The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ)
研究概览
简要总结
The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ)
时间窗: Baseline, 12 months
The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia.
Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire
时间窗: Day 1, 12 months
The Intermediate and Late Post-Operative Pain, Nausea and Dysphagia Questionnaire is a 7-item questionnaire with scores ranging 0-40 with the higher score indicating severe symptoms.
Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q)
时间窗: Baseline, 12 months
The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD.
Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire
时间窗: Day 1, 12 months
The Rhodes Index of Nausea, Vomiting and Retching Questionnaire is an 8-item questionnaire with scores ranging from 0 to 32 with a higher score indicating increased symptoms of nausea.
次要结局
- Correlation of the presence of hiatal hernias(Day 1)
研究者
Nestor De La Cruz-Munoz
Professor
University of Miami