Gastric Bypass After Previous Anti-reflux Surgery (NCT01041105) | Clinical Trial Compass
CompletedNot Applicable
Gastric Bypass After Previous Anti-reflux Surgery
United States22 participantsStarted 2008-12
Plain-language summary
The goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery "ARS" in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease "GERD", the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.
Who can participate
Age range
18 Years – 60 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.
Inclusion Criteria:
* Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:
* Met NIH criteria for bariatric surgery
* With functional or failed antireflux surgery (Nissen fundoplication)
* Laparoscopic approach for revisional surgery
Exclusion Criteria:
* Any other type of revisional bariatric procedure
* Nonstandard revisional RYGB surgery
* Open approach for revision surgery
* Missing records and/or unreachable patients with scant information for analysis
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.
What they're measuring
1
Morbidity and mortality
Timeframe: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years
2
Remission or improvement of GERD-related symptoms
Timeframe: 6 months, 1 year and annually thereafter for up to 4 years
3
Weight loss expressed as Body Mass Index and Percentage of excess weight loss
Timeframe: 6 months, 1 year, and annually thereafter for up to 4 years