an educational intervention promoting acceptance of cataract surgery in rural China using a randomized controlled design. Patients aged 50 years or older with presenting visual acuity (PVA) less than 6/18 in one or both eyes due to cataract were recruited from 26 screening sessions (13 intervention, 13 control) conducted by five rural hospitals in Guangdong, China. At intervention sessions, subjects were shown a 5-minute informational video, and counseled about cataract, surgery, and surgical cost. During screening, all subjects answered questionnaires on knowledge and attitudes about cataract, their finances, and transportation, and were referred for definitive examination if eligible. Study outcomes were acceptance of surgery (principal outcome) and hospital follow-up. Subjects in the intervention group were younger than controls (P = 0.01), but the groups did not otherwise differ. Among 212 intervention patients and 222 controls, no differences in knowledge and attitude regarding cataract were found. Surgery was accepted by 31.1% of intervention patients and 34.2% of controls (P > 0.50). Predictors of acceptance included younger age, worse logMAR PVA, knowing that cataract can be treated surgically only, greater anticipated loss in income from hospitalization, and greater house floor space per person. Membership in the intervention group was not associated with accepting surgery (odds ratio [OR] = 1.11, 95% confidence interval [CI] 0.67-1.84) or hospital follow-up (OR = 1.03, 95% CI = 0.63-1.67). Educational interventions that successfully impart the knowledge that cataract can be only treated surgically may be more effective in increasing uptake in this setting. (ClinicalTrials.gov number, NCT01123928.).

  10. Putting the baby back in the bathwater: the interpretation of randomised trials in surgery.

    Science.gov (United States)

    Gandhi, R; Perruccio, A V; Kakar, S; Haddad, F S

    2015-11-01

    Recently, several high impact randomised controlled trials have been published suggesting no greater benefit from orthopaedic surgery over conservative treatment, or limited surgical intervention. These studies can have profound effects on clinical practice, leading to the abandonment of previously widely-used operations. How do surgeons who believe these operations are beneficial over conservative treatment rationalise these findings, and justify their use with hospital administrators and health care funders who require evidence for the value and efficacy of surgical treatment? ©2015 The British Editorial Society of Bone & Joint Surgery.

  11. Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Björn Stessel, MD

    2014-12-01

    Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

  12. 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.

  13. 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

  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. 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.

  16. Optimization design for SST-1 Tokamak insulators

    International Nuclear Information System (INIS)

    Zhang Yuanbin; Pan Wanjiang

    2012-01-01

    With the help of ANSYS FEA technique, high voltage and cryogenic proper- ties of the SST-1 Tokamak insulators were obtained, and the structure of the insulators was designed and modified by taking into account the simulation results. The simulation results indicate that the optimization structure has better high voltage insulating property and cryogenic mechanics property, and also can fulfill the qualification criteria of the SST-1 Tokamak insulators. (authors)

  17. 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....

  18. Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial).

    NARCIS (Netherlands)

    Wind, J.; Hofland, J.; Preckel, B.; Hollman, M.W.; Bossuyt, P.M.M.; Gouma, D.J.; Berge Henegouwen, M.I.; Fuhring, J.W.; Dejong, C.H.C.; Dam, R.M. van; Cuesta, M.A.; Noordhuis, A.; Jong, D. de; Zalingen, E. van; Engel, A.F.; Goei, T.H.; Stoppelaar, I.E. de; Tets, W.F. van; Wagensveld, B.A. van; Swart, A.; Elsen, M.J.L.J. van den; Gerhards, M.F.; Wit, L.Th. De; Siepel, M.A.M.; Geloven, A.A.W. van; Juttmann, J.-W.; Clevers, J.C.; Bemelman, W.A.

    2006-01-01

    BACKGROUND: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay.The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst

  19. Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial)

    NARCIS (Netherlands)

    Wind, Jan; Hofland, Jan; Preckel, Benedikt; Hollmann, Markus W.; Bossuyt, Patrick M. M.; Gouma, Dirk J.; van Berge Henegouwen, Mark I.; Fuhring, Jan Willem; Dejong, Cornelis H. C.; van Dam, Ronald M.; Cuesta, Miguel A.; Noordhuis, Astrid; de Jong, Dick; van Zalingen, Edith; Engel, Alexander F.; Goei, T. Hauwy; de Stoppelaar, I. Erica; van Tets, Willem F.; van Wagensveld, Bart A.; Swart, Annemiek; van den Elsen, Maarten J. L. J.; Gerhards, Michael F.; de Wit, Laurens Th; Siepel, Muriel A. M.; van Geloven, Anna A. W.; Juttmann, Jan-Willem; Clevers, Wilfred; Bemelman, Willem A.

    2006-01-01

    BACKGROUND: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay.The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst

  20. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  1. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

    Directory of Open Access Journals (Sweden)

    McDonald AM

    2011-02-01

    Full Text Available Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons; plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists; three focus groups with anaesthetists (one national, two regional; 58 anaesthetists; two focus groups with members of the patient organisation Arthritis Care (7 participants; telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants; interviews with Chairs of UK ethics committees (6 individuals; postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists; two centre pilot (49 patients assessed. Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions proved easier than the method of anaesthesia (general anaesthesia. General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about

  2. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  3. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

    Science.gov (United States)

    Wentworth, John M; Playfair, Julie; Laurie, Cheryl; Ritchie, Matthew E; Brown, Wendy A; Burton, Paul; Shaw, Jonathan E; O'Brien, Paul E

    2014-07-01

    Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile

  4. 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

  5. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

    Directory of Open Access Journals (Sweden)

    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  6. 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

  7. 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.

  8. Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility.

    Science.gov (United States)

    Campbell, M K; Entwistle, V A; Cuthbertson, B H; Skea, Z C; Sutherland, A G; McDonald, A M; Norrie, J D; Carlson, R V; Bridgman, S

    2011-02-21

    Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this

  9. Gas fueling system for SST-1

    International Nuclear Information System (INIS)

    Dhanani, Kalpeshkumar R.; Khan, Ziauddin; Raval, Dilip; Semwal, Pratibha; George, Siju; Paravastu, Yuvakiran; Thankey, Prashant; Khan, Mohammad Shoaib; Pradhan, Subrata

    2015-01-01

    SST-1 Tokamak, the first Indian Steady-state Superconducting experimental device is at present under operation in Institute for Plasma Research. For plasma break down and initiation, the piezoelectric valve based gas feed system is implemented as primary requirement due to its precise control, easy handling, low costs for both construction and maintenance and its flexibility in working gas selection. The main functions of SST-1 gas feed system are to feed the required amount of ultrahigh purity hydrogen gas for specified period into the vessel during plasma operation and ultrahigh helium gas for glow discharge cleaning. In addition to these facilities, the gas feed system is used to feed a mixture gas of hydrogen and helium as well as other gases like nitrogen and Argon during divertor cooling etc. The piezoelectric valves used in SST-1 are remotely driven by a PXI based platform and are calibrated before the plasma operation during each SST-1 plasma operation with precise control. This paper will present the technical development and the results of gas fueling in SST-1. (author)

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

    Science.gov (United States)

    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. 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

  12. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål

    2017-01-01

    BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were...... undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born...

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. Effect of Oral Lactoferrin on Cataract Surgery Induced Dry Eye: A Randomised Controlled Trial.

    Science.gov (United States)

    Devendra, Jaya; Singh, Sneha

    2015-10-01

    Cataract surgery is one of the most frequently performed intra-ocular surgeries, of these manual Small Incision Cataract Surgery (SICS) is a time tested technique of cataract removal. Any corneal incisional surgery, including cataract surgery, can induce dry eye postoperatively. Various factors have been implicated, of which oneis the inflammation induced by the surgery. Lactoferrin, a glycoprotein present in tears is said to have anti-inflammatory effects, and promotes cell growth. It has been used orally in patients of immune mediated dry eye to alleviate symptoms. This study was aimed to evaluate the dry eyes induced by manual Small Incision Cataract Surgery, and the effect if any, of oral lactoferrin on the dry eyes. A single centre, prospective randomised controlled trial with a concurrent parallel design. The study was carried out on patients presenting in the OPD of Rohilkhand Medical College hospital for cataract surgery. Sixty four patients of cataract surgery were included in the study. Patients with pre-existing dry eyes, ocular disease or systemic disease predisposing to dry eyes were excluded from the study. The selected patients were assigned into two groups by simple randomisation-Control Group A-32 patients that did not receive oral lactoferrin postoperatively. Group B-32 patients that received oral lactoferrin 350 gm postoperatively from day 1 after SICS. All patients were operated for cataract and their pre and postoperative (on days 7, 14, 30 and 60) dry eye status was assessed using the mean tear film break-up time (tBUT) and Schirmer test 1 (ST 1) as the evaluating parameters. Subjective evaluation of dry eye was done using Ocular Surface Disease Index (OSDI) scoring. Data was analysed for 58 patients, as 6 did not complete the follow up. Unpaired t-test was used to calculate the p-values. There was a statistically significant difference between the tBUT values of the Control and Lactoferrin group from day 14 onwards. The tBUT of control group

  18. Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

    Science.gov (United States)

    Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

    2018-02-22

    Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The

  19. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  20. 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.

  1. 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.

  2. Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    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.

  3. Plasma position control in SST1 tokamak

    Indian Academy of Sciences (India)

    also placed inside the vessel, however the controller would ignore fast but insignificant changes in radius arising ... poloidal cross-sectional view of the SST1 plasma along with the stabilizers are shown in figure 1 and ... [1] model which has shown excellent agreement with control experiments in TCV tokamak and also with ...

  4. Improved VIIRS and MODIS SST Imagery

    Directory of Open Access Journals (Sweden)

    Irina Gladkova

    2016-01-01

    Full Text Available Moderate Resolution Imaging Spectroradiometers (MODIS and Visible Infrared Imaging Radiometer Suite (VIIRS radiometers, flown onboard Terra/Aqua and Suomi National Polar-orbiting Partnership (S-NPP/Joint Polar Satellite System (JPSS satellites, are capable of providing superior sea surface temperature (SST imagery. However, the swath data of these multi-detector sensors are subject to several artifacts including bow-tie distortions and striping, and require special pre-processing steps. VIIRS additionally does two irreversible data reduction steps onboard: pixel aggregation (to reduce resolution changes across the swath and pixel deletion, which complicate both bow-tie correction and destriping. While destriping was addressed elsewhere, this paper describes an algorithm, adopted in the National Oceanic and Atmospheric Administration (NOAA Advanced Clear-Sky Processor for Oceans (ACSPO SST system, to minimize the bow-tie artifacts in the SST imagery and facilitate application of the pattern recognition algorithms for improved separation of ocean from cloud and mapping fine SST structure, especially in the dynamic, coastal and high-latitude regions of the ocean. The algorithm is based on a computationally fast re-sampling procedure that ensures a continuity of corresponding latitude and longitude arrays. Potentially, Level 1.5 products may be generated to benefit a wide range of MODIS and VIIRS users in land, ocean, cryosphere, and atmosphere remote sensing.

  5. Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial

    Directory of Open Access Journals (Sweden)

    Swart Annemiek

    2006-11-01

    Full Text Available Abstract Background Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease. Methods/design The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a, open colectomy with fast track program (b, laparoscopic colectomy with standard care (c, and laparoscopic surgery with fast track program (d. Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8. With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36 questionnaire and social functioning can be detected. Discussion The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in

  6. 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.

  7. GHRSST Level 2P European Medspiration NAR16 SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — The EUMETSAT OSI-SAF NAR SST products are SST fields derived from NOAA/AVHRR data and available over 6 pre-defined zones, 4 times per day. After acquisition and...

  8. GHRSST Level 2P European Medspiration NAR18 SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — The EUMETSAT OSI-SAF NAR SST products are SST fields derived from NOAA/AVHRR data and available over 6 pre-defined zones, 4 times per day. After acquisition and...

  9. GHRSST Level 2P European Medspiration NAR17 SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — The EUMETSAT OSI-SAF NAR SST products are SST fields derived from NOAA/AVHRR data and available over 6 pre-defined zones, 4 times per day. After acquisition and...

  10. Meta-analysis of randomized trials of effect of milrinone on mortality in cardiac surgery: an update.

    Science.gov (United States)

    Majure, David T; Greco, Teresa; Greco, Massimiliano; Ponschab, Martin; Biondi-Zoccai, Giuseppe; Zangrillo, Alberto; Landoni, Giovanni

    2013-04-01

    The long-term use of milrinone is associated with increased mortality in chronic heart failure. A recent meta-analysis suggested that it might increase mortality in patients undergoing cardiac surgery. The authors conducted an updated meta-analysis of randomized trials in patients undergoing cardiac surgery to determine if milrinone impacted survival. A meta-analysis. Hospitals. One thousand thirty-seven patients from 20 randomized trials. None. Biomed, Central, PubMed, EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in adult and pediatric patients undergoing cardiac surgery. Authors of trials that did not include mortality data were contacted. Only trials for which mortality data were available were included. Overall analysis showed no difference in mortality between patients receiving milrinone versus control (12/554 [2.2%] in the milrinone group v 10/483 [2.1%] in the control arm; relative risk [RR] = 1.15; 95% confidence interval [CI], 0.55-2.43; p = 0.7) or in analysis restricted to adults (11/364 [3%] in the milrinone group v 9/371 [2.4%] in the control arm; RR = 1.17; 95% CI, 0.54-2.53; p = 0.7). Sensitivity analyses in trials with a low risk of bias showed a trend toward an increase in mortality with milrinone (8/153 [5.2%] in the milrinone arm v 2/152 [1.3%] in the control arm; RR = 2.71; 95% CI, 0.82-9; p for effect = 0.10). Despite theoretic concerns for increased mortality with intravenous milrinone in patients undergoing cardiac surgery, the authors were unable to confirm an adverse effect on survival. However, sensitivity analysis of high-quality trials showed a trend toward increased mortality with milrinone. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. 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

    2018-01-01

    Abstract OBJECTIVES 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. METHODS 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. RESULTS 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%). CONCLUSIONS 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. PMID:29186478

  12. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP...... cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children......) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10...

  13. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

    Directory of Open Access Journals (Sweden)

    Beyer-Westendorf J

    2017-01-01

    Full Text Available Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3 1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use. Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

  14. 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

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

    Science.gov (United States)

    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.

  16. [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.

  17. 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.

  18. 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.

  19. Immunohistochemical detection of somatostatin receptor subtypes sst1 and sst2A in human somatostatin receptor positive tumors

    NARCIS (Netherlands)

    L.J. Hofland (Leo); Q. Liu; P.M. van Koetsveld (Peter); J. Zuijderwijk; F. van der Ham (Frieda); R.R. de Krijger (Ronald); A. Schonbrunn; S.W.J. Lamberts (Steven)

    1999-01-01

    textabstractAlthough in situ hybridization has been used to examine the distribution of messenger RNA for somatostatin receptor subtypes (sst) in human tumors, the cellular localization of sst1 and sst2A receptors has not been reported. In this study, we describe the

  20. SST: Single-Stream Temporal Action Proposals

    KAUST Repository

    Buch, Shyamal; Escorcia, Victor; Shen, Chuanqi; Ghanem, Bernard; Niebles, Juan Carlos

    2017-01-01

    Our paper presents a new approach for temporal detection of human actions in long, untrimmed video sequences. We introduce Single-Stream Temporal Action Proposals (SST), a new effective and efficient deep architecture for the generation of temporal action proposals. Our network can run continuously in a single stream over very long input video sequences, without the need to divide input into short overlapping clips or temporal windows for batch processing. We demonstrate empirically that our model outperforms the state-of-the-art on the task of temporal action proposal generation, while achieving some of the fastest processing speeds in the literature. Finally, we demonstrate that using SST proposals in conjunction with existing action classifiers results in improved state-of-the-art temporal action detection performance.

  1. SST: Single-Stream Temporal Action Proposals

    KAUST Repository

    Buch, Shyamal

    2017-11-09

    Our paper presents a new approach for temporal detection of human actions in long, untrimmed video sequences. We introduce Single-Stream Temporal Action Proposals (SST), a new effective and efficient deep architecture for the generation of temporal action proposals. Our network can run continuously in a single stream over very long input video sequences, without the need to divide input into short overlapping clips or temporal windows for batch processing. We demonstrate empirically that our model outperforms the state-of-the-art on the task of temporal action proposal generation, while achieving some of the fastest processing speeds in the literature. Finally, we demonstrate that using SST proposals in conjunction with existing action classifiers results in improved state-of-the-art temporal action detection performance.

  2. 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.

  3. First experiments with SST-1 tokamak

    International Nuclear Information System (INIS)

    Saxena, Y.C.

    2005-01-01

    SST-1, a steady state superconducting tokamak, is undergoing commissioning tests at the Institute for Plasma Research. The objectives of SST-1 include studying the physics of the plasma processes in a tokamak under steady state conditions and learning technologies related to the steady state operation of the tokamak. These studies are expected to contribute to the tokamak physics database for very long pulse operations. Superconducting (SC) magnets are deployed for both the toroidal and poloidal field coils in SST-1. An Ohmic transformer is provided for plasma breakdown and initial current ramp up. SST-1 deploys a fully welded ultra high vacuum vessel. Liquid nitrogen cooled radiation shield are deployed between the vacuum vessel and SC magnets as well as SC magnets and cryostat, to minimize the radiation losses at the SC magnets. The auxiliary current drive is based on 1.0 MW of Lower Hybrid current drive (LHCD) at 3.7 GHz. Auxiliary heating systems include 1 MW of Ion Cyclotron Resonance Frequency system (ICRF) at 22 MHz to 91 MHz, 0.2 MW of Electron Cyclotron Resonance heating at 84 GHz and a Neutral Beam Injection (NBI) system with peak power of 0.8 MW (at 80 keV) with variable beam energy in range of 10-80 keV. The ICRF system would also be used for initial breakdown and wall conditioning experiments. Detailed commissioning tests on the cryogenic system and experiments on the hydraulic characters and cool down features of single TF coils have been completed prior to the cool down of the entire superconducting system. Results of the single TF magnet cool down, and testing of the magnet system are presented. First experiments related to the breakdown and the current ramp up will subsequently be carried out. (author)

  4. 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

  5. Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy (‘SMART’ Trial: a randomised trial

    Directory of Open Access Journals (Sweden)

    Md Ali Katijjahbe

    2018-04-01

    Full Text Available Question: In people who have undergone cardiac surgery via median sternotomy, does modifying usual sternal precautions to make them less restrictive improve physical function, pain, kinesiophobia and health-related quality of life? Design: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. Participants: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included. Intervention: Participants were randomly allocated to one of two groups at 4 (SD 1 days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions. The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks. Outcome measures: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded. Results: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI –0.2 to 2.3 and 12 weeks (MD 0.4, 95% CI –0.9 to 1.6 postoperatively. There were no statistically significant between-group differences in secondary outcomes. Conclusion: Modified (ie, less restrictive sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with

  6. 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)....

  7. 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

    analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267.

  8. Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

    Science.gov (United States)

    Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

    New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

  9. 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

  10. 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

  11. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  12. Cognitive training for technical and non-technical skills in robotic surgery: a randomised controlled trial.

    Science.gov (United States)

    Raison, Nicholas; Ahmed, Kamran; Abe, Takashige; Brunckhorst, Oliver; Novara, Giacomo; Buffi, Nicolò; McIlhenny, Craig; van der Poel, Henk; van Hemelrijck, Mieke; Gavazzi, Andrea; Dasgupta, Prokar

    2018-05-07

    To investigate the effectiveness of motor imagery (MI) for technical skill and non-technical skill (NTS) training in minimally invasive surgery (MIS). A single-blind, parallel-group randomised controlled trial was conducted at the Vattikuti Institute of Robotic Surgery, King's College London. Novice surgeons were recruited by open invitation in 2015. After basic robotic skills training, participants underwent simple randomisation to either MI training or standard training. All participants completed a robotic urethrovesical anastomosis task within a simulated operating room. In addition to the technical task, participants were required to manage three scripted NTS scenarios. Assessment was performed by five blinded expert surgeons and a NTS expert using validated tools for evaluating technical skills [Global Evaluative Assessment of Robotic Skills (GEARS)] and NTS [Non-Technical Skills for Surgeons (NOTSS)]. Quality of MI was assessed using a revised Movement Imagery Questionnaire (MIQ). In all, 33 participants underwent MI training and 29 underwent standard training. Interrater reliability was high, Krippendorff's α = 0.85. After MI training, the mean (sd) GEARS score was significantly higher than after standard training, at 13.1 (3.25) vs 11.4 (2.97) (P = 0.03). There was no difference in mean NOTSS scores, at 25.8 vs 26.4 (P = 0.77). MI training was successful with significantly higher imagery scores than standard training (mean MIQ score 5.1 vs 4.5, P = 0.04). Motor imagery is an effective training tool for improving technical skill in MIS even in novice participants. No beneficial effect for NTS was found. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

  13. 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.

  14. 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.

  15. Assessment of Global Forecast Ocean Assimilation Model (FOAM) using new satellite SST data

    Science.gov (United States)

    Ascione Kenov, Isabella; Sykes, Peter; Fiedler, Emma; McConnell, Niall; Ryan, Andrew; Maksymczuk, Jan

    2016-04-01

    There is an increased demand for accurate ocean weather information for applications in the field of marine safety and navigation, water quality, offshore commercial operations, monitoring of oil spills and pollutants, among others. The Met Office, UK, provides ocean forecasts to customers from governmental, commercial and ecological sectors using the Global Forecast Ocean Assimilation Model (FOAM), an operational modelling system which covers the global ocean and runs daily, using the NEMO (Nucleus for European Modelling of the Ocean) ocean model with horizontal resolution of 1/4° and 75 vertical levels. The system assimilates salinity and temperature profiles, sea surface temperature (SST), sea surface height (SSH), and sea ice concentration observations on a daily basis. In this study, the FOAM system is updated to assimilate Advanced Microwave Scanning Radiometer 2 (AMSR2) and the Spinning Enhanced Visible and Infrared Imager (SEVIRI) SST data. Model results from one month trials are assessed against observations using verification tools which provide a quantitative description of model performance and error, based on statistical metrics, including mean error, root mean square error (RMSE), correlation coefficient, and Taylor diagrams. A series of hindcast experiments is used to run the FOAM system with AMSR2 and SEVIRI SST data, using a control run for comparison. Results show that all trials perform well on the global ocean and that largest SST mean errors were found in the Southern hemisphere. The geographic distribution of the model error for SST and temperature profiles are discussed using statistical metrics evaluated over sub-regions of the global ocean.

  16. 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

  17. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

    International Nuclear Information System (INIS)

    Borstlap, W. A. A.; Tanis, P. J.; Koedam, T. W. A.; Marijnen, C. A. M.; Cunningham, C.

    2016-01-01

    Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5–20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion

  18. 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.

  19. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  20. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

    Science.gov (United States)

    Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

    2013-11-01

    After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus

  1. 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

  2. Assessment of Patient-Specific Surgery Effect Based on Weighted Estimation and Propensity Scoring in the Re-Analysis of the Sciatica Trial

    Science.gov (United States)

    Mertens, Bart J. A.; Jacobs, Wilco C. H.; Brand, Ronald; Peul, Wilco C.

    2014-01-01

    We consider a re-analysis of the wait-and-see (control) arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery. PMID:25353633

  3. Assessment of patient-specific surgery effect based on weighted estimation and propensity scoring in the re-analysis of the sciatica trial.

    Directory of Open Access Journals (Sweden)

    Bart J A Mertens

    Full Text Available We consider a re-analysis of the wait-and-see (control arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery.

  4. Operation of SST-1 TF power supply during SST-1 campaigns

    International Nuclear Information System (INIS)

    Sharma, Dinesh Kumar; Vora, Murtuza M.; Ojha, Amit; Singh, Akhilesh Kumar; Bhavsar, Chirag

    2015-01-01

    Highlights: • SST-1 TF power supply is 12 pulse SCR converter circuit. • TF power supply protection, measurement and control scheme are explained. • Quench, emergency and normal shot process is explained and results of SST-1 campaigns are shown. • Dynamic control of TF current. • The paper shows the results of last ten SST-1 campaigns. - Abstract: SST-1 TF power supply provides the direct current for the required magnetic field of TF coil. TF power supply includes transformer, 12-pulse converter, bus bar, water-cooled cable, protection and measuring equipments, and isolator, VME DAC system and GUI software. TF power supply is operated through GUI software built in TCL/Tk. VME DAC system monitors the parameters, provides On/Off commands, voltage and current references and initiates predefined reference to emergency shutdown. The emergency shutdown is hardwired to TF power supply from central control. During quench power supply converter opens DCCB and dump resistor is connected in the circuit and VME DAC system acquires bus bar voltage, dump voltage and dump current. Operation of TF power supply also requires monitoring of SCR and transformer temperature and water flow rate of water-cooled cable during high current long pulse shot. Before start up of TF power supply a quench simulation is performed to check the readiness of protection. This paper describes pre startup operation, normal shot operation, emergency and quench process, dynamic control and complete shutdown operation of TF power supply.

  5. Operation of SST-1 TF power supply during SST-1 campaigns

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, Dinesh Kumar, E-mail: dinesh@ipr.res.in; Vora, Murtuza M.; Ojha, Amit; Singh, Akhilesh Kumar; Bhavsar, Chirag

    2015-10-15

    Highlights: • SST-1 TF power supply is 12 pulse SCR converter circuit. • TF power supply protection, measurement and control scheme are explained. • Quench, emergency and normal shot process is explained and results of SST-1 campaigns are shown. • Dynamic control of TF current. • The paper shows the results of last ten SST-1 campaigns. - Abstract: SST-1 TF power supply provides the direct current for the required magnetic field of TF coil. TF power supply includes transformer, 12-pulse converter, bus bar, water-cooled cable, protection and measuring equipments, and isolator, VME DAC system and GUI software. TF power supply is operated through GUI software built in TCL/Tk. VME DAC system monitors the parameters, provides On/Off commands, voltage and current references and initiates predefined reference to emergency shutdown. The emergency shutdown is hardwired to TF power supply from central control. During quench power supply converter opens DCCB and dump resistor is connected in the circuit and VME DAC system acquires bus bar voltage, dump voltage and dump current. Operation of TF power supply also requires monitoring of SCR and transformer temperature and water flow rate of water-cooled cable during high current long pulse shot. Before start up of TF power supply a quench simulation is performed to check the readiness of protection. This paper describes pre startup operation, normal shot operation, emergency and quench process, dynamic control and complete shutdown operation of TF power supply.

  6. 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.

  7. Marginal artery stump pressure in left colic artery-preserving rectal cancer surgery: a clinical trial.

    Science.gov (United States)

    Guo, Yuchen; Wang, Daguang; He, Liang; Zhang, Yang; Zhao, Shishun; Zhang, Luyao; Sun, Xuan; Suo, Jian

    2017-07-01

    The aim of this clinical trial is to evaluate the influence of high and low ligation of the inferior mesenteric artery with apical lymph node dissection on the anastomotic blood supply, lymph node retrieval rate, operative time and anastomotic leakage rate in rectal cancer surgery. A total of 57 Chinese patients were randomly distributed into group A and group B and underwent radical resection of rectal cancer. Patients in group A underwent high ligation of the inferior mesenteric artery, and patients in group B underwent apical lymph node resection around the root of the inferior mesenteric artery with preservation of the left colic artery. The marginal artery stump pressure was measured after colon and artery reconstruction. Systemic pressure, distal colon length, operative time and lymph node retrieval rate were measured and recorded. The results were analysed and related to patient characteristics and post-operative complications. The anastomotic blood supply negatively and linearly correlated with age and distal colon length and showed a positive linear correlation with systemic pressure. Patients who received low ligation with apical lymph node dissection had a better anastomotic blood supply than those who received high ligation. No differences were found in lymph node retrieval rate, operative time and anastomotic leakage rate. Anastomotic leakage was associated with a worse anastomotic blood supply. Low ligation with apical lymph node dissection in rectal cancer treatment provides better anastomotic blood supply but is not associated with differences in node retrieval rate or operation time. © 2015 Royal Australasian College of Surgeons.

  8. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Constable, Lynda; Cotterill, Nikki; Cooper, David; Glazener, Cathryn; Drake, Marcus J; Forrest, Mark; Harding, Chris; Kilonzo, Mary; MacLennan, Graeme; McCormack, Kirsty; McDonald, Alison; Mundy, Anthony; Norrie, John; Pickard, Robert; Ramsay, Craig; Smith, Rebecca; Wileman, Samantha; Abrams, Paul

    2018-02-21

    Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to

  9. General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial.

    Science.gov (United States)

    Purwar, B; Ismail, K M; Turner, N; Farrell, A; Verzune, M; Annappa, M; Smith, I; El-Gizawy, Zeiad; Cooper, J C

    2015-08-01

    Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient's subjective perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

  10. Overview of data acquisition system for SST-1 diagnostics

    International Nuclear Information System (INIS)

    Sharma, Manika; Mansuri, Imran; Raval, Tushar; Sharma, A.L; Pradhan, S.

    2016-01-01

    Highlights: • An account of architecture and data acquisition activities of SST-1 data acquisition system (DAS) for SST-1 diagnostics and subsystems. • PXI based Data acquisition system and CAMAC based Data acquisition system for slow and fast plasma diagnostics. • SST-1 DAS interface and its communication with SST-1 central control system. Integration of SST-1 DAS with timing system. • SST-1 DAS data archival and data analysis. - Abstract: The recent first phase operations of SST-1 in short pulse mode have provided an excellent opportunity for the essential initial tests and benchmark of the SST-1 Data Acquisition System. This paper describes the SST-1 Data Acquisition systems (DAS), which with its heterogeneous composition and distributed architecture, aims to cover a wide range of slow to fast channels interfaced with a large set of diagnostics. The DAS also provides the essential user interface for data acquisition to cater both on and off-line data usage. The central archiving and retrieval service is based on a dual step architecture involving a combination of Network Attached Server (NAS) and a Storage Area Network (SAN). SST-1 Data Acquisition Systems have been reliably operated in the SST-1 experimental campaigns. At present different distributed DAS caters the need of around 130 channels from different SST-1 diagnostics and its subsystems. PXI based DAS and CAMAC based DAS have been chosen to cater the need, with sampling rates varying from 10Ksamples/sec to 1Msamples/sec. For these large sets of channels acquiring from individual diagnostics and subsystems has been a combined setup, subjected to a gradual phase of optimization and tests resulting into a series of improvisations over the recent operations. In order to facilitate a reliable data acquisition, the model further integrates the objects of the systems with the Central Control System of SST-1 using the TCP/IP communication. The associated DAS software essentially addresses the

  11. Overview of data acquisition system for SST-1 diagnostics

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, Manika, E-mail: bithi@ipr.res.in; Mansuri, Imran; Raval, Tushar; Sharma, A.L; Pradhan, S.

    2016-11-15

    Highlights: • An account of architecture and data acquisition activities of SST-1 data acquisition system (DAS) for SST-1 diagnostics and subsystems. • PXI based Data acquisition system and CAMAC based Data acquisition system for slow and fast plasma diagnostics. • SST-1 DAS interface and its communication with SST-1 central control system. Integration of SST-1 DAS with timing system. • SST-1 DAS data archival and data analysis. - Abstract: The recent first phase operations of SST-1 in short pulse mode have provided an excellent opportunity for the essential initial tests and benchmark of the SST-1 Data Acquisition System. This paper describes the SST-1 Data Acquisition systems (DAS), which with its heterogeneous composition and distributed architecture, aims to cover a wide range of slow to fast channels interfaced with a large set of diagnostics. The DAS also provides the essential user interface for data acquisition to cater both on and off-line data usage. The central archiving and retrieval service is based on a dual step architecture involving a combination of Network Attached Server (NAS) and a Storage Area Network (SAN). SST-1 Data Acquisition Systems have been reliably operated in the SST-1 experimental campaigns. At present different distributed DAS caters the need of around 130 channels from different SST-1 diagnostics and its subsystems. PXI based DAS and CAMAC based DAS have been chosen to cater the need, with sampling rates varying from 10Ksamples/sec to 1Msamples/sec. For these large sets of channels acquiring from individual diagnostics and subsystems has been a combined setup, subjected to a gradual phase of optimization and tests resulting into a series of improvisations over the recent operations. In order to facilitate a reliable data acquisition, the model further integrates the objects of the systems with the Central Control System of SST-1 using the TCP/IP communication. The associated DAS software essentially addresses the

  12. Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    2014-01-14

    E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

  13. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.

    Science.gov (United States)

    Semb, Gunvor; Enemark, Hans; Friede, Hans; Paulin, Gunnar; Lilja, Jan; Rautio, Jorma; Andersen, Mikael; Åbyholm, Frank; Lohmander, Anette; Shaw, William; Mølsted, Kirsten; Heliövaara, Arja; Bolund, Stig; Hukki, Jyri; Vindenes, Hallvard; Davenport, Peter; Arctander, Kjartan; Larson, Ola; Berggren, Anders; Whitby, David; Leonard, Alan; Neovius, Erik; Elander, Anna; Willadsen, Elisabeth; Bannister, R Patricia; Bradbury, Eileen; Henningsson, Gunilla; Persson, Christina; Eyres, Philip; Emborg, Berit; Kisling-Møller, Mia; Küseler, Annelise; Granhof Black, Birthe; Schöps, Antje; Bau, Anja; Boers, Maria; Andersen, Helene Søgaard; Jeppesen, Karin; Marxen, Dorte; Paaso, Marjukka; Hölttä, Elina; Alaluusua, Suvi; Turunen, Leena; Humerinta, Kirsti; Elfving-Little, Ulla; Tørdal, Inger Beate; Kjøll, Lillian; Aukner, Ragnhild; Hide, Øydis; Feragen, Kristin Billaud; Rønning, Elisabeth; Skaare, Pål; Brinck, Eli; Semmingsen, Ann-Magritt; Lindberg, Nina; Bowden, Melanie; Davies, Julie; Mooney, Jeanette; Bellardie, Haydn; Schofield, Nina; Nyberg, Jill; Lundberg, Maria; Karsten, Agneta Linder-Aronson; Larson, Margareta; Holmefjord, Anders; Reisæter, Sigvor; Pedersen, Nina-Helen; Rasmussen, Therese; Tindlund, Rolf; Sæle, Paul; Blomhoff, Reidunn; Jacobsen, Gry; Havstam, Christina; Rizell, Sara; Enocson, Lars; Hagberg, Catharina; Najar Chalien, Midia; Paganini, Anna; Lundeborg, Inger; Marcusson, Agneta; Mjönes, Anna-Britta; Gustavsson, Annica; Hayden, Christine; McAleer, Eilish; Slevan, Emma; Gregg, Terry; Worthington, Helen

    2017-02-01

    Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series. ISRCTN29932826.

  14. [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.

  15. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

    2014-05-02

    General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

  16. 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.

  17. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  18. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  19. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

    DEFF Research Database (Denmark)

    Skou, Soren Thorgaard; Lind, Martin; Holmich, Per

    2017-01-01

    INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger...... adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......: This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon...

  20. One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

    2016-02-17

    Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function

  1. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  2. EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme

    Directory of Open Access Journals (Sweden)

    Kennedy Robin H

    2012-05-01

    Full Text Available Abstract Background During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. Methods/design EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20 with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20

  3. 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.

  4. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marcelo Soares Privado

    Full Text Available CONTEXT AND OBJECTIVE: Controversy exists regarding the site of action of fentanyl after epidural injection. The objective of this investigation was to compare the efficacy of epidural and intravenous fentanyl for orthopedic surgery. DESIGN AND SETTING: A randomized double-blind study was performed in Hospital São Paulo. METHODS: During the postoperative period, in the presence of pain, 29 patients were divided into two groups: group 1 (n = 14 received 100 µg of fentanyl epidurally and 2 ml of saline intravenously; group 2 (n = 15 received 5 ml of saline epidurally and 100 µg of fentanyl intravenously. The analgesic supplementation consisted of 40 mg of tenoxicam intravenously and, if necessary, 5 ml of 0.25% bupivacaine epidurally. Pain intensity was evaluated on a numerical scale and plasma concentrations of fentanyl were measured simultaneously. RESULTS: The percentage of patients who required supplementary analgesia with tenoxicam was lower in group 1 (71.4% than in group 2 (100%: 95% confidence interval (CI = 0.001-0.4360 (P = 0.001, Fisher's exact test; relative risk, RR = 0.07. Epidural bupivacaine supplementation was also lower in group 1 (14.3% than in group 2 (53.3%: 95% CI = 0.06-1.05 (P = 0.03, Fisher's exact test; RR = 0.26. There was no difference in pain intensity on the numerical scale. Mean fentanyl plasma concentrations were similar in the two groups. CONCLUSION: Intravenous and epidural fentanyl appear to have similar efficacy for reducing pain according to the numerical scale, but supplementary analgesia was needed less frequently when epidural fentanyl was used. CLINICAL TRIAL REGISTRATION NUMBER: NCT00635986

  5. The role of internal limiting membrane peeling in epiretinal membrane surgery: a randomised controlled trial.

    Science.gov (United States)

    Tranos, Paris; Koukoula, Stavrenia; Charteris, Davic G; Perganda, Georgia; Vakalis, Athanasios; Asteriadis, Solon; Georgalas, Ilias; Petrou, Petros

    2017-06-01

    To compare the anatomical and functional outcomes after primary idiopathic epiretinal membrane (ERM) peeling with or without internal limiting membrane (ILM) peeling. A two-centre randomised, controlled clinical trial with 12 months of follow-up. One hundred and two eyes of 102 patients were included in the analysis and were randomised into two groups (ILM peeling (P) and non-ILM peeling (NP) group). Inclusion criteria were: Idiopathic ERM confirmed on optical coherence tomography, age ≥18 years, binocular distortion, best-corrected visual acuity (BCVA) ≤90 ETDRS letters, intraocular pressure ≤23 mm Hg and informed consent. The primary outcome measure was the mean change in the ETDRS distance BCVA at 12 months' follow-up for each group. The mean change in distance BCVA at 12 months was 0.30±0.24 logMAR (15 ETDRS letters) in the P group and 0.31±0.23 logMAR (14 ETDRS letters) in the NP group, a change that was not statistically significant (p=0.84). No statistically significant differences were observed when comparing the changes in distance BCVA, the changes in metamorphopsia (Amsler grid) and the changes in central retinal thickness between the two groups at any of the time points studied. Our analysis suggests that ILM peeling in idiopathic ERM surgery does not result in better visual improvement. The more frequent presence of an uninterrupted interdigitation zone in the P group did not result in a better functional outcome of our patients. No recurrent ERMs were noted in either group. 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/.

  6. Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial.

    Science.gov (United States)

    Esparza-Villalpando, Vicente; Chavarria-Bolaños, Daniel; Gordillo-Moscoso, Antonio; Masuoka-Ito, David; Martinez-Rider, Ricardo; Isiordia-Espinoza, Mario; Pozos-Guillen, Amaury

    2016-09-01

    The aim of this study was to compare the efficacy of preoperative and postoperative dexketoprofen trometamol for pain control after third molar surgery. Sixty subjects indicated for impacted mandibular third molar surgery were randomly assigned to two groups: preoperative (group 1, n = 30) and postoperative (group 2, n = 30) administration. Group 1 received 25 mg of dexketoprofen trometamol 30 min before surgery and 1 placebo capsule (same color and size with active drug) immediately after surgery. Group 2 received the placebo capsule 30 min before surgery and 25 mg of dexketoprofen trometamol immediately after surgery. Pain intensity was assessed using a numeric rating scale (NRS) during the first 8 h. The time of the need for a second dose of dexketoprofen trometamol, after the first administration, was recorded. The data were analyzed using mixed-model repeated-measures (MMRM), Wilcoxon rank-sum, and Kaplan-Meier analysis. After the 8 h period, no statistically significant difference was observed in the intensity of pain (MMRM, p = 0.41); and no significant difference in the time for a second dose (p = 0.956). In conclusion, preoperative administration of dexketoprofen trometamol is a reasonable clinical approach that is as effective as conventional postoperative pharmacological treatment, with the advantage of allowing early analgesia before pain develops. (ClinicalTrials.gov: NCT02380001). Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  7. 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."

  8. Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE)

    DEFF Research Database (Denmark)

    Duceppe, Emmanuelle; Yusuf, Salim; Tandon, Vikas

    2018-01-01

    BACKGROUND: Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral antico...

  9. The TaSST: Tactile Sleeve for Social Touch

    NARCIS (Netherlands)

    Huisman, G.; Darriba Frederiks, A.; van Dijk, B.; Heylen, D.; Kröse, B.

    2013-01-01

    In this paper we outline the design process of the TaSST (Tactile Sleeve for Social Touch), a touch-sensitive vibrotactile arm sleeve. The TaSST was designed to enable two people to communicate different types of touch over a distance. The touch-sensitive surface of the sleeve consists of a grid of

  10. The TaSST: Tactile sleeve for social touch

    NARCIS (Netherlands)

    Huisman, Gijs; Darriba Frederiks, Aduén; van Dijk, Elisabeth M.A.G.; Heylen, Dirk K.J.; Krose, Ben

    In this paper we outline the design process of the TaSST (Tactile Sleeve for Social Touch), a touch-sensitive vibrotactile arm sleeve. The TaSST was designed to enable two people to communicate different types of touch over a distance. The touch-sensitive surface of the sleeve consists of a grid of

  11. The TaSST - Tactile Sleeve for Social Touch

    NARCIS (Netherlands)

    Huisman, Gijs; Darriba Frederiks, Aduén; Van Dijk, Betsy; Heylen, Dirk

    2013-01-01

    In this paper we outline the design process of TaSST (Tactile Sleeve for Social Touch), a touch-sensitive vibrotactile arm sleeve. The TaSST was designed to enable two people to communicate different types of touches over a distance. The touch-sensitive surface of the sleeve consists of a grid of

  12. Nitrogen Gas Heating and Supply System for SST-1 Tokamak

    International Nuclear Information System (INIS)

    Khan, Ziauddin; Pathan, Firozkhan; Paravastu, Yuvakiran; George, Siju; Ramesh, Gattu; Bindu, Hima; Raval, Dilip C.; Thankey, Prashant; Dhanani, Kalpesh; Pradhan, Subrata

    2013-01-01

    Steady State Tokamak (SST-1) vacuum vessel baking as well as baking of the first wall components of SST-1 are essential to plasma physics experiments. Under a refurbishment spectrum of SST-1, the nitrogen gas heating and supply system has been fully refurbished. The SST-1 vacuum vessel consists of ultra-high vacuum (UHV) compatible eight modules and eight sectors. Rectangular baking channels are embedded on each of them. Similarly, the SST-1 plasma facing components (PFC) are comprised of modular graphite diverters and movable graphite based limiters. The nitrogen gas heating and supply system would bake the plasma facing components at 350°C and the SST-1 vacuum vessel at 150°C over an extended duration so as to remove water vapour and other absorbed gases. An efficient PLC based baking facility has been developed and implemented for monitoring and control purposes. This paper presents functional and operational aspects of a SST-1 nitrogen gas heating and supply system. Some of the experimental results obtained during the baking of SST-1 vacuum modules and sectors are also presented here. (fusion engineering)

  13. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery: An Update Meta-Analysis and Trial Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Benji Wang

    2018-01-01

    Full Text Available Background. Recent studies suggest that levosimendan does not provide mortality benefit in patients with low cardiac output syndrome undergoing cardiac surgery. These results conflict with previous findings. The aim of the current study is to assess whether levosimendan reduces postoperative mortality in patients with impaired left ventricular function (mean EF ≤ 40% undergoing cardiac surgery. Methods. We conducted a comprehensive search of PubMed, EMBASE, and Cochrane Library Database through November 20, 2017. Inclusion criteria were random allocation to treatment with at least one group receiving levosimendan and another group receiving placebo or other treatments and cardiac surgery patients with a left ventricular ejection fraction of 40% or less. The primary endpoint was postoperative mortality. Secondary outcomes were cardiac index, pulmonary capillary wedge pressure (PCWP, length of intensive care unit (ICU stay, postoperative atrial fibrillation, and postoperative renal replacement therapy. We performed trial sequential analysis (TSA to evaluate the reliability of the primary endpoint. Results. Data from 2,152 patients in 15 randomized clinical trials were analyzed. Pooled results demonstrated a reduction in postoperative mortality in the levosimendan group [RR = 0.53, 95% CI (0.38–0.73, I2=0]. However, the result of TSA showed that the conclusion may be a false positive. Secondary outcomes demonstrated that PCWP, postoperative renal replacement therapy, and length of ICU stay were significantly reduced. Cardiac index was greater in the levosimendan group. No difference was found in the rate of postoperative atrial fibrillation. Conclusions. Levosimendan reduces the rate of death and other adverse outcomes in patients with low ejection fraction who were undergoing cardiac surgery, but results remain inconclusive. More large-volume randomized clinical trials (RCTs are warranted.

  14. Progressive resistance training and stretching following surgery for breast cancer: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ward Leigh C

    2006-12-01

    Full Text Available Abstract Background Currently 1 in 11 women over the age of 60 in Australia are diagnosed with breast cancer. Following treatment, most breast cancer patients are left with shoulder and arm impairments which can impact significantly on quality of life and interfere substantially with activities of daily living. The primary aim of the proposed study is to determine whether upper limb impairments can be prevented by undertaking an exercise program of prolonged stretching and resistance training, commencing soon after surgery. Methods/design We will recruit 180 women who have had surgery for early stage breast cancer to a multicenter single-blind randomized controlled trial. At 4 weeks post surgery, women will be randomly assigned to either an exercise group or a usual care (control group. Women allocated to the exercise group will perform exercises daily, and will be supervised once a week for 8 weeks. At the end of the 8 weeks, women will be given a home-based training program to continue indefinitely. Women in the usual care group will receive the same care as is now typically provided, i.e. a visit by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be assessed at baseline, 8 weeks, and 6 months later. The primary measure is arm symptoms, derived from a breast cancer specific questionnaire (BR23. In addition, range of motion, strength, swelling, pain and quality of life will be assessed. Discussion This study will determine whether exercise commencing soon after surgery can prevent secondary problems associated with treatment of breast cancer, and will thus provide the basis for successful rehabilitation and reduction in ongoing problems and health care use. Additionally, it will identify whether strengthening exercises reduce the incidence of arm swelling. Trial Registration The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRN012606000050550.

  15. 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

    of subjective and objective snoring. Multi-stage radiofrequency surgery was not tested. Trial Registration ClinicalTrials.gov NCT01955083 PMID:24816691

  16. Effects of dexmedetomidine on heart arrhythmia prevention in off-pump coronary artery bypass surgery: A randomized clinical trial.

    Science.gov (United States)

    Soltani, Ghasem; Jahanbakhsh, Saeed; Tashnizi, Mohammad Abbasi; Fathi, Mehdi; Amini, Shahram; Zirak, Nahid; Sheybani, Shima

    2017-10-01

    Arrhythmia occurring during and after surgery is one of the major complications in open-heart surgery. Dexmedetomidine is an intravenous alpha-2 agonist and very specific short-acting drug to protect the various organs against ischemic injuries and blood reflow. However, the effect of dexmedetomidine for preventing intraoperative heart arrhythmias has not been recognized. This study aimed to determine the effect of dexmedetomidine on the incidence rate of heart arrhythmias and anesthetic required in off-pump coronary artery bypass surgery. This randomized clinical trial was conducted on patients who were candidates for off-pump coronary artery bypass referring to Imam Reza Hospital of Mashhad, Iran, from July 2016 through January 2017. The patients were randomly assigned to two groups of intervention (infusion of 0.5 mcg/kg/h dexmedetomidine together with induction followed by infusion of 0.5 mcg/kg/h by the end of the surgery) or control (saline infusion). Mean arterial pressure (MAP) and heart rate (HR) were measured before induction, during surgery operation and ICU admission. Data were analyzed by SPSS version 18 using Chi Square and independent-samples t-test. A total of 76 patients with a mean age of 59.8 ± 8.2 years (in two groups of 38) were studied. The two groups had no statistically significant difference in terms of background variables. The MAP and HR values before induction, during surgery and ICU admission were significantly higher in the control group than in the intervention group (p=0.001). Out of the studied arrhythmias, the values of PAC (55.2% vs. 15.7%), PVC (81.5% vs. 21.0%), AF (26.3% vs. 7.8%), VTAC (21.0% vs. 2.6%) were significantly lower in dexmedetomidine group (p=0.001). It seems that dexmedetomidine administration during induction and surgery can cause significant reduction in most of the common arrhythmias in off-pump coronary bypass surgery. The use of dexmedetomidine maintains MAP and HR at significantly lower values, and changes

  17. Effectiveness of manual therapy versus surgery in pain processing due to carpal tunnel syndrome: A randomized clinical trial.

    Science.gov (United States)

    Fernández-de-Las-Peñas, C; Cleland, J; Palacios-Ceña, M; Fuensalida-Novo, S; Alonso-Blanco, C; Pareja, J A; Alburquerque-Sendín, F

    2017-08-01

    People with carpal tunnel syndrome (CTS) exhibit widespread pressure pain and thermal pain hypersensitivity as a manifestation of central sensitization. The aim of our study was to compare the effectiveness of manual therapy versus surgery for improving pain and nociceptive gain processing in people with CTS. The trial was conducted at a local regional Hospital in Madrid, Spain from August 2014 to February 2015. In this randomized parallel-group, blinded, clinical trial, 100 women with CTS were randomly allocated to either manual therapy (n = 50), who received three sessions (once/week) of manual therapies including desensitization manoeuvres of the central nervous system, or surgical intervention (n = 50) group. Outcomes including pressure pain thresholds (PPT), thermal pain thresholds (HPT or CPT), and pain intensity which were assessed at baseline, and 3, 6, 9 and 12 months after the intervention by an assessor unaware of group assignment. Analysis was by intention to treat with mixed ANCOVAs adjusted for baseline scores. At 12 months, 95 women completed the follow-up. Patients receiving manual therapy exhibited higher increases in PPT over the carpal tunnel at 3, 6 and 9 months (all, p < 0.01) and higher decrease of pain intensity at 3 month follow-up (p < 0.001) than those receiving surgery. No significant differences were observed between groups for the remaining outcomes. Manual therapy and surgery have similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with CTS. Neither manual therapy nor surgery resulted in changes in thermal pain sensitivity. The current study found that manual therapy and surgery exhibited similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with carpal tunnel syndrome at medium- and long-term follow-ups investigating changes in nociceptive gain processing after treatment in carpal tunnel syndrome. © 2017 European Pain Federation - EFIC®.

  18. Preliminary analysis of accident in SST-1 current feeder system

    International Nuclear Information System (INIS)

    Roy, Swati; Kanabar, Deven; Garg, Atul; Singh, Amit; Tanna, Vipul; Prasad, Upendra; Srinivasan, R.

    2017-01-01

    Steady-state Tokamak-1 (SST-1) has 16 superconducting Toroidal field (TF) and 9 superconducting poloidal field (PF) coils rated for 10kA DC. All the TF are connected in series and are operated in DC condition whereas PF coils are individually operated in pulse mode during SST-1 campaigns. SST-1 current feeder system (CFS) houses 9 pairs of PF current leads and 1 pair of TF current leads. During past SST-1 campaign, there were arcing incidents within SST-1 CFS chamber which caused significant damage to PF superconducting current leads as well as its Helium cooling lines of the current leads. This paper brings out the preliminary analysis of the mentioned arcing incident, possible reasons and its investigation thereby laying out the sequence of events. From this analysis and observations, various measures to avoid such arcing incidents have also been proposed. (author)

  19. Impact of perioperative blood pressure variability on health resource utilization after cardiac surgery: an analysis of the ECLIPSE trials.

    Science.gov (United States)

    Aronson, Solomon; Levy, Jerrold H; Lumb, Philip D; Fontes, Manuel; Wang, Yamei; Crothers, Tracy A; Sulham, Katherine A; Navetta, Marco S

    2014-06-01

    To examine the impact of blood pressure control on hospital health resource utilization using data from the ECLIPSE trials. Post-hoc analysis of data from 3 prospective, open-label, randomized clinical trials (ECLIPSE trials). Sixty-one medical centers in the United States. Patients 18 years or older undergoing cardiac surgery. Clevidipine was compared with nitroglycerin, sodium nitroprusside, and nicardipine. The ECLIPSE trials included 3 individual randomized open-label studies comparing clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine. Blood pressure control was assessed as the integral of the cumulative area under the curve (AUC) outside specified systolic blood pressure ranges, such that lower AUC represents less variability. This analysis examined surgery duration, time to extubation, as well as intensive care unit (ICU) and hospital length of stay (LOS) in patients with AUC≤10 mmHg×min/h compared to patients with AUC>10 mmHg×min/h. One thousand four hundred ten patients were included for analysis; 736 patients (52%) had an AUC≤10 mmHg×min/h, and 674 (48%) had an AUC>10 mmHg×min/h. The duration of surgery and ICU LOS were similar between groups. Time to extubation and postoperative LOS were both significantly shorter (p = 0.05 and pAUC≤10. Multivariate analysis demonstrates AUC≤10 was significantly and independently associated with decreased time to extubation (hazard ratio 1.132, p = 0.0261) and postoperative LOS (hazard ratio 1.221, p = 0.0006). Based on data derived from the ECLIPSE studies, increased perioperative BP variability is associated with delayed time to extubation and increased postoperative LOS. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials.

    Science.gov (United States)

    Bittencourt, M-A-V; Paranhos, L-R; Martins-Filho, P-R-S

    2017-11-01

    Low-level laser has been widely used in Dentistry and many studies have focused on its application in oral surgeries. This study was conducted with the aim of searching for scientific evidence concerning the effectiveness of laser to reduce pain or paresthesia related to orthognathic surgery. An electronic search was performed in PubMed, Scopus, Science Direct, LILACS, SciELO, CENTRAL, Google Scholar, OpenGrey, and ClinicalTrials.gov, up to November 2016, with no restrictions on language or year of publication. Additionally, a hand search of the reference list of the selected studies was carried out. The PICOS strategy was used to define the eligibility criteria and only randomized clinical trials were selected. Out of 1,257 identified citations, three papers fulfilled the criteria and were included in the systematic review. The risk of bias was assessed according to the Cochrane Guidelines for Clinical Trials and results were exposed based on a descriptive analysis. One study showed that laser therapy was effective to reduce postoperative pain 24 hours (P=0.007) and 72 hours (P=0.007) after surgery. Other study revealed the positive effect of laser to improve neurosensory recovery 60 days after surgery, evaluated also by the two-point discrimination (P=0.005) and sensory (P=0.008) tests. The third study reported an improvement for general sensibility of 68.75% for laser group, compared with 21.43% for placebo (P=0.0095), six months after surgery. Individual studies suggested a positive effect of low-level laser therapy on reduction of postoperative pain and acceleration of improvement of paresthesia related to orthognathic surgery. However, due to the insufficient number and heterogeneity of studies, a meta-analysis evaluating the outcomes of interest was not performed, and a pragmatic recommendation about the use of laser therapy is not possible. This systematic review was conducted according to the statements of PRISMA and was registered at PROSPERO under the

  1. A virtual reality application in role-plays of social skills training for schizophrenia: a randomized, controlled trial.

    Science.gov (United States)

    Park, Kyung-Min; Ku, Jeonghun; Choi, Soo-Hee; Jang, Hee-Jeong; Park, Ji-Yeon; Kim, Sun I; Kim, Jae-Jin

    2011-09-30

    Although social skills training (SST) is an effective approach for improving social skills for schizophrenia, the motivational deficit attenuates its efficacy. Virtual reality (VR) applications have allowed individuals with mental disabilities to enhance their motivation for rehabilitation. We compared SST using VR role-playing (SST-VR) to SST using traditional role-playing (SST-TR). This randomized, controlled trial included 91 inpatients with schizophrenia who were assigned to either SST-VR (n=46) or SST-TR (n=45). Both groups were administered over 10 semiweekly group sessions. An experienced, blinded rater assessed vocal, nonverbal and conversational skills. We also obtained data on motivation for SST and various social abilities. Throughout the 10 sessions, the SST-VR group (n=33) showed greater interest in SST and generalization of the skills than the SST-TR group (n=31). After SST, the SST-VR group improved more in conversational skills and assertiveness than the SST-TR group, but less in nonverbal skills. The VR application in role-plays of SST for schizophrenia may be particularly beneficial in terms of improving the conversational skills and assertiveness, possibly through its advantages in enhancing motivation for SST and generalization of the skills, and thus it may be a useful supplement to traditional SST. Copyright © 2011 Elsevier Ltd. All rights reserved.

  2. Timing of surgery for sciatica: Subgroup analysis alongside a randomized trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); M.P. Arts (Mark); R. Brand (René); B.W. Koes (Bart)

    2009-01-01

    textabstractSurgery 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,

  3. Approach to intraoperative electromagnetic navigation in orthognathic surgery: A phantom skull based trial.

    Science.gov (United States)

    Berger, Moritz; Kallus, Sebastian; Nova, Igor; Ristow, Oliver; Eisenmann, Urs; Dickhaus, Hartmut; Kuhle, Reinald; Hoffmann, Jürgen; Seeberger, Robin

    2015-11-01

    Intraoperative guidance using electromagnetic navigation is an upcoming method in maxillofacial surgery. However, due to their unwieldy structures, especially the line-of-sight problem, optical navigation devices are not used for daily orthognathic surgery. Therefore, orthognathic surgery was simulated on study phantom skulls, evaluating the accuracy and handling of a new electromagnetic tracking system. Le-Fort I osteotomies were performed on 10 plastic skulls. Orthognathic surgical planning was done in the conventional way using plaster models. Accuracy of the gold standard, splint-based model surgery versus an electromagnetic tracking system was evaluated by measuring the actual maxillary deviation using bimaxillary splints and preoperative and postoperative cone beam computer tomography imaging. The distance of five anatomical marker points were compared pre- and postoperatively. The electromagnetic tracking system was significantly more accurate in all measured parameters compared with the gold standard using bimaxillary splints (p orthognathic surgery to 0.3 mm on average. The data of this preliminary study shows a high level of accuracy in surgical orthognathic performance using electromagnetic navigation, and may offer greater precision than the conventional plaster model surgery with bimaxillary splints. This preliminary work shows great potential for the establishment of an intraoperative electromagnetic navigation system for maxillofacial surgery. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  4. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefo...

  5. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...

  6. Vacuum system of SST-1 Tokamak

    International Nuclear Information System (INIS)

    Khan, Ziauddin; Pathan, Firozkhan; George, Siju; Semwal, Pratibha; Dhanani, Kalpesh; Paravastu, Yuvakiran; Thankey, Prashant; Ramesh, Gattu; Himabindu, Manthena; Pradhan, Subrata

    2013-01-01

    Highlights: ► Air leaks developed during ongoing SST-1 cooldown campaign were detected online using RGA. ► The presence of N 2 and O 2 gases with the ratio of their partial pressures with ∼3.81:1 confirmed the air leaks. ► Baking of SST-1 was done efficiently by flowing hot N 2 gas in C-channels welded on inner surfaces without any problem. ► In-house fabricated demountable bull nose couplers were demonstrated for high temperature and pressure applications. ► Cryopumping effect was observed when liquid helium cooled superconducting magnets reached below 63 K. -- Abstract: Vacuum chambers of Steady State Superconducting (SST-1) Tokamak comprises of the vacuum vessel and the cryostat. The plasma will be confined inside the vacuum vessel while the cryostat houses the superconducting magnet systems (TF and PF coils), LN 2 cooled thermal shields and hydraulics for these circuits. The vacuum vessel is an ultra-high (UHV) vacuum chamber while the cryostat is a high-vacuum (HV) chamber. In order to achieve UHV inside the vacuum vessel, it would be baked at 150 °C for longer duration. For this purpose, U-shaped baking channels are welded inside the vacuum vessel. The baking will be carried out by flowing hot nitrogen gas through these channels at 250 °C at 4.5 bar gauge pressure. During plasma operation, the pressure inside the vacuum vessel will be raised between 1.0 × 10 −4 mbar and 1.0 × 10 −5 mbar using piezoelectric valves and control system. An ultimate pressure of 4.78 × 10 −6 mbar is achieved inside the vacuum vessel after 100 h of pumping. The limitation is due to the development of few leaks of the order of 10 −5 mbar l/s at the critical locations of the vacuum vessel during baking which was confirmed with the presence of nitrogen gas and oxygen gas with the ratio of ∼3.81:1 indicating air leak. Similarly an ultimate vacuum of 2.24 × 10 −5 mbar is achieved inside the cryostat. Baking of the vacuum vessel up to 110 °C with ±10

  7. Vacuum system of SST-1 Tokamak

    Energy Technology Data Exchange (ETDEWEB)

    Khan, Ziauddin, E-mail: ziauddin@ipr.res.in [Institute for Plasma Research, Near Indira Bridge, Bhat, Gandhinagar 382 428 (India); Pathan, Firozkhan; George, Siju; Semwal, Pratibha; Dhanani, Kalpesh; Paravastu, Yuvakiran; Thankey, Prashant; Ramesh, Gattu; Himabindu, Manthena; Pradhan, Subrata [Institute for Plasma Research, Near Indira Bridge, Bhat, Gandhinagar 382 428 (India)

    2013-10-15

    Highlights: ► Air leaks developed during ongoing SST-1 cooldown campaign were detected online using RGA. ► The presence of N{sub 2} and O{sub 2} gases with the ratio of their partial pressures with ∼3.81:1 confirmed the air leaks. ► Baking of SST-1 was done efficiently by flowing hot N{sub 2} gas in C-channels welded on inner surfaces without any problem. ► In-house fabricated demountable bull nose couplers were demonstrated for high temperature and pressure applications. ► Cryopumping effect was observed when liquid helium cooled superconducting magnets reached below 63 K. -- Abstract: Vacuum chambers of Steady State Superconducting (SST-1) Tokamak comprises of the vacuum vessel and the cryostat. The plasma will be confined inside the vacuum vessel while the cryostat houses the superconducting magnet systems (TF and PF coils), LN{sub 2} cooled thermal shields and hydraulics for these circuits. The vacuum vessel is an ultra-high (UHV) vacuum chamber while the cryostat is a high-vacuum (HV) chamber. In order to achieve UHV inside the vacuum vessel, it would be baked at 150 °C for longer duration. For this purpose, U-shaped baking channels are welded inside the vacuum vessel. The baking will be carried out by flowing hot nitrogen gas through these channels at 250 °C at 4.5 bar gauge pressure. During plasma operation, the pressure inside the vacuum vessel will be raised between 1.0 × 10{sup −4} mbar and 1.0 × 10{sup −5} mbar using piezoelectric valves and control system. An ultimate pressure of 4.78 × 10{sup −6} mbar is achieved inside the vacuum vessel after 100 h of pumping. The limitation is due to the development of few leaks of the order of 10{sup −5} mbar l/s at the critical locations of the vacuum vessel during baking which was confirmed with the presence of nitrogen gas and oxygen gas with the ratio of ∼3.81:1 indicating air leak. Similarly an ultimate vacuum of 2.24 × 10{sup −5} mbar is achieved inside the cryostat. Baking of the

  8. Enhancing detection sensitivity of SST-1 Thomson scattering experiment

    Energy Technology Data Exchange (ETDEWEB)

    Chaudhari, Vishnu; Patel, Kiran; Thomas, Jinto; Kumar, Ajai, E-mail: ajai@ipr.res.in

    2016-10-15

    Thomson Scattering System (TSS) is the main diagnostic to extract electron temperature and density of steady state superconducting (SST-1) tokamak plasma. Silicon avalanche photo diode is used with low noise and fast signal conditioning electronics (SCE) to detect incoming Thomson scattered laser photons. A stringent requirement for the measurement is to detect high speed and low level light signal (detection of 100 numbers of Thomson scattered photons for 50 ns pulse width at input of active area of detector) in the presence of wide band electro-magnetic interference (EMI) noise. The electronics and instruments for different sub-systems kept in laboratory contribute to the radiated and conductive noise in a complex manner to the experiment, which can degrade the resultant signal to noise ratio (SNR <1). In general a repeated trial method with flexible grounding scheme are used to improve system signal to noise ratio, which is time consuming and less efficient. In the present work a simple, robust, cost-effective instrumentation system is used for the measurement and monitoring with improved ground scheme and shielding method to minimize noise, isolating the internal sub-system generated noise and external interference which leads to an improved SNR.

  9. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  10. Effect of tranexamic acid irrigation on perioperative blood loss during orthognathic surgery: a double-blind, randomized controlled clinical trial.

    Science.gov (United States)

    Eftekharian, Hamidreza; Vahedi, Ruhollah; Karagah, Tuba; Tabrizi, Reza

    2015-01-01

    Perioperative hemorrhage is an important concern during orthognathic surgery. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative hemorrhage during orthognathic surgery. In this double-blind, randomized controlled clinical trial, 56 participants who underwent orthognathic surgery were divided into 2 groups. The patients in the first group received TXA irrigation with normal saline (1 mg/mL), and the patients in the second group had normal saline for irrigation during orthognathic surgery. Age, gender, operation duration, the amount of irrigation solution used, and preoperative hemoglobin, hematocrit, and weight were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. Each group consisted of 28 patients. Group 1 consisted of 15 male patients (53.6%) and 13 female patients (46.4%) and group 2 consisted of 14 male patients (50%) and 14 female patients (50%). There was no difference in the distributions of the variables between the 2 groups, except for the duration of the operation. The mean duration of the operation was 3.94 ± 0.61 hours in group 1 and 4.17 ± 0.98 hours in group 2, and the difference in this respect between the 2 groups was statistically significant (P .05). TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  11. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial.

    Science.gov (United States)

    Bagheri-Nesami, Masoumeh; Shorofi, Seyed Afshin; Zargar, Nahid; Sohrabi, Maryam; Gholipour-Baradari, Afshin; Khalilian, Alireza

    2014-02-01

    To examine the effects of foot reflexology massage on anxiety in patients following CABG surgery. In this randomized controlled trial, 80 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups after they were matched on age and gender. On the days following surgery, the experimental group received foot reflexology massage on their left foot 20 min a day for 4 days, while the control group was given a gentle foot rub with oil for one minute. Anxiety was measured using the short-form of the Spielberger State-Trait Anxiety Inventory and the Visual Analogue Scale-Anxiety. Both measurement instruments confirmed a significant decrease in anxiety following the foot reflexology massage. The significant decrease in anxiety in the experimental group following the foot reflexology massage supports the use of this complementary therapy technique for the relief of anxiety. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  12. 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

  13. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Karsten, Agneta; Marcusson, Agneta; Hurmerinta, Kirsti

    2017-01-01

    controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total......- and intra-examiner reliability was good-to-excellent (0.61-0.94; 0.66-1.0, respectively). The mean total scores (+2 to -18) varied from -5.56 (Trial 2C) to -7.21 (Trial 3D). The mean anterior scores (+2 to -6) varied from -1.66 (Trial 2C) to -2.56 (Trial 3A). The mean posterior cleft-side scores (0 to -6......) varied from -3.24 (Trial 3A) to -3.82 (Trial 3D) and the mean non-cleft-side scores (0 to -6) varied from -0.60 (Trial 2C) to -1.30 (Trial 3A); however, no significant differences were found within the trials. CONCLUSION: There was no statistical evidence of a difference in occlusion between the two...

  14. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  15. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial

    Science.gov (United States)

    Skinner, Elizabeth H; Browning, Laura; Reeve, Julie; Anderson, Lesley; Hill, Cat; Robertson, Iain K; Story, David; Denehy, Linda

    2018-01-01

    Abstract Objective To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. Design Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. Setting Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. Participants 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. Interventions Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. Main outcome measures The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. Results The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute

  16. Enhanced recovery programs in lung cancer surgery: systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Li S

    2017-11-01

    Full Text Available Shuangjiang Li,1 Kun Zhou,1 Guowei Che,1 Mei Yang,1 Jianhua Su,2 Cheng Shen,1 Pengming Yu2 1Department of Thoracic Surgery, 2Department of Rehabilitation, Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, China Background: Enhanced recovery after surgery (ERAS program is an effective evidence-based multidisciplinary protocol of perioperative care, but its roles in thoracic surgery remain unclear. This systematic review of randomized controlled trials (RCTs aims to investigate the efficacy and safety of the ERAS programs for lung cancer surgery. Materials and methods: We searched the PubMed and EMBASE databases to identify the RCTs that implemented an ERAS program encompassing more than four care elements within at least two phases of perioperative care in lung cancer surgery. The heterogeneity levels between studies were estimated by the Cochrane Collaborations. A qualitative review was performed if considerable heterogeneity was revealed. Relative risk (RR and weighted mean difference served as the summarized statistics for the meta-analyses. Additional analyses were also performed to perceive potential bias risks. Results: A total of seven RCTs enrolling 486 patients were included. The meta-analysis indicated that the ERAS group patients had significantly lower morbidity rates (RR=0.64; p<0.001, especially the rates of pulmonary (RR=0.43; p<0.001 and surgical complications (RR=0.46; p=0.010, than those of control group patients. No significant reduction was found in the in-hospital mortality (RR=0.70; p=0.58 or cardiovascular complications (RR=1.46; p=0.25. In the qualitative review, most of the evidence reported significantly shortened length of hospital and intensive care unit stay and decreased hospitalization costs in the ERAS-treated patients. No significant publication bias was detected in the meta-analyses. Conclusion: Our review demonstrates that the implementation of an ERAS program for lung cancer

  17. Normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery (thermic-2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo; Rogers, Chris A

    2015-05-25

    During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body ("perfusion") while the heart is stopped. Typically the blood is cooled during this procedure ("hypothermia") and warmed to normal body temperature once the operation has been completed. The main rationale for "whole body cooling" is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body's metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery ("normothermia"). However, the two techniques have not been extensively compared in children. The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of

  18. 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

  19. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

    Science.gov (United States)

    Hofmeijer, Jeannette; Amelink, G Johan; Algra, Ale; van Gijn, Jan; Macleod, Malcolm R; Kappelle, L Jaap; van der Worp, H Bart

    2006-09-11

    Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

  20. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial

    NARCIS (Netherlands)

    Spieth, P. M.; Güldner, A.; Uhlig, C.; Bluth, T.; Kiss, T.; Conrad, C.; Bischlager, K.; Braune, A.; Huhle, R.; Insorsi, A.; Tarantino, F.; Ball, L.; Schultz, M. J.; Abolmaali, N.; Koch, T.; Pelosi, P.; Gama de Abreu, M.

    2018-01-01

    Experimental studies showed that controlled variable ventilation (CVV) yielded better pulmonary function compared to non-variable ventilation (CNV) in injured lungs. We hypothesized that CVV improves intraoperative and postoperative respiratory function in patients undergoing open abdominal surgery.

  1. 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.

  2. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Pedersen, Kirsten Mølsted; Humerinta, Kirsti; Küseler, Annelise

    2017-01-01

    BACKGROUND AND AIM: Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used...... the three trials. CONCLUSION: The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile. TRIAL REGISTRATION: ISRCTN...

  3. Factors affecting patient participation in orthopaedic trials comparing surgery to non-surgical interventions

    Directory of Open Access Journals (Sweden)

    Rajat Mittal

    2016-08-01

    Conclusion: Patient non-participation in an RCT comparing surgery to no surgery is related to concern about receiving a treatment through chance and the presence of a strong preference for a particular treatment, particularly a non-surgical one. To avoid protracted recruitment periods, investigators can increase the number of study sites and ensure personnel involved have equipoise and are trained to provide a balanced view of both treatment arms.

  4. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Science.gov (United States)

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  5. 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.

  6. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient.

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

    Science.gov (United States)

    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.

  8. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Armstrong Sarah J

    2010-04-01

    Full Text Available Abstract Background Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed. This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. Methods/Design Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported. Discussion This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. Trial registration Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

  9. A randomized trial of exercise on well-being and function following breast cancer surgery: the RESTORE trial.

    Science.gov (United States)

    Anderson, Roger T; Kimmick, Gretchen G; McCoy, Thomas P; Hopkins, Judith; Levine, Edward; Miller, Gary; Ribisl, Paul; Mihalko, Shannon L

    2012-06-01

    This study aimed to determine the effect of a moderate, tailored exercise program on health-related quality of life, physical function, and arm volume in women receiving treatment for nonmetastatic breast cancer. Women who were within 4-12 weeks of surgery for stage I-III breast cancer were randomized to center-based exercise and lymphedema education intervention or patient education. Functional assessment of cancer therapy-breast cancer (FACT-B), 6-min walk, and arm volume were performed at 3-month intervals through 18 months. Repeated measures analysis of covariance was used to model the total meters walked over time, FACT-B scores, and arm volume. Models were adjusted for baseline measurement, baseline affected arm volume, number of nodes removed, age, self-reported symptoms, baseline SF-12 mental and physical component scores, visit, and treatment group. Of the recruited 104 women, 82 completed all 18 months. Mean age (range) was 53.6 (32-82) years; 88% were Caucasian; 45% were employed full time; 44% were overweight; and 28% obese. Approximately, 46% had breast-conserving surgery; 79% had axillary node dissection; 59% received chemotherapy; and 64% received radiation. The intervention resulted in an average increase of 34.3 ml (SD = 12.8) versus patient education (p = 0.01). Changes in FACT-B scores and arm volumes were not significantly different. With this early exercise intervention after breast cancer diagnosis, a significant improvement was achieved in physical function, with no decline in health-related quality of life or detrimental effect on arm volume. Starting a supervised exercise regimen that is tailored to an individual's strength and stamina within 3 months following breast cancer surgery appears safe and may hasten improvements in physical functioning.

  10. SST, Aqua MODIS, NPP, 0.0125 degrees, Indonesia, Daytime

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA CoastWatch provides SST data from NASA's Aqua Spacecraft. Measurements are gathered by the Moderate Resolution Imaging Spectroradiometer (MODIS) carried aboard...

  11. Quench detection, protection and simulation studies on SST-1 magnets

    International Nuclear Information System (INIS)

    Sharma, Aashoo N.; Khristi, Yohan; Pradhan, Subrata; Doshi, Kalpesh; Prasad, Upendra; Banaudha, Moni; Varmora, Pankaj; Praghi, Bhadresh R.

    2015-01-01

    Steady-state Superconducting Tokamak-1 (SST-1) is India's first tokamak with superconducting toroidal field (TF) and Poloidal Field (PF) magnets. These magnets are made with NbTi based Cable-In-Conduit-Conductors. The quench characteristic of SST-1 CICC has been extensively studied both analytically and using simulation codes. Dedicated experiments like model coil test program, TF coil test program and laboratory experiments were conducted to fully characterize the performance of the CICC and the magnets made using this CICC. Results of quench experiments performed during these tests have been used to design the SST-1 quench detection and protection system. Simulation results of TF coil quenches and slow propagation quench of TF busbars have been used to further optimize these systems during the SST-1 tokamak operation. Redundant hydraulic based quench detection is also proposed for the TF coil quench detection. This paper will give the overview of these development and simulation activities. (author)

  12. Daily MUR SST, Interim near-real-time (nrt) product

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — A daily, global Sea Surface Temperature (SST) data set is produced at 1-km (MUR, or Multi-scale ultra-high resolution Temperature) by the JPL sciengists Drs. Mike...

  13. GHRSST Level 2P USA NAVOCEANO GOES11 SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — SST calculated from the IR channels of GOES-11 at full resolution on a half hourly basis. In raw satellite projection, vertically adjacent pixels averaged and read...

  14. GHRSST Level 2P European Medspiration SEVIRI SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — SST calculated from the IR channels of MSG at full resolution on a hourly basis. Remapping is made by space averaging, the production of the 3-hourly data is made by...

  15. NOAA High-Resolution Sea Surface Temperature (SST) Analysis Products

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This archive covers two high resolution sea surface temperature (SST) analysis products developed using an optimum interpolation (OI) technique. The analyses have a...

  16. COBE-SST2 Sea Surface Temperature and Ice

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — A new sea surface temperature (SST) analysis on a centennial time scale is presented. The dataset starts in 1850 with monthly 1x1 means and is periodically updated....

  17. Seasonal Mean SST images of Stellwagen Bank National Marine Sanctuary

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Average seasonal sea surface temperatures http://podaac.jpl.nasa.gov/ Naming Convention: XXXX_SSSYYYY_SST.tif XXXX=location (Stell) SSS=season (FAL=fall, SPR=spring,...

  18. Monthly SST images of Stellwagen Bank National Marine Sanctuary

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Average monthy Sea Surfact Temperature http://podaac.jpl.nasa.gov/ Naming Convention: XXXX_YYYYMM_SST.tif XXXX=location (Stell) YYYY=year MM=month Example filename:...

  19. Analysis of Pathfinder SST algorithm for global and regional conditions

    Indian Academy of Sciences (India)

    SST algorithms to improve the present accuracy of surface temperature measurements ... regions, except in the North Atlantic and adjacent seas, where the residuals are always positive. ..... the stratosphere causing significant contamination of.

  20. Global 1-km Sea Surface Temperature (G1SST)

    Data.gov (United States)

    National Aeronautics and Space Administration — JPL OurOcean Portal: A daily, global Sea Surface Temperature (SST) data set is produced at 1-km (also known as ultra-high resolution) by the JPL ROMS (Regional Ocean...

  1. GHRSST Level 4 Denmark DMI Global SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — The L4 analysis is based upon nighttime GHRSST L2P subskin SST observations from several satellites and instruments such as: AMSRE, ATS_NR_2P, AVHRR18_G,...

  2. GHRSST Level 4 Denmark DMI North Sea Baltic SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — The L4 analysis is based upon nighttime GHRSST L2P subskin SST observations from several satellites and instruments such as: AMSRE, ATS_NR_2P, AVHRR18_G,...

  3. GHRSST Level 2P USA NAVOCEANO GOES12 SST:1

    Data.gov (United States)

    National Aeronautics and Space Administration — SST calculated from the IR channels of GOES-12 at full resolution on a half hourly basis. In raw satellite projection, vertically adjacent pixels averaged and read...

  4. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Friede, Hans

    2017-01-01

    with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. METHOD: Ten established national or regional...... cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12...... months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. RESULTS: Recruitment of 448 infants took place over a 9-year...

  5. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Paulin, Gunnar

    2017-01-01

    with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. Method: Ten established national or regional...... cleft centres participated. Lip and soft palate closure at 3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4 months and hard and soft palate closure at 12...... months. Trial 3 compared it with lip and hard palate closure at 3–4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. Results: Recruitment of 448 infants took place over a 9-year...

  6. Superconducting magnets of SST-1 tokamak

    International Nuclear Information System (INIS)

    Subrata Pradhan; Saxena, Y.C.; Sarkar, B.; Bansal, G.; Sharma, A.N.; Thomas, K.J.; Bedakihale, V.; Doshi, B.; Dhard, C.P.; Prasad, U.; Rathod, P.; Bahl, R.; Varadarajulu, A.; Mankani, A.

    2005-01-01

    Magnet System of SST-1 comprises of sixteen superconducting D-shaped Toroidal Field (TF) coils, nine superconducting Poloidal Field (PF) coils and a pair of resistive PF coils inside the vacuum vessel. TF magnets generate the basic 3.0 T field at the major radius of 1.1 m. Low resistance lap inter-pancake joints within and inter-coil joints between the coils have been made. Magnets are cooled with supercritical helium at 4 bar and 4.5 K, which is fed at the high field region in the middle of each of the double pancake over a hydraulic path length of 47 m. Voltage taps across joints and termination location are used for quench detection. The quench detection front-end electronics ensures fail proof quench detection based on subtraction logic. Quench detection system sends the quench trigger to the power supply system directly on a dedicated fiber optic link. Flow meters at the inlet of the TF and PF magnets, temperature sensors at the critical joint locations and at the outlet of the flow paths for enthalpy estimation, hall probes for field direction and magnitude measurements are the other sensors. A 20 V, 10 kA power supply will excite the TF magnets whereas the PF power supplies have voltages from few volts to in excess of 100 V to cater the fast current ramp-up of the PF magnets during start-up scenarios. All power supplies have been equipped with dump resisters of appropriate ratings in parallel with a series combination of DC circuit interrupters and pyro-breakers. (author)

  7. ANALYSIS OF SST IMAGES BY WEIGHTED ENSEMBLE TRANSFORM KALMAN FILTER

    OpenAIRE

    Sai , Gorthi; Beyou , Sébastien; Memin , Etienne

    2011-01-01

    International audience; This paper presents a novel, efficient scheme for the analysis of Sea Surface Temperature (SST) ocean images. We consider the estimation of the velocity fields and vorticity values from a sequence of oceanic images. The contribution of this paper lies in proposing a novel, robust and simple approach based onWeighted Ensemble Transform Kalman filter (WETKF) data assimilation technique for the analysis of real SST images, that may contain coast regions or large areas of ...

  8. Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials

    Science.gov (United States)

    Franchini, Massimo; Mengoli, Carlo; Marietta, Marco; Marano, Giuseppe; Vaglio, Stefania; Pupella, Simonetta; Mannucci, Pier Mannuccio; Liumbruno, Giancarlo M.

    2018-01-01

    Among the various pharmacological options to decrease peri-operative bleeding, tranexamic acid appears to be one of the most interesting. Several trials have consistently documented the efficacy of this synthetic drug in reducing the risk of blood loss and the need for allogeneic blood transfusion in patients undergoing total hip and knee arthroplasty. The safety of intravenous tranexamic acid in major orthopaedic surgery, particularly regarding the risk of venous thromboembolism, was systematically analysed in this review. A systematic search of the literature identified 73 randomised controlled trials involving 4,174 patients and 2,779 controls. The raw overall incidence of venous thromboembolism was 2.1% in patients who received intravenous tranexamic acid and 2.0% in controls. A meta-analytic pooling showed that the risk of venous thromboembolism in tranexamic acid-treated patients was not significantly different from that of controls (risk difference: 0.01%, 95% confidence interval [CI]: −0.05%, 0.07%; risk ratio: 1.067, 95% CI: 0.760–1.496). Other severe drug-related adverse events occurred very rarely (0.1%). In conclusion, the results of this systematic review and meta-analysis show that intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopaedic surgery. PMID:29337665

  9. Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives.

    Science.gov (United States)

    Simon, Christian; Caballero, Carmela

    2018-05-24

    It is without question in the best interest of our patients, if we can identify ways to improve the quality of care we deliver to them. Great progress has been made within the last 25 years in terms of development and implementation of quality-assurance (QA) platforms and quality improvement programs for surgery in general, and within this context for head and neck surgery. As of now, we have successfully identified process indicators that impact outcome of our patients and the quality of care we deliver as surgeons. We have developed risk calculators to determine the risk for complications of individual surgical patients. We have created perioperative guidelines for complex head and neck procedures. We have in Europe and North America created audit registries that can gather and analyze data from institutions across the world to better understand which processes need change to obtain good outcomes and improve quality of care. QA platforms can be tested within the clearly defined environment of prospective clinical trials. If positive, such programs could be rolled out within national healthcare systems, if feasible. Testing quality programs in clinical trials could be a versatile tool to help head neck cancer patients benefit directly from such initiatives on a global level.

  10. The efficacy of an intraoperative cell saver during cardiac surgery: a meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Guyan; Bainbridge, Daniel; Martin, Janet; Cheng, Davy

    2009-08-01

    Cell salvage may be used during cardiac surgery to avoid allogeneic blood transfusion. It has also been claimed to improve patient outcomes by removing debris from shed blood, which may increase the risk of stroke or neurocognitive dysfunction. In this study, we sought to determine the overall safety and efficacy of cell salvage in cardiac surgery by performing a systematic review and meta-analysis of published randomized controlled trials. A comprehensive search was undertaken to identify all randomized trials of cell saver use during cardiac surgery. MEDLINE, Cochrane Library, EMBASE, and abstract databases were searched up to November 2008. All randomized trials comparing cell saver use and no cell saver use in cardiac surgery and reporting at least one predefined clinical outcome were included. The random effects model was used to calculate the odds ratios (OR, 95% confidence intervals [CI]) and the weighted mean differences (WMD, 95% CI) for dichotomous and continuous variables, respectively. Thirty-one randomized trials involving 2282 patients were included in the meta-analysis. During cardiac surgery, the use of an intraoperative cell saver reduced the rate of exposure to any allogeneic blood product (OR 0.63, 95% CI: 0.43-0.94, P = 0.02) and red blood cells (OR 0.60, 95% CI: 0.39-0.92, P = 0.02) and decreased the mean volume of total allogeneic blood products transfused per patient (WMD -256 mL, 95% CI: -416 to -95 mL, P = 0.002). There was no difference in hospital mortality (OR 0.65, 95% CI: 0.25-1.68, P = 0.37), postoperative stroke or transient ischemia attack (OR 0.59, 95% CI: 0.20-1.76, P = 0.34), atrial fibrillation (OR 0.92, 95% CI: 0.69-1.23, P = 0.56), renal dysfunction (OR 0.86, 95% CI: 0.41-1.80, P = 0.70), infection (OR 1.25, 95% CI: 0.75-2.10, P = 0.39), patients requiring fresh frozen plasma (OR 1.16, 95% CI: 0.82-1.66, P = 0.40), and patients requiring platelet transfusions (OR 0.90, 95% CI: 0.63-1.28, P = 0.55) between cell saver and

  11. Video-based peer feedback through social networking for robotic surgery simulation: a multicenter randomized controlled trial.

    Science.gov (United States)

    Carter, Stacey C; Chiang, Alexander; Shah, Galaxy; Kwan, Lorna; Montgomery, Jeffrey S; Karam, Amer; Tarnay, Christopher; Guru, Khurshid A; Hu, Jim C

    2015-05-01

    To examine the feasibility and outcomes of video-based peer feedback through social networking to facilitate robotic surgical skill acquisition. The acquisition of surgical skills may be challenging for novel techniques and/or those with prolonged learning curves. Randomized controlled trial involving 41 resident physicians performing the Tubes (Da Vinci Intuitive Surgical, Sunnyvale, CA) simulator exercise with versus without peer feedback of video-recorded performance through a social networking Web page. Data collected included simulator exercise score, time to completion, and comfort and satisfaction with robotic surgery simulation. There were no baseline differences between the intervention group (n = 20) and controls (n = 21). The intervention group showed improvement in mean scores from session 1 to sessions 2 and 3 (60.7 vs 75.5, P feedback subjects were more comfortable with robotic surgery than controls (90% vs 62%, P = 0.021) and expressed greater satisfaction with the learning experience (100% vs 67%, P = 0.014). Of the intervention subjects, 85% found that peer feedback was useful and 100% found it effective. Video-based peer feedback through social networking appears to be an effective paradigm for surgical education and accelerates the robotic surgery learning curve during simulation.

  12. 68Ga-DOTATOC PET/CT and somatostatin receptor (sst1-sst5) expression in normal human tissue: correlation of sst2 mRNA and SUVmax

    International Nuclear Information System (INIS)

    Boy, Christian; Poeppel, Thorsten D.; Jentzen, Walter; Brandau, Wolfgang; Bockisch, Andreas; Heusner, Till A.; Antoch, Gerald; Redmann-Bischofs, Anja; Unger, Nicole; Mann, Klaus; Petersenn, Stephan

    2011-01-01

    By targeting somatostatin receptors (sst) radiopeptides have been established for both diagnosis and therapy. For physiologically normal human tissues the study provides a normative database of maximum standardized uptake value (SUV max ) and sst mRNA. A total of 120 patients were subjected to diagnostic 68 Ga-DOTATOC positron emission tomography (PET)/CT (age range 19-83 years). SUV max values were measured in physiologically normal tissues defined by normal morphology, absence of surgical intervention and absence of metastatic spread during clinical follow-up. Expression of sst subtypes (sst1-sst5) was measured independently in pooled adult normal human tissue by real-time reverse transcriptase polymerase chain reaction (RT-PCR). SUV max revealed a region-specific pattern (e.g., mean ± SD, spleen 31.1 ± 10.9, kidney 16.9 ± 5.3, liver 12.8 ± 3.6, stomach 7.0 ± 3.1, head of pancreas 6.2 ± 2.3, small bowel 4.8 ± 1.8, thyroid 4.7 ± 2.2, bone 3.9 ± 1.3, large bowel 2.9 ± 0.8, muscle 2.1 ± 0.5, parotid gland 1.9 ± 0.6, axillary lymph node 0.8 ± 0.3 and lung 0.7 ± 0.3). SUV max was age independent. Gender differences were evident within the thyroid (female/male: 3.7 ± 1.6/5.5 ± 2.4, p max values exclusively correlated with sst2 expression (r = 0.846, p max with the expression of the other four subtypes. In normal human tissues 68 Ga-DOTATOC imaging has been related to the expression of sst2 at the level of mRNA. The novel normative database may improve diagnostics, monitoring and therapy of sst-expressing tumours or inflammation on a molecular basis. (orig.)

  13. Optimised anaesthesia to reduce post operative cognitive decline (POCD in older patients undergoing elective surgery, a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    Full Text Available BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls, mild (χ(2 = 17.9 p<0.0001, moderate (χ(2 = 7.8 p = 0.005 and severe (χ(2 = 5.1 p = 0.02 POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control. In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, χ(2 = 5.1 p = 0.02 and χ(2 = 5.9 p = 0.015, and moderate POCD was reduced at 1 and 52 weeks (χ(2 = 4.4 p = 0·037 and χ(2 = 5.4 p = 0.02. In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005, in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001, and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019. CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION

  14. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

    2016-11-07

    Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

  15. Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial.

    Science.gov (United States)

    Amanullah, Muhammad M; Hamid, Mohammad; Hanif, Hashim M; Muzaffar, Marium; Siddiqui, Maria T; Adhi, Fatima; Ahmad, Khabir; Khan, Shahjahan; Hasan, Zahra

    2016-03-01

    Cardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters. To assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery. A randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010-2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines - Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha - were measured. Clinical parameters were also assessed. Blood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups. Dexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

  16. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. 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).

  18. 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

  19. 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.

  20. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

  1. Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Willett, Keith; Keene, David J; Mistry, Dipesh; Nam, Julian; Tutton, Elizabeth; Handley, Robert; Morgan, Lesley; Roberts, Emma; Briggs, Andrew; Lall, Ranjit; Chesser, Timothy J S; Pallister, Ian; Lamb, Sarah E

    2016-10-11

    Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications. To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use. This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment. Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction. Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P

  2. 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.

  3. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial.

    Science.gov (United States)

    Franco, Lola; Blanck, Thomas J J; Dugan, Kimberly; Kline, Richard; Shanmugam, Geetha; Galotti, Angela; von Bergen Granell, Annelise; Wajda, Michael

    2016-09-01

    The objective of this study was to determine whether lavender fleur oil (LFO) aromatherapy would reduce anxiety when administered to women before undergoing breast surgery. This was a single-site, randomized study comparing the effect of LFO to unscented oil (UO). The study was conducted in the preoperative holding area of the ambulatory surgery department of NYU Langone Medical Center. Ninety three women, 18 years and older, scheduled for breast surgery. Women meeting inclusion/exclusion criteria were randomized to either LFO or UO aromatherapy and were blind to their assigned treatment. Subjects completed a Speilberger State Anxiety Inventory for Adults (STAI) before and after aromatherapy. Vital signs were recorded before and after aromatherapy. STAI-State questions were divided into positive and negative emotions for analysis. Before aromatherapy, there was no significant difference between groups by individual questions or overall average answer of either positive or negative questions. The use of both LFO and UO increased the positive STAI score totals, with the LFO group having a slightly, but statistically significant, greater increase. Both resulted in a statistically significant decrease in the negative score totals after treatment. There were no differences in vital signs between groups for either treatment. Following the conclusion of the trial LFO was analyzed and found to contain a very low content of the 2 major Lavandula angustifolia constituents. Both LFO and UO aromatherapy treatments lowered anxiety before surgery despite no significant changes in vital signs. LFO treatment generated a slight but statistically significant increase in positive feelings compared with UO treatment. It is probable that the beneficial effect observed was due to both aromatherapy with LFO and a placebo effect related to the added attention given to the patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Archer, Kristin R; Devin, Clinton J; Vanston, Susan W; Koyama, Tatsuki; Phillips, Sharon E; George, Steven Z; McGirt, Matthew J; Spengler, Dan M; Aaronson, Oran S; Cheng, Joseph S; Wegener, Stephen T

    2016-01-01

    The purpose of this study was to determine the efficacy of a cognitive-behavioral-based physical therapy (CBPT) program for improving outcomes in patients after lumbar spine surgery. A randomized controlled trial was conducted on 86 adults undergoing a laminectomy with or without arthrodesis for a lumbar degenerative condition. Patients were screened preoperatively for high fear of movement using the Tampa Scale for Kinesiophobia. Randomization to either CBPT or an education program occurred at 6 weeks after surgery. Assessments were completed pretreatment, posttreatment and at 3-month follow-up. The primary outcomes were pain and disability measured by the Brief Pain Inventory and Oswestry Disability Index. Secondary outcomes included general health (SF-12) and performance-based tests (5-Chair Stand, Timed Up and Go, 10-Meter Walk). Multivariable linear regression analyses found that CBPT participants had significantly greater decreases in pain and disability and increases in general health and physical performance compared with the education group at the 3-month follow-up. Results suggest a targeted CBPT program may result in significant and clinically meaningful improvement in postoperative outcomes. CBPT has the potential to be an evidence-based program that clinicians can recommend for patients at risk for poor recovery after spine surgery. This study investigated a targeted cognitive-behavioral-based physical therapy program for patients after lumbar spine surgery. Findings lend support to the hypothesis that incorporating cognitive-behavioral strategies into postoperative physical therapy may address psychosocial risk factors and improve pain, disability, general health, and physical performance outcomes. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  5. 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.

    Science.gov (United States)

    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

  6. SINGLE-DOSE VERSUS 3-DAY PROPHYLAXIS WITH CIPROFLOXACIN IN TRANSURETHRAL SURGERY - A CLINICAL-TRIAL

    NARCIS (Netherlands)

    BIJL, W; JANKNEGT, RA

    1993-01-01

    in 235 patients who underwent transurethral surgery, perioperative oral ciprofloxacin prophylaxis was given as a single dose 500 mg versus a 3-day regimen. Out of 180 evaluable patients, 84 received a single dose and 96 received a 3-day course. In the single dose prophylaxis group there were 5

  7. A randomized trial evaluating different modalities of levosimendan administration in cardiac surgery patients with myocardial dysfunction

    NARCIS (Netherlands)

    de Hert, Stefan G.; Lorsomradee, Suraphong; vanden Eede, Hervé; Cromheecke, Stefanie; van der Linden, Philippe J.

    2008-01-01

    OBJECTIVE: To evaluate the effects of 2 different administration modalities of levosimendan (start before cardiopulmonary bypass [CPB] and at the end of CPB) compared with a standard treatment with milrinone started at the end of CPB in cardiac surgery patients with a preoperative ejection fraction

  8. 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

  9. Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Nåsell, Hans; Adami, Johanna; Samnegård, Eva

    2010-01-01

    Tobacco smoking is a major health and economic concern and is also known to have a significant negative effect on surgical outcomes. The benefits of a smoking cessation intervention prior to elective orthopaedic surgery have been evaluated previously. Our aim was to assess whether a smoking...

  10. 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...

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Ibuprofen - a Safe Analgesic During Cardiac Surgery Recovery? A Randomized Controlled Trial?

    Directory of Open Access Journals (Sweden)

    Saddiq Mohammad Qazi

    2015-12-01

    Conclusion: The results of this study suggest that patients treated postoperatively, following cardiac surgery, are at no greater risk of harm if short term slow release ibuprofen combined with lansoprazole treatment is used when compared to an oxycodone based regimen. Renal function should, however, be closely monitored and in the event of any decrease in renal function ibuprofen must be discontinued.

  13. Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

    Science.gov (United States)

    Ahmed Ali, Usama; Issa, Yama; Bruno, Marco J; van Goor, Harry; van Santvoort, Hjalmar; Busch, Olivier R C; Dejong, Cornelis H C; Nieuwenhuijs, Vincent B; van Eijck, Casper H; van Dullemen, Hendrik M; Fockens, Paul; Siersema, Peter D; Gouma, Dirk J; van Hooft, Jeanin E; Keulemans, Yolande; Poley, Jan W; Timmer, Robin; Besselink, Marc G; Vleggaar, Frank P; Wilder-Smith, Oliver H; Gooszen, Hein G; Dijkgraaf, Marcel G W; Boermeester, Marja A

    2013-03-18

    In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least

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

    Directory of Open Access Journals (Sweden)

    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.

  15. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

    Science.gov (United States)

    Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

    2012-12-14

    Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

  16. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Gade, Josephine; Wilkens, Trine Levring; Hillingsø, Jens

    2016-01-01

    Major gastrointestinal surgery is associated with immune suppression and a high risk of postoperative complications. The aim of this open, randomized controlled trial was to examine the effect of supplementary per oral immunonutrition (IN) seven days before surgery for pancreatic cancer (PC......) on postoperative complications and length of hospital stay (LOS). Secondary outcomes were the changes in functional capability and body weight (BW). Consecutive patients referred for surgery for diagnosed or plausible PC were included. The patients in the intervention group received supplementary IN (Oral Impact...

  17. 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

  18. 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.

  19. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial.

    Science.gov (United States)

    Lockwood, Geoff G; Cabreros, Leilani; Banach, Dorota; Punjabi, Prakash P

    2017-10-01

    Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg -1 .hr -1 ) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l -1 . There were no adverse events as a consequence of the study. Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. ISRCTN13424423 ( https://www.isrctn.com ).

  20. 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.

  1. Quench detection electronics testing protocol for SST-1 magnets

    International Nuclear Information System (INIS)

    Banaudha, Moni; Varmora, Pankaj; Parghi, Bhadresh; Prasad, Upendra

    2017-01-01

    Quench Detection (QD) system consisting 204 signal channels has been successfully installed and working well during plasma experiment of SST-1 Tokamak. QD system requires testing, validation and maintenance in every SST-1 campaign for better reliability and maintainability of the system. Standalone test of each channel of the system is essential for hard-ware validation. The standard Testing Protocol follow in every campaign which validate each section of QD electronics as well as voltage tap signal cables which are routed inside the cryostat and then extended outside of the SST-1 machine up-to the magnet control room. Fiber link for Quench signal transmission to the SST-1 magnet power supply is also test and validate before every plasma campaign. Precise instrument used as a dummy source of quench signal and for manual quench generation to test the each channel and Master Quench Logic. Each signal Integrated with the magnet DAQ system, signal observed at 1Hz and 50Hz configuration to validate the logging data, compare with actual and previous test data. This paper describes the testing protocol follow in every campaign to validate functionality of QD electronics, limitation of testing, test results and overall integration of the quench detection system for SST-1 magnet. (author)

  2. Continuous transversus abdominis plane block vs intermittent bolus for analgesia after abdominal surgery: a randomized trial

    Directory of Open Access Journals (Sweden)

    Rao Kadam V

    2017-07-01

    Full Text Available Vasanth Rao Kadam,1 Roelof M Van Wijk,1 John L Moran,2 Shantan Ganesh,3 A Kumar,1 Rajesh Sethi,1 Patricia Williams2,4 1Department of Anaesthesia, The Queen Elizabeth Hospital, School of Medicine, University of Adelaide, Adelaide, SA, 2Intensive Care Unit, The Queen Elizabeth Hospital, School of Medicine, University of Adelaide, Adelaide, SA, 3Department of Surgery, The Queen Elizabeth Hospital, School of Medicine, University of Adelaide, Adelaide, SA, 4Department of Epidemiology and Preventive Medicine, School Public Health and Preventive Medicine, Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia Background: Continuous and intermittent bolus techniques of transversus abdominis plane (TAP blocks have been used for analgesia after abdominal surgery. Although both are effective, there are no studies comparing them. The aim of this study is to compare analgesia and cost-effectiveness between these groups.Methods: After obtaining ethical approval, 20 American Society of Anesthesiologists ASA grade I to III patients undergoing elective abdominal surgery were recruited with 10 patients allocated to each arm. Bilateral ultrasound-guided TAP blocks were performed with an initial bolus of 0.5% ropivacaine 20 mL per side, followed by catheter insertion. After surgery, the continuous infusion group received 0.2% ropivacaine 8 mL/hour on each side and the intermittent bolus group received doses of 0.2% ropivacaine 20 mL per side every 8 hours for 48 hours. Both groups received intravenous fentanyl patient-controlled analgesia and regular oral paracetamol. Parameters recorded included numerical rating scores for pain and post-operative analgesic consumption at baseline (time 0 and at 1 hour, 1 day and 2 days post-operatively. The duration of catheter insertion, complications, patient satisfaction and information regarding costs were also recorded. Patient satisfaction was assessed utilizing a 4-point

  3. Fracture Surgery of the extremities with the intra-operative use of 3D-RX: A randomized multicenter trial (EF3X-trial

    Directory of Open Access Journals (Sweden)

    Marmor Meir

    2011-07-01

    Full Text Available Abstract Background Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed. Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated. The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1 the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2 The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. Methods/design In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years with a traumatic intra-articular fracture of the

  4. Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  5. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial

    DEFF Research Database (Denmark)

    Christensen, U C; Krøyer, K; Sander, B

    2009-01-01

    AIM: To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS). METHODS: Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less...... than 1 year's duration of symptoms. Eyes were randomised to (1) vitrectomy alone without retinal surface manipulation, (2) vitrectomy plus 0.05% isotonic Indocyanine Green (ICG)-assisted ILM peeling or (3) vitrectomy plus 0.15% Trypan Blue (TB)-assisted ILM peeling. Main outcomes were hole closure...... after 3 and 12 months and best-corrected visual acuity after 12 months. RESULTS: 78 eyes were enrolled. Primary closure rates were significantly higher with ILM peeling than without peeling for both stage 2 holes (ICG peeling 100%, non-peeling 55%, p = 0.014) and for stage 3 holes (ICG peeling 91%, TB...

  6. Effects of foot reflexology on anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery: A clinical trial.

    Science.gov (United States)

    Abbaszadeh, Yaser; Allahbakhshian, Atefeh; Seyyedrasooli, Alehe; Sarbakhsh, Parvin; Goljarian, Sakineh; Safaei, Naser

    2018-05-01

    This study aimed to investigate the effect of foot reflexology on anxiety and physiological parameters in patients after CABG surgery. This was a single-blind, three-arm, parallel-group, randomized controlled trial with three groups of 40 male patients undergoing CABG. Participants were placed in three groups, named intervention, placebo, and control. Physiological parameters were measured including systolic and diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, percutaneous oxygen saturation, and anxiety of participants. Results showed a statistically significant difference between intervention and control groups in terms of the level of anxiety (p foot reflexology may be used by nurses as an adjunct to standard ICU care to reduce anxiety and stabilize physiological parameters such as systolic, diastolic, mean arterial pressure, and heart rate. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Directory of Open Access Journals (Sweden)

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  8. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Hudson, Jemma; Wood, Jessica; Kilonzo, Mary; Brown, Steven R; McDonald, Alison; Norrie, John; Bruhn, Hanne; Cook, Jonathan A

    2016-11-12

    Two commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  11. Effectiveness of a Cognitive Behavioral Therapy for Dysfunctional Eating among Patients Admitted for Bariatric Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hege Gade

    2014-01-01

    Full Text Available Objective. To examine whether cognitive behavioral therapy (CBT alleviates dysfunctional eating (DE patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females patients with a mean (SD age of 43 (10 years and BMI 43.5 (4.9 kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education. The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Results. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g=-.92, P≤.001; DE-uncontrolled eating, g=-.90, P≤.001, moderate (HADS-depression, g=-.73, P≤.001; DE-emotional eating, g=-.67, P≤.001; HADS-anxiety, g=-.62, P=.003, and low (BMI, g=-.24, P=.004. Conclusion. This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.

  12. 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.

  13. 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.

  14. Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

    Science.gov (United States)

    Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

    2017-02-01

    The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m 2 , and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

  15. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.We searched 25 electronic databases from their first available date until October 2014.Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated, the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07 and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  16. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1.

    Science.gov (United States)

    Wielders, Laura H P; Schouten, Jan S A G; Winkens, Bjorn; van den Biggelaar, Frank J H M; Veldhuizen, Claudette A; Findl, Oliver; Murta, Joaquim C N; Goslings, Willem R O; Tassignon, Marie-José; Joosse, Maurits V; Henry, Ype P; Rulo, Alexander H F; Güell, José L; Amon, Michael; Kohnen, Thomas; Nuijts, Rudy M M A

    2018-04-01

    To compare the efficacy of a topical nonsteroidal antiinflammatory drug, topical corticosteroid, and a combination of both drugs to prevent the occurrence of cystoid macular edema (CME) after cataract surgery in nondiabetic patients. Twelve European study centers. Randomized clinical trial. Nondiabetic patients having uneventful cataract surgery were included in this study. Patients were randomized to receive topical bromfenac 0.09% twice daily for 2 weeks or dexamethasone 0.1% 4 times daily with 1 drop less per day every following week, or a combination of both. The primary outcome was the difference in central subfield mean macular thickness 6 weeks postoperatively. Secondary outcome measures included corrected distance visual acuity as well as the incidence of CME and clinically significant macular edema (CSME) within 6 weeks and 12 weeks postoperatively. This study comprised 914 patients. Six weeks postoperatively, the central subfield mean macular thickness was 288.3 μm, 296.0 μm, and 284.5 μm in the bromfenac group, dexamethasone group, and combination treatment group, respectively (overall P = .006). The incidence of clinically significant macular edema within 12 weeks postoperatively was 3.6%, 5.1%, and 1.5%, respectively (overall P = .043). Patients treated with a combination of topical bromfenac 0.09% and dexamethasone 0.1% had a lower risk for developing CSME after cataract surgery than patients treated with a single drug. Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  17. Supraclavicular block versus interscalene brachial plexus block for shoulder surgery: A meta-analysis of clinical control trials.

    Science.gov (United States)

    Guo, C W; Ma, J X; Ma, X L; Lu, B; Wang, Y; Tian, A X; Sun, L; Wang, Y; Dong, B C; Teng, Y B

    2017-09-01

    The ultrasound-guided interscalene block (ISB) has been considered a standard technique in managing pain after shoulder surgery. However, this method was associated with the incidence of hemi-diaphragmatic paresis. In contrast to ISB, supraclavicular block (SCB) was suggested to provide effective anaesthesia for shoulder surgery with a low rate of side-effects. Thus, we performed a meta-analysis of randomised controlled trials (RCTs) to compare SCB with ISB for evaluating the efficacy and safety. The literature was searched from PubMed, Wiley Online Library, EMBASE, and the Cochrane Library by two reviewers up to April 2017. All available RCTs written in English that met the criteria were included. Two authors pulled data from relevant articles and assessed the quality with the Cochrane Handbook. Review Manager 5.3 software was used to analyse the data. Five RCTs and one prospective clinical study met the eligibility criteria and were included in the meta-analysis. We considered that there were no statistically significant differences between supraclavicular and interscalene groups in procedural time (P = 0.81), rescue analgesia (P = 0.53), and dyspnoea (P = 0.6). The incidence of hoarseness and Horner syndrome was statistically lower in the SCB group than in the ISB group (P = 0.0002 and P < 0.00001, respectively). The meta-analysis showed that ultrasound-guided SCB could become a feasible alternative technique to the ISB in shoulder surgery. Copyright © 2017. Published by Elsevier Ltd.

  18. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    van der Heijden, Marianne J E; Oliai Araghi, Sadaf; van Dijk, Monique; Jeekel, Johannes; Hunink, M G Myriam

    2015-01-01

    Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. We searched 25 electronic databases from their first available date until October 2014. Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music. 4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators. Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated), the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale. Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years) receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07) and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16. This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  19. 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

  20. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial.

    Science.gov (United States)

    Spieth, P M; Güldner, A; Uhlig, C; Bluth, T; Kiss, T; Conrad, C; Bischlager, K; Braune, A; Huhle, R; Insorsi, A; Tarantino, F; Ball, L; Schultz, M J; Abolmaali, N; Koch, T; Pelosi, P; Gama de Abreu, M

    2018-03-01

    Experimental studies showed that controlled variable ventilation (CVV) yielded better pulmonary function compared to non-variable ventilation (CNV) in injured lungs. We hypothesized that CVV improves intraoperative and postoperative respiratory function in patients undergoing open abdominal surgery. Fifty patients planned for open abdominal surgery lasting >3 h were randomly assigned to receive either CVV or CNV. Mean tidal volumes and PEEP were set at 8 ml kg -1 (predicted body weight) and 5 cm H 2 O, respectively. In CVV, tidal volumes varied randomly, following a normal distribution, on a breath-by-breath basis. The primary endpoint was the forced vital capacity (FVC) on postoperative Day 1. Secondary endpoints were oxygenation, non-aerated lung volume, distribution of ventilation, and pulmonary and extrapulmonary complications until postoperative Day 5. FVC did not differ significantly between CVV and CNV on postoperative Day 1, 61.5 (standard deviation 22.1) % vs 61.9 (23.6) %, respectively; mean [95% confidence interval (CI)] difference, -0.4 (-13.2-14.0), P=0.95. Intraoperatively, CVV did not result in improved respiratory function, haemodynamics, or redistribution of ventilation compared to CNV. Postoperatively, FVC, forced expiratory volume at the first second (FEV 1 ), and FEV 1 /FVC deteriorated, while atelectasis volume and plasma levels of interleukin-6 and interleukin-8 increased, but values did not differ between groups. The incidence of postoperative pulmonary and extrapulmonary complications was comparable in CVV and CNV. In patients undergoing open abdominal surgery, CVV did not improve intraoperative and postoperative respiratory function compared with CNV. NCT 01683578. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  1. Impaired alcohol metabolism after gastric bypass surgery: a case-crossover trial.

    Science.gov (United States)

    Woodard, Gavitt A; Downey, John; Hernandez-Boussard, Tina; Morton, John M

    2011-02-01

    Severe obesity remains the leading public health crisis of the industrialized world, with bariatric surgery the only effective and enduring treatment. Poor psychological adjustment has been occasionally reported postoperatively. In addition, evidence suggests that patients can metabolize alcohol differently after gastric bypass. Preoperatively and at 3 and 6 months postoperatively, 19 Roux-en-Y gastric bypass (RYGB) patients' breath alcohol content (BAC) was measured every 5 minutes after drinking 5 oz red wine to determine peak BAC and time until sober in a case-crossover design preoperatively and at 6 months postoperatively. Patients reported symptoms experienced when intoxicated and answered a questionnaire of drinking habits. The peak BAC in patients after RYGB was considerably higher at 3 months (0.059%) and 6 months (0.088%) postoperatively than matched preoperative levels (0.024%). Patients also took considerably more time to return to sober at 3 months (61 minutes) and 6 months (88 minutes) than preoperatively (49 minutes). Postoperative intoxication was associated with lower levels of diaphoresis, flushing, and hyperactivity and higher levels of dizziness, warmth, and double vision. Postoperative patients reported drinking considerably less alcohol, fewer preferred beer, and more preferred wine than before surgery. This is the first study to match preoperative and postoperative alcohol metabolism in gastric bypass patients. Post-RYGB patients have much higher peak BAC after ingesting alcohol and require more time to become sober. Patients who drink alcohol after gastric bypass surgery should exercise caution. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  2. 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.

  3. Using a 1-D model to reproduce diurnal SST signals

    DEFF Research Database (Denmark)

    Karagali, Ioanna; Høyer, Jacob L.

    2014-01-01

    The diurnal variability of SST has been extensively studied as it poses challenges for validating and calibrating satellite sensors, merging SST time series, oceanic and atmospheric modelling. As heat is significantly trapped close to the surface, the diurnal signal’s maximum amplitude is best...... captured by radiometers. The availability of infra-red retrievals from a geostationary orbit allows the hourly monitoring of the diurnal SST evolution. When infra-red SSTs are validated with in situ measurements a general mismatch is found, associated with the different reference depth of each type...... of measurement. A generally preferred approach to bridge the gap between in situ and remotely obtained measurements is through modelling of the upper ocean temperature. This ESA supported study focuses on the implementation of the 1 dimensional General Ocean Turbulence Model (GOTM), in order to resolve...

  4. Pneumonia After Cardiac Surgery: Experience of the NIH/CIHR Cardiothoracic Surgical Trials Network

    Science.gov (United States)

    Ailawadi, Gorav; Chang, Helena L.; O’Gara, Patrick T.; O'sullivan, Karen; Woo, Y. Joseph; DeRose, Joseph J.; Parides, Michael K.; Thourani, Vinod H.; Robichaud, Sophie; Gillinov, A. Marc; Taddei-Peters, Wendy C.; Miller, Marissa A.; Perrault, Louis P.; Smith, Robert L.; Goldsmith, Lyn; Horvath, Keith A.; Doud, Kristen; Baio, Kim; Gelijns, Annetine C.; Moskowitz, Alan J.; Bagiella, Emilia; Alexander, John H.; Iribarne, Alexander

    2017-01-01

    Rationale Pneumonia remains the most common major infection after cardiac surgery despite numerous preventive measures. Objectives To prospectively examine the timing, pathogens, and risk factors, including modifiable management practices, for post-operative pneumonia and estimate its impact on clinical outcomes. Methods 5,158 adult cardiac surgery patients were prospectively enrolled in a cohort study across 10 centers. All infections were adjudicated by an independent committee. Competing risk models were used to assess the association of patient characteristics and management practices with pneumonia within 65 days of surgery. Mortality was assessed by Cox proportional hazards model, and length of stay using a multi-state model. Measurements and Main Results The cumulative incidence of p neumonia was 2.4% ,33% of which occurred after discharge. Older age, lower hemoglobin level, chronic obstructive pulmonary disease, steroid use, operative time and left ventricular assist device/heart transplant were risk factors. Ventilation time (24–48 vs ≤24 hours;HR,2·83; 95% CI,1·72–4·66; >48 hours HR,4·67; 95% CI,2·70–8·08), nasogastric tubes (HR,1·80; 95% CI,1·10–2·94), and each unit of blood cells transfused (HR,1·16; 95% CI,1·08–1·26) increased pneumonia risk. Prophylactic use of second-generation cephalosporins (HR,0·66; 95% CI, 0·45–0·97) and platelet transfusions (HR, 0·49, 95% CI, 0·30–0·79) were protective. Pneumonia was associated with a marked increase in mortality (HR,8·89; 95% CI,5·02–15·75), and longer LOS of 13·55 ± 1·95 days (bootstrap 95% CI,10·31–16·58). Conclusions Pneumonia continues to impose a major impact on the health of patients after cardiac surgery. Adjusting for baseline risk, several specific management practices were associated with pneumonia, which offer targets for quality improvement and further research. PMID:28341473

  5. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  6. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica.

  7. High-Target vs Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients - A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Vedel, Anne G; Holmgaard, Frederik; Rasmussen, Lars S

    2018-01-01

    .71). No significant difference was observed in frequency of severe adverse events. Conclusions -Among patients undergoing on-pump cardiac surgery, targeting a higher versus a lower MAP during cardiopulmonary bypass did not seem to affect the volume or numbers of new cerebral infarcts. Clinical Trial Registration -URL...

  8. Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage (ECMOH: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zan Xin

    2012-06-01

    Full Text Available Abstract Background Spontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage. Methods Patients meet the criteria will be randomized into the endoscopic surgery group (endoscopic surgery for hematoma evacuation and the best medical treatment or the conservative treatment group (the best medical treatment. Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel Index(BI will also be evaluated. The sample size is 100 patients. Discussion The ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-11001614 (http://www.chictr.org/en/proj/show.aspx?proj=1618

  9. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...

  10. 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

  11. Vessel eddy current characteristics in SST-1 tokamak

    Energy Technology Data Exchange (ETDEWEB)

    Jana, Subrata; Pradhan, Subrata, E-mail: pradhan@ipr.res.in; Dhongde, Jasraj; Masand, Harish

    2016-11-15

    Highlights: • Eddy current distribution in the SST-1 vacuum vessel. • Circuit model analysis of eddy current. • A comparison of the field lines with and without the plasma column in identical conditions. • The influence of eddy current in magnetic NULL dynamics. - Abstract: Eddy current distribution in the vacuum vessel of the Steady state superconducting (SST-1) tokamak has been determined from the experimental data obtained using an array of internal voltage loops (flux loop) installed inside the vacuum vessel. A simple circuit model has been employed. The model takes into account the geometric and constructional features of SST-1 vacuum vessel. SST-1 vacuum vessel is a modified ‘D’ shaped vessel having major axis of 1.285 m and minor axis of 0.81 m and has been manufactured from non-magnetic stainless steel. The Plasma facing components installed inside the vacuum vessel are graphite blocks mounted on Copper Chromium Zirconium (CuCrZr) heat sink plates on inconel supports. During discharge of the central solenoid, eddy currents get generated in the vacuum vessel and passive supports on it. These eddy currents influence the early magnetic NULL dynamics and plasma break-down and start-up characteristics. The computed results obtained from the model have been benchmarked against experimental data obtained in large number of SST-1 plasma shots. The results are in good agreement. Once bench marked, the calculated eddy current based on flux loop signal and circuit equation model has been extended to the reconstruction of the overall B- field contours of SST-1 tokamak in the vessel region. A comparison of the field lines with and without the plasma column in identical conditions of the central solenoid and equilibrium field profiles has also been done with an aim to quantify the diagnostics responses in vacuum shots.

  12. Interannual to Decadal SST Variability in the Tropical Indian Ocean

    Science.gov (United States)

    Wang, G.; Newman, M.; Han, W.

    2017-12-01

    The Indian Ocean has received increasing attention in recent years for its large impacts on regional and global climate. However, due mainly to the close interdependence of the climate variation within the Tropical Pacific and the Indian Ocean, the internal sea surface temperature (SST) variability within the Indian Ocean has not been studied extensively on longer time scales. In this presentation we will show analysis of the interannual to decadal SST variability in the Tropical Indian Ocean in observations and Linear Inverse Model (LIM) results. We also compare the decoupled Indian Ocean SST variability from the Pacific against fully coupled one based on LIM integrations, to test the factors influence the features of the leading SST modes in the Indian Ocean. The result shows the Indian Ocean Basin (IOB) mode, which is strongly related to global averaged SST variability, passively responses to the Pacific variation. Without tropical Indo-Pacific coupling interaction, the intensity of IOB significantly decreases by 80%. The Indian Ocean Dipole (IOD) mode demonstrates its independence from the Pacific SST variability since the IOD does not change its long-term characteristics at all without inter-basin interactions. The overall SSTA variance decreases significantly in the Tropical Indian Ocean in the coupling restricted LIM runs, especially when the one-way impact from the Pacific to the Indian Ocean is turned off, suggesting that most of the variability in the Indian Ocean comes from the Pacific influence. On the other hand, the Indian Ocean could also transport anomalies to the Pacific, making the interaction a complete two-way process.

  13. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: final results from a prospective trial

    International Nuclear Information System (INIS)

    Maranzano, Ernesto; Latini, Paolo

    1995-01-01

    Purpose: In assessing effectiveness of radiation therapy (RT) in metastatic spinal cord compression (MSCC), we performed a prospective trial in which patients with this complication were generally treated with RT plus steroids, and surgery was reserved for selected cases. Methods and Materials: Two hundred seventy-five consecutive patients with MSCC entered this protocol. Twenty (7%) underwent surgery plus RT, another 255 received RT alone. Of all eligible patients, 25 (10%) early deaths and 21 (8%) entering a feasibility study of RT without steroids, were not evaluable. Of the 209 evaluable cases, 110 were females and 99 males, and median age was 62 years. Median follow-up was 49 months (range, 13 to 88) and treatment consisted of 30 Gy RT (using two different schedules) together with steroids (standard or high doses, depending on motor deficit severity). Response was assessed according to back pain and motor and bladder function before and after therapy. Results: Back pain total response rate was 82% (complete or partial response or stable pain, 54, 17, or 11%, respectively). About three-fourths of the patients (76%) achieved full recovery or preservation of walking ability and 44% with sphincter dysfunction improved. Early diagnosis was the most important response predictor so that a large majority of patients able to walk and with good bladder function maintained these capacities. When diagnosis was late, tumors with favorable histologies (i.e., myeloma, breast, and prostate carcinomas) above all responded to RT. Duration of response was also influenced by histology. Favorable histologies are associated to higher median response (myeloma, breast, and prostate carcinomas, 16, 12, and 10 months, respectively). Median survival time was 6 months, with a 28% probability of survival for 1 year. Survival time was longer for patients able to walk before and/or after RT, those with favourable histologies, and females. There was agreement between patient survival and

  14. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

    Science.gov (United States)

    Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

    2015-02-07

    Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

  15. Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

    Science.gov (United States)

    Bridoux, Valérie; Moutel, Grégoire; Schwarz, Lilian; Michot, Francis; Herve, Christian; Tuech, Jean-Jacques

    2014-10-01

    Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

  16. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  17. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

    Directory of Open Access Journals (Sweden)

    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. 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.

  19. FLAMMABLE GAS DIFFUSION THROUGH SINGLE SHELL TANK (SST) DOMES

    Energy Technology Data Exchange (ETDEWEB)

    MEACHAM, J.E.

    2003-11-10

    This report quantified potential hydrogen diffusion through Hanford Site Single-Shell tank (SST) domes if the SSTs were hypothetically sealed airtight. Results showed that diffusion would keep headspace flammable gas concentrations below the lower flammability limit in the 241-AX and 241-SX SST. The purpose of this document is to quantify the amount of hydrogen that could diffuse through the domes of the SSTs if they were hypothetically sealed airtight. Diffusion is assumed to be the only mechanism available to reduce flammable gas concentrations. The scope of this report is limited to the 149 SSTs.

  20. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  1. A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

    Science.gov (United States)

    Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

    2016-02-01

    The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

  2. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)

    Science.gov (United States)

    Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-01-01

    Objectives To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Setting Initial recruitment in 21 UK hospitals. Participants Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. Intervention The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Main outcome measures Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. Results By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), Preflux-related operations—most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. Conclusions After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse

  3. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vonk Noordegraaf Antonie

    2012-02-01

    Full Text Available Abstract Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR: NTR2087

  4. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery

    DEFF Research Database (Denmark)

    Vedel, Anne G.; Holmgaard, Frederik; Rasmussen, Lars Simon

    2016-01-01

    Background: Debilitating brain injury occurs in 1.6–5 % of patients undergoing cardiac surgery with cardiopulmonary bypass. Diffusion-weighted magnetic resonance imaging studies have reported stroke-like lesions in up to 51 % of patients after cardiac surgery. The majority of the lesions seem...... to be caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided...... by the cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure. Methods/design: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients...

  5. One-year results of total arterial revascularization vs. conventional coronary surgery: CARRPO trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Wetterslev, Jørn; Lund, Jens T

    2009-01-01

    +/- 18% in the conventional group (P = 0.52). In 72% of TAR patients and 67% of the conventional group, all grafts were patent (P = 0.45). Multiple imputation of missing angiographic data did not influence on results. Within 1 year, 37 (23%) TAR patients and 43 (25%) conventional group patients suffered...... cardiac events (HR 1.09, 95% CI 0.70-1.69, P = 0.70). One patient (0.6%) in the TAR group and two (1.2%) in the conventional group died (P = 1.00). CONCLUSION: Within 1 year post-operatively, TAR seems at least as safe and effective as CR. Prolonged follow-up will reveal whether this is sustained......AIMS: To investigate clinical and angiographic outcomes after coronary surgery using total arterial revascularization (TAR). METHODS AND RESULTS: We randomized 331 patients with multivessel or isolated left main disease to TAR [internal thoracic (ITA) and radial arteries] vs. conventional...

  6. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  7. Cardioprotection of Electroacupuncture for Enhanced Recovery after Surgery on Patients Undergoing Heart Valve Replacement with Cardiopulmonary Bypass: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fangxiang Zhang

    2017-01-01

    Full Text Available We attempted to investigate cardioprotection of electroacupuncture (EA for enhanced recovery after surgery on patients undergoing heart valve replacement with cardiopulmonary bypass. Forty-four patients with acquired heart valve replacement were randomly allocated to the EA group or the control group. Patients in the EA group received EA stimulus at bilateral Neiguan (PC6, Ximen (PC4, Shenting (GV24, and Baihui (GV20 acupoints twenty minutes before anesthesia induction to the end of surgery. The primary end point was cardioprotection effect of electroacupuncture postoperatively and the secondary endpoints were quality of recovery and cognitive functioning postoperatively. The present study demonstrated that electroacupuncture reduced the occurrence of complications and played a role of cardioprotective effect on patients after heart valve replacement surgery with cardiopulmonary bypass, and it benefits patients more comfortable and contributes to recovery after surgery. This trial is registered with ChiCTR-IOC-16009123.

  8. The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial controlled trial

    Directory of Open Access Journals (Sweden)

    Tharanon C

    2016-08-01

    Full Text Available Chantip Tharanon, Kovit Khampitak Department of Obstetrics and Gynecology, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand Objectives: To compare the effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery and the amount of postoperative analgesic dosage.Methods: The trial included 45 females who had undergone operations during the period December 2014 to October 2015. The patients were block randomized based on operating time (<2 and ≥2 hours. The intervention group (n=23 was treated with postoperative intraperitoneal gas drain and the control group (n=22 was not. The mean difference in scores for shoulder, epigastric, suprapubic, and overall pain at 6, 24, 48 hours postoperatively were statistically evaluated using mixed-effect restricted maximum likelihood regression. The differences in the analgesic drug usage between the groups were also analyzed using a Student’s t-test. The data were divided and analyzed to two subgroups based on operating time (<2 hours, n=20; and ≥2 hours, n=25.Results: The intervention had significantly lower overall pain than the control group, with a mean difference and 95% confidence interval at 6, 24, and 48 hours of 2.59 (1.49–3.69, 2.23 (1.13–3.34, and 1.48 (0.3–2.58, respectively. Correspondingly, analgesic drug dosage was significantly lower in the intervention group (3.52±1.47 mg vs 5.72±2.43 mg, P<0.001. The three largest mean differences in patients with operating times of ≥2 hours were in overall pain, suprapubic pain at 6 hours, and shoulder pain at 24 hours at 3.27 (1.14–5.39, 3.20 (1.11–5.26, and 3.13 (1.00–5.24, respectively. These were greater than the three largest mean differences in the group with operating times of <2 hours, which were 2.81 (1.31–4.29, 2.63 (0.51–4.73, and 2.02 (0.68–3.36. The greatest analgesic drug requirement was in the control group with a longer operative time.Conclusion: The use of

  9. Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

    Science.gov (United States)

    Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

    2018-02-17

    Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism." © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

  10. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.

    Science.gov (United States)

    Donnenfeld, Eric D; Holland, Edward J; Solomon, Kerry D; Fiore, Jay; Gobbo, Anthony; Prince, Jessica; Sandoval, Helga P; Shull, Emily R; Perry, Henry D

    2011-10-01

    To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery. Multicenter, randomized, contralateral-eye, double-masked trial. Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery. Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P eyes at day 30 (P eyes (P = .011). In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

  11. Overall behaviour of PFC integrated SST-1 vacuum system

    Science.gov (United States)

    Khan, Ziauddin; Raval, Dilip C.; Paravasu, Yuvakiran; Semwal, Pratibha; Dhanani, Kalpeshkumar R.; George, Siju; Shoaib, Mohammad; Prakash, Arun; Babu, Gattu R.; Thankey, Prashant; Pathan, Firozkhan S.; Pradhan, Subrata

    2017-04-01

    As a part of phase-I up-gradation of Steady-state Superconducting Tokamak (SST-1), Graphite Plasma Facing Components (PFCs) have been integrated inside SST-1 vacuum vessel as a first wall (FW) during Nov 14 and May 2015. The SST-1 FW has a total surface area of the installed PFCs exposed to plasma is ∼ 40 m2 which is nearly 50% of the total surface area of stainless steel vacuum chamber (∼75 m2). The volume of the vessel within the PFCs is ∼ 16 m3. After the integration of PFCs, the entire vessel as well as the PFC cooling/baking circuits has been qualified with an integrated helium leak tightness of baked at 250 °C for nearly 20 hours employing hot nitrogen gas to remove the absorbed water vapours. Thereafter, Helium glow discharges cleaning were carried out towards the removal of surface impurities. The pump down characteristics of SST-1 vacuum chamber and the changes in the residual gaseous impurities after the installation of the PFCs will be discussed in this paper.

  12. Comparative assessment of seller's staining test (SST) and direct ...

    African Journals Online (AJOL)

    the only standard method. Objective: This study was designed to assess the sensitivity and specificity of the SST in relation to the 'gold standard' dFAT in diagnosis of rabies in Nigeria. Methods: A total of 88 animal specimens submitted to the Rabies National Reference Laboratory, Nigeria were routinely tested for rabies by ...

  13. Are North Atlantic Multidecadal SST Anomalies Westward Propagating?

    NARCIS (Netherlands)

    Feng, Qingyi; Dijkstra, Hendrik

    2014-01-01

    The westward propagation of sea surface temperature (SST) anomalies is one of the main characteristics of one of the theories of the Atlantic Multidecadal Oscillation. Here we use techniques from complex network modeling to investigate the existence of the westward propagation in the North Atlantic

  14. The effect of SST emissions on the earth's ozone layer

    Science.gov (United States)

    Whitten, R. C.; Turco, R. P.

    1974-01-01

    The work presented here is directed toward assessment of environmental effects of the supersonic transport (SST). The model used for the purpose includes vertical eddy transport and the photochemistry of the O-H-N system. It is found that the flight altitude has a pronounced effect on ozone depletion. The largest ozone reduction occurs for NO deposition above an altitude of 20 km.

  15. Cryogenic operation strategy for the SST-1 device

    International Nuclear Information System (INIS)

    Tanna, V.L.; Pradhan, S.

    2013-01-01

    The SST-1 has been operated since 2012 as part of its engineering commissioning and almost 5 experimental campaigns have been successfully completed. Before final assembling, cool-down and current excitation tests for the Toroidal field coils and PF 3 (Upper) coil were demonstrated successfully as part of validation under coils test program. These superconducting coils consist of a cable-in-conduit conductor, (CICC) is cooled by the forced-flow Two-phase flow as well as supercritical helium conditions. During the recent campaigns, hydraulic characteristics of whole superconducting magnets along with the TF case cooling were studied as an integral system. Based on the experimental observations, efforts have been made to cryo stable conditions of the SST-1 superconducting magnets system in order to produce steady state TF magnetic field of 1.5 T at the plasma center. Optimization of Helium plant related processes have been worked out and implemented to realize the successful SST-1 device operation over a week. In order to have long experimental campaign, an intermediate temperature cooling down philosophy has been adopted. The complete superconducting coils flow distribution among their cooling channels and pressure head requirements were studied from the measurements. In this paper, we will highlight the recent cool-down results, flow distribution and temperature uniformity aspects while cooling down the SST-1 magnets system. (author)

  16. Initial results in SST-1 after up-gradation

    Science.gov (United States)

    Pradhan, S.; Khan, Z.; Tanna, V. L.; Prasad, U.; Paravastu, Y.; Raval, D. C.; Masand, H.; Kumar, Aveg; Dhongde, J. R.; Jana, S.; Kakati, B.; Patel, K. B.; Bhandarkar, M. K.; Shukla, B. K.; Ghosh, D.; Patel, H. S.; Parekh, T. J.; Mansuri, I. A.; Dhanani, K. R.; Varadharajulu, A.; Khristi, Y. S.; Biswas, P.; Gupta, C. N.; George, S.; Semwal, P.; Sharma, D. K.; Gulati, H. K.; Mahajan, K.; Praghi, B. R.; Banaudha, M.; Makwana, A. R.; Chudasma, H. H.; Kumar, M.; Manchanda, R.; Joisa, Y. S.; Asudani, K.; Pandya, S. N.; Pathak, S. K.; Banerjee, S.; Patel, P. J.; Santra, P.; Pathan, F. S.; Chauhan, P. K.; Khan, M. S.; Thankey, P. L.; Prakash, A.; Panchal, P. N.; Panchal, R. N.; Patel, R. J.; Mahsuria, G. I.; Sonara, D. P.; Patel, K. M.; Jayaswal, S. P.; Sharma, M.; Patel, J. C.; Varmora, P.; Srikanth, G. L. N.; Christian, D. R.; Garg, A.; Bairagi, N.; Babu, G. R.; Panchal, A. G.; Vora, M. M.; Singh, A. K.; Sharma, R.; Nimavat, H. D.; Shah, P. R.; Purwar, G.; Raval, T. Y.; Sharma, A. L.; Ojha, A.; Kumar, S.; Ramaiya, N. K.; Siju, V.; Gopalakrishna, M. V.; Kumar, A.; Sharma, P. K.; Atrey, P. K.; Kulkarni, SV; Ambulkar, K. K.; Parmar, P. R.; Thakur, A. L.; Raval, J. V.; Purohit, S.; Mishra, P. K.; Adhiya, A. N.; Nagora, U. C.; Thomas, J.; Chaudhari, V. K.; Patel, K. G.; Dalakoti, S.; Virani, C. G.; Gupta, S.; Kumar, Ajay; Chaudhari, B.; Kaur, R.; Srinivasan, R.; Raju, D.; Kanabar, D. H.; Jha, R.; Das, A.; Bora, D.

    2017-04-01

    SST-1 Tokamak has recently completed the 1st phase of up-gradation with successful installation and integration of all its First Wall components. The First Wall of SST-1 comprises of ∼ 3800 high heat flux compatible graphite tiles being assembled and installed on 132 CuCrZr heat sink back plates engraved with ∼ 4 km of leak tight baking and cooling channels in five major sub groups equipped with ∼ 400 sensors and weighing ∼ 6000 kg in total in thirteen isolated galvanic and six isolated hydraulic circuits. The phase-1 up-gradation spectrum also includes addition of Supersonic Molecular Beam Injection (SMBI) both on the in-board and out-board side, installation of fast reciprocating probes, adding some edge plasma probe diagnostics in the SOL region, installation and integration of segmented and up-down symmetric radial coils aiding/controlling plasma rotations, introduction of plasma position feedback and density controls etc. Post phase-I up-gradation spanning from Nov 2014 till June 2016, initial plasma experiments in up-graded SST-1 have begun since Aug 2016 after a brief engineering validation period in SST-1. The first experiments in SST-1 have revealed interesting aspects on the ‘eddy currents in the First Wall support structures’ influencing the ‘magnetic Null evolution dynamics’ and the subsequent plasma start-up characteristics after the ECH pre-ionization, the influence of the first walls on the ‘field errors’ and the resulting locked modes observed, the magnetic index influencing the evolution of the equilibrium of the plasma column, low density supra-thermal electron induced discharges and normal ohmic discharges etc. Presently; repeatable ohmic discharges regimes in SST-1 having plasma currents in excess of 65 KA (qa ∼ 3.8, BT = 1.5 T) with a current ramp rates ∼ 1.2 MA/s over a duration of ∼ 300 ms with line averaged densities ∼ 0.8 × 1019 and temperatures ∼ 200 eV with copious MHD signatures have been experimentally

  17. 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)

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

    Science.gov (United States)

    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

  19. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

    Science.gov (United States)

    Ferrando, Carlos; Soro, Marina; Unzueta, Carmen; Suarez-Sipmann, Fernando; Canet, Jaume; Librero, Julián; Pozo, Natividad; Peiró, Salvador; Llombart, Alicia; León, Irene; India, Inmaculada; Aldecoa, Cesar; Díaz-Cambronero, Oscar; Pestaña, David; Redondo, Francisco J; Garutti, Ignacio; Balust, Jaume; García, Jose I; Ibáñez, Maite; Granell, Manuel; Rodríguez, Aurelio; Gallego, Lucía; de la Matta, Manuel; Gonzalez, Rafael; Brunelli, Andrea; García, Javier; Rovira, Lucas; Barrios, Francisco; Torres, Vicente; Hernández, Samuel; Gracia, Estefanía; Giné, Marta; García, María; García, Nuria; Miguel, Lisset; Sánchez, Sergio; Piñeiro, Patricia; Pujol, Roger; García-Del-Valle, Santiago; Valdivia, José; Hernández, María J; Padrón, Oto; Colás, Ana; Puig, Jaume; Azparren, Gonzalo; Tusman, Gerardo; Villar, Jesús; Belda, Javier

    2018-03-01

    The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m 2 . Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O 2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic

  20. Laparoendoscopic Single-Site Surgery for the Treatment of Benign Adnexal Disease: A Prospective Trial

    Directory of Open Access Journals (Sweden)

    Anna Fagotti

    2010-01-01

    Full Text Available Background. To validate feasibility, efficacy, and safeness of laparoscopic treatment of benign adnexal diseases through a single transumbilical access (LESS in a prospective series of patients. Methods. A prospective clinical trial including 30 women has been conducted at the Division of Gynecology of Catholic University of Sacred Hearth of Rome. Patients underwent different laparoscopic procedures by LESS utilizing a multiport trocar and conventional straight laparoscopic instrumentation. Intra and perioperative outcome has been reported. Results. Ten mono/bilateral adnexectomies and 20 cystectomies have been performed by LESS approach. Laparoscopic procedures were completed through a single access in 28 cases (93.4%. No major intra- or postoperative complications were observed. Mean hospital stay was 1.3 days. Conclusions. LESS approach is feasible to treat benign adnexal disease with a very low conversion rate and no early or late complications. More clinical data are needed to confirm these advantages compared to standard laparoscopic technique.

  1. Evaluation of postoperative recovery in day surgery patients using a mobile phone application: a multicentre randomized trial.

    Science.gov (United States)

    Jaensson, M; Dahlberg, K; Eriksson, M; Nilsson, U

    2017-11-01

    Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores. The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14. On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound. Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care. NCT02492191. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia.

  2. Effects of Massage in Reducing the Pain and Anxiety of the Cardiac Surgery Critically Ill-a Randomized Controlled Trial.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Maheu, Christine; Laizner, Andréa Maria; Gélinas, Céline

    2018-03-30

    To evaluate the effectiveness of hand massage on the pain and anxiety of the cardiac surgery critically ill. A three-arm randomized controlled trial. This study was conducted in a medical-surgical intensive care unit in Canada. Adult patients who underwent elective cardiac surgery, who were able to speak French/English and to self-report symptoms, without a high risk of postoperative complications were eligible. Patients were randomly allocated to standard care plus either two 20-minute hand massages (experimental), two 20-minute hand holdings (active control), or two 20-minute rest periods (passive control/standard care). Pain intensity, pain unpleasantness, anxiety, muscle tension, and vital signs were evaluated before, after, and 30 minutes later for each intervention. From the 83 patients recruited, 60 were randomized (20 massage, 19 hand holding, 21 standard care). After controlling for baseline scores, the massage group reported significantly lower pain intensity, pain unpleasantness, and anxiety for the first data collection set compared with both hand holding and standard care (analysis of covariance, P < 0.02), with an average decrease of two points on a 0-10 scale. No statistically significant differences were noted between hand holding and standard care for any of the symptoms. Similar results were observed for the second data collection set (N = 43). Patients had decreased muscle tension post massage. Vital signs did not differ significantly between groups. Findings suggest that a 20-minute hand massage in addition to routine postoperative pain management can concomitantly reduce pain intensity, pain unpleasantness, and anxiety by two points on average on a 0-10 scale.

  3. 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.

  4. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sonia Gaucher

    Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.

  5. Are lower levels of red blood cell transfusion more cost-effective than liberal levels after cardiac surgery? Findings from the TITRe2 randomised controlled trial

    Science.gov (United States)

    Stokes, E A; Wordsworth, S; Bargo, D; Pike, K; Rogers, C A; Brierley, R C M; Angelini, G D; Murphy, G J; Reeves, B C

    2016-01-01

    Objective To assess the incremental cost and cost-effectiveness of a restrictive versus a liberal red blood cell transfusion threshold after cardiac surgery. Design A within-trial cost-effectiveness analysis with a 3-month time horizon, based on a multicentre superiority randomised controlled trial from the perspective of the National Health Service (NHS) and personal social services in the UK. Setting 17 specialist cardiac surgery centres in UK NHS hospitals. Participants 2003 patients aged >16 years undergoing non-emergency cardiac surgery with a postoperative haemoglobin of threshold during hospitalisation after surgery. Main outcome measures Health-related quality of life measured using the EQ-5D-3L to calculate quality-adjusted life years (QALYs). Results The total costs from surgery up to 3 months were £17 945 and £18 127 in the restrictive and liberal groups (mean difference is −£182, 95% CI −£1108 to £744). The cost difference was largely attributable to the difference in the cost of red blood cells. Mean QALYs to 3 months were 0.18 in both groups (restrictive minus liberal difference is 0.0004, 95% CI −0.0037 to 0.0045). The point estimate for the base-case cost-effectiveness analysis suggested that the restrictive group was slightly more effective and slightly less costly than the liberal group and, therefore, cost-effective. However, there is great uncertainty around these results partly due to the negligible differences in QALYs gained. Conclusions We conclude that there is no clear difference in the cost-effectiveness of restrictive and liberal thresholds for red blood cell transfusion after cardiac surgery. Trial registration number ISRCTN70923932; Results. PMID:27481621

  6. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  7. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Noordman, Bo Jan; Wijnhoven, Bas P L; Lagarde, Sjoerd M; Boonstra, Jurjen J; Coene, Peter Paul L O; Dekker, Jan Willem T; Doukas, Michael; van der Gaast, Ate; Heisterkamp, Joos; Kouwenhoven, Ewout A; Nieuwenhuijzen, Grard A P; Pierie, Jean-Pierre E N; Rosman, Camiel; van Sandick, Johanna W; van der Sangen, Maurice J C; Sosef, Meindert N; Spaander, Manon C W; Valkema, Roelf; van der Zaag, Edwin S; Steyerberg, Ewout W; van Lanschot, J Jan B

    2018-02-06

    Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not

  8. 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

  9. The ASTRI SST-2M prototype for the Cherenkov Telescope Array: prototype technologies goals and strategies for the future SST

    Science.gov (United States)

    Marchiori, Gianpietro; Busatta, Andrea; Giacomel, Stefano; Folla, Ivan; Valsecchi, Marco; Canestrari, Rodolfo; Bonnoli, Giacomo; Cascone, Enrico; Conconi, Paolo; Fiorini, Mauro; Giro, Enrico; La Palombara, Nicola; Pareschi, Giovanni; Perri, Luca; Rodeghiero, Gabriele; Sironi, Giorgia; Stringhetti, Luca; Toso, Giorgio; Tosti, Gino; Pellicciari, Carlo

    2014-07-01

    The Cherenkov Telescope Array (CTA) observatory will represent the next generation of Imaging Atmospheric Cherenkov Telescope. Using a combination of large-, medium-, and small-scale telescopes (LST, MST, SST, respectively), it will explore the Very High Energy domain from a few tens of GeVup to about few hundreds of TeV with unprecedented sensitivity, angular resolution and imaging quality. In this framework, the Italian ASTRI program, led by the Italian National Institute of Astrophysics (INAF) developed a 4-meter class telescope, which will adopt an aplanatic, wide-field, double-reflection optical layout in a Schwarzschild- Couder configuration. Within this program INAF assigned to the consortium between Galbiati Group and EIE Group the construction, assembly and tests activities of the prototype named ASTRI SST-2M. On the basis of the lesson learnt from the prototype, other telescopes will be produced, starting from a re-design phase, in order to optimize performances and the overall costs and production schedule for the CTA-SST telescope. This paper will firstly give an overview of the concept for the SST prototype mount structure. In this contest, the technologies adopted for the design, manufacturing and tests of the entire system will be presented. Moreover, a specific focus on the challenges of the prototype and the strategies associated with it will be provided, in order to outline the near future performance goals for this type of Cherenkov telescopes employed for Gamma ray science.

