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
Assistance Publique - Hôpitaux de Paris
1,658 participants
Oct 8, 2020
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
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.
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.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT02937649