Bougie Sleeve Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic sleeve gastrectomy using 48-Fr bougie, Laparoscopic sleeve gastrectomy using standard care bougie.
- Who it may be relevant to
- Registry conditions: Morbid Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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 result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.
The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.
Interventions
- Procedure Laparoscopic sleeve gastrectomy using 48-Fr bougie
After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie. - Procedure Laparoscopic sleeve gastrectomy using standard care bougie
After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
Primary outcome measures
- Postoperative gastric leak rate [Time frame: 30 days following the procedure]
Secondary outcome measures (4)
- Postoperative morbidity rate [Time frame: 90 days following the procedure]
- Short-term weight loss [Time frame: At 3 and 6 months after the procedure]
- Mid-term weight loss [Time frame: At 1 and 2 years after the procedure]
- Quality of life related to health [Time frame: At 3 months, 6 months, 1 year and 2 years after the procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 12 centers
- Hôpital Ambroise Paré — Boulogne-Billancourt
- Hôpital Côte de Nacre CHU de Caen — Caen
- CHU Antoine Béclère — Clamart
- Centre hospitalier Intercommunal de Créteil — Créteil
- Hôpital MICHALLON, CHU de Grenoble — La Tronche
- Hôpital Dupuytren - Limoges — Limoges
- Clinique de l'Yvette — Longjumeau
- Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat — Paris
- … and 4 more centers
Publications
- Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3. PMID 34781991
Identifiers
NCT: NCT02937649 · P150933