Comparing bougie sizes in laparoscopic sleeve gastrectomy for obesity
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
This study is testing whether using different sizes of a tool called a bougie during weight loss surgery can help prevent leaks in the stomach for people with severe obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1658 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 12 sites (Boulogne-Billancourt and 11 other locations) |
| Trial ID | NCT02937649 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of different bougie sizes on the rate of staple-line leaks following laparoscopic sleeve gastrectomy (LSG) in patients with morbid obesity. It is a prospective randomized trial that compares the outcomes of using standard bougie calibers (34, 36, or 38 Fr) versus a larger 48-Fr bougie. The hypothesis is that a larger bougie diameter may reduce the risk of gastric leaks without compromising long-term weight loss results. The study will involve patients who meet specific eligibility criteria and will be conducted at multiple hospital locations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a BMI over 40 or over 35 with related comorbidities, seeking primary bariatric surgery.
Not a fit: Patients with previous upper abdominal surgeries, significant comorbidities, or specific esophageal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced complications and improved outcomes for patients undergoing bariatric surgery.
How similar studies have performed: Other studies have explored bougie sizes in bariatric surgery, but this specific comparison of standard versus larger bougie sizes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boulogne-Billancourt and 11 other locations
- Hôpital Ambroise Paré — Boulogne-Billancourt, France (Suspended)
- Hôpital Côte de Nacre CHU de Caen — Caen, France (Withdrawn)
- CHU Antoine Béclère — Clamart, France (Recruiting)
- Centre hospitalier Intercommunal de Créteil — Créteil, France (Withdrawn)
- Hôpital MICHALLON, CHU de Grenoble — La Tronche, France (Withdrawn)
- Hôpital Dupuytren - Limoges — Limoges, France (Withdrawn)
- Clinique de l'Yvette — Longjumeau, France (Recruiting)
- Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat — Paris, France (Recruiting)
- CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye — Poissy, France (Recruiting)
- CH Saint-Denis — Saint-Denis, France (Recruiting)
- Clinique Mutualiste Chirurgicale — Saint-Etienne, France (Withdrawn)
- Hôpitaux de Brabois — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Hadrien TRANCHART, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Hadrien TRANCHART, Dr
- Email: hadrien.tranchart@aphp.fr
- Phone: (+33)145374037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.