Clinical trial

Bougie Sleeve Trial

Recruiting now · Not applicable · 1 countries · Registry ID NCT02937649

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionMorbid Obesity

Full registry criteria

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

Treatments and study arms

Laparoscopic sleeve gastrectomy using 48-Fr bougie

Procedure

After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.

Laparoscopic sleeve gastrectomy using standard care bougie

Procedure

After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.

Primary outcomes

Postoperative gastric leak rate30 days following the procedure

Postoperative gastric leak rate during the first month following the procedure will be proven either on: * Morphologic examination (with contrast ingestion) * Blue dye test during surgical reintervention or postoperative course * Contrast opacification during endoscopy