Gastric bypass trials
Arms and Interventions. Roux-en-Y gastric bypass: Stapling and reduction of the gastric chamber of approximately 18 cm, followed by anastomosis with a deviated bowel, and another bowel anastomosis with a bowel in a lower portion, for deviation of biliopancreatic secretions. Outcome Measures. Primary Outcome Measures : Assessment of excess body weight loss [ Time Frame: 3 months after surgery ] During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI.
During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. To assess access to the remaining stomach and duodenum, endoscopies will be performed after surgery by a professional from the endoscopy team at Hospital Geral Alberto Rassi. The questionnaire used for subjective evaluation of the surgery result and the post-operative quality of life adopted will be the BAROS Bariatric Analysis and Reporting Outcome.
The BAROS protocol consists of three major research areas weight loss, medical conditions and quality of life questionnaire , from which a maximum score of three points is obtained for each category, totaling a maximum of nine points. The questionnaire will be applied by trained researchers. Secondary Outcome Measures : Weight loss assessment through exams and interviews [ Time Frame: 18 months ] Monitoring of weight loss through weighing and questionnaire completed by the patient.
Eligibility Criteria. Patients already undergoing other bariatric surgeries. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Alberto Rassi. More Information. In addition, an institutional review board IRB approval is also required. These safeguards help make sure the risks of the clinical trial are as low as possible and are worth any potential benefits.
According to the Office for Human Research Protections, here are some questions to ask if you are considering joining a clinical trial:. As a service to our readers, we provide access below to the clinical trials database of the U. To participate in a clinical trial for bariatric surgery, please read the information and get in touch with the contact person directly.
Consumer Guide to Bariatric Surgery has no connection with the people and organizations who run these trials. Are Clinical Trials Safe? According to the Office for Human Research Protections, here are some questions to ask if you are considering joining a clinical trial: Why is the research being done?
Rodgers explaining the importance of participating in clinical trials. You can view a filtered list of clinical studies on weight-loss surgery that are federally funded, open, and recruiting at www. You can expand or narrow the list to include clinical studies from industry, universities, and individuals; however, the National Institutes of Health does not review these studies and cannot ensure they are safe.
Always talk with your health care provider before you participate in a clinical study. The researchers examined the safety and effectiveness of two types of weight-loss surgery in adults, gastric bypass and adjustable gastric band. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Blazeby bristol. Mazza bristol. Hopkins nbt. Long uhs. More Information. Additional Information: By-Band-Sleeve study website. What is the most effective operation for adults with severe and complex obesity? Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials.
The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Obes Rev. Epub Nov PLoS Med. Obes Surg. The use of adjustable gastric bands for management of severe and complex obesity.
Br Med Bull. Epub Mar Why the NHS should do more bariatric surgery; how much should we do? Erratum in: Obes Surg. The EQ-5D-5L is a valid approach to measure health related quality of life in patients undergoing bariatric surgery.
PLoS One. Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study. Int J Obes Lond. Epub Jul 3.
Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice.
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