Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-02-07
2030-01-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Nissen fundoplication
Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication
Nissen fundoplication
Hiatal hernia repair and Nissen fundoplication
Dor fundoplication
Hiatal hernia repair and Dor (anterior 180-degree) fundoplication
Dor fundoplication
Hiatal hernia repair and Dor fundoplication
Interventions
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Nissen fundoplication
Hiatal hernia repair and Nissen fundoplication
Dor fundoplication
Hiatal hernia repair and Dor fundoplication
Eligibility Criteria
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Inclusion Criteria
* 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
* Need for esophageal lengthening procedure (Collis)
* Gangrene or need for any resection during (emergency) surgery
* Need for laparotomy or thoracotomy/thoracoscopy
* No written consent
18 Years
ALL
No
Sponsors
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Kuopio University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ville Palomäki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital
Locations
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Kuopio University Hospital
Kuopio, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KUH5204535
Identifier Type: -
Identifier Source: org_study_id
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