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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Contact Information
Primary
Ville Palomäki, MD, PhD
Ville.Palomaki@pshyvinvointialue.fi
+35817 173 311
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2030-01-30
Participants
Target number of participants: 150
Treatments
Active_comparator: Nissen fundoplication
Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication
Experimental: Dor fundoplication
Hiatal hernia repair and Dor (anterior 180-degree) fundoplication
Sponsors
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov