Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair

Active, not recruiting

• Conditions: Umbilical Hernia; Epigastric Hernia

• Registration Number: NCT06783036
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

Detailed Description

Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7200

Inclusion Criteria

• Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
• Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database

Exclusion Criteria

• Hernia type misclassification (based on manual medical file review)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operation for hernia recurrence	Until december 31, 2023

Secondary Outcome Measures

Name	Time	Method
Operation for non-recurrence complication	Until december 31, 2023

Trial Locations

Locations (1)

Digestive Disease Center, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark