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EPI-WOMEN: Outcomes After Epigastric Hernia Repair in Women.

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06074146
Collaborator
(none)
3,031
Enrollment
1
Location
180
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nationwide cohort study on women undergoing epigastric hernia repair

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3031 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
    Actual Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. hernia recurrence [end of study]

      reoperation for recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • females undergoing epigastric hernia repair in Denmark
    Exclusion Criteria:
    • emergency repair umbilical hernias incisional hernias males

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mette Willaume Copenhagen Denmark 1660

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mette Willaume, Senior registrar, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT06074146
    Other Study ID Numbers:
    • EPI-WOMEN
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Hernia
    Hernia, Abdominal

    Study Results

    No Results Posted as of Oct 10, 2023