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

January 21, 2025 updated by: Erling Oma, Bispebjerg Hospital
Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

7200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Digestive Disease Center, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Nationwide population of patients registered in the Danish Ventral Hernia Database

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Emergency umbilical hernia repair
no study intervention
Elective umbilical hernia repair
no study intervention
Emergency epigastric hernia repair
no study intervention
Elective epigastric hernia repair
no study intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operation for hernia recurrence
Time Frame: Until december 31, 2023
Until december 31, 2023

Secondary Outcome Measures

Outcome Measure
Time Frame
Operation for non-recurrence complication
Time Frame: Until december 31, 2023
Until december 31, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2023-193
  • R-23045342 (Other Identifier: Team for journaldata, Center for sundhed)
  • DHDB-2023-04-03 (Other Identifier: Dansk herniedatabase)
  • FSEID-00006723 (Other Identifier: Sundhedsdatastyrelsen)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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