NCT06725433

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Feb 2025Jan 2030

First Submitted

Initial submission to the registry

November 26, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2030

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5 years

First QC Date

November 26, 2024

Last Update Submit

February 17, 2025

Conditions

Hiatal HerniaParaesophageal HerniaRecurrence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Symptomatic versus asymptomatic recurrence rates

    12 months

  • Reoperation rates

    20 years

  • Managing GERD symptoms with Nissen vs Dor fundoplication

    12 months

  • Dysphagia symptoms after Nissen vs Dor fundoplication

    12 months

  • Hiatal hernia size and recurrence rates

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Nissen fundoplication

ACTIVE COMPARATOR

Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication

Procedure: Nissen fundoplication

Dor fundoplication

EXPERIMENTAL

Hiatal hernia repair and Dor (anterior 180-degree) fundoplication

Procedure: Dor fundoplication

Interventions

Nissen fundoplicationPROCEDURE

Hiatal hernia repair and Nissen fundoplication

Nissen fundoplication
Dor fundoplicationPROCEDURE

Hiatal hernia repair and Dor fundoplication

Dor fundoplication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70200, Finland

RECRUITING

MeSH Terms

Conditions

Hernia, HiatalRecurrence

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ville Palomäki, MD, PhD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ville Palomäki, MD, PhD

CONTACT

+35817 173 311Ville.Palomaki@pshyvinvointialue.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective open label randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 10, 2024

Study Start

February 7, 2025

Primary Completion (Estimated)

January 30, 2030

Study Completion (Estimated)

January 30, 2030

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)