Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

NCT ID: NCT02564757

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Recurrent Hernia of Anterior Abdominal Wall

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Fertile female patient

Exclusion Criteria

* non-Danish citizen
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erling Oma

Research scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars N Jorgensen, MD, DMSc

Role: STUDY_CHAIR

Bispebjerg Hospital, University of Copenhagen

Other Identifiers

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eoma2

Identifier Type: -

Identifier Source: org_study_id

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