Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

Summary

Study Title:

Comparing Surgical Glue (Cyanoacrylate) vs. Omentum Tissue to Strengthen Staple Lines in Weight-Loss Sleeve Surgery

What is the purpose of this study? This study will compare two ways to strengthen the staple line during weight-loss sleeve surgery. One way uses a medical glue called cyanoacrylate, and the other uses a piece of tissue from the abdomen called omentum. The goal is to see which method works better to lower the chance of bleeding, pain, or leaks after surgery.

Who can take part?

Adults ages 18-65 who:

* Have a body mass index (BMI) over 35, or over 30 if they also have health problems related to obesity.
* Are scheduled to have weight-loss sleeve surgery at Cairo University Hospital.

Participants cannot take part if they:

* Are younger than 18 or older than 65.
* Have had weight-loss surgery before.

What will happen in the study?

* Participants will be assigned by chance to one of two groups:

1. Glue group: The staple line will be sealed with medical glue.
2. Omentum group:The staple line will be covered and sewn with a piece of the body's own tissue.
* Everyone will have the same type of surgery and be cared for in the same way afterward.
* Participants will be monitored closely for one month after surgery to check for problems like bleeding, pain, or leaks.
* Follow-up visits will happen within one week after surgery and again at one month.

What are the possible risks? The risks are low and similar to those of regular weight-loss surgery. Some people may feel pain or anxiety after surgery. The study team will watch for any problems and treat them right away.

Why is this study being done? Weight-loss sleeve surgery is common, but sometimes the staple line can leak or bleed. Finding a better way to strengthen it may help people recover more safely and with less pain.

How long will the study last? The study will take about six months to complete, including surgery and follow-up.

Who is running the study? The study is being done by doctors in the General Surgery Department at Cairo University's Faculty of Medicine.

Conditions

• Obesity

Interventions

DEVICE

Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.

A synthetic surgical adhesive applied to the staple line for reinforcement and hemostasis using its proprietary delivery applicator.

BIOLOGICAL

Autologous Greater Omentum

pedicled flap of the patient's own greater omentum sutured over the staple line for reinforcement using a PDS 2/0 round needle suture.

PROCEDURE

Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy

Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-20

Primary Completion

2026-05-06

Completion

2026-05-14

Countries

• Egypt

Study Locations