Risk Factors for Morbidity After Parastomal Hernia Repair (PAHEREP)

June 26, 2018 updated by: Frederik Helgstrand, Zealand University Hospital

Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All principal parastomal hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Study Type

Observational

Enrollment (Actual)

199

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
    • Region Sjælland
      • Køge, Region Sjælland, Denmark, 4600
        • Køge 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All incisional hernia repairs registered in the Danish National Hernia Database from January 1st 2007 to December 31st 2010

Description

Inclusion Criteria:

  • All parastomal hernia repairs registered in the Danish National Ventral Hernia Database

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
Patients with parastomal hernia repair
Patients registered in the Danish Ventral Hernia database
Procedure: differences in surgical techniques
follow the risk for morbidity after incisional hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence repair
Time Frame: up to 4 years after operation
Surgical risk factors for recurrence repair after parastomal hernia repair.
up to 4 years after operation

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Frederik Helgstrand, MD, Dept. surgery Koege 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

January 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parastoma

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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