NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair

What this Trial Is About

Hiatal hernia can cause various symptoms, and traditional surgical repair often uses Nissen fundoplication. However, recurrence and the need for additional surgery remain common. This randomized controlled trial compares Nissen and Dor fundoplication techniques to see which method better prevents hiatal hernia from coming back and lowers the chance of needing another operation. The study is sponsored by Kuopio University Hospital and focuses on patients undergoing minimally invasive surgery for hiatal hernia repair. Participants will be randomly assigned to receive either Nissen fundoplication, which is a 360-degree posterior wrap, or Dor fundoplication, an anterior 180-degree wrap, during their hiatal hernia surgery. The primary evaluation occurs 12 months after surgery, using computed tomography scans and symptom assessments to measure anatomical and symptomatic hernia recurrence. The study also looks at medication use for acid reflux, quality of life related to gastroesophageal reflux disease (GERD), and swallowing difficulties. A long-term follow-up using national registry data will monitor reoperation rates and medication use for up to 20 years. During the study, participants will have postoperative scans and symptom evaluations at 12 months to assess the success of the surgery and any recurrence. Researchers will track outcomes such as hernia size, use of proton pump inhibitors, and the effects of factors like age, body mass index, and albumin levels on recurrence and reoperation. Long-term data collection through registries will continue to monitor these outcomes for two decades, providing comprehensive information about the durability and impact of the two surgical methods.

Nissen Versus Dor Hiatal Hernia Repair