NCT02937649Recruiting
Bougie Sleeve Trial
Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1658 (estimated)
- First submitted
- 17 Oct 2016
- Start date
- 8 Oct 2020
- Primary completion date
- 8 Jun 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT02937649
What you commit to
- Study type: Interventional
- Planned participants: 1658
- From 8 Oct 2020 to the primary completion date, 8 Jun 2025
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous upper abdominal surgery (cholecystectomy excepted)
Other illness
- Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
- Coagulation disorder
- Patient with known silicon allergy (calibration bougie contains medical silicon)
Other
- ASA (American Society of Anesthesiologists) score \> 3
- Ongoing pregnancy or breast feeding
- Patient not covered by social security service and patient on AME
- Patient under legal guardianship and trusteeship
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Ambroise-Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Suspended |
| Hôpital Côte de Nacre - CHU de Caen Coordinator of this site? Confirm its status | Caen | France | Withdrawn |
| CHU Antoine Béclère Coordinator of this site? Confirm its status | Clamart | France | Recruiting |
| Centre Hospitalier Intercommunal de Créteil Coordinator of this site? Confirm its status | Créteil | France | Withdrawn |
| Hôpital MICHALLON, CHU de Grenoble Coordinator of this site? Confirm its status | La Tronche | France | Withdrawn |
| Hôpital Dupuytren - Limoges Coordinator of this site? Confirm its status | Limoges | France | Withdrawn |
| Clinique de l'Yvette Coordinator of this site? Confirm its status | Longjumeau | France | Recruiting |
| Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| CH Saint Denis Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| Clinique Mutualiste Chirurgicale Coordinator of this site? Confirm its status | Saint-Etienne | France | Withdrawn |
| Hôpitaux de Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.