  10. CORE STABILIZATION EXERCISES AFTER ACL RECONSTRUCTION SURGERY PROVIDES BETTER OUTCOMES: A RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Dilpreet Kaur

    2015-12-01

    Full Text Available Background: Decreased core stability displaces center of gravity away from base of support reducing activity participation of athlete. Present study was conducted to study the effect of core stabilization exercises after reconstruction surgery of ACL on functional outcomes. Methods: 30 subjects following 5 months of ACL reconstruction were randomly assigned to either group that performed (study group or did not performed (control group additional core stabilization exercises in conjugation with standard rehabilitation protocol. Outcome measures were: activity level using Tegnar activity level scale and functional performance using triple hop test. Outcome measures were compared at day 1 and day 42 of the treatment. Result: Significant improvement was seen in the study group for Tegnar score with mean difference changing from 4.5 to 1.5 from day 1 to day 42 of treatment (p=0.039 while the control group showed improvement in mean difference changing from 3.8 to 1.4 (p=.045 from day 1 to day 42 of treatment. Highly significant improvement was seen in the study group for triple hop test with mean difference changing from 25 to 6.7 (p<.001 compared to the control group with mean difference changing from 15.2 to 9.7(p=.005 from day 1 to day 42 of treatment. Conclusions: Both the groups showed improvement for activity level and functional performance but highly significant improvement was seen in the study group for functional performance. Core stabilization exercises in conjugation with the standard ACL rehabilitation protocol results better improvement in the triple hop test.

  11. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

    Science.gov (United States)

    Vonk Noordegraaf, Antonie; Huirne, Judith A F; Brölmann, Hans A M; Emanuel, Mark H; van Kesteren, Paul J M; Kleiverda, Gunilla; Lips, Jos P; Mozes, Alexander; Thurkow, Andreas L; van Mechelen, Willem; Anema, Johannes R

    2012-02-01

    Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Netherlands Trial Register (NTR): NTR2087.

  12. Hypothalamic Obesity following Craniopharyngioma Surgery: Results of a Pilot Trial of Combined Diazoxide and Metformin Therapy

    Directory of Open Access Journals (Sweden)

    Ahmet Alexandra

    2011-03-01

    Full Text Available Objective. To assess the effect of combined diazoxide-metformin therapy in obese adolescents treated for craniopharyngioma. Design. A prospective open-label 6-month pilot treatment trial in 9 obese subjects with craniopharyngioma. Diazoxide (2 mg/kg divided b.i.d., maximum 200 mg/day and metformin (1000 mg b.i.d.. Whole body insulin sensitivity index (WBISI and area-under-the-curve insulin (AUCins were calculated. Results. Seven subjects completed: 4M/3F, mean ± SD age years, weight  kg, BMI  kg/m2, and BMI SDS . Two were withdrawn due to vomiting and peripheral edema. Of participants completing the study, the mean ± SD weight gain, BMI, and BMI SDS during the 6 months were reduced compared to the 6 months prestudy ( versus  kg, ; versus  kg/m2, ; versus , , resp.. AUCins correlated with weight loss (, and BMI decrease (, . Conclusion. Combined diazoxide-metformin therapy was associated with reduced weight gain in patients with hypothalamic obesity. AUCins at study commencement predicted effectiveness of the treatment.

  13. Multicenter trial of prophylaxis with clindamycin plus aztreonam or cefotaxime in gynecologic surgery.

    Science.gov (United States)

    Mangioni, C; Bianchi, L; Bolis, P F; Lomeo, A M; Mazzeo, F; Ventriglia, L; Scalambrino, S

    1991-01-01

    A prospective, randomized, multicenter study was conducted on the efficacy and safety of two prophylactic antibiotic regimens in both abdominal and vaginal hysterectomy. Patients received three intravenous doses of clindamycin (900 mg) plus either aztreonam (1 g) or cefotaxime (1 g); the doses were given at the induction of anesthesia and 8 and 16 hours later. A total of 170 patients undergoing abdominal hysterectomy and 142 patients undergoing vaginal hysterectomy completed the trial and were evaluated. Following abdominal hysterectomy infections occurred at the operative site in 1.2% of patients given a regimen including aztreonam and in 4.7% of those given a regimen including cefotaxime; the difference between the two groups was not significant. Neither were significant differences observed in the incidence of fever, the incidence of bacteriuria, the need for postoperative antibiotics, or the duration of postoperative hospitalization, although results were slightly better for patients receiving clindamycin plus aztreonam. Following vaginal hysterectomy, slightly but not significantly better results for the same parameters were obtained in the group given clindamycin plus cefotaxime. Diarrhea was the only adverse reaction attributable to antibiotic treatment and occurred more frequently in patients given cefotaxime. It was concluded that the two regimens were similarly effective and safe in preventing infections following hysterectomy.

  14. 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.

  15. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

    Science.gov (United States)

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Tassie, Emma; Scotland, Graham; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Francis, Jill; Wileman, Samantha; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; MacLennan, Graeme; Prior, Maria; Bolsover, Denise; Campbell, Marion K

    2015-01-01

    BACKGROUND Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. OBJECTIVES To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. DESIGN A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. SETTING Eleven UK specialist vascular centres. PARTICIPANTS Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212). INTERVENTIONS Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). PRIMARY OUTCOME MEASURES Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. SECONDARY OUTCOME MEASURES Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. RESULTS The results appear generalisable in that participants' baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no

  16. On the warm nearshore bias in Pathfinder monthly SST products over Eastern Boundary upwelling systems

    CSIR Research Space (South Africa)

    Dufois, F

    2012-01-01

    Full Text Available Using in situ sea surface temperature (SST) data and MODIS/TERRA SST, the monthly AVHRR Pathfinder (version 5.0 and 5.2) SST product was evaluated within the four main Eastern Boundary Upwelling Systems. A warm bias in the monthly Pathfinder data...

  17. Efficacy of Nalbuphine with Flurbiprofen on Multimodal Analgesia with Transverse Abdominis Plane Block in Elderly Patients Undergoing Open Gastrointestinal Surgery: A Randomized, Controlled, Double-Blinded Trial

    Directory of Open Access Journals (Sweden)

    Yu Mao

    2018-01-01

    Full Text Available Objective. To assess different doses of nalbuphine with flurbiprofen compared to sufentanil with flurbiprofen in multimodal analgesia efficacy for elderly patients undergoing gastrointestinal surgery with a transverse abdominis plane block (TAPB. Methods. 158 elderly patients scheduling for elective open gastrointestinal surgery under general anesthesia and TAPB were randomly assigned to four groups according to different doses of nalbuphine with flurbiprofen in postoperative intravenous analgesia (PCIA. Postoperative pain intensity, effective pressing numbers of PCIA, and adverse effects were recorded at 6, 12, 24, and 48 hours after surgery. Results. Postoperative pain intensity, effective pressing numbers, and the incidence of postoperative nausea and vomiting (PONV were similar among the four groups after surgery, while the severity of PONV was decreased in Group L compared with Group S at 6, 12, and 48 h after surgery. No individual experienced pruritus, respiratory depression, or hypotension. Conclusions. Low dose of nalbuphine (15 μg·kg−1·ml−1 combined with flurbiprofen is superior for elderly patients undergoing elective open gastrointestinal surgery with TAPB in terms of the efficient postoperative analgesia and decreased severity of PONV. This trial is registered with NCT02984865.

  18. AVHRR GAC SST Reanalysis Version 1 (RAN1

    Directory of Open Access Journals (Sweden)

    Alexander Ignatov

    2016-04-01

    Full Text Available In response to its users’ needs, the National Oceanic and Atmospheric Administration (NOAA initiated reanalysis (RAN of the Advanced Very High Resolution Radiometer (AVHRR Global Area Coverage (GAC; 4 km sea surface temperature (SST data employing its Advanced Clear Sky Processor for Oceans (ACSPO retrieval system. Initially, AVHRR/3 data from five NOAA and two Metop satellites from 2002 to 2015 have been reprocessed. The derived SSTs have been matched up with two reference SSTs—the quality controlled in situ SSTs from the NOAA in situ Quality Monitor (iQuam and the Canadian Meteorological Centre (CMC L4 SST analysis—and analyzed in the NOAA SST Quality Monitor (SQUAM online system. The corresponding clear-sky ocean brightness temperatures (BT in AVHRR bands 3b, 4 and 5 (centered at 3.7, 11, and 12 µm, respectively have been compared with the Community Radiative Transfer Model simulations in another NOAA online system, Monitoring of Infrared Clear-sky Radiances over Ocean for SST (MICROS. For some AVHRRs, the time series of “AVHRR minus reference” SSTs and “observed minus model” BTs are unstable and inconsistent, with artifacts in the SSTs and BTs strongly correlated. In the official “Reanalysis version 1” (RAN1, data from only five platforms—two midmorning (NOAA-17 and Metop-A and three afternoon (NOAA-16, -18 and -19—were included during the most stable periods of their operations. The stability of the SST time series was further improved using variable regression SST coefficients, similarly to how it was done in the NOAA/NASA Pathfinder version 5.2 (PFV5.2 dataset. For data assimilation applications, especially those blending satellite and in situ SSTs, we recommend bias-correcting the RAN1 SSTs using the newly developed sensor-specific error statistics (SSES, which are reported in the product files. Relative performance of RAN1 and PFV5.2 SSTs is discussed. Work is underway to improve the calibration of AVHRR/3s and

  19. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Daniel Caldeira

    2017-05-01

    Full Text Available Background: Venous thromboembolism (VTE is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non–vitamin K antagonists oral anticoagulants (NOAC, including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Objectives: Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH for thromboprophylaxis in patients undergoing knee or hip replacement. Data sources: MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. Study eligibility criteria, participants, and intervention: All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Data extraction: Two independent reviewers, using a predetermined form. Study appraisal and synthesis methods: The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR and 95% confidence intervals (95% CI using random-effects meta-analysis. Trial sequential analysis (TSA was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE Working Group methodology. Results: Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement. The overall risk of bias across studies was low. In comparison with LMWH (all regimens

  20. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

    Science.gov (United States)

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Tassie, Emma; Scotland, Graham; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Francis, Jill; Wileman, Samantha; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; MacLennan, Graeme; Prior, Maria; Bolsover, Denise; Campbell, Marion K

    2015-04-01

    Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. Eleven UK specialist vascular centres. Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212). Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. The results appear generalisable in that participants' baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The

  1. 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

  2. Nutritional risk in major abdominal surgery: NURIMAS Liver (DRKS00010923 – protocol of a prospective observational trial to evaluate the prognostic value of different nutritional scores in hepatic surgery

    Directory of Open Access Journals (Sweden)

    Pascal Probst

    Full Text Available Background: Malnutrition is commonly known as a risk factor in surgical procedures. The nutritional status seems particularly relevant to the clinical outcome of patients undergoing hepatic resection. Thus, identifying affected individuals and taking preventive therapeutic actions before surgery is an important task. However, there are only very few studies, that investigate which existing nutritional assessment score (NAS is suited best to predict the postoperative outcome in liver surgery. Objective: Nutritional Risk in Major Abdominal Surgery (NURIMAS Liver is a prospective observational trial that analyses the predictive value of 12 different NAS for postoperative morbidity and mortality after liver resection. Methods: After admission to the surgical department of the University Hospital in Heidelberg or the municipal hospital of Karlsruhe, all patients scheduled for elective liver resection will be screened for eligibility. Participants will fill in a questionnaire and undergo a physical examination in order to evaluate nutritional status according to Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System, Imperial Nutritional Screening System II, Nutritional Risk Classification and the ESPEN malnutrition criteria. Postoperative morbidity and mortality will be tracked prospectively throughout the postoperative course. The association of malnutrition according to each score and occurrence of at least one major complication will be analysed using both chi-squared tests and a multivariable logistic regression analysis. Already established risk factors in liver surgery will be added as covariates. Discussion: NURIMAS Liver is a bicentric, prospective observational trial. The aim of this study is to investigate the predictive value of clinical nutritional assessment

  3. Choosing surgery

    DEFF Research Database (Denmark)

    Thorstensson, Carina; Lohmander, L; Frobell, Richard

    2009-01-01

    -depth qualitative interviews were conducted with young (aged 18-35), physically active individuals with ACL rupture who were participating in a RCT comparing training and surgical reconstruction with training only. 22/34 were randomised to training only but crossed over to surgery. Of these, 11 were interviewed......ABSTRACT: BACKGROUND: The objective was to understand patients' views of treatment after acute anterior cruciate ligament (ACL) injury, and their reasons for deciding to request surgery despite consenting to participate in a randomised controlled trial (to 'cross-over'). METHODS: Thirty-four in...... before surgery, and 11 were interviewed at least 6 months after surgery. To provide additional information, 12 patients were interviewed before randomisation. Interviews were audio-recorded, transcribed and analysed using the Framework approach. RESULTS: Strong preference for surgery was commonplace...

  4. No effect of melatonin to modify surgical-stress response after major vascular surgery: a randomised placebo-controlled trial

    DEFF Research Database (Denmark)

    Kücükakin, B; Wilhelmsen, M; Lykkesfeldt, Jens

    2010-01-01

    A possible mechanism underlying cardiovascular morbidity after major vascular surgery may be the perioperative ischaemia-reperfusion with excessive oxygen-derived free-radical production and increased levels of circulating inflammatory mediators. We examined the effect of melatonin infusion during...... surgery and oral melatonin treatment for 3 days after surgery on biochemical markers of oxidative and inflammatory stress....

  5. Modelling the diurnal variability of SST and its vertical extent

    DEFF Research Database (Denmark)

    Karagali, Ioanna; Høyer, Jacob L.; Donlon, Craig J.

    2014-01-01

    of the water column where most of the heat is absorbed and where the exchange of heat and momentum with the atmosphere occurs. During day-time and under favourable conditions of low winds and high insolation, diurnal warming of the upper layer poses challenges for validating and calibrating satellite sensors......Sea Surface Temperature (SST) is a key variable in air-sea interactions, partly controlling the oceanic uptake of CO2 and the heat exchange between the ocean and the atmosphere, amongst others. Satellite SSTs are representative of skin and sub-skin temperature, i.e. in the upper millimetres...... and merging SST time series. When radiometer signals, typically from satellites, are validated with in situ measurements from drifting and moored buoys a general mismatch is found, associated with the different reference depth of each type of measurement. A generally preferred approach to bridge the gap...

  6. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  7. 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.

  8. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

    Science.gov (United States)

    Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

    2011-05-06

    Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

  9. Electronics and instrumentation for the SST-1 superconducting magnet system

    International Nuclear Information System (INIS)

    Khristi, Yohan; Pradhan, Subrata; Varmora, Pankaj; Banaudha, Moni; Praghi, Bhadresh R.; Prasad, Upendra

    2015-01-01

    Steady State Superconducting Tokamak-1 (SST-1) at Institute for Plasma Research (IPR), India is now in operation phase. The SST-1 magnet system consists of sixteen superconducting (SC), D-shaped Toroidal Field (TF) coils and nine superconducting Poloidal Field (PF) coils together with a pair of resistive PF coils, inside the vacuum vessel of SST-1. The magnets were cooled down to 4.5 K using either supercritical or two-phase helium, after which they were charged up to 10 kA of transport current. Precise quench detection system, cryogenic temperature, magnetic field, strain, displacement, flow and pressure measurements in the Superconducting (SC) magnet were mandatory. The Quench detection electronics required to protect the SC magnets from the magnet Quench therefore system must be reliable and prompt to detect the quench from the harsh tokamak environment and high magnetic field interference. A ∼200 channels of the quench detection system for the TF magnet are working satisfactorily with its design criteria. Over ∼150 channels Temperature measurement system was implemented for the several locations in the magnet and hydraulic circuits with required accuracy of 0.1K at bellow 30K cryogenic temperature. Whereas the field, strain and displacement measurements were carried out at few predefined locations on the magnet. More than 55 channels of Flow and pressure measurements are carried out to know the cooling condition and the mass flow of the liquid helium (LHe) coolant for the SC Magnet system. This report identifies the different in-house modular signal conditioning electronics and instrumentation systems, calibration at different levels and the outcomes for the SST-1 TF magnet system. (author)

  10. Operational and troubleshooting experiences in the SST-1 cryogenic system

    Science.gov (United States)

    Mahesuria, G.; Panchal, P.; Panchal, R.; Patel, R.; Sonara, D.; Gupta, N. C.; Srikanth, G. L. N.; Christian, D.; Garg, A.; Bairagi, N.; Patel, K.; Shah, P.; Nimavat, H.; Sharma, R.; Patel, J. C.; Tank, J.; Tanna, V. L.; Pradhan, S.

    2014-01-01

    Recently, the cooldown and current charging campaign have been carried out towards the demonstration of the first successful plasma discharge in the steady state superconducting Tokomak (SST-1). The SST-1 machine consists of cable-in-conduit wound superconducting toroidal as well as poloidal coils, cooled using 1.3 kW at 4.5 K helium refrigerator -cum- liquefier (HRL) system. The cryo system provides the two-phase helium at 0.13 MPa at 4.5 K as well as forced-flow pressurized helium at 0.4 MPa and in addition to 7 g-s-1 liquefaction capacity required for the current leads and other cold mass at 4.5 K. The entire integrated cold masses having different thermo hydraulic resistances cooled with the SST-1 HRL in optimised process parameters. In order to maintain different levels of temperatures and to facilitate smooth and reliable cooldown, warm-up, normal operations as well as to handle abnormal events such as, quench or utilities failures etc., exergy efficient process are adopted for the helium refrigerator-cum-liquefier (HRL) with an installed equivalent capacity of 1.3 kW at 4.5 K. Using the HRL, the cold mass of about 40 tons is being routinely cooled down from ambient temperature to 4.5 K with an average cooldown rate of 0.75 - 1 K-h-1. Long-term cryogenic stable conditions were obtained within 15 days in the superconducting coils and their connecting feeders. Afterwards, all of the cold mass is warmed-up in a controlled manner to ambient temperature. In this paper, we report the recent operational results of the cryogenic system during the first plasma discharge in SST-1 as well as the troubleshooting experiences of the cryogenic plant related hardware.

  11. Clinical Trials

    Medline Plus

    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  12. Recent SST trends and Flood Disasters in Brazil

    Science.gov (United States)

    Yamashiki, Y.; Behera, S. K.; Inoue, S.; Netrananda, S.; Silva, R. D.; Takara, K. T.; Yamagata, T.

    2010-12-01

    We analyzed recent variations in the sea surface temperature (SST) anomalies of Pacific and Atlantic Oceans to understand their roles in extreme discharge of Amazon River Basin. In general, higher than monthly average discharge appears when La Niña condition forms and lower than monthly average discharge appears when El Niño condition forms. We also investigated the relationship between SST anomalies and recent floods in Brazil during the period of 1980-2010. Most severe floods (e.g. 2003 and 2010 Rio de Janeiro-São Paulo Flood) in austral summer occurred when El Niño Modoki appears in the Pacific Ocean. In addition, warm waters in tropical South Atlantic Ocean between American and African Coast also helped the moisture convergence to the affected region. Floods in some other locations (for example, Itaipava flood occurred in Maranhao State in 2008) occurred when a La Niña Modoki appeared in Pacific Ocean. These flood disasters in Brazil associated with climate phenomena may increase due to warmer SST trend under the global warming stress.

  13. Baking of SST-1 vacuum vessel modules and sectors

    International Nuclear Information System (INIS)

    Pathan, Firozkhan S; Khan, Ziauddin; Yuvakiran, Paravastu; George, Siju; Ramesh, Gattu; Manthena, Himabindu; Shah, Virendrakumar; Raval, Dilip C; Thankey, Prashant L; Dhanani, Kalpesh R; Pradhan, Subrata

    2012-01-01

    SST-1 Tokamak is a steady state super-conducting tokamak for plasma discharge of 1000 sec duration. The plasma discharge of such long time duration can be obtained by reducing the impurities level, which will be possible only when SST-1 vacuum chamber is pumped to ultra high vacuum. In order to achieve UHV inside the chamber, the baking of complete vacuum chamber has to be carried out during pumping. For this purpose the C-channels are welded inside the vacuum vessel. During baking of vacuum vessel, these welded channels should be helium leak tight. Further, these U-channels will be in accessible under operational condition of SST-1. So, it will not possible to repair if any leak is developed during experiment. To avoid such circumstances, a dedicated high vacuum chamber is used for baking of the individual vacuum modules and sectors before assembly so that any fault during welding of the channels will be obtained and repaired. This paper represents the baking of vacuum vessel modules and sectors and their temperature distribution along the entire surface before assembly.

  14. Experience of superconducting current feeders system of SST-1

    International Nuclear Information System (INIS)

    Gupta, N.C.; Garg, A.; Sonara, D.

    2014-01-01

    The superconducting current feeder system for SST-1 which has been installed and commissioned recently along with SST-1, felicitates to energize the SST-1. The CFS consists of ten pairs of 10,000 Ampere (A) rating helium vapor cooled conventional current leads, interconnecting Cu-SC joints, three numbers of cryo-compatible SC feeders ducts, current leads assembly chamber, hydraulic network and three numbers of joint boxes operated at different current rating to charge Toroidal Field and Poloidal Field coils separately. During the last three campaigns, it was possible to achieve a controlled cool down up to 4 K and showed its rated operational performance. Actively cooled liquid nitrogen shield showed temperature profile in the temperature range of 80-85K and the whole system was evacuated up to 6x10 -6 mbar. The measured LHe consumption rates from TF VCCL were 0.3 g/s and 0.35 g/s at zero current and 1 kA respectively. (author)

  15. Eight-year follow-up of the Clopidogrel After Surgery for Coronary Artery Disease (CASCADE) trial.

    Science.gov (United States)

    Hage, Ali; Voisine, Pierre; Erthal, Fernanda; Larose, Éric; Glineur, David; Chow, Benjamin; Tremblay, Hugo; Fortier, Jacqueline; Ko, Gifferd; Une, Dai; Farkouh, Michael; Mesana, Thierry G; LeMay, Michel; Kulik, Alexander; Ruel, Marc

    2018-01-01

    In this 8 years' follow-up study, we evaluated the long-term outcomes of the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting, versus aspirin plus placebo, with respect to survival, major adverse cardiac, or major cerebrovascular events, including revascularization, functional status, graft patency, and native coronary artery disease progression. In the initial Clopidogrel After Surgery for Coronary Artery Disease trial, 113 patients were randomized to receive either daily clopidogrel (n = 56) or placebo (n = 57), in addition to aspirin, in a double-blind fashion for 1 year after coronary artery bypass grafting. All patients were re-evaluated to collect long-term clinical data. Surviving patients with a glomerular filtration rate > 30 mL/min were asked to undergo a coronary computed tomography angiogram to evaluate the late saphenous vein graft patency and native coronary artery disease progression. At a median follow-up of 7.6 years, survival rate was 85.5% ± 3.8% (P = .23 between the 2 groups). A trend toward enhanced freedom from all-cause death or major adverse cardiac or cerebrovascular events, including revascularization, was observed in the aspirin-clopidogrel group (P = .11). No difference in functional status or freedom from angina was observed between the 2 groups (P > .57). The long-term patency of saphenous vein graft was 89.11% in the aspirin-clopidogrel group versus 91.23% in the aspirin-placebo group (P = .79). A lower incidence of moderate to severe native disease progression was observed in the aspirin-clopidogrel group versus the aspirin-placebo group (7 out of 122 vs 13 out of 78 coronary segments that showed progression, respectively [odds ratio, 0.3 ± 0.2; 95% confidence interval, 0.1-0.8; P = .02]). At 8 years' follow-up, the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting exhibited a lower incidence of moderate to severe

  16. 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.

  17. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

    Science.gov (United States)

    Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

    2017-04-01

    To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, pgout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, pgout and hyperuricaemia in obese subjects. NCT01479452; Results. 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/.

  18. 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

    Directory of Open Access Journals (Sweden)

    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.

  19. Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

    International Nuclear Information System (INIS)

    Rutten, Marianne J; Pijnenborg, Johanna MA; Schreuder, Henk WR; Schutter, Eltjo MJ; Spijkerboer, Anje M; Wensveen, Celesta WM; Zusterzeel, Petra; Mol, Ben Willem J; Kenter, Gemma G; Buist, Marrije R; Gaarenstroom, Katja N; Van Gorp, Toon; Meurs, Hannah S van; Arts, Henriette JG; Bossuyt, Patrick M; Ter Brugge, Henk G; Hermans, Ralph HM; Opmeer, Brent C

    2012-01-01

    Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer. Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat. Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence

  20. Attenuation of Hemodynamic Responses to Intubation by Gabapentin in Coronary Artery Bypass Surgery: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyed Mojtaba Marashi

    2015-12-01

    Full Text Available A varieties of medications have been suggested to prevent hemodynamic instabilities following laryngoscopy and endotracheal intubation. This study was conducted to determine the beneficial effects of gabapentin on preventing hemodynamic instabilities associated with intubation in patients who were a candidate for coronary artery bypass surgery (CABG. This double blinded randomized, parallel group clinical trial was carried out on 58 normotensive patients scheduled for elective CABG under general anesthesia with endotracheal intubation in Shariati Hospital. Patients were randomly allocated to two groups of 29 patients that received 1200 mg of gabapentin in two dosages (600 mg, 8 hours before anesthesia induction and 600 mg, 2 hours before anesthesia induction as gabapentin group or received talc powder as placebo (placebo group. Heart rate, mean arterial pressure, systolic and diastolic blood pressure were measured immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation. Inter-group comparisons significantly showed higher systolic and diastolic blood pressure, mean arterial pressure and heart rate immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation in the placebo group in comparison to gabapentin group. The median of anxiety  verbal analog scale (VAS at the pre-induction room in gabapentin and placebo groups were 2 and 4,  respectively that was significantly lower in the former group (P. value =0.04 ; however, regarding median of pain score no difference was observed between them (P. value =0.07. Gabapentin (1200mg given preoperatively can effectively attenuate the hemodynamic response to laryngoscopy, intubation and also reduce preoperative related anxiety in patients who were a candidate for CABG.

  1. Phase II trial of induction chemotherapy followed by surgery for squamous cell carcinoma of the oral tongue in young adults.

    Science.gov (United States)

    Kies, Merrill S; Boatright, Dowin H; Li, Guojun; Blumenschein, George; El-Naggar, Adel K; Brandon Gunn, G; Lewin, Jan S; Steinhaus, Ganene D; Sturgis, Erich M

    2012-09-01

    We conducted a phase II clinical trial of induction chemotherapy followed by surgery ± radiotherapy for squamous cell carcinoma of the oral tongue (SCCOT) in young adults. From September 2001 to October 2004, 23 patients aged 18 to 49 years with clinical T2-3 N0-2 M0 SCCOT and no prior radiotherapy, chemotherapy, or neck dissection underwent induction chemotherapy (paclitaxel, ifosfamide, and carboplatin) followed by glossectomy and neck dissection ± radiotherapy and chemotherapy. On final surgical pathology, 9 patients (39%) had a complete/major (2 complete) histologic response at the primary tumor site; 8 patients (35%) had no response or progression. Similarly, 9 patients (39%) had a complete response in the neck or remained node negative; 6 patients (26%) had an increase in nodal category. No treatment-associated deaths occurred, and toxicity was modest. At a median follow-up from the end of treatment of 52 months (minimum, 23 months), 10 patients (43%) developed recurrence, and all 10 died of cancer. Crude recurrence/cancer death rates were associated with ≤ a partial response at the tongue (p = .029), poor histologic differentiation (p = .012), and multiple adverse features on final surgical pathology (p = .040). Response rates and overall survival with this induction chemotherapy regimen were limited, but complete/major response at the tongue was associated with excellent prognosis. Additionally, improved patient selection and predictive tumor biomarkers will be needed for induction chemotherapy to be routinely incorporated into the treatment of oral tongue cancer in young adults. Copyright © 2011 Wiley Periodicals, Inc.

  2. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial.

    Science.gov (United States)

    Shariff, U; Kullar, N; Haray, P N; Dorudi, S; Balasubramanian, S P

    2015-05-01

    Conventional teaching in surgical training programmes is constrained by time and cost, and has room for improvement. This study aimed to determine the effectiveness of a multimedia educational tool developed for an index colorectal surgical procedure (anterior resection) in teaching and assessment of cognitive skills and to evaluate its acceptability amongst general surgical trainees. Multimedia educational tools in open and laparoscopic anterior resection were developed by filming multiple operations which were edited into procedural steps and substeps and then integrated onto interactive navigational platforms using Adobe® Flash® Professional CS5 10.1. A randomized controlled trial was conducted on general surgical trainees to evaluate the effectiveness of online multimedia in comparison with conventional 'study day' teaching for the acquisition of cognitive skills. All trainees were assessed before and after the study period. Trainees in the multimedia group evaluated the tools by completing a survey. Fifty-nine trainees were randomized but 27% dropped out, leaving 43 trainees randomized to the multimedia group (n = 25) and study day group (n = 18) who were available for analysis. Posttest scores improved significantly in both groups (P multimedia group was not significantly different from the study day group (6.02 ± 5.12 and 5.31 ± 3.42, respectively; P = 0.61). Twenty-five trainees completed the evaluation survey and experienced an improvement in their decision making (67%) and in factual and anatomical knowledge (88%); 96% agreed that the multimedia tool was a useful additional educational resource. Multimedia tools are effective for the acquisition of cognitive skills in colorectal surgery and are well accepted as an educational resource. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  3. Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

    Directory of Open Access Journals (Sweden)

    Ayansina Dolapo

    2011-03-01

    Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

  4. Test results on systems developed for SST-1 tokamak

    International Nuclear Information System (INIS)

    Bora, D.

    2003-01-01

    Steady state Superconducting Tokamak (SST-1) is a large aspect ratio tokamak, configured to run double null diverted plasmas with significant elongation (κ) and triangularity Superconducting (SC) magnets are deployed for both the toroidal and poloidal field coils in SST-1. A NbTi based cable-in-conduit conductor (CICC) has been fabricated by M/S Hitachi Cables Ltd., Japan under specification and supervision of IPR. The suitability of this CICC for the SST-1 magnets has been validated through test carried out on a model coil (MC) wound from this CICC. Toroidal and poloidal SC magnets have been fabricated and factory acceptance tests have been performed. SC magnets require liquid helium (LHe) cooled current leads, electrical isolators at LHe temperature, superconducting bus bars and LHe transfer lines. Full scale prototypes of these have been developed and tested successfully. SC magnets will be cooled to 4.5K by forced flow of supercritical Helium through the CICC. A 1 kW grade liquefier/refrigerator has been installed and is in final stages of commissioning at IPR. SST-1 deploys a fully welded ultra high vacuum vessel, made up of 16 vessel sectors having ports and 16 rings with D-shaped cross-section. To establish the fabrication methodology for this, a full scale proto-type of the vessel with two vessel sectors and three rings has been fabricated and tested successfully. Based on this the fabrication of the vessel sectors and rings is in final stage of fabrication. Liquid nitrogen cooled radiation shield are deployed between the vacuum vessel and SC magnets as well as SC magnets and cryostat, to minimize the radiation losses at the SC magnets. SST-1 will have three different high power radio frequency (RF) systems to additionally heat and non-inductively drive plasma current to sustain the plasma in steady state for a duration of up to 1000 sec. Ion cyclotron resonance frequency (ICRF) and electron cyclotron resonance frequency (ECRF) systems will primarily be

  5. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).

    Science.gov (United States)

    Glazener, Cathryn Ma; Breeman, Suzanne; Elders, Andrew; Hemming, Christine; Cooper, Kevin G; Freeman, Robert M; Smith, Anthony Rb; Reid, Fiona; Hagen, Suzanne; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; McDonald, Alison; McPherson, Gladys; MacLennan, Graeme; Norrie, John

    2017-01-28

    The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh

  6. Epsilon aminocaproic acid reduces blood transfusion and improves the coagulation test after pediatric open-heart surgery: a meta-analysis of 5 clinical trials.

    Science.gov (United States)

    Lu, Jun; Meng, Haoyu; Meng, Zhaoyi; Sun, Ying; Pribis, John P; Zhu, Chunyan; Li, Quan

    2015-01-01

    Excessive postoperative blood loss after cardiopulmonary bypass is a common problem, especially in patients suffering from congenital heart diseases. The efficacy of epsilon aminocaproic acid (EACA) as a prophylactic treatment for postoperative bleeding after pediatric open-heart surgery has not been determined. This meta-analysis investigates the efficacy of EACA in the minimization of bleeding and blood transfusion and the maintenance of coagulation tests after pediatric open-heart surgery. A comprehensive literature search was performed to identify all randomized clinical trials on the subject. PubMed, Embase, the Cochrane Library, and the Chinese Medical Journal Network were screened. The primary outcome used for the analysis was postoperative blood loss. Secondary outcomes included postoperative blood transfusion, re-exploration rate and postoperative coagulation tests. The mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) were used as summary statistics. Five trials were included in this meta-analysis of 515 patients. Prophylactic EACA was associated with a reduction in postoperative blood loss, but this difference did not reach statistical significance (MD: -7.08; 95% CI: -16.11 to 1.95; P = 0.12). Patients treated with EACA received fewer postoperative blood transfusions, including packed red blood cells (MD: -8.36; 95% CI: -12.63 to -4.09; P = 0.0001), fresh frozen plasma (MD: -3.85; 95% CI: -5.63 to -2.08; P open-heart surgery. Prophylactic EACA minimizes postoperative blood transfusion and helps maintain coagulation in pediatric patients undergoing open-heart surgery. Therefore, the results of this study indicate that adjunctive EACA is a good choice for the prevention of postoperative blood transfusion following pediatric cardiac surgery.

  7. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Science.gov (United States)

    Rawal, Narinder; Macquaire, Valery; Catalá, Elena; Berti, Marco; Costa, Rui; Wietlisbach, Markus

    2011-01-01

    This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set) and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable) was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24) and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain) had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0) on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment). Rescue medication leading to withdrawal (diclofenac 50 mg) was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness, somnolence, vomiting, and increased sweating) occurred less frequently in patients under combination treatment (P = 0.004). Tramadol/paracetamol combination tablets provided comparable analgesic efficacy with a better safety profile to tramadol capsules in patients experiencing postoperative pain following ambulatory hand surgery. PMID:21559356

  8. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

    Directory of Open Access Journals (Sweden)

    Hengwei Jin

    2017-09-01

    Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

  9. The Relationships between Tropical Pacific and Atlantic SST and Northeast Brazil Monthly Precipitation.

    Science.gov (United States)

    Bertacchi Uvo, Cintia; Repelli, Carlos A.; Zebiak, Stephen E.; Kushnir, Yochanan

    1998-04-01

    The monthly patterns of northeast Brazil (NEB) precipitation are analyzed in relation to sea surface temperature (SST) in the tropical Pacific and Atlantic Oceans, using singular value decomposition. It is found that the relationships between precipitation and SST in both basins vary considerably throughout the rainy season (February-May). In January, equatorial Pacific SST is weakly correlated with precipitation in small areas of southern NEB, but Atlantic SST shows no significant correlation with regional precipitation. In February, Pacific SST is not well related to precipitation, but south equatorial Atlantic SST is positively correlated with precipitation over the northern Nordeste, the latter most likely reflecting an anomalously early (or late) southward migration of the ITCZ precipitation zone. During March, equatorial Pacific SST is negatively correlated with Nordeste precipitation, but no consistent relationship between precipitation and Atlantic SST is found. Atlantic SST-precipitation correlations for April and May are the strongest found among all months or either ocean. Precipitation in the Nordeste is positively correlated with SST in the south tropical Atlantic and negatively correlated with SST in the north tropical Atlantic. These relationships are strong enough to determine the structure of the seasonal mean SST-precipitation correlations, even though the corresponding patterns for the earlier months of the season are quite different. Pacific SST-precipitation correlations for April and May are similar to those for March. Extreme wet (dry) years for the Nordeste occur when both Pacific and Atlantic SST patterns for April and May occur simultaneously. A separate analysis reinforces previous findings in showing that SST in the tropical Pacific and the northern tropical Atlantic are positively correlated and that tropical Pacific-south Atlantic correlations are negligible.Time-lagged analyses show the potential for forecasting either seasonal mean

  10. Overview of data acquisition and central control system of steady state superconducting Tokamak (SST-1)

    International Nuclear Information System (INIS)

    Pradhan, S.; Mahajan, K.; Gulati, H.K.; Sharma, M.; Kumar, A.; Patel, K.; Masand, H.; Mansuri, I.; Dhongde, J.; Bhandarkar, M.; Chudasama, H.

