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

The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

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Key information

Conditions

Complication of Surgical Procedure Leak; Blood

Age range

28 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Morbidly obese patients waiting for sleeve gastrectomy

Exclusion criteria

BMI<35 Kg/m2,
Important comorbidities

Treatment and study plan

bariatric surgery

Procedure

Staple line reinforcement during sleeve gastrectomy

Other names: bariatric surgical procedure, gastric resection, steaple line reinforcement

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

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Oct 25, 2011
Registry last updated: Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed