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Bougie Sleeve Trial

2016-10-19 02:38:21 | BioPortfolio

Summary

Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a bougie calibre of 36 or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

Description

Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.

The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a bougie calibre of 36 or 48-Fr on postoperative gastric leak and mid-term weight loss.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Morbid Obesity

Intervention

Laparoscopic sleeve gastrectomy using 48-Fr bougie, Laparoscopic sleeve gastrectomy using 36-Fr bougie

Status

Not yet recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-19T02:38:21-0400

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Medical and Biotech [MESH] Definitions

Excision of the whole (total gastrectomy) or part (subtotal gastrectomy, partial gastrectomy, gastric resection) of the stomach. (Dorland, 28th ed)

Excision of the gallbladder through an abdominal incision using a laparoscope.

A serotonin antagonist and a histamine H1 blocker used as antipruritic, appetite stimulant, antiallergic, and for the post-gastrectomy dumping syndrome, etc.

Placement of one of the surgeon's gloved hands into the ABDOMINAL CAVITY to perform manual manipulations that facilitate the laparoscopic procedures.

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