    2016-01-01

    Highlights: • The paper gives overview on SST-1 data acquisition and central control system and future upgrade plans. • The lossless PXI based data acquisition of SST-1 is capable of acquiring around 130 channels with sampling frequency ranging from 10 KHz to 1 MHz sampling frequency. • Design, architecture and technologies used for central control system (CCS) of SST-1. • Functions performed by CCS. - Abstract: Steady State Superconducting Tokamak (SST-1) has been commissioned successfully and has been carrying out limiter assisted ohmic plasma experiments since the beginning of 2014 achieving a maximum plasma current of 75 kA at a central field of 1.5 T and the plasma duration ∼500 ms. In near future, SST-1 looks forward to carrying out elongated plasma experiments and stretching plasma pulses beyond 1 s. The data acquisition and central control system (CCS) for SST-1 are distributed, modular, hierarchical and scalable in nature The CCS has been indigenously designed, developed, implemented, tested and validated for the operation of SST-1. The CCS has been built using well proven technologies like Redhat Linux, vxWorks RTOS for deterministic control, FPGA based hardware implementation, Ethernet, fiber optics backbone for network, DSP for real-time computation & Reflective memory for high-speed data transfer etc. CCS in SST-1 controls & monitors various heterogeneous SST-1 subsystems dispersed in the same campus. The CCS consists of machine control system, basic plasma control system, GPS time synchronization system, storage area network (SAN) for centralize data storage, SST-1 networking system, real-time networks, SST-1 control room infrastructure and many other supportive systems. Machine Control System (MCS) is a multithreaded event driven system running on Linux based servers, where each thread of the software communicates to a unique subsystem for monitoring and control from SST-1 central control room through network programming. The CCS hardware

  11. Overview of data acquisition and central control system of steady state superconducting Tokamak (SST-1)

    Energy Technology Data Exchange (ETDEWEB)

    Pradhan, S., E-mail: pradhan@ipr.res.in; Mahajan, K.; Gulati, H.K.; Sharma, M.; Kumar, A.; Patel, K.; Masand, H.; Mansuri, I.; Dhongde, J.; Bhandarkar, M.; Chudasama, H.

    2016-11-15

    Highlights: • The paper gives overview on SST-1 data acquisition and central control system and future upgrade plans. • The lossless PXI based data acquisition of SST-1 is capable of acquiring around 130 channels with sampling frequency ranging from 10 KHz to 1 MHz sampling frequency. • Design, architecture and technologies used for central control system (CCS) of SST-1. • Functions performed by CCS. - Abstract: Steady State Superconducting Tokamak (SST-1) has been commissioned successfully and has been carrying out limiter assisted ohmic plasma experiments since the beginning of 2014 achieving a maximum plasma current of 75 kA at a central field of 1.5 T and the plasma duration ∼500 ms. In near future, SST-1 looks forward to carrying out elongated plasma experiments and stretching plasma pulses beyond 1 s. The data acquisition and central control system (CCS) for SST-1 are distributed, modular, hierarchical and scalable in nature The CCS has been indigenously designed, developed, implemented, tested and validated for the operation of SST-1. The CCS has been built using well proven technologies like Redhat Linux, vxWorks RTOS for deterministic control, FPGA based hardware implementation, Ethernet, fiber optics backbone for network, DSP for real-time computation & Reflective memory for high-speed data transfer etc. CCS in SST-1 controls & monitors various heterogeneous SST-1 subsystems dispersed in the same campus. The CCS consists of machine control system, basic plasma control system, GPS time synchronization system, storage area network (SAN) for centralize data storage, SST-1 networking system, real-time networks, SST-1 control room infrastructure and many other supportive systems. Machine Control System (MCS) is a multithreaded event driven system running on Linux based servers, where each thread of the software communicates to a unique subsystem for monitoring and control from SST-1 central control room through network programming. The CCS hardware

  12. Single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone after arthroscopic knee surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yang, Ye; Zeng, Chao; Wei, Jie; Li, Hui; Yang, Tuo; Deng, Zhen-Han; Li, Yu-Sheng; Yang, Tu-Bao; Lei, Guang-Hua

    2017-03-01

    The purpose of this meta-analysis was to compare the efficacy and safety of single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone for pain management following arthroscopic knee surgery. A comprehensive literature search was conducted to identify randomized controlled trials that used single-dose intra-articular bupivacaine plus morphine and bupivacaine alone for post-operative pain, using MEDLINE (1966-2014), Cochrane Library and EMBASE databases. The weighted mean difference (WMD), relative risk (RR) and their corresponding 95 % confidence intervals (CIs) were calculated using RevMan statistical software. A total of twenty-nine trials (n = 1167) were included. The post-operative visual analog scale (VAS) pain score of the bupivacaine plus morphine group compared with the bupivacaine alone group was significantly lower (WMD -1.15, 95 % CI -1.67 to -0.63, p bupivacaine plus morphine was shown to be significantly better than bupivacaine alone at relieving post-operative pain after arthroscopic knee surgery without increasing the short-term side effects. Routine use of single-dose intra-articular bupivacaine plus morphine is an effective way for pain management after arthroscopic knee surgery. II.

  13. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  14. A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design

    International Nuclear Information System (INIS)

    Lefevre, Jérémie H; Rousseau, Alexandra; Svrcek, Magali; Parc, Yann; Simon, Tabassome; Tiret, Emmanuel

    2013-01-01

    Neoadjuvant radiochemotherapy (RCT) is now part of the armamentarium of cancer of the lower and middle rectum. It is recommended in current clinical practice prior to surgical excision if the lesion is classified T3/T4 or N+. Histological complete response, defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) after pathological examination of surgical specimen has been shown to be an independent prognostic factor of overall survival and disease-free survival. Surgical excision is usually performed between 6 and 8 weeks after completion of CRT and pathological complete response rate ranges around 12%. In retrospective studies, a lengthening of the interval after RCT beyond 10 weeks was found as an independent factor increasing the rate of pathological complete response (between 26% and 31%), with a longer disease-free survival and without increasing the operative morbidity. The aim of the present study is to evaluate in 264 patients the rate of pathological complete response rate of rectal cancer after RCT by lengthening the time between RCT and surgery. The current study is a multicenter randomized trial in two parallel groups comparing 7 and 11 weeks of delay between the end of RCT and cancer surgery of rectal tumors. At the end of the RCT, surgery is planified and randomization is performed after patient’s written consent for participation. The histological complete response (ypT0N0) will be determined with analysis of the complete residual tumor and double reading by two pathologists blinded of the group of inclusion. Patients will be followed in clinics for 5 years after surgery. Participation in this trial does not change patient’s management in terms of treatment, investigations or visits. Secondary endpoints will include overall and disease free survival, rate of sphincter conservation and quality of mesorectal excision. The number of patients needed is 264. ClinicalTrial.gov: http://www.clinicaltrials.gov/NCT01648894

  15. Design and Architecture of SST-1 basic plasma control system

    Energy Technology Data Exchange (ETDEWEB)

    Patel, Kirit, E-mail: kpatel@ipr.res.in; Raju, D.; Dhongde, J.; Mahajan, K.; Chudasama, H.; Gulati, H.; Chauhan, A.; Masand, H.; Bhandarkar, M.; Pradhan, S.

    2016-11-15

    Highlights: • Reflective Memory network. • FPAG based Timing system for trigger distribution. • IRIG-B network for GPS time synchronization. • PMC based Digital Signal Processors and VME. • Simultaneous sampling ADC. - Abstract: Primary objective of SST-1 Plasma control system is to achieve Plasma position, shape and current profile control. Architecture of control system for SST-1 is distributed in nature. Fastest control loop time requirement of 100 μs is achieved using VME based simultaneous sampling ADCs, PMC based quad core DSP, Reflective Memory [RFM] based real-time network, VME based real-time trigger distribution network and Ethernet network. All the control loops for shape control, position control and current profile control share common signals from Magnetic diagnostic so it is planned to accommodate all the algorithms on the same PMC based quad core DSP module TS C-43. RFM based real-time data network replicate data from one node to next node in a ring network topology at sustained throughput rate of 13.4 MBps. Real-time Timing System network provides guaranteed trigger distribution in 3.8 μs from one node to all node of the network. Monitoring and configuration of different systems participating in the operation of SST-1 is done by Ethernet network. Magnetic sensors data is acquired using Pentek 6802 simultaneously sampling ADC card at the rate of 10KSPS. All the real-time raw data along with the control data will be archived using RFM network and SCSI HDD for the experiment duration of 1000 s. RFM network is also planned for real-time plotting of key parameter of Plasma during long experiment. After experiment this data is transferred to central storage server for archival purpose. This paper discusses the architecture and hardware implementation of the control system by describing all the involved hardware and software along with future plans for up-gradations.

  16. Ultrasound guided pectoral nerve blockade versus thoracic spinal blockade for conservative breast surgery in cancer breast: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hala M.S. ELdeen

    2016-01-01

    Conclusion: In conclusion, both Pecs and TSB provide effective intraoperative anesthesia and prolonged postoperative pain relief after breast surgery, but the Pecs block is technically simple and easy to learn with few contraindications, provides hemodynamic stability, and has a low complication rate and it is therefore a safe and effective technique in performing intraoperative anesthesia and controlling postoperative pain after unilateral conservative breast surgery.

  17. Comparison of the efficacy between topical diquafosol and artificial tears in the treatment of dry eye following cataract surgery: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhao, Xinyu; Xia, Song; Chen, Youxin

    2017-09-01

    The prevalence of dry eye following cataract surgery was reported as high as 55.7%, this acute and iatrogenic disorder urgently required appropriate clinical management. The purpose of this study is to compare the efficacy of diquafosol sodium ophthalmic solution (DQS) and conventional artificial tears (AT) for the treatment of dry eye following cataract surgery. The PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from their earliest entries through June 2017 to obtain the studies, which evaluated the efficacy of DQS for patients with dry eye after cataract surgery. The relevant data were analyzed using StataSE 12.0 software. The PRISMA checklist was used as protocol of the meta-analysis and the guideline was followed. The weighted mean difference, relative risk, and their 95% confidence interval were used to assess the strength of the association. The authors identified 21 references of which 4 studies evaluating the efficacy of DQS for patients with dry eye after cataract surgery were included. The dataset consisted of 291 patients of dry eye following cataract surgery (371 postoperative eyes). The pooling result of our study suggested that the DQS could significantly better improve the indices like corneal and conjunctival fluorescein staining scores, tear breakup time, and Schirmer I test than AT (P dry eye. Based on the available evidence, topical DQS has a superior efficacy than AT in the management of dry eye after cataract surgery; however, further researches with larger sample sizes and focus on indicators such as higher-order aberrations, symptom questionnaire scores, and cost-effective ratio are required to reach a firmer conclusion.

  18. A randomized controlled trial of skin care protocols for facial resurfacing: lessons learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research study.

    Science.gov (United States)

    Pannucci, Christopher J; Reavey, Patrick L; Kaweski, Susan; Hamill, Jennifer B; Hume, Keith M; Wilkins, Edwin G; Pusic, Andrea L

    2011-03-01

    The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.

  19. A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

    2011-01-01

    Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

  20. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial.

    Science.gov (United States)

    Kamiya, Yoshinori; Hasegawa, Miki; Yoshida, Takayuki; Takamatsu, Misako; Koyama, Yu

    2018-03-01

    block improved postoperative pain but not the postoperative QoR-40 score due to the factors that cannot be measured by analgesia immediately after surgery, such as rebound pain. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000013435).

  1. Characterisation and quantification of regional diurnal SST cycles from SEVIRI

    DEFF Research Database (Denmark)

    Karagali, Ioanna; Høyer, J.L.

    2014-01-01

    seas. Six years of SST fields from SEVIRI are validated against the Advanced Along-Track Scanning Radiometer (AATSR) Reprocessed for Climate (ARC) data set. The overall SEVIRI–AATSR bias is −0.07 K, and the standard deviation is 0.51 K, based on more than 53×106 matchups. Identification of the diurnal...... in the tropics. Longer diurnal warming duration is identified in the high latitudes compared to the tropics. The maximum monthly mean diurnal signal can be up to 0.5K in specific regions....

  2. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    analysis included the formation of foreign body granuloma in the gastroenteroanastomosis and enteroanastomosis in 88.9% of the swine that underwent manual suture and in none of the swine that underwent stapling. There was also a significant statistical difference among swine from Group A, and those from groups B, C and D regarding the degree of inflammation, being more intense in those swine that underwent manual suture. Conclusion: This study shows that both types of suture promoted proper healing of gastroenteroanastomosis and enteroanastomosis, although there was a higher degree of inflammation and an increased occurrence of foreign body granuloma in swine subjected to manual suture, although there have been similarities in safety, efficiency, and effectiveness between the models of linear mechanical staplers tested during the performance of these anastomoses on swine. Keywords: linear mechanical stapler, stapler, manual suture, surgery, gastroenteroanastomosis, enteroanastomosis, swine, randomized clinical trial

  3. Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: a strategy to reduce the incidence of postoperative delirium in elderly patients.

    Science.gov (United States)

    Li, Tianjing; Wieland, L Susan; Oh, Esther; Neufeld, Karin J; Wang, Nae-Yuh; Dickersin, Kay; Sieber, Frederick E

    2017-06-01

    Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others

  4. Use of Levosimendan in Cardiac Surgery: An Update After the LEVO-CTS, CHEETAH, and LICORN Trials in the Light of Clinical Practice.

    Science.gov (United States)

    Guarracino, Fabio; Heringlake, Matthias; Cholley, Bernard; Bettex, Dominique; Bouchez, Stefaan; Lomivorotov, Vladimir V; Rajek, Angela; Kivikko, Matti; Pollesello, Piero

    2018-01-01

    Levosimendan is a calcium sensitizer and adenosine triphosphate-dependent potassium channel opener, which exerts sustained hemodynamic, symptomatic, and organ-protective effects. It is registered for the treatment of acute heart failure, and when inotropic support is considered appropriate. In the past 15 years, levosimendan has been widely used in clinical practice and has also been tested in clinical trials to stabilize at-risk patients undergoing cardiac surgery. Recently, 3 randomized, placebo-controlled, multicenter studies (LICORN, CHEETAH, and LEVO-CTS) have been published reporting on the perioperative use of levosimendan in patients with compromised cardiac ventricular function. Taken together, many smaller trials conducted in the past suggested beneficial outcomes with levosimendan in perioperative settings. By contrast, the latest 3 studies were neutral or inconclusive. To understand the reasons for such dissimilarity, a group of experts from Austria, Belgium, Finland, France, Germany, Italy, Switzerland, and Russia, including investigators from the 3 most recent studies, met to discuss the study results in the light of both the previous literature and current clinical practice. Despite the fact that the null hypothesis could not be ruled out in the recent multicenter trials, we conclude that levosimendan can still be viewed as a safe and effective inodilator in cardiac surgery.

  5. Supplemental Peri-Operative Oxygen and Incision Site Infection after Surgery for Perforated Peptic Ulcer: A Randomized, Double-Blind Monocentric Trial.

    Science.gov (United States)

    Schietroma, Mario; Cecilia, Emanuela Marina; De Santis, Giuseppe; Carlei, Francesco; Pessia, Beatrice; Amicucci, Gianfranco

    2016-02-01

    The clinical role of hyperoxia for preventing surgical site infection (SSI) remains uncertain because randomized controlled trials on this topic have reported disparate results. One of the principal reasons for this outcome may be that prior trials have entered heterogeneous populations of patients and a variety of procedures. The aim of our study was to assess the influence of hyperoxygenation on SSI using a homogeneous study population. From January 2004 to April 2013, we studied, in a randomized trial, 239 patients, who underwent open surgery for perforated peptic ulcer (PPU). The surgical procedure was performed through an upper abdominal midline incision, and closure of PPU was achieved by suture alone or in combination with an omental patch. Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen (FiO2) of 30% (n = 120) or 80% (n = 119). Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery. The overall incision infection rate was 38.4% (92 of 239): 61 patients (50.8%) had an infection in the 30% FiO2 group and 31 (26%) in the 80% FiO2 group (p operative SSI, should be considered part of ongoing quality improvement activities related to surgical care, with few risks to the patient and little associated cost.

  6. Efficacy and feasibility of frontozygomatic angle approach for extra oral maxillary nerve block in oral surgery: a descriptive clinical trial.

    Science.gov (United States)

    Radder, Kiran; Shah, Ashwin; Fatima, Shereen; Kothari, Chaitanya; Zakaullah, Syed; Siddiqua, Aaisha

    2014-09-01

    Pain control is an integral part of minor oral surgery and maxillary/mandibular nerve blocks have proved promising in achieving the same. Although intra oral techniques of maxillary nerve block are common and are widely used, there are certain inherent disadvantages and potential complications. Less commonly described in the literature, the extra oral techniques have a wide spectrum of indications as well as can be more advantageous than the intra oral approach. This prospective clinical trial is an attempt to evaluate the feasibility and the efficacy of the extra oral frontozygomatic approach to the foramen rotundum to block the maxillary nerve. Sample size was 100 patients and the inclusion criteria were patients of ASA I or II category who needed extraction of a minimum of 4 maxillary teeth in the same quadrant in a single sitting while exclusion criteria were patients with a history of allergy to local anesthesia, medically compromised patients in whom dental extraction was contraindicated. Mean age was 71.9 years and 56 patients were males while 44 were females. Only a single quadrant (first or second) was chosen as the operative site in each patient and local anaesthesia was secured using a 21 gauge 89 mm long spinal needle with frontozygomatic angle approach and the parameters used were pain experienced during the injection, onset of subjective symptoms, time required for the peak effect (objective symptoms), pain during extraction and the duration of anesthesia. All the parameters were expressed as mean values with standard deviations. A successful anesthesia was secured in first attempt in 98 patients while in 2 patients, the procedure had to be repeated owing to the difficulty in reaching the target site. A majority of the patients i.e., 71 % scored 0-2 (no pain) on visual analogue scale (VAS) while only 2 patients experienced a moderate degree of pain. Subjective symptoms were reported in 27.24 s (mean value) and 12.93 s (mean value) in the palate

  7. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

    Science.gov (United States)

    Courcoulas, Anita P; Belle, Steven H; Neiberg, Rebecca H; Pierson, Sheila K; Eagleton, Jessie K; Kalarchian, Melissa A; DeLany, James P; Lang, Wei; Jakicic, John M

    2015-10-01

    Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). To compare the remission of T2DM following surgical and nonsurgical treatments. In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P lifestyle treatment at 5.7% (2.4%) (P lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. clinicaltrials.gov Identifier: NCT

  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. Ringer's lactate, but not hydroxyethyl starch, prolongs the food intolerance time after major abdominal surgery; an open-labelled clinical trial.

    Science.gov (United States)

    Li, Yuhong; He, Rui; Ying, Xiaojiang; Hahn, Robert G

    2015-05-06

    The infusion of large amounts of Ringer's lactate prolongs the functional gastrointestinal recovery time and increases the number of complications after open abdominal surgery. We performed an open-labelled clinical trial to determine whether hydroxyethyl starch or Ringer's lactate exerts these adverse effects when the surgery is performed by laparoscopy. Eighty-eight patients scheduled for major abdominal cancer surgery (83% by laparoscopy) received a first-line fluid treatment with 9 ml/kg of either 6% hydroxyethyl starch 130/0.4 (Voluven) or Ringer's lactate, just after induction of anaesthesia; this was followed by a second-line infusion with 12 ml/kg of either starch or Ringer's lactate over 1 hour. Further therapy was managed at the discretion of the attending anaesthetist. Outcome data consisted of postoperative gastrointestinal recovery time, complications and length of hospital stay. The order of the infusions had no impact on the outcome. Both the administration of ≥ 2 L of Ringer's lactate and the development of a surgical complication were associated with a longer time period of paralytic ileus and food intolerance (two-way ANOVA, P food intolerance time amounted to 2 days each. The infusion of ≥ 1 L of hydroxyethyl starch did not adversely affect gastrointestinal recovery. Ringer's lactate, but not hydroxyethyl starch, prolonged the gastrointestinal recovery time in patients undergoing laparoscopic cancer surgery. Surgical complications prolonged the hospital stay.

  10. 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.

  11. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

    Science.gov (United States)

    Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

    2015-06-01

    At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. 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/

  13. The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

    2016-03-01

    Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

  14. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    Science.gov (United States)

    Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

    2005-01-01

    Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

  15. 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.

  16. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

    Science.gov (United States)

    Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

    2017-09-01

    Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

  17. Superconducting magnets and cryogenics for the steady state superconducting tokamak SST-1

    International Nuclear Information System (INIS)

    Saxena, Y.C.

    2000-01-01

    SST-1 is a steady state superconducting tokamak for studying the physics of the plasma processes in tokamak under steady state conditions and to learn technologies related to the steady state operation of the tokamak. SST-1 will have superconducting magnets made from NbTi based conductors operating at 4.5 K temperature. The design of the superconducting magnets and the cryogenic system of SST-1 tokamak are described. (author)

  18. Assembly and metrology of first wall components of SST-1

    International Nuclear Information System (INIS)

    Parekh, Tejas; Santra, Prosenjit; Biswas, Prabal

    2015-01-01

    First Wall components (FWC) of SST-1 tokamak, which are in the immediate vicinity of plasma comprises of limiters, divertors, baffles, passive stabilizers are designed to operate long duration (1000 s) discharges of elongated plasma. All FWC consists of a copper alloy heat sink modules with SS cooling tubes brazed onto it, graphite tiles acting as armour material facing the plasma, and are mounted to the vacuum vessels with suitable Inconel support structures at ring and port locations. The FWC are very recently assembled and commissioned successfully inside the vacuum vessel of SST-1 under going a meticulous planning of assembly sequence, quality checks at every stage of the assembly process. This paper will present the metrology aspects and procedure of each FWC, both outside the vacuum vessel, and inside the vessel, assembly tolerances, tools, equipment and jig/fixtures, used at each stage of assembly, starting from location of support bases on vessel rings, fixing of copper modules on support structures, around 3800 graphite tile mounting on 136 copper modules with proper tightening torques, till final toroidal and poloidal geometry of the in-vessel components are obtained within acceptable limits, also ensuring electrical continuity of passive stabilizers to form a closed saddle loop, electrical isolation of passive stabilizers from vacuum vessel. (author)

  19. Assembly & Metrology of First Wall Components of SST-1

    Science.gov (United States)

    Parekh, Tejas; Santra, Prosenjit; Biswas, Prabal; Patel, Hiteshkumar; Paravastu, Yuvakiran; Jaiswal, Snehal; Chauhan, Pradeep; Babu, Gattu Ramesh; A, Arun Prakash; Bhavsar, Dhaval; Raval, Dilip C.; Khan, Ziauddin; Pradhan, Subrata

    2017-04-01

    First Wall Components (FWC) of SST-1 tokamak, which are in the immediate vicinity of plasma comprises of limiters, divertors, baffles, passive stabilizers are designed to operate long duration (1000 s) discharges of elongated plasma. All FWC consists of a copper alloy heat sink modules with SS cooling tubes brazed onto it, graphite tiles acting as armour material facing the plasma, and are mounted to the vacuum vessels with suitable Inconel support structures at ring & port locations. The FWC are very recently assembled and commissioned successfully inside the vacuum vessel of SST-1 undergoing a meticulous planning of assembly sequence, quality checks at every stage of the assembly process. This paper will present the metrology aspects & procedure of each FWC, both outside the vacuum vessel, and inside the vessel, assembly tolerances, tools, equipment and jig/fixtures, used at each stage of assembly, starting from location of support bases on vessel rings, fixing of copper modules on support structures, around 3800 graphite tile mounting on 136 copper modules with proper tightening torques, till final toroidal and poloidal geometry of the in-vessel components are obtained within acceptable limits, also ensuring electrical continuity of passive stabilizers to form a closed saddle loop, electrical isolation of passive stabilizers from vacuum vessel.

  20. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  1. Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial.

    Science.gov (United States)

    Cro, Suzie; Mehta, Saahil; Farhadi, Jian; Coomber, Billie; Cornelius, Victoria

    2018-01-01

    Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. Before testing the effectiveness of heat preconditioning in a definitive randomised controlled trial (RCT), we must first establish the best way to measure skin necrosis and estimate the event rate using this definition. PREHEAT is a single-blind randomised controlled feasibility trial comparing local heat preconditioning, using a hot water bottle, against standard care on skin necrosis among breast cancer patients undergoing reconstructive breast surgery. The primary objective of this study is to determine the best way to measure skin necrosis and to estimate the event rate using this definition in each trial arm. Secondary feasibility objectives include estimating recruitment and 30 day follow-up retention rates, levels of compliance with the heating protocol, length of stay in hospital and the rates of surgical versus conservative management of skin necrosis. The information from these objectives will inform the design of a larger definitive effectiveness and cost-effectiveness RCT. This article describes the PREHEAT trial protocol and detailed statistical analysis plan, which includes the pre-specified criteria and process for establishing the best way to measure necrosis. This study will provide the evidence needed to establish the best way to measure skin necrosis, to use as the primary outcome in a future RCT to definitively test the effectiveness of local heat preconditioning. The pre-specified statistical analysis plan, developed prior to unblinded data extraction, sets out the analysis strategy and a comparative framework to support a committee evaluation of skin necrosis measurements. It will increase the transparency of the data analysis for the

  2. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  3. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Directory of Open Access Journals (Sweden)

    Rawal N

    2011-04-01

    Full Text Available Narinder Rawal1, Valery Macquaire2, Elena Catalá3, Marco Berti4, Rui Costa5, Markus Wietlisbach61Department of Anesthesiology and Intensive Care, Örebro University Hospital, Örebro, Sweden; 2Clinique du Parc Leopold, Brussels, Belgium; 3Pain Clinic, Department Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 4Department of Anesthesiology and Reanimation, Parma Hospital, Parma, Italy; 5Garcia de Orta Hospital, Almada, Portugal; 6Department of Anesthesiology, Sursee Hospital, Sursee, SwitzerlandAbstract: This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24 and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0 on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment. Rescue medication leading to withdrawal (diclofenac 50 mg was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness

  4. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  5. Comparative study between ultrasound guided tap block and paravertebral block in upper abdominal surgeries. Randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ruqaya M. Elsayed

    2017-01-01

    Conclusion: We concluded that ultrasound guided transversus abdominis plane block and thoracic paravertebral block were safe and effective anesthetic technique for upper abdominal surgery with longer and potent postoperative analgesia in thoracic paravertebral block than transversus abdominis block.

  6. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Kelly Ickmans

    2016-07-01

    Discussion: This study will determine whether pain neuroscience education is worthwhile for patients undergoing surgery for lumbar radiculopathy. It is expected that participants who receive perioperative pain neuroscience education will report less pain and have improved endogenous pain modulation, lower postoperative healthcare costs and improved surgical experience. Lower pain and improved endogenous pain modulation after surgery may reduce the risk of developing postoperative chronic pain.

  7. PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer

    International Nuclear Information System (INIS)

    Owadally, Waheeda; Hurt, Chris; Timmins, Hayley; Parsons, Emma; Townsend, Sarah; Patterson, Joanne; Hutcheson, Katherine; Powell, Ned; Beasley, Matthew; Palaniappan, Nachi; Robinson, Max; Jones, Terence M.; Evans, Mererid

    2015-01-01

    Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity

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

    Science.gov (United States)

    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.

  9. Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Park, Dae Hyun; Chung, Jin Kwon; Seo, Du Ri; Lee, Sung Jin

    2016-03-01

    To compare the efficacies and safety profiles of 3% diquafosol and 0.1% sodium hyaluronate in patients with dry eye after cataract surgery. Randomized controlled trial. setting: Soonchunhyang University Hospital, Seoul, South Korea. In all, 130 eyes of 86 dry eye patients who had undergone cataract surgery between January 2014 and January 2015 were enrolled and randomly divided into a diquafosol group and a sodium hyaluronate group. The diquafosol group used diquafosol 6 times a day and the hyaluronate group used sodium hyaluronate 6 times a day after cataract surgery. Evaluations of efficacy were conducted based on an Ocular Surface Disease Index questionnaire, tear breakup time (TBUT), Schirmer I test, corneal fluorescein and conjunctival lissamine green staining scores, serial measurement of ocular higher-order aberrations (HOAs), corneal HOAs, and uncorrected distance visual acuity test. Safety evaluations were based on anterior chamber inflammation and discontinuation of the eye drops. Objective signs and subjective symptoms were aggravated at 1 week postoperatively and began to recover significantly 4 weeks after surgery. The diquafosol group showed significantly superior TBUT (P < .001), corneal fluorescein (P = .045), and conjunctival staining (P = .001) compared to the sodium hyaluronate group throughout the study period. TBUT (P < .001) and the change in HOAs (P = .018) recovered significantly more quickly in the diquafosol group. The safety evaluations showed no intergroup differences. Eye drops of 3% diquafosol may be an effective and safe treatment for the management of cataract surgery-induced dry eye aggravation in patients with preexisting dry eye. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Costello, John M; Dunbar-Masterson, Carolyn; Allan, Catherine K; Gauvreau, Kimberlee; Newburger, Jane W; McGowan, Francis X; Wessel, David L; Mayer, John E; Salvin, Joshua W; Dionne, Roger E; Laussen, Peter C

    2014-07-01

    We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. http://www.clinicaltrials.gov. Unique identifier: NCT00543309. © 2014 American Heart Association, Inc.

  11. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin.

    Science.gov (United States)

    Falk-Brynhildsen, K; Söderquist, B; Friberg, O; Nilsson, U G

    2013-06-01

    Sternal wound infection after cardiac surgery is a serious complication. Various perioperative strategies, including plastic adhesive drapes, are used to reduce bacterial contamination of surgical wounds. To compare plastic adhesive drape to bare skin regarding bacterial growth in wound and time to recolonization of the adjacent skin intraoperatively, in cardiac surgery patients. This single-blinded randomized controlled trial (May 2010 to May 2011) included 140 patients scheduled for cardiac surgery via median sternotomy. The patients were randomly allocated to the adhesive drape (chest covered with plastic adhesive drape) or bare skin group. Bacterial samples were taken preoperatively and intraoperatively every hour during surgery until skin closure. Disinfection with 0.5% chlorhexidine solution in 70% alcohol decreased coagulase-negative staphylococci (CoNS), while the proportion colonized with Propionibacterium acnes was not significantly reduced and was still present in more than 50% of skin samples. P. acnes was significantly more common in men than in women. Progressive bacterial recolonization of the skin occurred within 2-3 h. At 120 min there were significantly more positive cultures in the adhesive drape group versus bare skin group for P. acnes (63% vs 44%; P = 0.034) and for CoNS (45% vs 24%; P = 0.013). The only statistically significant difference in bacterial growth in the surgical wound was higher proportion of CoNS at the end of surgery in the adhesive drape group (14.7% vs 4.4%; P = 0.044). Plastic adhesive drape does not reduce bacterial recolonization. P. acnes colonized men more frequently, and was not decreased by disinfection with chlorhexidine solution in alcohol. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  12. Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial.

    Science.gov (United States)

    Gheza, Federico; Raimondi, Paolo; Solaini, Leonardo; Coccolini, Federico; Baiocchi, Gian Luca; Portolani, Nazario; Tiberio, Guido Alberto Massimo

    2018-04-11

    Outside the US, FLS certification is not required and its teaching methods are not well standardized. Even if the FLS was designed as "stand alone" training system, most of Academic Institution offer support to residents during training. We present the first systematic application of FLS in Italy. Our aim was to evaluate the role of mentoring/coaching on FLS training in terms of the passing rate and global performance in the search for resource optimization. Sixty residents in general surgery, obstetrics & gynecology, and urology were selected to be enrolled in a randomized controlled trial, practicing FLS with the goal of passing a simulated final exam. The control group practiced exclusively with video material from SAGES, whereas the interventional group was supported by a mentor. Forty-six subjects met the requirements and completed the trial. For the other 14 subjects no results are available for comparison. One subject for each group failed the exam, resulting in a passing rate of 95.7%, with no obvious differences between groups. Subgroup analysis did not reveal any difference between the groups for FLS tasks. We confirm that methods other than video instruction and deliberate FLS practice are not essential to pass the final exam. Based on these results, we suggest the introduction of the FLS system even where a trained tutor is not available. This trial is the first single institution application of the FLS in Italy and one of the few experiences outside the US. Trial Number: NCT02486575 ( https://www.clinicaltrials.gov ).

  13. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial – the PRODIGE 22 - ECKINOXE trial

    International Nuclear Information System (INIS)

    Karoui, Mehdi; Rullier, Anne; Luciani, Alain; Bonnetain, Franck; Auriault, Marie-Luce; Sarran, Antony; Monges, Geneviève; Trillaud, Hervé; Le Malicot, Karine; Leroy, Karen; Sobhani, Iradj; Bardier, Armelle; Moreau, Marie; Brindel, Isabelle; Seitz, Jean François; Taieb, Julien

    2015-01-01

    In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 20 to 30 % of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for these CCs and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery. PRODIGE 22 - ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy and feasibility of two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4 + Cetuximab) in a peri-operative strategy in patients with bulky CCs. Patients with CC deemed as high risk T3, T4 and/or N2 on initial abdominopelvic CT scan are randomized to either colectomy and adjuvant chemotherapy (control arm), or 4 cycles of neoadjuvant chemotherapy with FOLFOX-4 (for RAS mutated patients). In RAS wild-type patients a third arm testing FOLFOX+ cetuximab has been added prior to colectomy. Patients in the neoadjuvant chemotherapy arms will receive postoperative treatment for 4 months (8 cycles) to complete their therapeutic schedule. The primary endpoint of the study is the histological Tumor Regression Grade (TRG) as defined by Ryan. The secondary endpoints are: treatment strategy safety (toxicity, primary tumor related complications under chemotherapy, peri-operative morbidity), disease-free and recurrence free survivals at 3 years, quality of life, carcinologic quality and

  14. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial.

    Science.gov (United States)

    Karoui, Mehdi; Rullier, Anne; Luciani, Alain; Bonnetain, Franck; Auriault, Marie-Luce; Sarran, Antony; Monges, Geneviève; Trillaud, Hervé; Le Malicot, Karine; Leroy, Karen; Sobhani, Iradj; Bardier, Armelle; Moreau, Marie; Brindel, Isabelle; Seitz, Jean François; Taieb, Julien

    2015-07-10

    In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 20 to 30% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for these CCs and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery. PRODIGE 22--ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy and feasibility of two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4 + Cetuximab) in a peri-operative strategy in patients with bulky CCs. Patients with CC deemed as high risk T3, T4 and/or N2 on initial abdominopelvic CT scan are randomized to either colectomy and adjuvant chemotherapy (control arm), or 4 cycles of neoadjuvant chemotherapy with FOLFOX-4 (for RAS mutated patients). In RAS wild-type patients a third arm testing FOLFOX+ cetuximab has been added prior to colectomy. Patients in the neoadjuvant chemotherapy arms will receive postoperative treatment for 4 months (8 cycles) to complete their therapeutic schedule. The primary endpoint of the study is the histological Tumor Regression Grade (TRG) as defined by Ryan. The secondary endpoints are: treatment strategy safety (toxicity, primary tumor related complications under chemotherapy, peri-operative morbidity), disease-free and recurrence free survivals at 3 years, quality of life, carcinologic quality and

  15. Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    DEFF Research Database (Denmark)

    Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

    2016-01-01

    and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...

  16. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery

    NARCIS (Netherlands)

    Oomens, M.A.E.M.; Lazzari, S.; Heymans, M.W.; Forouzanfar, T.

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and

  17. Design of new central solenoid for SST-1

    Science.gov (United States)

    Prasad, Upendra; Pradhan, Subrata; Ghate, Mahesh; Raj, Piyush; Tanna, V. L.; Khan, Ziauddin; Roy, Swati; Santra, Prosenjit; Biswas, Prabal; Sharma, A. N.; Khristi, Yohan; Kanaber, Deven; Varmora, Pankaj

    2017-04-01

    The key role of central solenoid (CS) magnet of a Tokamak is for gas breakdown, ramp up and maintaining of plasma current. The magnetic flux change in CS along with other PF coils generates magnetic null and induces electric field in toroidal direction. The induced toroidal electric field accelerates the residual electrons which collide with the neutrals and an avalanche takes place which led to the net plasma in the vacuum vessel of a Tokamak. In order to maximize the CS volt-sec capability, the higher magnetic field with a greater magnetic flux linkage is necessary. In order to facilitate all these requirements of SST-1 a new superconducting CS has been designed for SST-1. The design of new central solenoid has two bases; first one is physics and second is smart engineering in limited bore diameter of ∼ 655 mm. The physics basis of the design includes volt-sec storage capacity of ∼ 0.8 volt-sec, magnetic field null around 0.2 m over major radius of 1.1 m and toroidal electric field of ∼ 0.3 volt/m. The engineering design of new CS consists of Nb3Sn cable in conduit conductor (CICC) of operating current of 14 kA @ 4.5 K at 6 T, consolidated winding pack, smart quench detection system, protection system, housing cryostat and conductor terminations and joint design. The winding pack consists of 576 numbers of turns distributed in four layers with 0.75 mm FRP tape soaked with cyanide Easter based epoxy resin turn insulation and 3 mm of ground insulation. The interlayer low resistance (∼1 nΩ) terminal praying hand joints at 14 kA at 4.5 K has been designed for making winding pack continuous. The total height of winding pack is 2500 mm. The stored energy of this winding pack is ∼ 3 MJ at 14 kA of operating current. The expected heat load at cryogenic temperature is ∼ 10 W per layer, which requires helium mass flow rate of 1.4 g/s at 1.4 bars @ 4.5 K. The typical diameter and height of housing cryostat are 650 mm and 2563 mm with 80 K shield respectively

  18. Design of new central solenoid for SST-1

    International Nuclear Information System (INIS)

    Prasad, Upendra; Pradhan, Subrata; Ghate, Mahesh; Raj, Piyush; Tanna, V L; Khan, Ziauddin; Roy, Swati; Santra, Prosenjit; Biswas, Prabal; Sharma, A N; Khristi, Yohan; Kanaber, Deven; Varmora, Pankaj

    2017-01-01

    The key role of central solenoid (CS) magnet of a Tokamak is for gas breakdown, ramp up and maintaining of plasma current. The magnetic flux change in CS along with other PF coils generates magnetic null and induces electric field in toroidal direction. The induced toroidal electric field accelerates the residual electrons which collide with the neutrals and an avalanche takes place which led to the net plasma in the vacuum vessel of a Tokamak. In order to maximize the CS volt-sec capability, the higher magnetic field with a greater magnetic flux linkage is necessary. In order to facilitate all these requirements of SST-1 a new superconducting CS has been designed for SST-1. The design of new central solenoid has two bases; first one is physics and second is smart engineering in limited bore diameter of ∼ 655 mm. The physics basis of the design includes volt-sec storage capacity of ∼ 0.8 volt-sec, magnetic field null around 0.2 m over major radius of 1.1 m and toroidal electric field of ∼ 0.3 volt/m. The engineering design of new CS consists of Nb3Sn cable in conduit conductor (CICC) of operating current of 14 kA @ 4.5 K at 6 T, consolidated winding pack, smart quench detection system, protection system, housing cryostat and conductor terminations and joint design. The winding pack consists of 576 numbers of turns distributed in four layers with 0.75 mm FRP tape soaked with cyanide Easter based epoxy resin turn insulation and 3 mm of ground insulation. The interlayer low resistance (∼1 nΩ) terminal praying hand joints at 14 kA at 4.5 K has been designed for making winding pack continuous. The total height of winding pack is 2500 mm. The stored energy of this winding pack is ∼ 3 MJ at 14 kA of operating current. The expected heat load at cryogenic temperature is ∼ 10 W per layer, which requires helium mass flow rate of 1.4 g/s at 1.4 bars @ 4.5 K. The typical diameter and height of housing cryostat are 650 mm and 2563 mm with 80 K shield respectively

  19. Design of new superconducting central solenoid of SST-1 tokamak

    International Nuclear Information System (INIS)

    Prasad, Upendra; Pradhan, Subrata; Ghate, Mahesh

    2015-01-01

    The key role of the central solenoid (CS) magnet of a Tokamak is for gas breakdown, ramp up and maintaining of plasma current for longer duration. The magnetic flux change in CS along with other PF coils generates magnetic null and induces electric field in toroidal direction. The induced toroidal electric field accelerates the residual electrons which collide with the neutrals and an avalanche takes place which led to the net plasma in the vacuum vessel of a Tokamak. In order to maximize the CS volt-sec capability, the higher magnetic field with a greater magnetic flux linkage is necessary. In order to facilitate all these requirements of SST-1 a new superconducting CS has been designed for SST-1. The design of new central solenoid has two bases; first one is physics and second is smart engineering in limited bore diameter of ∼655 mm. The physics basis of the design includes volt-sec storage capacity of ∼0.8 volt-sec, magnetic field null around 0.2 m over major radius of 1.1 m and toroidal electric field of ∼0.3 volt/m.The engineering design of new CS consists of Nb 3 Sn cable in conduit conductor (CICC) of operating current of 14 kA @ 4.5 K at 6 T, consolidated winding pack, smart quench detection system, protection system, housing cryostat and conductor terminations and joint design. The winding pack consists of 576 numbers of turns distributed in four layers with 0.75 mm FRP tape soaked with cyanide Easter based epoxy resin turn insulation and 3 mm of ground insulation. The inter-layer low resistance (∼1 nΩ) at 14 kA @ 4.5 K terminal praying hand joints has been designed for making winding pack continuous. The total height of winding pack is 2500 mm. The stored energy of this winding pack is ∼3 MJ at 14 kA of operating current. The expected heat load at cryogenic temperature is ∼10 W per layer, which requires helium mass flow rate of 1.4 g/s at 1.4 bars @ 4.5 K. The typical diameter and height of housing cryostat are 650 mm and 2563 mm with 80 K

  20. SST and ice sheet impacts on the MIS-13 climate

    Energy Technology Data Exchange (ETDEWEB)

    Muri, Helene; Berger, Andre; Yin, Qiuzhen; Sundaram, Suchithra [Universite catholique de Louvain, Georges Lemaitre Centre for Earth and Climate Research (TECLIM), Earth and Life Institute (ELI), Louvain la Neuve (Belgium); Voldoire, Aurore; Melia, David Salas Y. [CNRM-GAME Meteo-France/CNRS, Toulouse Cedex (France)

    2012-10-15

    As a first qualitative assessment tool, LOVECLIM has been used to investigate the interactions between insolation, ice sheets and the East Asian Monsoon at the Marine Isotopic Stage 13 (MIS-13) in work by Yin et al. (Clim Past 4:79-90, 2008, Clim Past 5:229-243, 2009). The results are in need of validation with a more sophisticated model, which is done in this work with the ARPEGE atmospheric general circulation model. As in the Earth system Model of Intermediate Complexity, LOVECLIM, ARPEGE shows that the northern hemispheric high insolation in summer leads to strong MIS-13 monsoon precipitation. Data from the Chinese Loess Plateau indicate that MIS-13 was locally a warm and humid period (Guo et al. in Clim Past 5:21-31, 2009; Yin and Guo in Chin Sci Bull 51(2):213-220, 2006). This is confirmed by these General Circulation Model (GCM) results, where the MIS-13 climate is found to be hotter and more humid both in the presence and absence of any added ice sheets. LOVECLIM found that the combined effects of the ice sheets and their accompanying SSTs contribute to more precipitation in eastern China, whilst in ARPEGE the impact is significant in northeastern China. Nonetheless the results of ARPEGE confirm the counter-intuitive results of LOVECLIM where ice sheets contribute to enhance monsoon precipitation. This happens through a topography induced wave propagating through Eurasia with an ascending branch over northeastern China. A feature which is also seen in LOVECLIM. The SST forcing in ARPEGE results in a strong zonal temperature gradient between the North Atlantic and east Eurasia, which in turn triggers an atmospheric gravity wave. This wave induces a blocking Okhotskian high, preventing the northwards penetration of the Meiyu monsoon front. The synergism between the ice sheets and SST is found through the factor separation method, yielding an increase in the Meiyu precipitation, though a reduction of the Changma precipitation. The synergism between the ice

  1. Absolute Thermal SST Measurements over the Deepwater Horizon Oil Spill

    Science.gov (United States)

    Good, W. S.; Warden, R.; Kaptchen, P. F.; Finch, T.; Emery, W. J.

    2010-12-01

    Climate monitoring and natural disaster rapid assessment require baseline measurements that can be tracked over time to distinguish anthropogenic versus natural changes to the Earth system. Disasters like the Deepwater Horizon Oil Spill require constant monitoring to assess the potential environmental and economic impacts. Absolute calibration and validation of Earth-observing sensors is needed to allow for comparison of temporally separated data sets and provide accurate information to policy makers. The Ball Experimental Sea Surface Temperature (BESST) radiometer was designed and built by Ball Aerospace to provide a well calibrated measure of sea surface temperature (SST) from an unmanned aerial system (UAS). Currently, emissive skin SST observed by satellite infrared radiometers is validated by shipborne instruments that are expensive to deploy and can only take a few data samples along the ship track to overlap within a single satellite pixel. Implementation on a UAS will allow BESST to map the full footprint of a satellite pixel and perform averaging to remove any local variability due to the difference in footprint size of the instruments. It also enables the capability to study this sub-pixel variability to determine if smaller scale effects need to be accounted for in models to improve forecasting of ocean events. In addition to satellite sensor validation, BESST can distinguish meter scale variations in SST which could be used to remotely monitor and assess thermal pollution in rivers and coastal areas as well as study diurnal and seasonal changes to bodies of water that impact the ocean ecosystem. BESST was recently deployed on a conventional Twin Otter airplane for measurements over the Gulf of Mexico to access the thermal properties of the ocean surface being affected by the oil spill. Results of these measurements will be presented along with ancillary sensor data used to eliminate false signals including UV and Synthetic Aperture Radar (SAR

  2. Neuropsychological outcome after percutaneous coronary intervention or coronary artery bypass grafting: results from the Stent or Surgery (SoS) Trial.

    Science.gov (United States)

    Währborg, Peter; Booth, Jean E; Clayton, Tim; Nugara, Fiona; Pepper, John; Weintraub, William S; Sigwart, Ulrich; Stables, Rod H

    2004-11-30

    Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome. In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups. We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

  3. 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.

  4. Adjuvant therapy for melanoma in dogs: results of randomized clinical trials using surgery, liposome-encapsulated muramyl tripeptide, and granulocyte macrophage colony-stimulating factor.

    Science.gov (United States)

    MacEwen, E G; Kurzman, I D; Vail, D M; Dubielzig, R R; Everlith, K; Madewell, B R; Rodriguez, C O; Phillips, B; Zwahlen, C H; Obradovich, J; Rosenthal, R C; Fox, L E; Rosenberg, M; Henry, C; Fidel, J

    1999-12-01

    Spontaneous canine oral melanoma (COM) is a highly metastatic cancer, resistant to chemotherapy, and can serve as a model for cancer immunotherapy. Liposome-encapsulated muramyl tripeptide-phosphatidylethanolamine (L-MTP-PE) can activate the tumoricidal activity of the monocyte-macrophage system following i.v. injection. The objective of these studies was to evaluate the therapeutic effectiveness of L-MTP-PE administered alone and combined with recombinant canine granulocyte macrophage colony-stimulating factor (rcGM-CSF) in dogs undergoing surgery for oral melanoma. Ninety-eight dogs with histologically confirmed, clinically staged, oral melanoma were entered into two randomized, double-blind, surgical adjuvant trials. In trial 1, 50 dogs were stratified based on clinical stage and randomized to once a week L-MTP-PE or lipid equivalent (control). When all of the clinical stages were combined, no difference in disease-free survival or in survival time (ST) were detected. However, within stage I, dogs receiving L-MTP-PE had a significant increase in ST compared with control, with 80% of the dogs treated with L-MTP-PE still alive at >2 years. Within each stage II and stage III, there was no difference detected between the treatment groups. In trial 2, 48 dogs were stratified on the basis of clinical stage and extent of surgery (simple resection or radical excision), treated with L-MTP-PE two times a week, and randomized to rcGM-CSF or saline (placebo) given s.c. daily for 9 weeks. Within each stage and when all of the stages were combined, there was no difference between the treatment groups. In both studies, stage I COM is associated with a better prognosis. No effect on survival was observed with regard to tumor location in the oral cavity, sex, type/extent of surgery, or age. In a subset of dogs tested, pulmonary alveolar macrophage cytotoxicity was enhanced with combined rcGM-CSF and L-MTP-PE but not in dogs treated with L-MTP-PE alone. The present study

  5. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hila Hajizadeh

    2017-07-01

    Full Text Available Objectives This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS after periodontal surgery. Materials and Methods Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil S3 Bond (Kuraray Dental, G2: Gluma Desensitizer (Heraeus Kulzer, and G3: placebo (water. The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0, 1 day after treatment (T1, after 1 week (T2, and after 1 month (T3 according to visual analog scale (VAS. Results Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S3 Bond can have some benefits.

  6. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial.

    Science.gov (United States)

    Lagier, David; Nee, Laetitia; Guieu, Régis; Kerbaul, François; Fenouillet, Emmanuel; Roux, Nicolas; Giorgi, Roch; Theron, Alexis; Grisoli, Dominique; Gariboldi, Vlad; Collart, Frederic; Bruder, Nicolas; Velly, Lionel; Guidon, Catherine

    2018-04-26

    Raised plasma levels of endogenous adenosine after cardiac surgery using cardiopulmonary bypass (CPB) have been related to the incidence of postoperative atrial fibrillation (POAF). We wished to assess if caffeine, an adenosine receptor antagonist could have a beneficial effect on the incidence of POAF. A randomised controlled study. Single University Hospital. One hundred and ten patients scheduled for heart valve surgery with CPB. We randomly assigned patients to receive peri-operative oral caffeine (400 mg every 8 h for 2 days) or placebo. Adenosine plasma concentrations and caffeine pharmacokinetic profile were evaluated in a subgroup of 50 patients. The primary endpoint was the rate of atrial fibrillation during postoperative hospital stay. The current study was stopped for futility by the data monitoring board after an interim analysis. The incidence of atrial fibrillation was similar in the caffeine and in the placebo group during hospital stay (33 vs. 29%, P = 0.67) and the first 3 postoperative days (18 vs. 15%; P = 0.60). Basal and postoperative adenosine plasma levels were significantly associated with the primary outcome. Adenosine plasma levels were similar in the two treatment groups. Caffeine administration was associated with a higher incidence of postoperative nausea and vomiting (27 vs. 7%, P = 0.005). Oral caffeine does not prevent POAF after heart valve surgery with CPB but increased the incidence of postoperative nausea and vomiting. ClinicalTrials.gov, no.: NCT01999829.

  7. Study comparing 3 hour and 24 hour post-operative removal of bladder catheter and vaginal pack following vaginal surgery: a randomised controlled trial.

    Science.gov (United States)

    Rajan, Priya; Soundara Raghavan, S; Sharma, Deepak

    2017-09-11

    Traditional practice after vaginal hysterectomy was to keep the vaginal pack and urinary catheter for 24 hours post operatively. But there were studies that prolonged cathterisation was associated with urinary infection. So this study was conducted to compare the post operative outcome when the urinary catheter and vaginal pack were removed after 3 hours and after 24 hours after surgery. The study was done in the Department of Obstetrics and Gynecology, in a tertiary teaching institute of South India from September 2008 to March 2010. It was a randomised controlled trial involving 200 women undergoing vaginal surgery, who were randomly assigned to 2 groups - catheter and vaginal pack were removed either in 3 h in study group or were removed in 24 h in control group. The outcome of the study were vaginal bleeding, urinary retention, febrile morbidity, and urinary infection. There was no significant difference between the study and control groups with respect to vaginal bleeding (0 and 1%, p = 1), urinary retention (9 and 4%, p = 0.15), febrile morbidity (7 and 4%, p = 0.35), and urinary infection (26% in each group, p = 1.0). Keeping the urinary catheter and vaginal pack for 24 h following vaginal surgery does not offer any additional benefit against removing them after 3 h.

  8. Moderate hypothermia and its effects in reducing the applied dose of anesthetics for patients with opium dependence in cardiac surgery: A randomized controlled trial.

    Science.gov (United States)

    Taghadomi, Reza Jalaian; Golmakani, Ebrahim; Alizadeh, Kambiz; Mottahedi, Behrooz; Rahdari, Ali; Sheybani, Shima

    2016-09-01

    An increasing number of patients addicted to opium are experiencing awareness during coronary artery bypass surgery (CABG) as a result of tolerance to anesthetics. This research was primarily intended to determine the potential diminishing effects of moderate hypothermia on anesthetic dosage and recall of anesthesia during the procedure. In this double-blind randomized controlled trial, a total of 80 CABG candidates with known addiction to opium were divided into two groups: one normothermic (N) and the other moderately hypothermic (H), both undergoing induction as well as close monitoring from September 2014 to January 2016. The candidates were initially set for a target bispectral index (BIS) score of between 40 and 60. As the score rose to 60, an additional dose of propofol was administered, alongside rise in blood pressure and tear-shedding. To enhance the accuracy of our evaluation of anesthetic depth, we also used two questionnaires to test candidates' recall filled with the assistance of a colleague 24 hours following surgery. Independent-samples t-test and chi-square test were used by SPSS v 18 for data analysis. Eighty patients were studied in two groups of normothermic (N) (n = 40) and hypothermic (H) (n = 40). Given similar demographic data as well as the duration of surgery, we arrived at a propofol dose of 122.52±13.11 cc for normothermic patients and 101.28±14.06 cc for hypothermic subjects (p=0.001). As for fentanyl, the total required sum came up to 39.60±21.04 cc and 31.72±5.81 cc for the above-mentioned groups in order (p=0.025). Moreover, the post-operative interview showed that there was no report of a patient with memory recall following surgery. Moderate hypothermia can substantially reduce the need for anesthetics in patients with addiction to opium when undergoing CABG surgery. This study is registered in Iranian Registry of Clinical Trials with registration number of IRCT2014050513159N5. This research was supported financially by the

  9. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial.

    Science.gov (United States)

    Schrøder, Cecilie Piene; Skare, Øystein; Reikerås, Olav; Mowinckel, Petter; Brox, Jens Ivar

    2017-12-01

    Labral repair and biceps tenodesis are routine operations for superior labrum anterior posterior (SLAP) lesion of the shoulder, but evidence of their efficacy is lacking. We evaluated the effect of labral repair, biceps tenodesis and sham surgery on SLAP lesions. A double-blind, sham-controlled trial was conducted with 118 surgical candidates (mean age 40 years), with patient history, clinical symptoms and MRI arthrography indicating an isolated type II SLAP lesion. Patients were randomly assigned to either labral repair (n=40), biceps tenodesis (n=39) or sham surgery (n=39) if arthroscopy revealed an isolated SLAP II lesion. Primary outcomes at 6 and 24 months were clinical Rowe score ranging from 0 to 100 (best possible) and Western Ontario Shoulder Instability Index (WOSI) ranging from 0 (best possible) to 2100. Secondary outcomes were Oxford Instability Shoulder Score, change in main symptoms, EuroQol (EQ-5D and EQ-VAS), patient satisfaction and complications. There were no significant between-group differences at any follow-up in any outcome. Between-group differences in Rowe scores at 2 years were: biceps tenodesis versus labral repair: 1.0 (95% CI -5.4 to 7.4), p=0.76; biceps tenodesis versus sham surgery: 1.6 (95% CI -5.0 to 8.1), p=0.64; and labral repair versus sham surgery: 0.6 (95% CI -5.9 to 7.0), p=0.86. Similar results-no differences between groups-were found for WOSI scores. Postoperative stiffness occurred in five patients after labral repair and in four patients after tenodesis. Neither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied. ClinicalTrials.gov identifier: NCT00586742. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

    Science.gov (United States)

    Grant, A M; Boachie, C; Cotton, S C; Faria, R; Bojke, L; Epstein, D M; Ramsay, C R; Corbacho, B; Sculpher, M; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-06-01

    Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years

  11. Effect of lung-protective ventilation with lower tidal volumes on clinical outcomes among patients undergoing surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Gu, Wan-Jie; Wang, Fei; Liu, Jing-Chen

    2015-02-17

    In anesthetized patients undergoing surgery, the role of lung-protective ventilation with lower tidal volumes is unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of this ventilation strategy on postoperative outcomes. We searched electronic databases from inception through September 2014. We included RCTs that compared protective ventilation with lower tidal volumes and conventional ventilation with higher tidal volumes in anesthetized adults undergoing surgery. We pooled outcomes using a random-effects model. The primary outcome measures were lung injury and pulmonary infection. We included 19 trials (n=1348). Compared with patients in the control group, those who received lung-protective ventilation had a decreased risk of lung injury (risk ratio [RR] 0.36, 95% confidence interval [CI] 0.17 to 0.78; I2=0%) and pulmonary infection (RR 0.46, 95% CI 0.26 to 0.83; I2=8%), and higher levels of arterial partial pressure of carbon dioxide (standardized mean difference 0.47, 95% CI 0.18 to 0.75; I2=65%). No significant differences were observed between the patient groups in atelectasis, mortality, length of hospital stay, length of stay in the intensive care unit or the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen. Anesthetized patients who received ventilation with lower tidal volumes during surgery had a lower risk of lung injury and pulmonary infection than those given conventional ventilation with higher tidal volumes. Implementation of a lung-protective ventilation strategy with lower tidal volumes may lower the incidence of these outcomes. © 2015 Canadian Medical Association or its licensors.

  12. Adjuvant radiation therapy versus surgery alone in operable breast cancer: long-term follow-up of a randomized clinical trial.

    Science.gov (United States)

    Rutqvist, L E; Pettersson, D; Johansson, H

    1993-02-01

    This paper presents long-term results from a randomized trial of pre- or postoperative megavoltage radiation therapy versus surgery alone in pre- and postmenopausal women with operable breast cancer. Treatment outcome after relapse among patients who developed loco-regional recurrences was also analyzed. A total of 960 patients were included in the trial. The mean follow-up was 16 years (range: 13-19 years). The radiation therapy was individually planned. It included the chest wall (and the breast in the preoperative cases) and the regional lymph nodes. The tumor dose was 45 Gy/5 weeks. No adjuvant systemic therapy was used. The results showed a significant benefit with radiation therapy in terms of recurrence-free survival during the entire follow-up period. There was also an overall survival difference-corresponding to a 16% reduction of deaths-in favor of the irradiated patients which, however, was not statistically significant (p = 0.09). Among those 169 patients who developed locoregional recurrences long-term control was only achieved in about one-third of the cases. This figure was similar among those who had received adjuvant radiation therapy (34%) compared to those initially treated with surgery alone (32%). This implied that the overall proportion of patients who eventually developed uncontrolled local disease was significantly higher among those initially allocated to surgery alone (16%) compared to those allocated to pre- or postoperative radiation therapy (6%, p < 0.01). These results suggest that local undertreatment may be deleterious in subgroups of patients.

  13. PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

    Science.gov (United States)

    Cooke, Marie; Rickard, Claire; Rapchuk, Ivan; Shekar, Kiran; Marshall, Andrea P; Comans, Tracy; Doi, Suhail; McDonald, John; Spooner, Amy

    2014-11-13

    Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach. 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36 h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV. Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results. Australian New Zealand Clinical Trials Registry--ACTRN12614000589684. Published by the BMJ

  14. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial.

    Science.gov (United States)

    Badiola, Ignacio; Liu, Jiabin; Huang, Stephanie; Kelly, John D; Elkassabany, Nabil

    2018-05-31

    This randomized controlled single blinded clinical trial compared the fascia iliaca block (FIB) and the lumbar plexus block (LPB) in patients with moderate to severe pain following hip arthroscopic surgery. Single blinded randomized trial. Postoperative recovery area, postoperative days 0 and 1. Fifty patients undergoing hip arthroscopy were approached in the Post Anesthesia Care Unit (PACU) if they had moderate to severe pain (defined as > or equal 4/10 on the numeric rating scale). Twenty-five patients were allocated to the FIB and twenty-five patients to the LPB. Fascia iliaca block or lumbar plexus block. A blinded observer recorded pain scores just prior to the block, 15 min following the block (primary endpoint), and then every 15 min for 2 h (or until the patient was discharged). Total PACU time and opioid use were recorded. Pain scores and analgesic use on postoperative day (POD) 0, and POD 1 were recorded. At 24 h post block the Quality of Recovery 9 questionnaire was administered. The mean pre-block pain scores were comparable between the two groups (P = 0.689). There was no difference in mean post block pain scores between the two groups at 15 min (P = 0.054). In the PACU patients who underwent a LPB consumed less opioids compared to FIB patients (P = 0.02), however no differences were noted between the two groups in PACU length of stay, or POD 0 or 1 opioid use. A fascia iliaca block is not inferior to a lumbar plexus block in reducing PACU pain scores in patients with moderate to severe pain following hip arthroscopic surgery and is a viable option to help manage postoperative pain following hip arthroscopic surgery. Copyright © 2018. Published by Elsevier Inc.

  15. The accuracy of SST retrievals from AATSR: An initial assessment through geophysical validation against in situ radiometers, buoys and other SST data sets

    Science.gov (United States)

    Corlett, G. K.; Barton, I. J.; Donlon, C. J.; Edwards, M. C.; Good, S. A.; Horrocks, L. A.; Llewellyn-Jones, D. T.; Merchant, C. J.; Minnett, P. J.; Nightingale, T. J.; Noyes, E. J.; O'Carroll, A. G.; Remedios, J. J.; Robinson, I. S.; Saunders, R. W.; Watts, J. G.

    The Advanced Along-Track Scanning Radiometer (AATSR) was launched on Envisat in March 2002. The AATSR instrument is designed to retrieve precise and accurate global sea surface temperature (SST) that, combined with the large data set collected from its predecessors, ATSR and ATSR-2, will provide a long term record of SST data that is greater than 15 years. This record can be used for independent monitoring and detection of climate change. The AATSR validation programme has successfully completed its initial phase. The programme involves validation of the AATSR derived SST values using in situ radiometers, in situ buoys and global SST fields from other data sets. The results of the initial programme presented here will demonstrate that the AATSR instrument is currently close to meeting its scientific objectives of determining global SST to an accuracy of 0.3 K (one sigma). For night time data, the analysis gives a warm bias of between +0.04 K (0.28 K) for buoys to +0.06 K (0.20 K) for radiometers, with slightly higher errors observed for day time data, showing warm biases of between +0.02 (0.39 K) for buoys to +0.11 K (0.33 K) for radiometers. They show that the ATSR series of instruments continues to be the world leader in delivering accurate space-based observations of SST, which is a key climate parameter.

  16. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vanita Ahuja

    2015-01-01

    Full Text Available Background and Aims: Flupirtine maleate is a centrally acting, non-opioid analgesic with unique muscle relaxant properties as compared to common analgesics. The aim of this study was to compare post-operative analgesic efficacy of flupirtine maleate and ibuprofen in patients undergoing gynaecological ambulatory surgeries. Methods: This prospective, randomised controlled study was conducted in 60 women of American Society of Anesthesiologists physical status I/II, 18-70 years of age and scheduled to undergo gynaecological ambulatory surgeries. The participants were randomised to receive either 100 mg oral flupirtine maleate (group flupirtine, n = 30 or 800 mg oral ibuprofen (group ibuprofen, n = 30, 1 h prior to surgery and then every 8 h for 48 h. Verbal Numerical Rating Scale (VNRS on movement was assessed at 0, 2, 4, 6 and 8 h following surgery. Following discharge from hospital, the patients were interviewed telephonically at 12, 24 and 48 h post-operatively. VNRS was statistically analysed using Mann-Whitney test. Results: VNRS on movement was statistically reduced at 2 h after surgery (P = 0.04 in group flupirtine as compared to group ibuprofen. The analgesic efficacy was similar in both the groups at 4, 6, 8, 12, 24 and 48 h after surgery. The satisfaction scores at 24 and 48 h post-operatively were superior in group flupirtine as compared to group ibuprofen (P < 0.001. Conclusion: Analgesic efficacy of flupirtine maleate was comparable with ibuprofen in patients in ambulatory gynaecological patients up to 48 h postoperatively with superior satisfaction scores.

  17. U.S. West Coast MODIS Aqua High Resolution SST Climatology Fields (July 2002 - March 2014)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This suite of CHLA and SST climatology and anomaly data products are derived from daily, 0.0125 degree x 0.0125 degree, MODIS Aqua CHLA and SST fields that cover the...

  18. Novel sst2-selective somatostatin agonists. Three-dimensional consensus structure by NMR

    Science.gov (United States)

    Grace, Christy Rani R.; Erchegyi, Judit; Koerber, Steven C.; Reubi, Jean Claude; Rivier, Jean; Riek, Roland

    2008-01-01

    The three-dimensional NMR structures of six octapeptide agonist analogues of somatostatin (SRIF) in the free form are described. These analogues, with the basic sequence H-DPhe/Phe2-c[Cys3-Xxx7-DTrp8-Lys9-Thr10-Cys14]-Thr-NH2 (the numbering refers to the position in native SRIF), with Xxx7 being Ala/Aph, exhibit potent and highly selective binding to human SRIF type 2 (sst2) receptors. The backbone of these sst2-selective analogues have the usual type-II’ β-turn reported in the literature for sst2/3/5-subtype-selective analogues. Correlating biological results and NMR studies led to the identification of the side chains of DPhe2, DTrp8 and Lys9 as the necessary components of the sst2 pharmacophore. This is the first study to show that the aromatic ring at position 7 (Phe7) is not critical for sst2 binding and that it plays an important role in sst3 and sst5 binding. This pharmacophore is therefore different from that proposed by others for sst2/3/5 analogues. PMID:16854054

  19. Single-Shell Tank (SST) Retrieval Sequence Fiscal Year 2000 Update

    International Nuclear Information System (INIS)

    GARFIELD, J.S.

    2000-01-01

    This document describes the baseline single-shell tank (SST) waste retrieval sequence for the River Protection Project (RPP) updated for Fiscal Year 2000. The SST retrieval sequence identifies the proposed retrieval order (sequence), the tank selection and prioritization rationale, and planned retrieval dates for Hanford SSTs. In addition, the tank selection criteria and reference retrieval method for this sequence are discussed

  20. ESA STSE “SST Diurnal Variability: Regional Extend - Implications in Atmospheric Modelling”

    DEFF Research Database (Denmark)

    Karagali, Ioanna

    The diurnal variability of SST, driven by the coincident occurrence of low enough wind and solar heating, has been observed in various regions of the global ocean [4, 5, 6]. Atmospheric, oceanic and climate models are not adequately resolving the daily SST cycle, resulting in biases of the total...

  1. U.S. West Coast MODIS Aqua High Resolution SST Anomaly Fields (July 2002 - March 2014)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This suite of CHLA and SST climatology and anomaly data products are derived from daily, 0.0125 degree x 0.0125 degree, MODIS Aqua CHLA and SST fields that cover the...

  2. Tasmaloum, Vanuatu Fossil Coral SST Reconstruction for 4200 YrBP

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Vanuatu Fossil Coral SST Reconstruction, 4200 YrBP. Paleobathymetry estimated at 10-15 m. SST reconstruction is based on the analysis of Sr/Ca and U/Ca ratios in...

  3. Interpreting survival data from clinical trials of surgery versus stereotactic body radiation therapy in operable Stage I non-small cell lung cancer patients.

    Science.gov (United States)

    Samson, Pamela; Keogan, Kathleen; Crabtree, Traves; Colditz, Graham; Broderick, Stephen; Puri, Varun; Meyers, Bryan

    2017-01-01

    To identify the variability of short- and long-term survival outcomes among closed Phase III randomized controlled trials with small sample sizes comparing SBRT (stereotactic body radiation therapy) and surgical resection in operable clinical Stage I non-small cell lung cancer (NSCLC) patients. Clinical Stage I NSCLC patients who underwent surgery at our institution meeting the inclusion/exclusion criteria for STARS (Randomized Study to Compare CyberKnife to Surgical Resection in Stage I Non-small Cell Lung Cancer), ROSEL (Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer), or both were identified. Bootstrapping analysis provided 10,000 iterations to depict 30-day mortality and three-year overall survival (OS) in cohorts of 16 patients (to simulate the STARS surgical arm), 27 patients (to simulate the pooled surgical arms of STARS and ROSEL), and 515 (to simulate the goal accrual for the surgical arm of STARS). From 2000 to 2012, 749/873 (86%) of clinical Stage I NSCLC patients who underwent resection were eligible for STARS only, ROSEL only, or both studies. When patients eligible for STARS only were repeatedly sampled with a cohort size of 16, the 3-year OS rates ranged from 27 to 100%, and 30-day mortality varied from 0 to 25%. When patients eligible for ROSEL or for both STARS and ROSEL underwent bootstrapping with n=27, the 3-year OS ranged from 46 to 100%, while 30-day mortality varied from 0 to 15%. Finally, when patients eligible for STARS were repeatedly sampled in groups of 515, 3-year OS narrowed to 70-85%, with 30-day mortality varying from 0 to 4%. Short- and long-term survival outcomes from trials with small sample sizes are extremely variable and unreliable for extrapolation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. The effect of adjuvant vitamin C after varicocele surgery on sperm quality and quantity in infertile men: a double blind placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ali Cyrus

    2015-04-01

    Full Text Available Varicocele is one of the most common causes of male infertility and spontaneous pregnancy rate after varicocelectomy is only about 30%. The most important seminal antioxidant is vitamin C but recent studies about the effects of vitamin C on spermatogenesis are controversial; therefore, we decided to evaluate its role after varicocelectomy. In a double blind randomized controlled clinical trial, 115 men with infertility and clinical varicocele with abnormal semen analyses were recruited. After surgery, the intervention group received vitamin C (250 mg bid and the control group received placebo for three months. Mean sperm count, motility, and morphology index of two semen analyses (before and after surgery were compared between the two groups. Univariate general linear model and stepwise linear regression were used in analysis. The mean age (±SD of participants was 27.6±5.3 years. Vitamin C group had statistically significant better normal motility (20.8 vs. 12.6, P=0.041 and morphology (23.2 vs. 10.5, P<0.001 than placebo group. Considering the values prior to surgery as covariate, vitamin C was not effective on sperm count (P=0.091; but it improved sperm motility (P=0.016 and morphology (P<0.001 even after excluding the confounding effect of age (P=0.044 and P=0.001, respectively. Vitamin C was also an independent factor in predicting motility and normal morphology after surgery. Ascorbic acid can play a role as adjuvant treatment after varicocelectomy in infertile men.

  5. 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.

  6. Early Versus Delayed Postoperative Feeding After Major Gynaecological Surgery and its Effects on Clinical Outcomes, Patient Satisfaction, and Length of Stay: A Randomized Controlled Trial.

