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

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05750368
• Collaborator: Herlev Hospital (Other)
• Enrollment: 3,031
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 603

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epigastric Hernia; Women With Epigastric Hernias

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 Design

• Study Type: Observational
• Actual Enrollment: 3031 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
• Actual Study Start Date: Sep 1, 2022
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
women undergoing epigastric hernia repair all women who have undergone epigastric hernia repair open or laparoscopic in Denmark during af 4-year period from January 1st, 2018, to Dec 31st, 2021.

Outcome Measures

Primary Outcome Measures

1. operation for recurrence [4 year]

   operation for recurrence during the observation period

Secondary Outcome Measures

1. Readmittance [90 days]

   readmittance within 90 days after repair

2. operation for complications [90 days]

   90 days operation for complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Copenhagen		Denmark	2400

Sponsors and Collaborators

• Bispebjerg Hospital
• Herlev Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mette Willaume, MD, ph.d., Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT05750368
• Other Study ID Numbers: women-epigastric
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Hernia, Abdominal

Study Results

No Results Posted as of Mar 7, 2023