Switching a failed sleeve gastrectomy to SADI-S, RYGB, or OAGB
Official title: Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB
Run by General Committee of Teaching Hospitals and Institutes, Egypt · NCT05608772 · Data updated 2026-11-12
This tests three surgical options—SADI-S, RYGB, and OAGB—for people who regained weight after a sleeve gastrectomy to see which gives the best weight loss, complication profile, and nutritional outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 234 (estimated) |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Status | Recruiting |
| Started | March 15, 2023 |
| Main results expected | March 15, 2028 |
| Study ends | April 15, 2028 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT05608772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who previously had laparoscopic sleeve gastrectomy and now have clinically significant weight regain (BMI over 35, typically around 45 at revisional surgery), with or without mild-to-moderate GERD (LA grade A–B), who can provide informed consent and attend follow-up are ideal candidates.
✕Probably not a fit
Patients with severe GERD (Los Angeles grade C or higher), those unable to follow preoperative care or give informed consent, or those without meaningful weight regain are unlikely to benefit from these revisional procedures in the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Many patients regain weight or develop reflux after laparoscopic sleeve gastrectomy, prompting consideration of revisional operations. This interventional study will convert patients with prior LSG and clinically significant weight regain to one of three revisional procedures (SADI-S, RYGB, or OAGB) and follow them prospectively. Key outcomes include percent excess BMI loss (%EBMIL), surgical complications, nutritional laboratory status, and resolution or improvement of obesity-related comorbidities. The trial plans for 78 patients per group (234 total) to detect about a 10% difference in %EBMIL with 80% power and a 0.05 significance level.
Why it matters
Potential benefit: If successful, the study could identify which revisional surgery gives the best additional weight loss with acceptable complication and nutrition profiles, helping surgeons and patients choose the optimal option.
How similar studies have gone: Individual series and cohort studies show each procedure can produce further weight loss and comorbidity improvement after sleeve failure, but direct head-to-head controlled comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergone primary laparoscopic sleeve gastrectomy in the past * Weight regain * defined as any increase in weight above the nadir as reported by the patient * BMI at the time of revisional surgery was around 45 kg/m2 * weight regain was defined as an increase in BMI after bariatric surgery to exceed 35 * With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification \[7\] will be excluded from the study Exclusion Criteria: * Didn't follow preoperative consultation * Cannot give of sign informed consent
Where it's running
-
Madina Women's Hospital
Alexandria, Alexandria Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Mohamed Ashour, MD — University of Alexandria
- Study coordinator: Bart Torensma, PHD
- Email: bart@torensmaresearch.nl
- Phone: +31641389070
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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.