    Science.gov (United States)

    Balayla, Jacques; Bujold, Emmanuel; Lapensée, Louise; Mayrand, Marie-Hélène; Sansregret, Andrée

    2015-12-01

    To compare early versus delayed postoperative feeding in women undergoing major gynaecological surgery with regard to clinical outcomes, duration of postoperative stay, and patient satisfaction. We conducted a parallel-randomized controlled trial at a tertiary care centre in Montreal, Quebec, between June 2000 and July 2001. Patients undergoing major gynaecological surgery were randomized following a 1:1 allocation ratio to receive either early postoperative feeding in which oral clear fluids were begun up to six hours after surgery followed by solid foods as tolerated, or delayed postoperative feeding, in which clear fluids were begun on the first postoperative day and solid foods on the second or third day as tolerated. The primary outcomes analyzed were duration of postoperative stay and patient satisfaction. Secondary outcomes included mean time to appetite, passage of flatus, and bowel movement, as well as the presence of symptoms of paralytic ileus. A total of 119 patients were randomized; 61 patients were assigned to the early feeding group and 58 to the delayed feeding group. Demographic characteristics, including age, weight, smoking status, and prior surgical history were comparable between both groups. There was no difference in length of postoperative stay between the two groups (86.4 ± 21.0 hours in the early feeding group vs. 85.6 ± 26.2 hours in the delayed feeding group; P > 0.05). No significant difference was noted in patient satisfaction (P > 0.05). No difference was found in the frequency of postoperative ileus, mean time to appetite, passage of flatus, or first bowel movement. The introduction of early postoperative feeding appears to be safe and well tolerated by patients undergoing major gynaecological surgery. The duration of postoperative stay, patient satisfaction, and gastrointestinal symptoms are comparable between patients undergoing early or delayed postoperative feeding.

  7. Effectiveness of Standardized Physical Therapy Exercises for Patients With Difficulty Returning to Usual Activities After Decompression Surgery for Subacromial Impingement Syndrome: Randomized Controlled Trial.

    Science.gov (United States)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah; Haahr, Jens Peder; Frich, Lars Henrik; Andrea, Linda Christie; Svendsen, Susanne Wulff

    2016-06-01

    Little is known about the effectiveness of exercise programs after decompression surgery for subacromial impingement syndrome. For patients with difficulty returning to usual activities, special efforts may be needed to improve shoulder function. The purpose of this study was to evaluate the effectiveness at 3 and 12 months of a standardized physical therapy exercise intervention compared with usual care in patients with difficulty returning to usual activities after subacromial decompression surgery. A multicenter randomized controlled trial was conducted. The study was conducted in 6 public departments of orthopedic surgery, 2 departments of occupational medicine, and 2 physical therapy training centers in Central Denmark Region. One hundred twenty-six patients reporting difficulty returning to usual activities at the postoperative clinical follow-up 8 to 12 weeks after subacromial decompression surgery participated. A standardized exercise program consisting of physical therapist-supervised individual training sessions and home training was used. The primary outcome measure was the Oxford Shoulder Score. Secondary outcome measures were the Constant Score and the Fear-Avoidance Beliefs Questionnaire. At 3 and 12 months, follow-up data were obtained for 92% and 83% of the patients, respectively. Intention-to-treat analyses suggested a between-group difference on the Oxford Shoulder Score favoring the exercise group at 3 months, with an adjusted mean difference of 2.0 (95% confidence interval=-0.5, 4.6), and at 12 months, with an adjusted mean difference of 5.8 (95% confidence interval=2.8, 8.9). Significantly larger improvements for the exercise group were observed for most secondary and supplementary outcome measures. The nature of the exercise intervention did not allow blinding of patients and care providers. The standardized physical therapy exercise intervention resulted in statistically significant and clinically relevant improvement in shoulder pain and

  8. Effect of 0.2% Chlorhexidine Gel on Frequency of Dry Socket Following Mandibular Third Molar Surgery: A Double-Blind Clinical Trial Clinical Trial

    Directory of Open Access Journals (Sweden)

    Baratollah Shaban

    2014-09-01

    Full Text Available Introduction: Alveolar osteitis (AO is one of the most common postoperative complications after third molar surgery. Various techniques have been used to reduce the risk of AO. The aim of the current study was to evaluate the effect of Chlorhexidine (CHX bioadhesive gel in preventing the development of AO. Methods: Patients with bilateral impacted mandibular third molars underwent surgical extraction of both teeth. One socket was randomly received CHX gel and the contralateral socket served as the control. The outcome variable was development of AO and the CHX gel application was the predictor variable. Data were analyzed using chi-square test with the confidence interval of 95%. Results: 41 patients (27 females and 14 males with mean age of 24.15 ± 5.02 years underwent 82 surgeries. Total of 11 sockets (13.41% developed AO. The frequency of AO in CHX gel (2 cases, 4.87% side was significantly lower than control (9 cases, 21.95% side (P-value < 0.05. No side effects observed following CHX gel application. Conclusion: Application of CHX gel could be an effective approach to reduce the risk of developing AO following mandibular third molar surgery.

  9. 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.

  10. Warming and humidification of insufflation carbon dioxide in laparoscopic colonic surgery: a double-blinded randomized controlled trial.

    Science.gov (United States)

    Sammour, Tarik; Kahokehr, Arman; Hayes, Julian; Hulme-Moir, Mike; Hill, Andrew G

    2010-06-01

    We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced postoperative pain and improved recovery by reducing peritoneal inflammation in laparoscopic colonic surgery. Warming and humidification of insufflation gas is thought be beneficial in laparoscopic surgery, but evidence in prolonged laparoscopic procedures is lacking. We used a multicenter, double-blinded, randomized controlled design. The Study Group received warmed (37 degrees C), humidified (98% RH) insufflation carbon dioxide, and the Control Group received standard gas (19 degrees C, 0% RH). Anesthesia and analgesia were standardized. Intraoperative oesophageal temperature was measured at 15 minutes intervals. At the conclusion of surgery, the primary surgeon was asked to rate camera fogging on a Likert scale. Postoperative opiate usage was determined using Morphine Equivalent Daily Dose (MEDD), and pain was measured using visual analogue scores. Peritoneal and plasma cytokine concentrations were measured at 20 hours postoperatively. Postoperative recovery was measured using defined discharge and complication criteria, and the Surgical Recovery Score. Eighty-two patients were randomized, with 41 in each arm. Groups were well matched at baseline. Intraoperative core temperature was similar in both groups. Median camera fogging score was significantly worse in the Study group (4 vs. 2, P = 0.040). There were marginal differences in pain scores, but no significant differences were detected in MEDD usage, cytokine concentrations, or any recovery parameters measured. Warming and humidification of insufflation CO2 does not attenuate the early inflammatory cytokine response, and confers no clinically significant benefit in laparoscopic colonic surgery.

  11. 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.

  12. The effects of perioperative music interventions in pediatric surgery: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); M. Van Dijk (Monique); J. Jeekel (Johannes); M.G.M. Hunink (Myriam)

    2015-01-01

    textabstractObjective: Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing

  13. Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial.

    Science.gov (United States)

    Brocki, Barbara Cristina; Andreasen, Jan Jesper; Langer, Daniel; Souza, Domingos Savio R; Westerdahl, Elisabeth

    2016-05-01

    The aim was to investigate whether 2 weeks of inspiratory muscle training (IMT) could preserve respiratory muscle strength in high-risk patients referred for pulmonary resection on the suspicion of or confirmed lung cancer. Secondarily, we investigated the effect of the intervention on the incidence of postoperative pulmonary complications. The study was a single-centre, parallel-group, randomized trial with assessor blinding and intention-to-treat analysis. The intervention group (IG, n = 34) underwent 2 weeks of postoperative IMT twice daily with 2 × 30 breaths on a target intensity of 30% of maximal inspiratory pressure, in addition to standard postoperative physiotherapy. Standard physiotherapy in the control group (CG, n = 34) consisted of breathing exercises, coughing techniques and early mobilization. We measured respiratory muscle strength (maximal inspiratory/expiratory pressure, MIP/MEP), functional performance (6-min walk test), spirometry and peripheral oxygen saturation (SpO2), assessed the day before surgery and again 3-5 days and 2 weeks postoperatively. Postoperative pulmonary complications were evaluated 2 weeks after surgery. The mean age was 70 ± 8 years and 57.5% were males. Thoracotomy was performed in 48.5% (n = 33) of cases. No effect of the intervention was found regarding MIP, MEP, lung volumes or functional performance at any time point. The overall incidence of pneumonia was 13% (n = 9), with no significant difference between groups [IG 6% (n = 2), CG 21% (n = 7), P = 0.14]. An improved SpO2 was found in the IG on the third and fourth postoperative days (Day 3: IG 93.8 ± 3.4 vs CG 91.9 ± 4.1%, P = 0.058; Day 4: IG 93.5 ± 3.5 vs CG 91 ± 3.9%, P = 0.02). We found no association between surgical procedure (thoracotomy versus thoracoscopy) and respiratory muscle strength, which was recovered in both groups 2 weeks after surgery. Two weeks of additional postoperative IMT, compared with standard physiotherapy alone, did not preserve

  14. Comparison of the effectiveness of femoral fixation techniques (Aperfix and Endobutton in anterior cruciate ligament surgery: A clinical trial in men with complete anterior cruciate ligament rupture

    Directory of Open Access Journals (Sweden)

    Seyyed Raza Sharifzadeh

    2017-09-01

    Full Text Available Background Anterior cruciate ligament (ACL is a Strengthener ligament of the knee. About 50 persons per 100,000 annually counter ACL rupture. Based on studies, the majority of people who have high mobility jobs, and had reconstruction surgery after ACL rupture, have returned to pre-injury level of activity. Aims We compared two methods of surgery (aperfix and endobutton in this article. We want to answer these two main questions in this study:1 is the effectiveness of surgical methods (aperfix and endobutton in patients with anterior cruciate ligament rupture, the same?.2 Are the aspects of the knee function, in two surgical methods (aperfix and endobutton after ACL reconstruction surgery, the same? Methods This study is a prospective clinical trial on patients who had complete ACL rupture in an isolated trauma, who were nominated for ACL reconstruction surgery. We excluded the cases that had underlying disease or other damages from the study. 100 patients were randomly divided into two groups of 50 individuals. Then each group underwent surgery. The femoral fixations were by the two common methods of ";;;;;;;;;;;Aperfix";;;;;;;;;;; or ";;;;;;;;;;;Endobutton";;;;;;;;;;;. We followed up, the cases one year after surgery and evaluated them by lysholm score as well as with IKDC score. Results The mean lysholm score and IKDC score do not have statistically significant difference in the two groups. (Mean lysholm score in Aperfix group=95.66 vs. 94.56 in Endobutton group (p=0.057 and IKDC score=92.32 in Aperfix group vs 92.20 in Endobutton group (p=0.28. However, in some aspects of knee function, such as locking, Swelling, and climbing stairs, patients who had undergone Aperfix approach, had better results. Conclusion Surgical methods have little difference however due to better results in some aspects of knee functions in this study and due to other studies, it can be said Aperfix method slightly has more benefits. Further investigations with larger

  15. SST algorithms in ACSPO reanalysis of AVHRR GAC data from 2002-2013

    Science.gov (United States)

    Petrenko, B.; Ignatov, A.; Kihai, Y.; Zhou, X.; Stroup, J.

    2014-05-01

    In response to a request from the NOAA Coral Reef Watch Program, NOAA SST Team initiated reprocessing of 4 km resolution GAC data from AVHRRs flown onboard NOAA and MetOp satellites. The objective is to create a longterm Level 2 Advanced Clear-Sky Processor for Oceans (ACSPO) SST product, consistent with NOAA operations. ACSPO-Reanalysis (RAN) is used as input in the NOAA geo-polar blended Level 4 SST and potentially other Level 4 SST products. In the first stage of reprocessing (reanalysis 1, or RAN1), data from NOAA-15, -16, -17, -18, -19, and Metop-A and -B, from 2002-present have been processed with ACSPO v2.20, and matched up with quality controlled in situ data from in situ Quality Monitor (iQuam) version 1. The ~12 years time series of matchups were used to develop and explore the SST retrieval algorithms, with emphasis on minimizing spatial biases in retrieved SSTs, close reproduction of the magnitudes of true SST variations, and maximizing temporal, spatial and inter-platform stability of retrieval metrics. Two types of SST algorithms were considered: conventional SST regressions, and recently developed incremental regressions. The conventional equations were adopted in the EUMETSAT OSI-SAF formulation, which, according to our previous analyses, provide relatively small regional biases and well-balanced combination of precision and sensitivity, in its class. Incremental regression equations were specifically elaborated to automatically correct for model minus observation biases, always present when RTM simulations are employed. Improved temporal stability was achieved by recalculation of SST coefficients from matchups on a daily basis, with a +/-45 day window around the current date. This presentation describes the candidate SST algorithms considered for the next round of ACSPO reanalysis, RAN2.

  16. Fast-track surgery protocol in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liu G

    2016-06-01

    Full Text Available Guozheng Liu,1 Fengguo Jian,2 Xiuqin Wang,2 Lin Chen1 1Department of General Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China; 2Second Department of General Surgery, Changyi People’s Hospital, Shandong, People’s Republic of China Aim: To study the efficacy of the fast-track surgery (FTS program combined with laparoscopic radical gastrectomy for elderly gastric cancer (GC patients.Methods: Eighty-four elderly patients diagnosed with GC between September 2014 and August 2015 were recruited to participate in this study and were divided into four groups randomly based on the random number table as follows: FTS + laparoscopic group (Group A, n=21, FTS + laparotomy group (Group B, n=21, conventional perioperative care (CC + laparoscopic group (Group C, n=21, and CC + laparotomy group (Group D, n=21. Observation indicators include intrasurgery indicators, postoperative recovery indicators, nutritional status indicators, and systemic stress response indicators.Results: Preoperative and intraoperative baseline characteristics showed no significant differences between patients in each group (P>0.05. There were no significant differences between each group in nausea and vomiting, intestinal obstruction, urinary retention, incision infection, pulmonary infection, and urinary tract infection after operation (P>0.05. Time of first flatus and postoperative hospital stay time of FTS Group A were the shortest, and total medical cost of this group was the lowest. For all groups, serum albumin, prealbumin, and transferrin significantly decreased, while CRP and interleukin 6 were significantly increased postoperative day 1. From postoperative day 4–7, all indicators of the four groups gradually recovered, but compared with other three groups, those of Group A recovered fastest.Conclusion: FTS combined with laparoscopic surgery can promote faster postoperative recovery, improve early postoperative nutritional status, and more

  17. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 3. Descriptive study of postoperative nursing care following first stage cleft closure.

    Science.gov (United States)

    Bannister, Patricia; Lindberg, Nina; Jeppesen, Karin; Elfving-Little, Ulla; Semmingsen, Ann-Margritt; Paganini, Anna; Gustavsson, Annica; Slevin, Emma; Jacobsen, Gry; Eyres, Phil; Semb, Gunvor

    2017-02-01

    Cleft lip and palate is one of the most common congenital anomalies requiring surgical treatment in children, normally commenced in the first year of life. Following the initiation of a group of multicentre surgical trials of primary surgery, variations in postoperative recovery and management became apparent. An agreement was made for a nurse-led survey in eight surgical centres to document postoperative care and recovery. A postoperative recovery clinical report form was developed to capture relevant data for the children participating in the four arms of the trials. This included the age and weight at admission, the postoperative recovery setting, pain management, postoperative feeding, post-operative complications, and length of hospital stay. Four hundred and three nursing forms from the first surgical procedure were returned for analysis. Differences in important aspects of care such as postoperative analgesia and postoperative feeding were evident. Postoperative care was influenced by local custom and practice, as little firm clinical evidence exists to guide optimal management. Postoperative recovery may play a significant role in the future selection of surgical protocols, and future trials need to consider cross-study site training to familiarise nurses, prior to any changes in surgical methods. ISRCTN29932826.

  18. Comparison of Paravertebral Block by Anatomic Landmark Technique to Ultrasound-Guided Paravertebral Block for Breast Surgery Anesthesia: A Randomized Controlled Trial.

    Science.gov (United States)

    Patnaik, Rupali; Chhabra, Anjolie; Subramaniam, Rajeshwari; Arora, Mahesh K; Goswami, Devalina; Srivastava, Anurag; Seenu, Vuthaluru; Dhar, Anita

    2018-05-01

    Paravertebral block (PVB) is an established technique for providing anesthesia for breast surgery. The primary objective was to compare anatomical landmark technique (ALT) to the ultrasound-guided (USG) PVB block for providing surgical anesthesia. Secondary objectives included comparison of perioperative analgesia and complications. This randomized, controlled, observer-blinded study included 72 females, aged 18 to 65 years, American Society of Anesthesiologists physical status I or II, undergoing elective unilateral breast surgery. Study participants were randomized to the ALT group or USG group. Ipsilateral PVB was performed with the respective technique from T1 to T6. Five milliliters of local anesthetic mixture (0.5% ropivacaine, 5 μg/mL adrenaline, 1 μg/kg clonidine) was administered at each level. Paravertebral catheter was inserted at T4/T3 level. After confirming sensory loss, patients were taken up for surgery with propofol sedation (20-50 μg/kg per minute). More patients in the USG group (34/36 [94.44%]) had a successful block as compared with the ALT group (26/36 [72.22%]) (P = 0.024). Difference in proportion was 18.1 (95% confidence interval, 0.15-36.0) (P = 0.024) after adjustment for age. More dermatomes were blocked in the USG group (P = 0.0018) with less sparing of upper T2 and T3 dermatomes (P = 0.003, P = 0.006, respectively). Median time to first postoperative analgesic requirement was 502.5 minutes (range, 195-1440 minutes) in the USG group versus 377.5 minutes (range, 215-1440 minutes) in the ALT group. Pain at rest and movement 2 and 4 hours postoperatively and number of catheter top-ups in 24 hours postoperatively were lesser in the USG group (P = 0.012). Complications were comparable. Ultrasound-guided PVB provided better anesthesia and perioperative analgesia than the landmark technique for breast surgery. The trial was registered retrospectively at the Clinical Trial Registry of India, CTRI/2015/05/005774.

  19. Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial.

    Science.gov (United States)

    Klaiber, Ulla; Stephan-Paulsen, Lisa M; Bruckner, Thomas; Müller, Gisela; Auer, Silke; Farrenkopf, Ingrid; Fink, Christine; Dörr-Harim, Colette; Diener, Markus K; Büchler, Markus W; Knebel, Phillip

    2018-05-24

    The prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients' wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting. Adult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department's standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat. In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/- 12.0) days versus 16.1 (+/- 15.0) days, p = 0.285) were also similar in the intervention and control groups. Cluster

  20. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene MH

    2017-01-01

    Background Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. Objective The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). Methods The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child’s postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. Results The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. Conclusions To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool

  1. 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...

  2. Lifestyle intervention and one-year prognosis of patients following open heart surgery: a randomised clinical trial.

    Science.gov (United States)

    Kadda, Olga; Kotanidou, Anastasia; Manginas, Athanasios; Stavridis, George; Nanas, Serafim; Panagiotakos, Demosthenes B

    2015-06-01

    To evaluate the one-year prognosis of a lifestyle counselling intervention (diet, smoking cessation and exercise) among patients who had open heart surgery. Cardiovascular disease is the leading cause of morbidity worldwide in both developing and developed countries. Lifestyle modification plays an important role for patients who are at a high risk of developing cardiovascular disease and for those with an established cardiovascular disease. Randomised, nonblind and lifestyle counselling intervention study with a one-year follow-up. A randomised, nonblind intervention study was performed on 500 patients who had open heart surgery. After hospital discharge, 250 patients (intervention group) were randomly allocated lifestyle counselling according to the recent guidelines provided by the European Society of Cardiology (European Journal Preventive Cardiology, 19, 2012, 585). The remaining 250 patients (control group) received the regular instructions. Primary end-point was the development of a cardiovascular disease (nonfatal event) during the first year; secondary end-points included fatal events, smoking abstinence, dietary habits and a physical activity evaluation. According to the primary end-point, the odds of having a nonfatal cardiovascular disease event are 0·56-times (95%CI 0·28, 0·96, p = 0·03) lower for the intervention group compared to the control group. One-year after surgery, it was found that participants in the intervention group were 1·96-times (95%CI 1·31, 2·93, p open heart surgery can improve health outcomes and reduce the risk of a new cardiac event. Health care services must recommend and organise well-structured cardiac rehabilitation programmes adjusted to the patient's needs. A well-structured cardiac rehabilitation programme adjusted to the patient's profile is a safe and cost-effective way to improve patients' outcome. © 2015 John Wiley & Sons Ltd.

  3. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes

    Science.gov (United States)

    Moss, Emmanuel; Miller, Corey S.; Jensen, Henrik; Basmadjian, Arsène; Bouchard, Denis; Carrier, Michel; Perrault, Louis P.; Cartier, Raymond; Pellerin, Michel; Demers, Philippe

    2013-01-01

    OBJECTIVES Mediastinal drainage following cardiac surgery with traditional large-bore plastic tubes can be painful and cumbersome. This study was designed to determine whether prolonged drainage (5 days) with a silastic tube decreased the incidence of significant pericardial effusion and tamponade following aortic or valvular surgery. METHODS One hundred and fifty patients undergoing valvular or aortic surgery in a tertiary cardiac surgery institution were randomized to receive a conventional mediastinal tube plus a silastic Blake drain (n = 75), or two conventional tubes (n = 75). Conventional drains were removed on postoperative day (POD) 1, while Blake drains were removed on POD 5. The primary end-point was the combined incidence of significant pericardial effusion (≥15 mm) or tamponade through POD 5. Secondary end-points included total mediastinal drainage, postoperative atrial fibrillation (AF) and pain. RESULTS Analysis was performed for 67 patients in the Blake group and 73 in the conventional group. There was no difference between the two groups in the combined end-point of significant effusion or tamponade (7.4 vs 8.3%, P = 0.74), or in the incidence of AF (47 vs 46%, P = 0.89). Mean 24-h drainage was greater in the Blake group than in the conventional group (749 ± 444 ml vs 645 ± 618 ml, P tubes is safe and does not increase postoperative pain. There was no difference between the Blake and conventional drains with regard to significant pericardial effusion or tamponade in this cohort; however, this conclusion is limited by the low overall incidence of the primary outcome in this cohort. PMID:23575759

  4. Overview Of Hanford Single Shell Tank (SST) Structural Integrity - 12123

    International Nuclear Information System (INIS)

    Rast, R.S.; Rinker, M.W.; Washenfelder, D.J.; Johnson, J.B.

    2012-01-01

    To improve the understanding of the single-shell tanks (SSTs) integrity, Washington River Protection Solutions, LLC (WRPS), the USDOE Hanford Site tank contractor, developed an enhanced Single-Shell Tank Integrity Project in 2009. An expert panel on SST integrity, consisting of various subject matters experts in industry and academia, was created to provide recommendations supporting the development of the project. This panel developed 33 recommendations in four main areas of interest: structural integrity, liner degradation, leak integrity and prevention, and mitigation of contamination migration. Seventeen of these recommendations were used to develop the basis for the M-45-10-1 Change Package for the Hanford Federal Agreement and Compliance Order, which is also known as the Tri-Party Agreement. The structural integrity of the tanks is a key element in completing the cleanup mission at the Hanford Site. There are eight primary recommendations related to the structural integrity of Hanford SSTs. Six recommendations are being implemented through current and planned activities. The structural integrity of the Hanford SSTs is being evaluated through analysis, monitoring, inspection, materials testing, and construction document review. Structural evaluation in the form of analysis is performed using modern finite element models generated in ANSYS(reg s ign) The analyses consider in-situ, thermal, operating loads and natural phenomena such as earthquakes. Structural analysis of 108 of 149 Hanford SSTs has concluded that the tanks are structurally sound and meet current industry standards. Analyses of the remaining Hanford SSTs are scheduled for FY2013. Hanford SSTs are monitored through a dome deflection program. The program looks for deflections of the tank dome greater than 1/4 inch. No such deflections have been recorded. The tanks are also subjected to visual inspection. Digital cameras record the interior surface of the concrete tank domes, looking for cracks and

  5. OVERVIEW OF HANFORD SINGLE SHELL TANK (SST) STRUCTURAL INTEGRITY - 12123

    Energy Technology Data Exchange (ETDEWEB)

    RAST RS; RINKER MW; WASHENFELDER DJ; JOHNSON JB

    2012-01-25

    To improve the understanding of the single-shell tanks (SSTs) integrity, Washington River Protection Solutions, LLC (WRPS), the USDOE Hanford Site tank contractor, developed an enhanced Single-Shell Tank Integrity Project in 2009. An expert panel on SST integrity, consisting of various subject matters experts in industry and academia, was created to provide recommendations supporting the development of the project. This panel developed 33 recommendations in four main areas of interest: structural integrity, liner degradation, leak integrity and prevention, and mitigation of contamination migration. Seventeen of these recommendations were used to develop the basis for the M-45-10-1 Change Package for the Hanford Federal Agreement and Compliance Order, which is also known as the Tri-Party Agreement. The structural integrity of the tanks is a key element in completing the cleanup mission at the Hanford Site. There are eight primary recommendations related to the structural integrity of Hanford SSTs. Six recommendations are being implemented through current and planned activities. The structural integrity of the Hanford SSTs is being evaluated through analysis, monitoring, inspection, materials testing, and construction document review. Structural evaluation in the form of analysis is performed using modern finite element models generated in ANSYS{reg_sign} The analyses consider in-situ, thermal, operating loads and natural phenomena such as earthquakes. Structural analysis of 108 of 149 Hanford SSTs has concluded that the tanks are structurally sound and meet current industry standards. Analyses of the remaining Hanford SSTs are scheduled for FY2013. Hanford SSTs are monitored through a dome deflection program. The program looks for deflections of the tank dome greater than 1/4 inch. No such deflections have been recorded. The tanks are also subjected to visual inspection. Digital cameras record the interior surface of the concrete tank domes, looking for cracks and

  6. Breast-conserving surgery with or without radiotherapy in women with ductal carcinoma in situ: a meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Leon Paola G

    2007-08-01

    Full Text Available Abstract Background To investigate whether Radiation therapy (RT should follow breast conserving surgery in women with ductal carcinoma in situ from breast cancer (DCIS with objective of decreased mortality, invasive or non invasive recurrence, distant metastases and contralateral breast cancer rates. We have done a meta-analysis of these results to give a more balanced view of the total evidence and to increase statistical precision. Methods A meta-analysis of randomized controlled trials (RCT was performed comparing RT treatment for DCIS of breast cancer to observation. The MEDLINE, EMBASE, CANCERLIT, Cochrane Library databases, Trial registers, bibliographic databases, and recent issues of relevant journals were searched. Relevant reports were reviewed by two reviewers independently and the references from these reports were searched for additional trials, using guidelines set by QUOROM statement criteria. Results The reviewers identified four large RCTs, yielding 3665 patients. Pooled results from this four randomized trials of adjuvant radiotherapy showed a significant reduction of invasive and DCIS ipsilateral breast cancer with odds ratio (OR of 0.40 (95% CI 0.33 – 0.60, p Conclusion The conclusion from our meta-analysis is that the addition of radiation therapy to lumpectomy results in an approximately 60% reduction in breast cancer recurrence, no benefit for survival or distant metastases compared to excision alone. Patients with high-grade DCIS lesions and positive margins benefited most from the addition of radiation therapy. It is not yet clear which patients can be successfully treated with lumpectomy alone; until further prospective studies answer this question, radiation should be recommended after lumpectomy for all patients without contraindications.

  7. Improved oxygenation during standing performance of deep breathing exercises with positive expiratory pressure after cardiac surgery: A randomized controlled trial.

    Science.gov (United States)

    Pettersson, Henrik; Faager, Gun; Westerdahl, Elisabeth

    2015-09-01

    Breathing exercises after cardiac surgery are often performed in a sitting position. It is unknown whether oxygenation would be better in the standing position. The aim of this study was to evaluate oxygenation and subjective breathing ability during sitting vs standing performance of deep breathing exercises on the second day after cardiac surgery. Patients undergoing coronary artery bypass grafting (n = 189) were randomized to sitting (controls) or standing. Both groups performed 3 × 10 deep breaths with a positive expiratory pressure device. Peripheral oxygen saturation was measured before, directly after, and 15 min after the intervention. Subjective breathing ability, blood pressure, heart rate, and pain were assessed. Oxygenation improved significantly in the standing group compared with controls directly after the breathing exercises (p < 0.001) and after 15 min rest (p = 0.027). The standing group reported better deep breathing ability compared with controls (p = 0.004). A slightly increased heart rate was found in the standing group (p = 0.047). After cardiac surgery, breathing exercises with positive expiratory pressure, performed in a standing position, significantly improved oxygenation and subjective breathing ability compared with sitting performance. Performance of breathing exercises in the standing position is feasible and could be a valuable treatment for patients with postoperative hypoxaemia.

  8. 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

  9. 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

  10. Prophylactic furosemide infusion decreasing early major postoperative renal dysfunction in on-pump adult cardiac surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fakhari S

    2017-01-01

    Full Text Available Solmaz Fakhari,1 Fariba Mirzaei Bavil,2 Eissa Bilehjani,1 Sona Abolhasani,3 Moussa Mirinazhad,2 Bahman Naghipour2 1Department of Anesthesiology, 2Department of Physiology, 3Tabriz University of Medical Sciences, Tabriz, Iran Introduction: Acute renal dysfunction is a common complication of cardiac surgery. Furosemide is used in prevention, or treatment, of acute renal dysfunction. This study was conducted to evaluate the protective effects of intra- and early postoperative furosemide infusion on preventing acute renal dysfunction in elective adult cardiac surgery. Methods: Eighty-one patients, candidates of elective cardiac surgery, were enrolled in this study in either the furosemide (n=41 or placebo (n=40 group. Furosemide (2 mg/h or 0.9% saline was administered and continued up to 12 hours postoperatively. We measured serum creatinine (Scr at preoperative and on the second and fifth postoperative days. Then calculated estimated glomerular filtration rate (eGFR at these times. An increase in Scr of >0.5 mg/dL and/or >25%–50%, compared to preoperative values, was considered as acute kidney injury (AKI. In contrast, an increase in Scr by >50% and/or the need for hemodialysis was regarded as acute renal failure (ARF. At the end we compared the AKI or ARF incidence between the two groups. Results: On the second and fifth postoperative days, Scr was lower, and the eGFR was higher in the furosemide group. AKI incidence was similar in the two groups (11 vs 12 cases; P-value 0.622; however, ARF rate was lower in furosemide group (1 vs 6 cases; P-value 0.044. During the study period, Scr was more stable in the furosemide group, however in the placebo group, Scr initially increased and then decreased to its preoperative value after a few days. Conclusion: This study showed that intra- and early postoperative furosemide infusion has a renal protective effect in adult cardiac surgery with cardiopulmonary bypass. Although this protective effect cannot

  11. Clinical Trials

    Medline Plus

    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

  12. Comparably improved health-related quality of life after total arterial revascularization versus conventional coronary surgery--Copenhagen arterial revascularization randomized patency and outcome trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Lund, Jens T; Lilleør, Nikolaj B

    2011-01-01

    OBJECTIVE: We compared health-related quality of life up to 11 months after coronary artery bypass grafting using total arterial revascularization versus conventional coronary surgery. METHODS: In this randomized single-center trial, 161 patients underwent total arterial revascularization using.......01). For total arterial revascularization, there were also not statistically significant improvements for 'physical component summary' (P=0.09), 'bodily pain' (P=0.07) and 'vitality' (P=0.08). CONCLUSION: Health-related quality of life up to 1 year after total arterial revascularization is equal or slightly...... of the general Danish population. On all scales of the SF-36, there was statistically significant improvement at 3 and 11 months in both groups. For 'social functioning', the improvement following total arterial revascularization was significantly higher than following conventional revascularization (P=0...

  13. Early Contralateral Shoulder-Arm Morbidity in Breast Cancer Patients Enrolled in a Randomized Trial of Post-Surgery Radiation Therapy

    Directory of Open Access Journals (Sweden)

    Nele Adriaenssens

    2012-01-01

    Full Text Available Introduction Shoulder/arm morbidity is a common complication of breast cancer surgery and radiotherapy (RT, but little is known about acute contralateral morbidity. Methods Patients were 118 women enrolled in a RT trial. Arm volume and shoulder mobility were assessed before and 1–3 months after RT. Correlations and linear regression were used to analyze changes affecting ipsilateral and contralateral arms, and changes affecting relative interlimb differences (RID. Results Changes affecting one limb correlated with changes affecting the other limb. Arm volume between the two limbs correlated (R = 0.57. Risk factors were weight increase and axillary dissection. Contralateral and ipsilateral loss of abduction strongly correlated (R = 0.78. Changes of combined RID exceeding 10% affected the ipsilateral limb in 25% of patients, and the contralateral limb in 18%. Aromatase inhibitor therapy was significantly associated with contralateral loss of abduction. Conclusions High incidence of early contralateral arm morbidity warrants further investigations.

  14. The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: A clinical trial study.

    Science.gov (United States)

    Ebadi, Abbas; Kavei, Parastoo; Moradian, Seyyed Tayyeb; Saeid, Yaser

    2015-08-01

    The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value foot reflexology in shortening the length of weaning time. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Serum levels of bupivacaine after pre-peritoneal bolus vs. epidural bolus injection for analgesia in abdominal surgery: A safety study within a randomized controlled trial.

    Science.gov (United States)

    Mungroop, Timothy H; van Samkar, Ganapathy; Geerts, Bart F; van Dieren, Susan; Besselink, Marc G; Veelo, Denise P; Lirk, Philipp

    2017-01-01

    Continuous wound infiltration (CWI) has become increasingly popular in recent years as an alternative to epidural analgesia. As catheters are not placed until the end of surgery, more intraoperative opioid analgesics might be needed. We, therefore, added a single pre-peritoneal bolus of bupivacaine at the start of laparotomy, similar to the bolus given with epidural analgesia. This was a comparative study within a randomized controlled trial (NTR4948). Patients undergoing hepato-pancreato-biliary surgery received either a pre-peritoneal bolus of 30ml bupivacaine 0.25%, or an epidural bolus of 10ml bupivacaine 0.25% at the start of laparotomy. In a subgroup of patients, we sampled blood and determined bupivacaine serum levels 20, 40, 60 and 80 minutes after bolus injection. We assumed toxicity of bupivacaine to be >1000 ng/ml. A total of 20 patients participated in this sub-study. All plasma levels measured as well as the upper limit of the predicted 99% confidence intervals per time point were well below the toxicity limit. In a mixed linear-effect model both groups did not differ statistically significant (p = 0.131). The intra-operative use of opioids was higher with CWI as compared to epidural (86 (SD 73) μg sufentanil vs. 50 (SD 32). In this exploratory study, the pre-peritoneal bolus using bupivacaine resulted in serum bupivacaine concentrations well below the commonly accepted toxic threshold. With CWI more additional analgesics are needed intraoperatively as compared to epidural analgesia, although this is compensated by a reduction in use of vasopressors with CWI. Netherlands Trial Register NTR4948.

  16. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

    Science.gov (United States)

    Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

    2018-05-01

    Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

  17. Design of plasma facing components for the SST-1 tokamak

    International Nuclear Information System (INIS)

    Jacob, S.; Chenna Reddy, D.; Choudhury, P.; Khirwadkar, S.; Pragash, R.; Santra, P.; Saxena, Y.C.; Sinha, P.

    2000-01-01

    Steady state Superconducting Tokamak, SST-1, is a medium sized tokamak with major and minor radii of 1.10 m and 0.20 m respectively. Elongated plasma operation with double null poloidal divertor is planned with a maximum input power of 1 MW. The Plasma Facing Components (PFC) like Divertors and Baffles, Poloidal limiters and Passive stabilizers form the first material boundary around the plasma and hence receive high heat and particle fluxes. The PFC design should ensure efficient heat and particle removal during steady state tokamak operation. A closed divertor geometry is adopted to ensure high neutral pressure in the divertor region (and hence high recycling) and less impurity influx into the core plasma. A set of poloidal limiters are provided to assist break down, current ramp-up and current ramp down phases and for the protection of the in-vessel components. Two pairs of Passive stabilizers, one