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NCT01665859 Clinical Trial

Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

Umbilical Hernia Clinical Trial

Official title:
Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01665859
Other study ID # FH09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2007
Est. completion date July 2012

Study information
Verified date July 2023
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results. The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.

Description:

All elective umbilical or epigastric 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.

Recruitment information / eligibility
Status Completed
Enrollment 6783
Est. completion date July 2012
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - Umbilical or epigastric hernia repair Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Køge Hospital Køge

Sponsors (1)
Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary readmission Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair 30 days
Secondary reoperation for recurrence Risk factors for recurrence repair after umbilical or epigastric hernia repair up to 4 years
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Completed NCT01607801 - Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair N/A
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