Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega (OMEGA10)
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).
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Robert CAIAZZO, MD,PhD
- 电话号码：+33 0320445962
- 邮箱：robert.caiazzo@chru-lille.fr
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
This study involves patients:
- operated between 2008 and 2013 for an OAGB with a 150 or 200cm biliary limb
- fulfilling the HAS criteria(HAS, 2009) at the time of their surgery: BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with a comorbidity likely to be improved by weight loss
- benefiting from a follow-up.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
OAGB150
One anastomosis gastric bypass with 150cm biliary limb
|
Clinical, biological and endoscopic evaluation
|
|
OAGB200
One anastomosis gastric bypass with 200cm biliary limb
|
Clinical, biological and endoscopic evaluation
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of serious surgery-related adverse events
大体时间：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.
|
10 years after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
incidence of serious adverse events not related to surgery
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Nutritional biological status , assessed by evaluation of malnutrition parameters
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Nutritional clinical status, assessed by dietitian evaluation
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Excess weight loss percentage
大体时间：10 years after surgery
|
calculated as follows: (weight at 10 years - initial weight) / (initial weight - ideal weight) x 100 The ideal weight is defined as the weight corresponding to a BMI = 25 kg/m2.
The initial weight is the weight on the day of surgery.
|
10 years after surgery
|
|
Metabolic comorbidities remission
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Diabetes remission
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Hypertension remission
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Obstructive sleep apnea remission
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Dyslipidemia remission
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)
大体时间：10 years after surgery
|
10 years after surgery
|
|
|
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires
大体时间：10 years after surgery
|
The GIQLI is a score to evaluate digestive disorders in 36 items, ranging from 0 (the worst quality of life) to 144 (the best quality of life).
|
10 years after surgery
|
|
GERD
大体时间：10 years after surgery
|
GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia
|
10 years after surgery
|
合作者和调查者
调查人员
- 首席研究员：Robert CAIAZZO, MD,PhD、University Hospital, Lille
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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