Viewing Study NCT05750368


Ignite Creation Date: 2025-12-24 @ 5:53 PM
Ignite Modification Date: 2026-01-02 @ 11:06 AM
Study NCT ID: NCT05750368
Status: COMPLETED
Last Update Posted: 2023-03-07
First Post: 2023-02-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Sponsor: Bispebjerg Hospital
Organization:

Study Overview

Official Title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EPI-WOMEN
Brief Summary: The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.
Detailed Description: Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.

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

Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: