Medical glue versus omentum to reinforce the staple line in sleeve gastrectomy
Cyanoacrylate Versus Omentum for Enforcement of the Staple Line in Sleeve Operation
This trial will test whether medical glue (cyanoacrylate) or using a patient's own omentum better prevents bleeding, pain, or leaks after laparoscopic sleeve gastrectomy in adults with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Cairo, Al-Manial Cairo and 1 other locations) |
| Trial ID | NCT07339020 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center trial assigns adults undergoing laparoscopic sleeve gastrectomy to have the staple line reinforced with either Glubran®2 n-butyl-2-cyanoacrylate surgical glue or an autologous greater omentum (omentopexy). Surgeons apply the assigned reinforcement during the standard LSG procedure and patients are followed for postoperative outcomes including staple-line bleeding, pain, and leaks. Eligible participants are adults 18–65 years with BMI ≥35, or ≥30 with obesity-related comorbidities; patients with prior bariatric surgery or major contraindications are excluded. The trial is conducted at the Faculty of Medicine, Cairo University with outcomes compared between groups to identify which method lowers early complication rates.
Who should consider this trial
Good fit: Adults aged 18–65 with BMI ≥35 (or ≥30 with obesity-related health problems) who are candidates for primary laparoscopic sleeve gastrectomy at Cairo University are ideal candidates.
Not a fit: Patients with prior bariatric surgery, severe GERD, Crohn's disease, significant bleeding disorders, extensive prior abdominal surgeries, uncontrolled psychiatric illness, or those outside the specified age/BMI criteria are unlikely to qualify or receive benefit.
Why it matters
Potential benefit: If successful, the preferred reinforcement method could reduce staple-line bleeding, pain, and leaks after sleeve gastrectomy, lowering complication rates and speeding recovery.
How similar studies have performed: Previous small trials and case series have used cyanoacrylate and omentopexy for staple-line reinforcement with mixed and inconclusive results, so a direct randomized comparison remains warranted.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo, Al-Manial Cairo and 1 other locations
- Faculty of Medicine Cairo University — Cairo, Al-Manial Cairo, Egypt (Completed)
- Faculty of Medicine Cairo University — Cairo, Al-Manial Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Eid Aziz, Lecturer
- Email: Ahmed-eid@kasralainy.edu.eg
- Phone: +201127060844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.