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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Nissen fundoplication | Hiatal hernia repair and Nissen fundoplication |
| PROCEDURE | Dor fundoplication | Hiatal 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.