NCT04845438Unknown不适用
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Private Healthcare Institution Clinical Hospital RGD-Medicine2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年12月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Success
研究概览
简要总结
MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications.
The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbid obesity
- •BMI above 35 kg/m2 with obesity related comorbidity
- •BMI above 40 kg/m2
- •undergoing MGB/OAGB
- •no bile reflux during preoperative period
排除标准
- •revisional operations
- •therapy-resistant bile reflux during preoperative period
- •history of bariatric surgery
结局指标
主要结局
Success
时间窗: 12 month
Determination of the BRI index in patients undergoing MGB/OAGB can be used as a screening method for diagnosing biliary reflux in order to prevent and develop tactic for further management of patients from a risk group of complications associated with the toxic effects of an aggressive bile
次要结局
未报告次要终点
研究者
研究点 (2)
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