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NCT Number: NCT07339020

Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy

Procedure

Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.

Primary outcomes

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

    Time frame: From surgery up to 30 days postoperatively

    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).

Secondary outcomes

  1. Comparison of Operative Time Between Reinforcement Methods

    Time frame: Measured on the day of surgery.

    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.

  2. Length of Hospital Stay After Sleeve Gastrectomy

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

    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.

  3. Economic Cost of Reinforcement Materials

    Time frame: Assessed on the day of surgery

    This measure compares the direct cost of the reinforcement materials used in each group: cyanoacrylate glue versus omentum

  4. Incidence of Delayed Staple Line Complications

    Time frame: From discharge up to 30 days postoperatively.

    This measure assesses whether any staple line complications (such as delayed leakage or bleeding) occur after discharge, within the first month post-surgery.

  5. Rate of Hospital Readmission Within 30 Days

    Time frame: Within 30 days after discharge.

    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.

  6. Rate of Reoperation Within 30 Days

    Time frame: Within 30 days postoperatively.

    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.

Other outcomes

  1. Postoperative Pain Intensity Assessment

    Time frame: Daily from day of surgery up to 7 days postoperatively.

    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.

  2. Postoperative Nausea and Vomiting (PONV) Incidence

    Time frame: From end of surgery up to 48 hours postoperatively.

    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.

  3. Time to First Oral Intake

    Time frame: From end of surgery up to 48 hours.

    This measure compares the time (in hours) from end of surgery to first tolerated oral fluid intake (sips of water) between the two groups.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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