Oversewing versus surgical ligation clips to reinforce the gastric pouch after one-anastomosis gastric bypass
Official title: A Comparative Study to Evaluate Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass
Run by Cairo University · NCT07238309 · Data updated 2026-11-12
This trial will test whether oversewing or surgical clips better reduce bleeding and the need for blood transfusions after laparoscopic one-anastomosis gastric bypass in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | May 18, 2025 |
| Main results expected | May 2026 |
| Study ends | June 2026 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07238309 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are fit for bariatric surgery with BMI ≥40 kg/m2 or BMI 35–40 kg/m2 with significant comorbidities and who have tried non-surgical weight-loss measures for at least six months and can provide informed consent.
✕Probably not a fit
Patients with known bleeding disorders, pregnant or breastfeeding women, those requiring re-exploration for bleeding not related to the staple line, or anyone not undergoing OAGB are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional comparison at the Faculty of Medicine, Cairo University enrolls adults undergoing laparoscopic one-anastomosis gastric bypass (OAGB) and assigns them to either oversewing or surgical ligation clips for staple-line reinforcement of the gastric pouch. Participants are followed for postoperative staple-line bleeding, need for blood transfusion, operative time, and cost outcomes. The primary outcomes are rates of postoperative bleeding and transfusion requirement, with secondary outcomes including operative duration and a cost analysis. Key exclusions include bleeding disorders, pregnancy or breastfeeding, and refusal of consent.
Why it matters
Potential benefit: If successful, this could lower postoperative bleeding and transfusion rates after OAGB, shorten operating time, and reduce procedural costs, improving patient safety and recovery.
How similar studies have gone: Staple-line reinforcement methods have been compared in other bariatric procedures with mixed results, and direct high-quality evidence specifically comparing oversewing versus clips for OAGB is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ✔ Age ≥ 18years old * Sex: both sex * Fit for bariatric surgery * body mass index (BMI) of 40 kg/m 2 or higher or BMI between 35 and 40 kg/m2 with significant comorbidities, such as T2DM, hypertension, OSAS or significant osteo- articular alterations, not responsive to medical therapies * Patients should have tried and failed to lose weight using diet, exercise, and/or medication for at least 6 months * Patients or first guardians accept to participate in the current study * Patients or first guardians accept to provide informed written consent Exclusion Criteria: * Patients less than 18 years old * Patients or first guardians refused to participate in the current study * Patients or first guardians refused to provide informed written consent * All patients with bleeding disorders and patients needing re-exploration for bleeding other than staple line Pregnant or breastfeeding women
Where it's running
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Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Principal investigator: George AbdElFady Nashed Aiad, M.D — professor in General and Laparoscopic surgery
- Study coordinator: Sameh Gamal Abd Elghany, MSc
- Email: smsm_surgeon@yahoo.com
- Phone: 01001841011
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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.