Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

Обзор

The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted. The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).

Вмешательства

• Другое Ten year evaluation
  Clinical, biological and endoscopic evaluation

Первичные конечные точки

• Incidence of serious surgery-related adverse events [Срок оценки: 10 years after surgery]

Вторичные конечные точки (12)

• incidence of serious adverse events not related to surgery [Срок оценки: 10 years after surgery]
• Nutritional biological status , assessed by evaluation of malnutrition parameters [Срок оценки: 10 years after surgery]
• Nutritional clinical status, assessed by dietitian evaluation [Срок оценки: 10 years after surgery]
• Excess weight loss percentage [Срок оценки: 10 years after surgery]
• Metabolic comorbidities remission [Срок оценки: 10 years after surgery]
• Diabetes remission [Срок оценки: 10 years after surgery]
• Hypertension remission [Срок оценки: 10 years after surgery]
• Obstructive sleep apnea remission [Срок оценки: 10 years after surgery]
• Dyslipidemia remission [Срок оценки: 10 years after surgery]
• Quality of life by BAROS score (Bariatric analysis and reporting outcome system) [Срок оценки: 10 years after surgery]
• Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires [Срок оценки: 10 years after surgery]
• GERD [Срок оценки: 10 years after surgery]

Критерии участия

Критерии включения

• Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center.
• Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center.
• Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years
• Patients who gave their consent
• Patients with health insurance coverage

Критерии исключения

• Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009)
• Persons deprived of liberty, under guardianship, or under curatorship
• Patients included in a protocol with a conflict of interest with OMEGA10.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne — Lille

Идентификаторы

NCT: NCT04930029 · 2020_82 · 2020-A03156-33

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