Revisional Roux-en-Y gastric bypass with or without a fixed ring after sleeve gastrectomy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT07436013 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Some evidence from primary bariatric procedures suggests ringed RYGB can help maintain restriction, but evidence specifically in the revisional setting is limited and inconclusive.
Eligibility criteria
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 this trial is running
Alexandria, Alexandria Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.