Bougie Sleeve Trial

Morbid Obesity Clinical Trial

— BOUST  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02937649
• Other study ID #: P150933
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hadrien TRANCHART, Dr
• Phone: (+33)145374037
• Email: hadrien.tranchart[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1658
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	Hôpital Côte de Nacre CHU de Caen	Caen
France	CHU Antoine Béclère	Clamart
France	Centre hospitalier Intercommunal de Créteil	Créteil
France	Hôpital MICHALLON, CHU de Grenoble	La Tronche
France	Hôpital Dupuytren - Limoges	Limoges
France	Clinique de l'Yvette	Longjumeau
France	Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat	Paris
France	CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye	Poissy
France	CH Saint-Denis	Saint-Denis
France	Clinique Mutualiste Chirurgicale	Saint-Étienne
France	Hôpitaux de Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative morbidity rate	Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.	90 days following the procedure
Secondary	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
Secondary	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
Secondary	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