Clinical trial NCT02937649: Bougie Sleeve Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Bariatric surgery
Sleeve gastrectomy
Staple-line Leak
Bougie
Calibration
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 1658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Postoperative gastric leak rate
timeFrame: 30 days following the procedure
Secondary outcomes:
measure: Postoperative morbidity rate
timeFrame: 90 days following the procedure
measure: Short-term weight loss
timeFrame: At 3 and 6 months after the procedure
measure: Mid-term weight loss
timeFrame: At 1 and 2 years after the procedure
measure: Quality of life related to health
timeFrame: At 3 months, 6 months, 1 year and 2 years after the procedure
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Caen
country: France
facility: Hôpital Côte de Nacre CHU de Caen
city: Clamart
country: France
facility: CHU Antoine Béclère
city: Créteil
country: France
facility: Centre hospitalier Intercommunal de Créteil
city: La Tronche
country: France
facility: Hôpital MICHALLON, CHU de Grenoble
city: Limoges
country: France
facility: Hôpital Dupuytren - Limoges
city: Longjumeau
country: France
facility: Clinique de l'Yvette
city: Paris
country: France
facility: Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
city: Poissy
country: France
facility: CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
city: Saint-Denis
country: France
facility: CH Saint-Denis
city: Saint-Étienne
country: France
facility: Clinique Mutualiste Chirurgicale
city: Vandœuvre-lès-Nancy
country: France
facility: Hôpitaux de Brabois
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hadrien TRANCHART, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.