Bougie Sleeve Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie
* Procedure: Laparoscopic sleeve gastrectomy using standard care bougie


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic sleeve gastrectomy using 48-Fr bougie<br>Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie | Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie<br>* 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.<br>|
| Active Comparator: Laparoscopic sleeve gastrectomy using standard care bougie<br>Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr) | Procedure: Laparoscopic sleeve gastrectomy using standard care bougie<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative gastric leak rate | Postoperative gastric leak rate during the first month following the procedure will be proven either on: Morphologic examination (with contrast ingestion) Blue dye test during surgical reintervention or postoperative course Contrast opacification during endoscopy | 30 days following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity rate | Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure. | 90 days following the procedure | 
| Short-term weight loss | Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure. | At 3 and 6 months after the procedure | 
| Mid-term weight loss | Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure. | At 1 and 2 years after the procedure | 
| Quality of life related to health | Quality of life related to health will be assessed at 3 months, 6 months, 1 year and 2 years after the procedure with the validated GIQLI scale (Gastro Intestinal Quality of Life Index) | At 3 months, 6 months, 1 year and 2 years after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric surgery, Sleeve gastrectomy, Staple-line Leak, Bougie, Calibration