Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Number of participants with GERD post-op
研究概览
简要总结
Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.
详细描述
Prospective Randomized Controlled Trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair. Patients with known objective gastroesophageal reflux disease prior to surgery, those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements and/or endoscopic valve grade will be excluded.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing laparoscopic paraesophageal hernia repair
排除标准
- •History of a prior hiatal hernia/paraesophageal hernia repair
- •Patients with objective GERD preoperatively
- •Intra-operative short esophagus
- •Defective gastroesophageal reflux barrier as determined by impedance planimetry (FLIP)
- •Defective gastroesophageal reflux barrier as determined by intra-operative endoscopy
研究组 & 干预措施
Control Group
Fundoplication
Study Group
No Fundoplication
干预措施: Laparoscopic paraesophageal hernia repair without fundoplication (Procedure)
结局指标
主要结局
Number of participants with GERD post-op
时间窗: 12 months
Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair.
次要结局
- Number of participants with hernia recurrence(12 months)
研究者
Christy M. Dunst
Program Director Complex GI-Foregut Fellowship, Providence Portland Medical Center
The Oregon Clinic