Comparing two surgical methods for hiatal hernia repair
NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
NA · Kuopio University Hospital · NCT06725433
This study is testing which of two surgical methods for fixing hiatal hernias works better to prevent them from coming back and improve quality of life for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kuopio University Hospital (other) |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT06725433 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two surgical techniques, Nissen fundoplication and Dor fundoplication, in preventing the recurrence of hiatal hernias. Participants will be randomly assigned to one of the two procedures during minimally invasive surgery. The study will assess anatomical and symptomatic recurrence rates, the use of anti-reflux medications, and quality of life related to gastroesophageal reflux disease (GERD) at 12 months post-operation. Additionally, a long-term follow-up will analyze reoperation rates using national registry data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type II-IV hiatal hernias scheduled for minimally invasive repair.
Not a fit: Patients with recurrent hiatal hernias or those requiring additional surgical procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with hiatal hernias.
How similar studies have performed: Previous studies have shown varying success rates with different surgical techniques for hiatal hernia repair, making this comparison relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Recurrent hiatal hernia * Need for esophageal lengthening procedure (Collis) * Gangrene or need for any resection during (emergency) surgery * Need for laparotomy or thoracotomy/thoracoscopy * No written consent
Where this trial is running
Kuopio
- Kuopio University Hospital — Kuopio, Finland (RECRUITING)
Study contacts
- Principal investigator: Ville Palomäki, MD, PhD — Kuopio University Hospital
- Study coordinator: Ville Palomäki, MD, PhD
- Email: Ville.Palomaki@pshyvinvointialue.fi
- Phone: +35817 173 311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiatal Hernia, Paraesophageal Hernia, Recurrence