Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07339020

Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

Led by Cairo University · Updated on 2026-05-11

100

Participants Needed

2

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Body mass index (BMI) of 35 or higher, or BMI over 30 with health problems related to obesity
  • Scheduled for laparoscopic sleeve gastrectomy surgery
Not Eligible

You will not qualify if you...

  • Previous weight-loss (bariatric) surgery
  • Multiple extensive previous surgeries
  • Crohn's disease
  • Severe gastroesophageal reflux disease (GERD)
  • Severe bleeding disorders
  • Psychiatric illness or cognitive impairment affecting consent or compliance
  • Elderly patients with extensive comorbidities

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, Egypt, 11956

Completed

2

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, Egypt, 11956

Actively Recruiting

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Research Team

A

Ahmed Eid Aziz, Lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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