Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional… (NCT06794892) | Clinical Trial Compass
CompletedNot Applicable
Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery
Italy328 participantsStarted 2019-01-01
Plain-language summary
Study Description
This prospective, multicenter study aims to compare the outcomes of One-Anastomosis Gastric Bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) as revisional procedures for patients experiencing insufficient weight loss or weight regain following restrictive bariatric surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). Conducted between January 2019 and December 2021, the study involves a three-year follow-up of 328 patients across high-volume bariatric centers.
The primary objective is to evaluate the effectiveness of these revisional procedures in achieving additional weight loss. Secondary objectives include analyzing differences in operative times, complication rates (short- and long-term), reduction of obesity-related comorbidities, mortality, and overall patient outcomes.
This study uniquely integrates comprehensive pre- and postoperative assessments, including radiological evaluations, to better understand predictors of success and provide evidence for optimal surgical strategies in revisional bariatric care.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18-65 years.
* Experienced insufficient weight loss, defined as:
* Excess weight loss (EWL) \< 50%.
* Total weight loss (TWL) \< 25%.
* BMI \> 40 kg/m² at least two years after primary restrictive surgery.
* Previously underwent laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB).
* Undergoing revisional surgery specifically for inadequate weight loss or weight regain.
Exclusion Criteria:
* Revisional surgery performed for indications other than inadequate weight loss or weight regain (e.g., complications of the primary procedure such as stenosis or refractory gastroesophageal reflux, or for comorbidity management).
* Known psychiatric illness or untreated eating disorders.
* Pregnancy.
* History of prior gastric surgery unrelated to bariatric interventions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.