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

Epigastric Hernia Clinical Trial

— EPI-WOMEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750368
• Other study ID #: women-epigastric
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3031
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epigastric Hernia
• Hernia
• Hernia, Abdominal

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation for recurrence	operation for recurrence during the observation period	4 year
Secondary	Readmittance	readmittance within 90 days after repair	90 days
Secondary	operation for complications	90 days operation for complications	90 days