Bougie Sleeve Trial

Официальное название

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

Обзор

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.

Подробное описание

Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Postoperative gastric leak rate [Срок оценки: 30 days following the procedure]

Вторичные конечные точки (4)

• Postoperative morbidity rate [Срок оценки: 90 days following the procedure]
• Short-term weight loss [Срок оценки: At 3 and 6 months after the procedure]
• Mid-term weight loss [Срок оценки: At 1 and 2 years after the procedure]
• Quality of life related to health [Срок оценки: At 3 months, 6 months, 1 year and 2 years after the procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 12 центров

• Hôpital Ambroise Paré — Boulogne-Billancourt
• Hôpital Côte de Nacre CHU de Caen — Caen
• CHU Antoine Béclère — Clamart
• Centre hospitalier Intercommunal de Créteil — Créteil
• Hôpital MICHALLON, CHU de Grenoble — La Tronche
• Hôpital Dupuytren - Limoges — Limoges
• Clinique de l'Yvette — Longjumeau
• Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat — Paris
• … и ещё 4 центра

Публикации

• 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. PMID 34781991

Идентификаторы

NCT: NCT02937649 · P150933

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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