Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Not Applicable

Completed

• Conditions: Complication of Surgical Procedure; Leak; Blood
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT01459471
• Lead Sponsor: University of Rome Tor Vergata

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-21
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-25
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria

• BMI<35 Kg/m2,
• Important comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bleeding, leak, operative time	Bariatric surgery	-

Primary Outcome Measures

Name	Time	Method
safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.	six months	a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed