Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02564757

Enrollment

3578

Registered

2015-10-01

Start date

2015-09-30

Completion date

2016-05-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Hernia of Anterior Abdominal Wall

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Fertile female patient

Exclusion criteria

* non-Danish citizen

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results