Actively Recruiting
Bougie Sleeve Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06
1658
Participants Needed
12
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bougie Sleeve Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 70 years
- Sleeve gastrectomy as a primary bariatric procedure
- Body Mass Index (BMI) > 40 kg/m6 or > 35 kg/m6 with at least one related health condition such as hypertension, sleep apnea, severe respiratory disorders, type 2 diabetes, severe joint disorders, or non-alcoholic steatohepatitis
- Decision for surgery made after multidisciplinary discussion
- Provided written informed consent
You will not qualify if you...
- Previous upper abdominal surgery (except gallbladder removal)
- American Society of Anesthesiologists (ASA) score greater than 3
- Current pregnancy or breastfeeding
- Esophagus diseases such as varices, diverticula, tumors, or strictures
- Blood clotting disorders
- Not covered by social security or under AME
- Under legal guardianship or trusteeship
- Known allergy to silicone
- Any other contraindications to using an esophageal bougie as identified by medical literature or the treating physician
AI-Screening
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Trial Site Locations
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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
Research Team
H
Hadrien TRANCHART, Dr
CONTACT
I
Ibrahim DAGHER, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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