Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

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

Study Overview

• Status: Completed
• Conditions: Recurrent Hernia of Anterior Abdominal Wall

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 Type: Observational
• Enrollment (Actual): 3578

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Fertile female patients who have undergone ventral hernia repair

Description

Inclusion Criteria:

• Fertile female patient

Exclusion Criteria:

• non-Danish citizen

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: University of Copenhagen
• Investigators: Study Chair: Lars N Jorgensen, MD, DMSc, Bispebjerg Hospital, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Recurrence; Hernia, Ventral
• Other Study ID Numbers: eoma2