Comparing bougie sizes in sleeve gastrectomy for morbid obesity
Compares two bougie sizes during stomach surgery for severe obesity, to see leak rates.
Plain-language title generated from the registry record
Registry title: Bougie Sleeve Trial
Key facts
- Where
- Boulogne-Billancourt, Caen, Clamart, Créteil, La Tronche, Limoges, Longjumeau, Paris, Poissy, Saint-Denis, Saint-Etienne, and Vandœuvre-lès-Nancy, FranceSee the 12 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT02937649, who can take part
Where in France
- Hôpital Ambroise-ParéBoulogne-Billancourt, FranceNo longer taking part
- Hôpital Côte de Nacre - CHU de CaenCaen, FranceNo longer taking part
- CHU Antoine BéclèreClamart, FranceTaking people
- Centre Hospitalier Intercommunal de CréteilCréteil, FranceNo longer taking part
- Hôpital MICHALLON, CHU de GrenobleLa Tronche, FranceNo longer taking part
- Hôpital Dupuytren - LimogesLimoges, FranceNo longer taking part
- Clinique de l'YvetteLongjumeau, FranceTaking people
- Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital BichatParis, FranceTaking people
- CHI - Centre Hospitalier Poissy/Saint-Germain-en-LayePoissy, FranceTaking people
- CH Saint DenisSaint-Denis, FranceTaking people
- Clinique Mutualiste ChirurgicaleSaint-Etienne, FranceNo longer taking part
- Hôpitaux de BraboisVandœuvre-lès-Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT02937649
- Record updated
- 6 April 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Previous upper abdominal surgery (cholecystectomy excepted); Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures); Coagulation disorder; Patient with known silicon allergy (calibration bougie contains medical silicon); ASA (American Society of Anesthesiologists) score > 3; Ongoing pregnancy or breast feeding; Patient not covered by social security service and patient on AME; Patient under legal guardianship and trusteeship; 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.