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

150 Participants
are divided into 2 treatment groups

Locations

1
Kuopio University Hospital70200, Kuopio Finland

Sponsors and collaborators

Kuopio University Hospital

Lead sponsor