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NCT Number: NCT06725433

Nissen Versus Dor 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

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Key information

Conditions

Hiatal Hernia Disease Attributes Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Paraesophageal Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70200, Finland

Location status: Recruiting

Location contact

Ville A. Palomäki, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nissen fundoplication

Procedure

Hiatal hernia repair and Nissen fundoplication

Dor fundoplication

Procedure

Hiatal hernia repair and Dor fundoplication

Primary outcomes

  1. Anatomical recurrence of hiatal hernia

    Time frame: 12 months after the surgery

    Computed tomography based recurrence after Nissen versus Dor fundoplication

  2. 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

Secondary outcomes

  1. Symptomatic versus asymptomatic recurrence rates

    Time frame: 12 months

    Symptomatic versus asymptomatic recurrence rates at 12 months

  2. Reoperation rates

    Time frame: 20 years

    Reoperation rates at 3-, 5-, 10- and 20-years following the surgery

  3. Managing GERD symptoms with Nissen vs Dor fundoplication

    Time frame: 12 months

    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.

  4. Dysphagia symptoms after Nissen vs Dor fundoplication

    Time frame: 12 months

    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.

  5. Hiatal hernia size and recurrence rates

    Time frame: 12 months

    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."

  6. Proton pump inhibitor usage

    Time frame: 20 years

    Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery

  7. The impact of Body Mass Index on recurrence and reoperation rates

    Time frame: 20 years

    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)

  8. The impact of age on recurrence and reoperation rates

    Time frame: 20 years

    The impact of subject age (years) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)

  9. The impact of albumin level on recurrence and reoperation rates

    Time frame: 20 years

    The impact of albumin level (g/l) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)

Study contacts

Contact information is provided by the study sponsor or research team.

Ville Palomäki, MD, PhD

CONTACT

[email protected]

+35817 173 311

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair

Acronym: NiDor

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 10, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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