RecruitingNot ApplicableNCT06725433

Nissen Versus Dor Hiatal Hernia Repair

NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair


Sponsor

Kuopio University Hospital

Enrollment

150 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

PROCEDURENissen fundoplication

Hiatal hernia repair and Nissen fundoplication

PROCEDUREDor fundoplication

Hiatal hernia repair and Dor fundoplication


Locations(1)

Kuopio University Hospital

Kuopio, Finland

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NCT06725433


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