- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430676
Risk Factors for Morbidity After Incisional Hernia Repairs
June 26, 2018 updated by: Frederik Helgstrand, Zealand University Hospital
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 incisional hernia repair.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All principal incisional 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)
3460
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
-
-
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Køge, Denmark, 4600
- Køge Hospital
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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 |
Intervention / Treatment |
---|---|
Danish Ventral Hernia Database
Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010
|
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
|
Risk factors for recurrence repair after incisional hernia repair
|
up to 4 years
|
Readmission
Time Frame: 30 days after operation
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Riskfactors for readmission within 30 days after incisional hernia repair
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30 days after operation
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Reoperation
Time Frame: 30 days
|
Riskfactors for reoperation (any procedure) within 30 days after incisional hernia repair
|
30 days
|
Death
Time Frame: 30 days
|
Riskfactors for death within 30 days after incisional hernia repair
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30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frederik Helgstrand, MD, dept. surgery, Køge sygehus, Denmark
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)
January 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
September 5, 2011
First Submitted That Met QC Criteria
September 7, 2011
First Posted (Estimate)
September 8, 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
- FH-2
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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