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OpenTrials
Completed

NCT Number: NCT02564757

Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

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

Completed

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Key information

Conditions

Recurrent Hernia of Anterior Abdominal Wall Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

12 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fertile female patient

Exclusion criteria

  • non-Danish citizen

Treatment and study plan

Primary outcomes

  1. Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence

    Time frame: 0-7 years

    Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.

  2. Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair

    Time frame: 0-8 years

    Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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