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Nissen Versus Dor Hiatal Hernia Repair

NCT06725433 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-02-19

No results posted yet for this study

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

  • Hiatal Hernia
  • Paraesophageal Hernia
  • Recurrence

Interventions

PROCEDURE

Nissen fundoplication

Hiatal hernia repair and Nissen fundoplication

PROCEDURE

Dor fundoplication

Hiatal hernia repair and Dor fundoplication

Sponsors & Collaborators

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Ville Palomäki, MD, PhD · Kuopio University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2030-01-30
Completion
2030-01-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725433 on ClinicalTrials.gov