Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

Recurrent Hernia of Anterior Abdominal Wall Clinical Trial

Official title:

Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564757
• Other study ID #: eoma2
• Status: Completed
• Phase: N/A
• First received: September 29, 2015
• Last updated: January 30, 2017
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3578
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 45 Years

Eligibility

Inclusion Criteria:

• Fertile female patient

Exclusion Criteria:

• non-Danish citizen

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Recurrence
• Recurrent Hernia of Anterior Abdominal Wall

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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