Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.
Study Overview
Brief Summary
The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.
Detailed Description
The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 28 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Morbidly obese patients waiting for sleeve gastrectomy
Exclusion Criteria
- •BMI<35 Kg/m2,
- •Important comorbidities
Outcomes
Primary Outcomes
safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.
Time Frame: six months
a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed
Secondary Outcomes
No secondary outcomes reported
Investigators
Paolo Gentileschi
Professor
University of Rome Tor Vergata