Bougie Sleeve Trial

Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate

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.

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.

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