Comparing two surgical methods for hiatal hernia repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.