Bougie Sleeve Trial

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


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.


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


Morbid Obesity


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


Not yet recruiting


Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results


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

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PubMed Articles [847 Associated PubMed Articles listed on BioPortfolio]

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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)

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

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

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

Sequelae of gastrectomy from the second week after operation on. Include recurrent or anastomotic ulcer, postprandial syndromes (DUMPING SYNDROME and late postprandial hypoglycemia), disordered bowel action, and nutritional deficiencies.

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