Revisional Roux-en-Y gastric bypass with or without a fixed ring after sleeve gastrectomy
Official title: A Prospective Randomized Controlled Trial Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy: 5-Year Outcomes on Weight Loss, BAROS Score, Quality of Life, and Food Tolerance
Run by General Committee of Teaching Hospitals and Institutes, Egypt · NCT07436013 · Data updated 2026-11-12
This compares revisional Roux-en-Y gastric bypass with and without a fixed ring to see if the ring helps people who had a sleeve gastrectomy and then regained weight or lost too little.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | March 2031 |
| Study ends | March 2031 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07436013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 who experienced suboptimal weight loss or recurrent weight gain after sleeve gastrectomy and who are medically fit for revisional bariatric surgery are the ideal candidates.
✕Probably not a fit
Patients with severe psychiatric disease, uncontrolled substance abuse, active cancer, severe cardiopulmonary disease, or those unable to comply with follow-up may not receive benefit from this surgical approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized comparison of two revisional surgical approaches for patients with suboptimal weight loss or recurrent weight gain after laparoscopic sleeve gastrectomy. Adults aged 18–65 who are fit for surgery are randomized to standard revisional Roux-en-Y gastric bypass or revisional banded (ringed) Roux-en-Y gastric bypass and followed for five years. Primary outcomes include long-term weight maintenance and composite measures such as the BAROS score, with secondary outcomes including food tolerance and quality of life. The trial aims to determine whether adding a fixed ring reduces pouch dilation and improves sustained weight outcomes in the revisional setting.
Why it matters
Potential benefit: If successful, adding a fixed ring could improve long-term weight maintenance and overall outcomes for patients who regain weight after sleeve gastrectomy.
How similar studies have gone: Some evidence from primary bariatric procedures suggests ringed RYGB can help maintain restriction, but evidence specifically in the revisional setting is limited and inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-65 years. * Patients who experienced recurrent weight gain, suboptimal weight loss, or both within 12-24 months or more following sleeve gastrectomy. * Eligible and fit for bariatric surgery. * Willing to provide informed consent and adhere to follow-up. Exclusion Criteria: * Severe psychiatric disorders or uncontrolled substance abuse. * Pregnancy or planned pregnancy within 2 years post-surgery. * Chronic steroid use or immunosuppressive therapy. * Active malignancy or history of gastrointestinal cancer. * Severe cardiac or pulmonary disease precluding surgery. * Uncontrolled endocrine disorders (other than T2DM). * Inability to comply with follow-up or protocol requirements.
Where it's running
-
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Alexandria Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed H Ashour, PhD
- Email: dr.mhany@gmail.com
- Phone: 00201002600970
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Magnetic bariatric revisional surgery for weight loss and GERD resolution
This study tests if a new type of weight loss surgery using magnets can help people with obesity and acid reflux feel better after previous weight loss surgeries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.