Nissen Versus Dor Hiatal Hernia Repair (NiDor)

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

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Hiatal Hernia; Paraesophageal Hernia
• Intervention / Treatment: Procedure: Nissen fundoplication; Procedure: Dor fundoplication

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ville Palomäki, MD, PhD; Phone Number: +35817 173 311; Email: Ville.Palomaki@pshyvinvointialue.fi

Study Locations

• Finland
  • Kuopio, Finland, 70200
    • Recruiting
    • Kuopio University Hospital
    • Contact: Ville A. Palomäki, MD, PhD; Email: Ville.Palomaki@pshyvinvoitialue.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nissen fundoplication; Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication	Procedure: Nissen fundoplication; Hiatal hernia repair and Nissen fundoplication
Experimental: Dor fundoplication; Hiatal hernia repair and Dor (anterior 180-degree) fundoplication	Procedure: Dor fundoplication; Hiatal hernia repair and Dor fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical recurrence of hiatal hernia	Computed tomography based recurrence after Nissen versus Dor fundoplication	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	12 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic versus asymptomatic recurrence rates	Symptomatic versus asymptomatic recurrence rates at 12 months	12 months
Reoperation rates	Reoperation rates at 3-, 5-, 10- and 20-years following the surgery	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.	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.	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."	12 months
Proton pump inhibitor usage	Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery	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)	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)	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)	20 years

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Investigators: Principal Investigator: Ville Palomäki, MD, PhD, Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): January 30, 2030

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Internal Hernia; Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Hernia, Diaphragmatic; Recurrence; Hernia; Hernia, Hiatal
• Other Study ID Numbers: KUH5204535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No