RecruitingNot ApplicableNCT07238309

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

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


Sponsor

Cairo University

Enrollment

30 participants

Start Date

May 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

1. To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass. 2. To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB). 3. To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • ✔ 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 Criteria4

  • 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

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Interventions

PROCEDUREOversewing

Through-and-through sutures with 3-0 absorbable monofilament sutures will be placed over the staple line to reinforce it in laparoscopic one anastomosis gastric bypass surgery.

PROCEDURESurgical Ligation Clips

Titanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.


Locations(1)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

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NCT07238309


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