| NCT ID | NCT06725433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kuopio University Hospital |
| Condition | Hiatal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2030-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-02-07 with a primary completion date of 2030-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ville Palomäki, MD, PhD
PRINCIPAL INVESTIGATOR
Kuopio University Hospital
Frequently Asked Questions
Who can join the NCT06725433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiatal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725433 currently recruiting?
Yes, NCT06725433 is actively recruiting participants. Contact the research team at Ville.Palomaki@pshyvinvointialue.fi for enrollment information.
Where is the NCT06725433 trial being conducted?
This trial is being conducted at Kuopio, Finland.
Who is sponsoring the NCT06725433 clinical trial?
NCT06725433 is sponsored by Kuopio University Hospital. The principal investigator is Ville Palomäki, MD, PhD at Kuopio University Hospital. The trial plans to enroll 150 participants.