Nissen Versus Dor Hiatal Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nissen fundoplication, Dor fundoplication.
- Who it may be relevant to
- Registry conditions: Hiatal Hernia, Paraesophageal Hernia, Recurrence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
Overview
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
Interventions
- Procedure Nissen fundoplication
Hiatal hernia repair and Nissen fundoplication - Procedure Dor fundoplication
Hiatal hernia repair and Dor fundoplication
Primary outcome measures
- Anatomical recurrence of hiatal hernia [Time frame: 12 months after the surgery]
- Symptomatic recurrence of hiatal hernia [Time frame: 12 months after the surgery]
Secondary outcome measures (9)
- Symptomatic versus asymptomatic recurrence rates [Time frame: 12 months]
- Reoperation rates [Time frame: 20 years]
- Managing GERD symptoms with Nissen vs Dor fundoplication [Time frame: 12 months]
- Dysphagia symptoms after Nissen vs Dor fundoplication [Time frame: 12 months]
- Hiatal hernia size and recurrence rates [Time frame: 12 months]
- Proton pump inhibitor usage [Time frame: 20 years]
- The impact of Body Mass Index on recurrence and reoperation rates [Time frame: 20 years]
- The impact of age on recurrence and reoperation rates [Time frame: 20 years]
- The impact of albumin level on recurrence and reoperation rates [Time frame: 20 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Finland · 1 center
- Kuopio University Hospital — Kuopio
Identifiers
NCT: NCT06725433 · KUH5204535