Comparing bougie sizes in laparoscopic sleeve gastrectomy for obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the impact of different bougie sizes on the rate of staple-line leaks following laparoscopic sleeve gastrectomy (LSG) in patients with morbid obesity. It is a prospective randomized trial that compares the outcomes of using standard bougie calibers (34, 36, or 38 Fr) versus a larger 48-Fr bougie. The hypothesis is that a larger bougie diameter may reduce the risk of gastric leaks without compromising long-term weight loss results. The study will involve patients who meet specific eligibility criteria and will be conducted at multiple hospital locations.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Antoine Béclère
  Clamart, France Recruiting
• Clinique de l'Yvette
  Longjumeau, France Recruiting
• Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
  Paris, France Recruiting
• CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
  Poissy, France Recruiting
• CH Saint-Denis
  Saint-Denis, France Recruiting
• Hôpitaux de Brabois
  Vandœuvre-lès-Nancy, France Recruiting

Study contacts

• Principal investigator: Hadrien TRANCHART, Dr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Hadrien TRANCHART, Dr
• Email: hadrien.tranchart@aphp.fr
• Phone: (+33)145374037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.