Outcomes After Epigastric Hernia Repair in Women.

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: NCT06074146
• Other study ID #: EPI-WOMEN
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Nationwide cohort study on women undergoing epigastric hernia repair

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3031
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• females undergoing epigastric hernia repair in Denmark

Exclusion Criteria:

• emergency repair umbilical hernias incisional hernias males

Related Conditions & MeSH terms

• Epigastric Hernia
• Hernia
• Hernia, Abdominal

Locations

Country	Name	City	State
Denmark	Mette Willaume	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hernia recurrence	reoperation for recurrence	end of study