Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

Completed

• Conditions: Recurrent Hernia of Anterior Abdominal Wall

• Registration Number: NCT02564757
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3578

Inclusion Criteria

• Fertile female patient

Exclusion Criteria

• non-Danish citizen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence	0-7 years	Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.
Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair	0-8 years	Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.