Bougie Sleeve Trial (BOUST)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Morbid Obesity

Treatments: Procedure: Laparoscopic sleeve gastrectomy using standard care bougie; Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie

Study type: Interventional

Funder types: Other

Identifiers

NCT02937649

P150933

Details and patient eligibility

About

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 standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

Full 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 standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.

Enrollment: 1,658 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 and 70 years
• Sleeve gastrectomy as a primary bariatric procedure
• Body Mass Index (BMI) > 40 kg/m² or > 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis)
• Decision for intervention after multidisciplinary discussion
• Written informed consent

Exclusion criteria

• Previous upper abdominal surgery (cholecystectomy excepted)
• ASA (American Society of Anesthesiologists) score > 3
• Ongoing pregnancy or breast feeding
• Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
• Coagulation disorder
• Patient not covered by social security service and patient on AME
• Patient under legal guardianship and trusteeship
• Patient with known silicon allergy (calibration bougie contains medical silicon)
• More generally, all other contraindications to the use of esophageal bougie MID-TUBE that have been the subject of a scientific paper or have been identified by the practitioner or practitioners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,658 participants in 2 patient groups

Laparoscopic sleeve gastrectomy using 48-Fr bougie

Experimental group

Description:

Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie

Treatment:

Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie

Laparoscopic sleeve gastrectomy using standard care bougie

Active Comparator group

Description:

Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)

Treatment:

Procedure: Laparoscopic sleeve gastrectomy using standard care bougie