Single-stage stapled conversion of gastric bypass to sleeve gastrectomy
Exploring the Efficacy of Single-stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?
This trial will try a single-stage laparoscopic stapled conversion from prior gastric bypass to sleeve gastrectomy in adults with post-bypass complications to see if it is safe and improves symptoms, nutrition, and weight control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo, Old Cairo) |
| Trial ID | NCT07038148 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm trial enrolling 11 adult patients at Kasr El Aini who undergo a single-stage laparoscopic stapled conversion of Roux-en-Y or one-anastomosis gastric bypass to sleeve gastrectomy. Preoperative 3D CT gastric volumetry and routine laboratory testing are performed, and patients are followed monthly for weight with nutritional labs, GERD scoring, and bariatric quality-of-life assessments at 3 and 6 months. The study records perioperative outcomes including leaks, complications, and length of hospital stay, as well as short-term changes in nutritional status and symptom burden. All procedures use a stapling technique and data collection focuses on safety and early patient-centered outcomes.
Who should consider this trial
Good fit: Adults aged 18–70 with prior laparoscopic gastric bypass (RYGB or OAGB) who require conversion for persistent complications and can consent and commit to follow-up are the intended participants.
Not a fit: Patients who need reversal to normal anatomy, those with uncontrolled systemic disease, active psychological disorders or substance abuse, or intraoperative findings that prevent conversion are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could treat post-bypass complications without reversing anatomy and may preserve prior weight loss while improving symptoms and nutritional status.
How similar studies have performed: Small case series and institutional reports have described similar bypass-to-sleeve conversions, but high-quality comparative evidence on safety and long-term outcomes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18-70 * Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy. * Patients accept to sign an informed consent and will commit to follow-up. Exclusion Criteria: * Patients with reversal gastric bypass to normal anatomy. * Patient with uncontrolled systemic disease. * Patients with active psychological disorders. * Patients with active substance abuse. * Patients with intra-operative technical difficulties hindering the conversion of gastric bypass to sleeve gastrectomy. * Patients refusing to sign an informed consent.
Where this trial is running
Cairo, Old Cairo
- Kasr Alainy Medical School, Cairo University — Cairo, Old Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Associate Professor of General and Laparosocpic Surgery
- Email: a.abd.elsalam@kasralainy.edu.eg
- Phone: +201111577188
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.