Overview

This trial is active, not recruiting.

Condition recurrent hernia of anterior abdominal wall
Sponsor Bispebjerg Hospital
Collaborator University of Copenhagen
Start date September 2015
End date January 2016
Trial size 3600 participants
Trial identifier NCT02564757, eoma2

Summary

The investigators will examine if pregnancy increases risk of ventral hernia recurrence

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence
time frame: 0-7 years
Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair
time frame: 0-8 years

Eligibility Criteria

Female participants from 12 years up to 45 years old.

Inclusion Criteria: - Fertile female patient Exclusion Criteria: - non-Danish citizen

Additional Information

Official title Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
Description The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR). From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence. From CPR, date of death or emigration will be noted. Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.