Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06725433

Nissen Versus Dor Hiatal Hernia Repair

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Kuopio University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDURENissen fundoplicationHiatal hernia repair and Nissen fundoplication
PROCEDUREDor fundoplicationHiatal hernia repair and Dor fundoplication

Timeline

Start date
2025-02-07
Primary completion
2030-01-30
Completion
2030-01-30
First posted
2024-12-10
Last updated
2025-02-19

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT06725433. Inclusion in this directory is not an endorsement.