Late Mesh Complications After 3258 Incisional Hernia Operations

June 26, 2018 updated by: Frederik Helgstrand, Zealand University Hospital
The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

Study Overview

Status

Completed

Conditions

Detailed Description

All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Study Type

Observational

Enrollment (Actual)

3258

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
      • Køge, Denmark, 4600
        • Køge Sygehus

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 tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Description

Inclusion Criteria:

  • Incisional Hernia Repair

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
Danish Hernia Database
Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: Up to 7 years
Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair
Up to 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: Up to 7 years
Riskfactors for readmission later than 30 days after incisional hernia repair
Up to 7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Up to 7 years
Riskfactors for death later than 30 days after incisional hernia repair
Up to 7 years

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Dunja Kokotovic, MS, Dept. of Surgery, Køge University 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)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

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

  • DK_02

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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