| NCT ID | NCT02937649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,658 participants |
| Start Date | 2020-10-08 |
| Primary Completion | 2025-06-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,658 participants in total. It began in 2020-10-08 with a primary completion date of 2025-06-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Hadrien TRANCHART, Dr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT02937649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02937649 currently recruiting?
Yes, NCT02937649 is actively recruiting participants. Contact the research team at hadrien.tranchart@aphp.fr for enrollment information.
Where is the NCT02937649 trial being conducted?
This trial is being conducted at Boulogne-Billancourt, France, Caen, France, Clamart, France, Créteil, France and 8 additional locations.
Who is sponsoring the NCT02937649 clinical trial?
NCT02937649 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Hadrien TRANCHART, Dr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,658 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.