Bougie Sleeve Trial
Recruiting · NCT02937649 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
Laparoscopic sleeve gastrectomy using 48-Fr bougieLaparoscopic sleeve gastrectomy using standard care bougie
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
12 locations listed.
- 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
- CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye - Poissy, France
- CH Saint-Denis - Saint-Denis, France
- Clinique Mutualiste Chirurgicale - Saint-Etienne, France
- Hôpitaux de Brabois - Vandœuvre-lès-Nancy, France