Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Обзор

The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy. This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy. Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life). The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)

Вмешательства

• Процедура sleeve gastrectomy
  The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
• Процедура sleeve gastrectomy with omentopexy
  After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature

Первичные конечные точки

• Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone [Срок оценки: 2 years postoperatively]

Критерии участия

Критерии включения

• Patient ≥ 18 years old,
• Patient to be operated in first intention of a sleeve gastrectomy
• Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.

OR initial BMI ≥ 40 Kg/m².

• Multidisciplinary follow-up of at least 6 months before surgery
• Validation of the surgical intervention in a multidisciplinary consultation meeting
• Certificate of no contraindication by a psychiatrist
• Patient who has the capacity to understand the protocol and has given consent to participate in the research,
• Patient with social security coverage.

Критерии исключения

• Eating disorder or mental disorder
• Misunderstanding of the protocol
• Psychiatric contraindication
• Initial BMI <35Kg/m².
• Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
• Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
• CARLSSON score (score ≥ 4) preoperatively
• Presence of a Proton-Pump Inhibitors treatment
• Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
• Patient participating in another interventional clinical research protocol involving a drug or medical device
• Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
• Patient under guardianship, curators or legal protection,P

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 · 9 центров

• CH de la Cote Basque — Bayonne
• CHD Vendée — La Roche-sur-Yon
• Centre Hospitalier Emile Roux — Le Puy-en-Velay
• CHU Nantes — Nantes
• Clinique Jules Verne — Nantes
• Centre Hospitalier Régional et Universitaire d'Orléans — Orléans
• Hopital Pontchaillou — Rennes
• Clinique Mutualiste de la Sagesse — Rennes
• … и ещё 1 центр

Идентификаторы

NCT: NCT04994665 · CHD21_0032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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