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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01325246
Other study ID # FH-1
Secondary ID
Status Completed
Phase N/A
First received September 14, 2010
Last updated December 3, 2013
Start date September 2010
Est. completion date June 2011

Study information

Verified date December 2013
Source University Hospital Koge
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations.

The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.


Description:

all patients in a restricted area (all patients in the part of Denmark called Zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). The patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.


Recruitment information / eligibility

Status Completed
Enrollment 945
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Primary ventral hernia repair performed in the region of Zealand in Denmark

Exclusion Criteria:

- Patients who died and patients not resident in region Zealand

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Dept. of surgery, Køge Hospital Køge

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical recurrence after ventral hernia repair up to 4 years No
Secondary explanations for not having a recurrence repair up to 4 years No
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