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

NCT ID: NCT07238309

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-18
• Study Completion Date: 2026-06-30

Brief 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

Detailed Description

Obesity is a disease related to reduced life expectancy, as well as increased morbidity and mortality. In recent years, bariatric surgery has become an increasingly widespread form of treatment for severe obesity and its associated diseases . The increased spread of bariatric surgery is associated with its long-term reliability and also its high cost-benefit ratio.

According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) registry (calendar years 2014-2018), there are three main surgical procedures in common use: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) and laparoscopic one anastomosis gastric bypass (OAGB) . OAGB, introduced by Rutledge in 1997 is a restrictive and malabsorptive bariatric surgical procedure and is the fourth most performed bariatric technique in Europe and in the Asia/Pacific area, with an increasing trend .

In the last 15 years, several authors have demonstrated the effectiveness of this surgical technique in terms of both weight loss and the resolution of comorbidities, especially type 2 diabetes mellitus (T2DM).

Despite the described advantages, LSG still conveys some risks. Early staple line complications, such as bleeding and leaks, may occur, and their incidence may vary from 1 to 6% . Such complications can be devastating and life-threatening. Besides, they entail additional healthcare-related costs. It has been proposed that staple line complications can be reduced by staple line reinforcement (SLR).

Staple line reinforcement (SLR) has been proposed to decrease the risk of these complications by several options: oversewing the staple line with a running absorbable suture, buttressing it with specific materials or roofing the staple line. Although it has been postulated that there are fewer complications, SLR remains controversial and its effectiveness is still unclear . Some surgeons still have concerns about SLR, either because of Uncertainty about its benefits and/or its financial costs. Moreover, it has been argued that oversewing itself could carry additional risks. The potential for leakage and bleeding could increase due to tearing at the suture penetration point, and the running suture may lead to sleeve stricture and tissue ischemia.

Two common techniques for this purpose are oversewing and the use of surgical ligation clips. Oversewing involves suturing over the staple line, which has been shown to significantly reduce the incidence of staple line bleeding, with rates dropping from 9-13.7% to as low as 1.4-2%, While effective and cost-efficient.

Oversewing can increase operative time due to the additional suturing required .

On the other hand, surgical ligation clips provide a rapid method for achieving hemostasis and reinforcing the staple line. Research indicates that ligation clips are effective in controlling bleeding, with low complication rates (e.g., only 1.7% episodes of melena reported).

Both techniques demonstrate comparable efficacy in preventing complications, and the choice between them may depend on clinical context, surgeon preference, and resource availability. Further studies comparing long-term outcomes would enhance understanding of their relative effectiveness.

Conditions

Gastric Bypass Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Through-and-through sutures

through-and-through sutures with 3-0 absorbable monofilament sutures will be used .

Group Type: EXPERIMENTAL

Oversewing

Intervention Type: PROCEDURE

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.

Titanium Ligation clips

Titanium Ligation clips will be used .

Group Type: EXPERIMENTAL

Surgical Ligation Clips

Intervention Type: PROCEDURE

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

Interventions

Oversewing

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.

Intervention Type: PROCEDURE

Surgical 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Gamal Abd Elghany

General and Laparoscopic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George AbdElFady Nashed Aiad, M.D

Role: PRINCIPAL_INVESTIGATOR

professor in General and Laparoscopic surgery

Locations

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sameh Gamal Abd Elghany, MSc

Role: CONTACT

smsm_surgeon@yahoo.com

01001841011

George AbdElFady Nashed Aiad, M.D

Role: CONTACT

george.ayad@kasralainy.edu.eg

01223980146

References

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Reference Type: BACKGROUND

PMID: 28604169 (View on PubMed)

Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.

Reference Type: BACKGROUND

PMID: 27230645 (View on PubMed)

Other Identifiers

laparoscopic gastric bypass

Identifier Type: -

Identifier Source: org_study_id