Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1658 participants
INTERVENTIONAL
2020-10-08
2027-09-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laparoscopic sleeve gastrectomy using 48-Fr bougie
Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie
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
Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Hadrien TRANCHART, Dr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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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-Etienne, , France
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Aziz KARAA, Dr
Role: primary
Tigran POGHOSYAN, Dr
Role: primary
Antonio D'ALESSANDRO, Dr
Role: primary
Jean-Marc CATHELINE
Role: primary
Laurent BRUNAUD, Dr
Role: primary
References
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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.
Other Identifiers
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P150933
Identifier Type: -
Identifier Source: org_study_id
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