Hiatal HerniaNiDorNCT06725433
Nissen Versus Dor Hiatal Hernia Repair
A study testing Nissen fundoplication and Dor fundoplication in people with Hiatal Hernia and Paraesophageal Hernia, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia, Paraesophageal Hernia, Recurrence
- What is being tested?
- Nissen fundoplication and Dor fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 7 Feb 2025to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70200
Ville A. Palomäki, MD, PhD, Ville.Palomaki@pshyvinvoitialue.fi
About this study
Official title: NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
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
- Conditions
- Hiatal Hernia, Paraesophageal Hernia, Recurrence
- Being tested
- Nissen fundoplication, Dor fundoplication
- Medical subject headings
- Hernia, Hiatal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nissen fundoplicationProcedure or surgery
Hiatal hernia repair and Nissen fundoplication
Dor fundoplicationProcedure or surgery
Hiatal hernia repair and Dor fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Nissen fundoplication | Active comparator | Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication Receives: Procedure: Nissen fundoplication |
| Dor fundoplication | Experimental | Hiatal hernia repair and Dor (anterior 180-degree) fundoplication Receives: Procedure: Dor fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical recurrence of hiatal hernia
Computed tomography based recurrence after Nissen versus Dor fundoplication
Measured: 12 months after the surgery
Symptomatic recurrence of hiatal hernia
Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence
Measured: 12 months after the surgery
Secondary outcomes (9)
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates at 12 months
Measured: 12 months
Reoperation rates
Reoperation rates at 3-, 5-, 10- and 20-years following the surgery
Measured: 20 years
Managing GERD symptoms with Nissen vs Dor fundoplication
The efficacy of Nissen vs Dor fundoplication techniques in improving the Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (GERD-HRQL) scores at 12 months. Minimum score 0 = no symptoms, maximum score 75 = worst symptoms.
Measured: 12 months
Dysphagia symptoms after Nissen vs Dor fundoplication
The effect of different fundoplication techniques on dysphagia symptoms assessed by Eating Assessment Tool (EAT-10 ) at 12 months. Score range from 0 to 40 with higher scores indicating more severe dysphagia.
Measured: 12 months
Hiatal hernia size and recurrence rates
The association between hiatal hernia size and recurrence rates. During surgery, the left-to-right and posterior-to-anterior dimensions of the hiatal opening, as well as whether more than 30% of stomach is herniated , will be recorded. These measurements will then be compared to postoperative recurrence rates."
Measured: 12 months
Proton pump inhibitor usage
Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery
Measured: 20 years
The impact of Body Mass Index on recurrence and reoperation rates
The impact of initial Body Mass Index (BMI, kg/m^2) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)
Measured: 20 years
The impact of age on recurrence and reoperation rates
The impact of subject age (years) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)
Measured: 20 years
The impact of albumin level on recurrence and reoperation rates
The impact of albumin level (g/l) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start7 Feb 2025
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open label randomized trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ville Palomäki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725433
- Sponsor's protocol ID
- KUH5204535
- Acronym
- NiDor
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
- ClinicalTrials.gov ID
- NCT06725433
- Acronym / sponsor ID
- NiDor / KUH5204535
- Conditions
- Hiatal Hernia, Paraesophageal Hernia, Recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective open label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Nissen fundoplication | Active comparator | Procedure: Nissen fundoplicationHiatal hernia repair and Nissen (posterior 360-degree) fundoplication |
| Dor fundoplication | Experimental | Procedure: Dor fundoplicationHiatal hernia repair and Dor (anterior 180-degree) fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nissen fundoplicationHiatal hernia repair and Nissen fundoplication | Procedure or surgery | Nissen fundoplication |
| Dor fundoplicationHiatal hernia repair and Dor fundoplication | Procedure or surgery | Dor fundoplication |
Primary outcome
Anatomical recurrence of hiatal hernia
Time frame: 12 months after the surgery
Computed tomography based recurrence after Nissen versus Dor fundoplication
Symptomatic recurrence of hiatal hernia
Time frame: 12 months after the surgery
Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ville Palomäki, MD, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen fundoplication and Dor fundoplication in people with Hiatal Hernia and Paraesophageal Hernia, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Palomäki, MD, PhD (+35817 173 311, Ville.Palomaki@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical recurrence of hiatal hernia (time frame: 12 months after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.