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Bougie Sleeve Trial

RecruitingNAAges 18 Years - 70 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Laparoscopic sleeve gastrectomy using 48-Fr bougie
  • Laparoscopic sleeve gastrectomy using standard care bougie
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Where

12 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, France
Hôpital Côte de Nacre CHU de Caen
Caen, France
CHU Antoine Béclère
Clamart, France
Centre hospitalier Intercommunal de Créteil
Créteil, France
Hôpital MICHALLON, CHU de Grenoble
La Tronche, France
Hôpital Dupuytren - Limoges
Limoges, France
Clinique de l'Yvette
Longjumeau, France
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
Paris, France

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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