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NCT02263612 Clinical Trial

Late Mesh Complications After 3258 Incisional Hernia Operations

Incisional Hernia Clinical Trial

Official title:
Late Mesh Complications After 3258 Incisional Hernia Operations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02263612
Other study ID # DK_02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2007
Est. completion date September 2015

Study information
Verified date June 2018
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3258
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Incisional Hernia Repair

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Køge Sygehus Køge

Sponsors (1)
Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Death Riskfactors for death later than 30 days after incisional hernia repair Up to 7 years
Primary Reoperation Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair Up to 7 years
Secondary Readmission Riskfactors for readmission later than 30 days after incisional hernia repair Up to 7 years
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Completed NCT05579652 - Change in Fascial Tension in Open Abdomens
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