Outcomes After Epigastric Hernia Repair in Women. (EPI-WOMEN)

October 6, 2023 updated by: Mette Willaume, Bispebjerg Hospital

Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study

Nationwide cohort study on women undergoing epigastric hernia repair

Study Overview

Status

Completed

Conditions

Detailed Description

Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias.

The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.

Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. A 100% follow-up was obtained by combining data from the National Civil Register. The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.

Study Type

Observational

Enrollment (Actual)

3031

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, 1660
        • Mette Willaume

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

Yes

Sampling Method

Non-Probability Sample

Study Population

females in Denmark undergoing epigastric hernia repair

Description

Inclusion Criteria:

  • females undergoing epigastric hernia repair in Denmark

Exclusion Criteria:

  • emergency repair umbilical hernias incisional hernias males

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hernia recurrence
Time Frame: end of study
reoperation for recurrence
end of study

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)

January 1, 2007

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-WOMEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

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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