Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy
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About
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?
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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.
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Everyone will have the same type of surgery and be cared for in the same way afterward.
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Participants will be monitored closely for one month after surgery to check for problems like bleeding, pain, or leaks.
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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.
Enrollment
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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
Trial design
Primary purpose
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Interventional model
Masking
100 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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