Bougie Sleeve Trial
Recruiting
N/A
Interventional Study
Morbid Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,658 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 syn…
Contacts