Status:
RECRUITING
Bougie Sleeve Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can re...
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 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
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2027
Estimated Enrollment :
1658 Patients enrolled
Trial Details
Trial ID
NCT02937649
Start Date
October 8 2020
End Date
September 8 2027
Last Update
April 6 2025
Active Locations (12)
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1
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92104
2
Hôpital Côte de Nacre CHU de Caen
Caen, France, 14033
3
CHU Antoine Béclère
Clamart, France, 92140
4
Centre hospitalier Intercommunal de Créteil
Créteil, France, 94010