Cyanoacrylate Versus Omentum for Enforcement of the Staple Line in Sleeve Operation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Comparison of Staple Line Complications After Sleeve Gastrectomy: Glubran vs. Omentum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator. (Device)
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
Intervention: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy (Procedure)
Group B: Omentopexy
Group B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round.
Intervention: Autologous Greater Omentum (Biological)
Group B: Omentopexy
Group B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round.
Intervention: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy (Procedure)
Outcomes
Primary Outcomes
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
- 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.)
- Rate of Reoperation Within 30 Days(Within 30 days postoperatively.)
Investigators
Ahmed Eid Ali Ahmed Aziz
Lecturer
Cairo University