Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2020
septembre 2027
28 août 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE ST-DENIS | TRANCHART Hadrien | 18/09/2025 17:37:54 | Contacter | ||
| CHI DE CRETEIL | TRANCHART Hadrien | 18/09/2025 17:37:54 | Contacter | ||
| CHI POISSY ST-GERMAIN | TRANCHART Hadrien | 18/09/2025 17:37:54 | Contacter | ||
| CLINIQUE DE L YVETTE | TRANCHART Hadrien | 18/09/2025 17:37:54 | Contacter | ||
| HOPITAL DE LA CROIX SAINT SIMON | TRANCHART Hadrien | 18/09/2025 17:37:54 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:37:54 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Antoine Béclère | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:37:53 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:37:53 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:37:53 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:37:54 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:37:54 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:37:54 | Contact (sur clinicalTrials) | ||||
| Centre hospitalier Intercommunal de Créteil - 94010 - Créteil - France | 18/09/2025 17:37:53 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Antoine Béclère - 92140 - Clamart - France | Hadrien TRANCHART, Dr | Contact (sur clinicalTrials) | |||
| Clinique de l'Yvette - 91120 - Longjumeau - France | Aziz KARAA, Dr | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste Chirurgicale - 42100 - Saint-Étienne - France | Contact (sur clinicalTrials) | ||||
| Hôpital Ambroise Paré - 92104 - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
| Hôpital Côte de Nacre CHU de Caen - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Hôpital Dupuytren - Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital MICHALLON, CHU de Grenoble - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux de Brabois - 54500 - Vandœuvre-lès-Nancy - France | Laurent BRUNAUD, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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