An interventional study of Nissen fundoplication and Dor fundoplication in Hiatal Hernia, Paraesophageal Hernia and Recurrence, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Prevention
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
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication
Procedure: Nissen fundoplication
Hiatal hernia repair and Dor (anterior 180-degree) fundoplication
Procedure: Dor fundoplication
Hiatal hernia repair and Nissen fundoplication
Hiatal hernia repair and Dor fundoplication
Anatomical recurrence of hiatal hernia
Computed tomography based recurrence after Nissen versus Dor fundoplication
Time frame: 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
Time frame: 12 months after the surgery
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates at 12 months
Time frame: 12 months
Reoperation rates
Reoperation rates at 3-, 5-, 10- and 20-years following the surgery
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 12 months
Proton pump inhibitor usage
Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 20 years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Jan 2030, 59 months after the start.
Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 59 months is close to that.
How these figures are worked out, and which studies are left out of them.
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