Pregnancy Subsequent to Ventral Hernia Repair

January 11, 2016 updated by: Erling Oma, Bispebjerg Hospital

Pregnancy Subsequent to Ventral Hernia Repair: a Nationwide Cohort Study

We will examine the outcome of ventral hernia repair with subsequent pregnancy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Digestive disease center, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Nationwide study population of patients registered with a ventral hernia repair in The Danish Hernia Database between January 1 2007 and December 31 2014

Description

Inclusion Criteria:

  • History of ventral hernia repair with subsequent pregnancy
  • Born between January 1 1955 and January 1 1995

Exclusion Criteria:

  • Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort

Patients with a history of ventral hernia repair (umbilical/epigastric and incisional) with subsequent pregnancy

Ventral hernia repair - perioperative factors of interest:

- mesh vs sutured repair, age, planned vs emergency repair, open vs laparoscopic approach,

Pregnancy and delivery - factors of interest:

- vaginal vs caesearan section, single vs multiple pregnancy

Subgroup of patients with mesh repair:

- subanalysis on main attributes

Subgroup of patients with sutured repair:

- mono- vs multifilament, slowly vs rapidly absorbable
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of ventral hernia
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

Investigators

  • Study Chair: Lars N Jorgensen, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH-2015-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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