About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Recurrent hiatal hernia
Need for esophageal lengthening procedure (Collis)
Gangrene or need for any resection during (emergency) surgery
Need for laparotomy or thoracotomy/thoracoscopy
Trial design
Treatments tested in this trial
- Nissen fundoplication
- Dor fundoplication
Treatment groups
Locations
1Sponsors and collaborators
Kuopio University Hospital
Lead sponsor