Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

Cyanoacrylate Versus Omentum for Enforcement of the Staple Line in Sleeve Operation

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy; Biological: Autologous Greater Omentum

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Manial Cairo
    • Cairo, Al-Manial Cairo, Egypt, 11956
      • Faculty of medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: cyanoacrylate sealant (Glubran®); 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.; A synthetic surgical adhesive applied to the staple line for reinforcement and hemostasis using its proprietary delivery applicator.; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy; Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.
Active Comparator: Group B: Omentopexy; Group B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round.	Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy; Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Operative Time Between Reinforcement Methods	This measure compares the total surgical time (in hours) from skin incision to closure between the two study groups: cyanoacrylate glue reinforcement vs. omentum reinforcement.	Measured on the day of surgery.
Length of Hospital Stay After Sleeve Gastrectomy	This measure compares the number of days patients stay in the hospital after surgery between the two reinforcement groups, from the day of surgery until discharge.	From surgery until discharge, assessed up to 30 days postoperatively.
Economic Cost of Reinforcement Materials	This measure compares the direct cost of the reinforcement materials used in each group: cyanoacrylate glue versus omentum	Assessed on the day of surgery
Incidence of Delayed Staple Line Complications	This measure assesses whether any staple line complications (such as delayed leakage or bleeding) occur after discharge, within the first month post-surgery.	From discharge up to 30 days postoperatively.
Rate of Hospital Readmission Within 30 Days	This measure compares the proportion of patients in each group who are readmitted to the hospital within 30 days after discharge due to any surgery-related complication.	Within 30 days after discharge.
Rate of Reoperation Within 30 Days	This measure compares the proportion of patients in each group who require a second surgical intervention (reoperation) within 30 days after the initial surgery due to complications such as bleeding, leakage, or hematoma.	Within 30 days postoperatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity Assessment	This measure compares patient-reported pain levels (using a visual analog scale, VAS) (VAS, 0-10) during the first 7 days after surgery between the cyanoacrylate and omentum reinforcement groups.	Daily from day of surgery up to 7 days postoperatively.
Postoperative Nausea and Vomiting (PONV) Incidence	This measure compares the incidence and severity of postoperative nausea and vomiting (PONV) in the first 48 hours after surgery between the two reinforcement groups.	From end of surgery up to 48 hours postoperatively.
Time to First Oral Intake	This measure compares the time (in hours) from end of surgery to first tolerated oral fluid intake (sips of water) between the two groups.	From end of surgery up to 48 hours.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Actual): May 6, 2026
• Study Completion (Actual): May 14, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bariatric surgery; Cyanoacrylate; Laparoscopic sleeve gastrectomy; Postoperative Hemorrhage; Staple Line Reinforcement; Omentopexy; Glubran; Surgical Leak
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Hemorrhage; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Postoperative Hemorrhage
• Other Study ID Numbers: ms-199-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No