Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

• Conditions: Hiatal Hernia Large
• Interventions: Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication

• Registration Number: NCT03025932
• Lead Sponsor: Prof Urs Zingg

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient cohort	repair of giant hiatal hernia with mesh and anterior fundoplication	Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication

Primary Outcome Measures

Name	Time	Method
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan	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 Outcome Measures

Name	Time	Method
Peri- and postoperative morbidity / mortality	minimum 1 year after surgery	Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination
Quality of life by GIQLI	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
Clinical outcome	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.