Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

NCT07339020 | Recruiting

• 1 other identifier: ms-199-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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:
• Glue group: The staple line will be sealed with medical glue.
• 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

Keywords

Bariatric surgery; Cyanoacrylate; Glubran; Laparoscopic sleeve gastrectomy; Omentopexy; Staple Line Reinforcement; Postoperative Hemorrhage; Surgical Leak

Outcome Measures

Primary Outcomes (1)

• Comparison of Staple Line Complications After Sleeve Gastrectomy: Glubran vs. Omentum

  This measure compares two methods of staple line reinforcement during laparoscopic sleeve gastrectomy to see which works better at preventing complications within the first 30 days after surgery. The complications of interest are postoperative leakage (staple line leak), bleeding requiring intervention, and abdominal pain. Patients are randomly assigned to have their staple line reinforced either with medical glue (cyanoacrylate) or with the patient's own fatty tissue (omentum).

  From surgery up to 30 days postoperatively

Secondary Outcomes (6)

• Comparison of Operative Time Between Reinforcement Methods

  Measured on the day of surgery.

• Length of Hospital Stay After Sleeve Gastrectomy

  From surgery until discharge, assessed up to 30 days postoperatively.

• Economic Cost of Reinforcement Materials

  Assessed on the day of surgery

• Incidence of Delayed Staple Line Complications

  From discharge up to 30 days postoperatively.

• Rate of Hospital Readmission Within 30 Days

  Within 30 days after discharge.

Other Outcomes (3)

• Postoperative Pain Intensity Assessment

  Daily from day of surgery up to 7 days postoperatively.

• Postoperative Nausea and Vomiting (PONV) Incidence

  From end of surgery up to 48 hours postoperatively.

• Time to First Oral Intake

  From end of surgery up to 48 hours.

Study Arms (2)

Group A: cyanoacrylate sealant (Glubran®)

EXPERIMENTAL

Group A: the reinforcement of staple line was done by cyanoacrylate sealant (Glubran®) from the angle of His till the lower end using its applicator through the right working port

Device: Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy

Group B: Omentopexy

ACTIVE COMPARATOR

Group B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round.

Biological: Autologous Greater Omentum; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy

Interventions

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

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

Group A: cyanoacrylate sealant (Glubran®)

Autologous Greater Omentum BIOLOGICAL

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

Group B: Omentopexy

Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy PROCEDURE

Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.

Group A: cyanoacrylate sealant (Glubran®); Group B: Omentopexy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases underwent LSG with age ≥18 years old and ≤65 years old and BMI ≥35 or ≥30 with comorbid disease related to obesity.
• Candidate for Laparoscopic Sleeve Gastrectomy

You may not qualify if:

• Cases underwent previous bariatric surgery.
• Multiple Extensive previous surgeries.
• Crohn's Disease.
• Elderly patients with extensive comorbidities
• Severe gastroesophageal reflux disease (GERD)
• Severe Bleeding disorders
• Psychiatric illness or cognitive impairment affecting consent or compliance

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

ACTIVE NOT RECRUITING

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Postoperative Complications

Central Study Contacts

Ahmed Eid Aziz, Lecturer

CONTACT

+201127060844; Ahmed-eid@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 14, 2026
• Study Start: June 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)