Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06
1658
Participants Needed
12
Research Sites
117 weeks
Total Duration
Researchers are evaluating how the size of the bougie used during laparoscopic sleeve gastrectomy (LSG) affects the rate of postoperative stomach leaks, which is the most common and serious complication after this weight loss surgery. This prospective randomized trial compares the use of a larger 48-Fr bougie to standard smaller bougie sizes (34, 36, or 38 Fr) to see if a bigger diameter lowers leak risk without reducing long-term weight loss. Participants will undergo laparoscopic sleeve gastrectomy using either the 48-Fr bougie or a standard care bougie. The bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach before the gastrectomy is performed alongside it. Patients do not know which bougie size they receive. This study aims to assess differences in leak rates and weight loss outcomes between the two bougie sizes. During the study, researchers will monitor participants for stomach leaks within 30 days after surgery as the primary outcome. Secondary outcomes include complications within 90 days, weight loss at 3, 6, 12, and 24 months, and quality of life up to 2 years. Participants will have follow-up visits for these assessments to track recovery, safety, and weight changes over time.
CONDITIONS
Bougie Sleeve Trial
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day or until discharge
Participants undergo laparoscopic sleeve gastrectomy using either a 48-Fr bougie or a standard care bougie. The surgery is followed by immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 2 years
Participants are monitored for postoperative gastric leak, morbidity, and recovery, including assessments of weight loss and quality of life.
Follow-up visits at 3 months, 6 months, 1 year, and 2 years
Total: 12 locations
1
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92104
Suspended
2
Hôpital Côte de Nacre CHU de Caen
Caen, France, 14033
Withdrawn
3
CHU Antoine Béclère
Clamart, France, 92140
Actively Recruiting
4
Centre hospitalier Intercommunal de Créteil
Créteil, France, 94010
Withdrawn
5
Hôpital MICHALLON, CHU de Grenoble
La Tronche, France, 38700
Withdrawn
6
Hôpital Dupuytren - Limoges
Limoges, France, 87042
Withdrawn
7
Clinique de l'Yvette
Longjumeau, France, 91120
Actively Recruiting
8
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
Paris, France, 75018
Actively Recruiting
9
CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
Poissy, France, 78300
Actively Recruiting
10
CH Saint-Denis
Saint-Denis, France, 93200
Actively Recruiting
11
Clinique Mutualiste Chirurgicale
Saint-Etienne, France, 42100
Withdrawn
12
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
H
Hadrien TRANCHART, Dr
I
Ibrahim DAGHER, Pr
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Martin Gaillard, Panagiotis Lainas, Hélène Agostini...
https://pubmed.ncbi.nlm.nih.gov/34781991