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

Completed

• Conditions: Women With Epigastric Hernias; Epigastric Hernia

• Registration Number: NCT05750368
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Status Verified: 2023-03
• Study First Posted: 2023-03-01
• Last Update Submitted: 2023-03-05
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3031

Inclusion Criteria

• All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.

Exclusion Criteria

• umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
operation for recurrence	4 year	operation for recurrence during the observation period

Secondary Outcome Measures

Name	Time	Method
Readmittance	90 days	readmittance within 90 days after repair
operation for complications	90 days	90 days operation for complications

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark