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Enrolling by Invitation

NCT Number: NCT03025932

Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.

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Key information

Conditions

Hiatal Hernia Large

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age older than 18 years
  • Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
  • Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication
  • Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion criteria

  • Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
  • Performance of anterior fundoplication without mesh
  • Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study

Treatment and study plan

repair of giant hiatal hernia with mesh and anterior fundoplication

Procedure

Primary outcomes

  1. Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan

    Time frame: minimum 1 year after surgery

    To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography

Secondary outcomes

  1. Quality of life by GIQLI

    Time frame: minimum 1 year after surgery

    Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery

  2. Clinical outcome

    Time frame: minimum 1 year after surgery

    Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.

  3. Peri- and postoperative morbidity / mortality

    Time frame: minimum 1 year after surgery

    Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination

Sponsors and collaborators

Lead sponsor

Prof Urs Zingg

Other

Registry information

Official study title

Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2017
Registry last updated
Jun 9, 2026

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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