Nissen Versus Dor Hiatal Hernia Repair

Recruiting now · Not applicable

Conditions studied: Hiatal Hernia, Paraesophageal Hernia, Recurrence

In brief

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

Key facts

Study ID

NCT06725433

Run by

Kuopio University Hospital

People needed

150

Starts

2025-02-07

Expected to finish

2030-01-30

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Kuopio University Hospital — Kuopio, Finland (enrolling)

Full record on ClinicalTrials.gov

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