NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Anatomical recurrence of hiatal hernia
研究概览
简要总结
Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation
Participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •At least 18 years of age
- •Type II-IV hiatal hernia, confirmed by radiology or endoscopy
- •Scheduled for mini-invasive hiatal hernia repair
- •Emergency mini-invasive surgery for hiatal hernia
- •The informed consent is acquired
排除标准
- •Recurrent hiatal hernia
- •Need for esophageal lengthening procedure (Collis)
- •Gangrene or need for any resection during (emergency) surgery
- •Need for laparotomy or thoracotomy/thoracoscopy
- •No written consent
结局指标
主要结局
Anatomical recurrence of hiatal hernia
时间窗: 12 months after the surgery
Computed tomography based recurrence after Nissen versus Dor fundoplication
Symptomatic recurrence of hiatal hernia
时间窗: 12 months after the surgery
Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence
次要结局
- Symptomatic versus asymptomatic recurrence rates(12 months)
- Reoperation rates(20 years)
- Managing GERD symptoms with Nissen vs Dor fundoplication(12 months)
- Dysphagia symptoms after Nissen vs Dor fundoplication(12 months)
- Hiatal hernia size and recurrence rates(12 months)
- Proton pump inhibitor usage(20 years)
- The impact of Body Mass Index on recurrence and reoperation rates(20 years)
- The impact of age on recurrence and reoperation rates(20 years)
- The impact of albumin level on recurrence and reoperation rates(20 years)