Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Incidence of serious surgery-related adverse events
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Incidence of serious surgery-related adverse events
时间窗: 10 years after surgery
A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The "surgery-related" character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study.
次要结局
- Dyslipidemia remission(10 years after surgery)
- Obstructive sleep apnea remission(10 years after surgery)
- GERD(10 years after surgery)
- Nutritional biological status , assessed by evaluation of malnutrition parameters(10 years after surgery)
- Diabetes remission(10 years after surgery)
- Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires(10 years after surgery)
- Excess weight loss percentage(10 years after surgery)
- incidence of serious adverse events not related to surgery(10 years after surgery)
- Quality of life by BAROS score (Bariatric analysis and reporting outcome system)(10 years after surgery)
- Nutritional clinical status, assessed by dietitian evaluation(10 years after surgery)
- Metabolic comorbidities remission(10 years after surgery)
- Hypertension remission(10 years after surgery)