A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).
研究概览
简要总结
The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.
详细描述
The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
- •> 18 years of age and < 75 years of age
排除标准
- •hiatal hernias measuring > 7 cm
- •esophageal body amplitude < 30 or in two or more segments
- •< 40% propagated peristaltic waves
- •GE junction > 5 cm above the esophageal hiatus
- •dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
- •body mass index > 40
结局指标
主要结局
Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).
时间窗: 1 year
Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.
次要结局
未报告次要终点