Study Comparing Different Bougie Sizes During Laparoscopic Sleeve Gastrectomy to Reduce Postoperative Staple-line Leaks and Maintain Weight Loss
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06
1658
Participants Needed
12
Research Sites
117 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating how the size of the bougie used during laparoscopic sleeve gastrectomy LSG affects the rate of postoperative stomach leaks, which is the most common and serious complication after this weight loss surgery. This prospective randomized trial compares the use of a larger 48-Fr bougie to standard smaller bougie sizes 34, 36, or 38 Fr to see if a bigger diameter lowers leak risk without reducing long-term weight loss.
Participants will undergo laparoscopic sleeve gastrectomy using either the 48-Fr bougie or a standard care bougie. The bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach before the gastrectomy is performed alongside it. Patients do not know which bougie size they receive. This study aims to assess differences in leak rates and weight loss outcomes between the two bougie sizes.
During the study, researchers will monitor participants for stomach leaks within 30 days after surgery as the primary outcome. Secondary outcomes include complications within 90 days, weight loss at 3, 6, 12, and 24 months, and quality of life up to 2 years. Participants will have follow-up visits for these assessments to track recovery, safety, and weight changes over time.
CONDITIONS
Brief Title
Bougie Sleeve Trial
Research Team
H
Hadrien TRANCHART, Dr
I
Ibrahim DAGHER, Pr
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Sleeve gastrectomy as a primary bariatric procedure
Body Mass Index (BMI) over 40 kg/m² or over 35 kg/m² with at least one related health problem such as high blood pressure, sleep apnea, severe metabolic disorders including type 2 diabetes, osteo-articular disorders, or non-alcoholic steatohepatitis
Decision for surgery made after multidisciplinary discussion
Written informed consent provided
You will not qualify if you...
Previous upper abdominal surgery except gallbladder removal
ASA (American Society of Anesthesiologists) score greater than 3
Current pregnancy or breastfeeding
Esophagus conditions like varices, diverticula, tumors, or strictures
Blood clotting disorders
Not covered by social security or on medical aid
Under legal guardianship or trusteeship
Known allergy to medical silicon in the calibration bougie
Other contraindications to esophageal bougie use identified by medical literature or practitioners
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day or until discharge
Participants undergo laparoscopic sleeve gastrectomy using either a 48-Fr bougie or a standard care bougie. The surgery is followed by immediate post-operative care.
1 surgical visit and hospital stay
Post-operative Follow-up
Duration - Up to 2 years
Participants are monitored for postoperative gastric leak, morbidity, and recovery, including assessments of weight loss and quality of life.
Follow-up visits at 3 months, 6 months, 1 year, and 2 years
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial.
Martin Gaillard, Panagiotis Lainas, Hélène Agostini...