Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325246
• Other study ID #: FH-1
• 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

• Hernia
• Hernia, Ventral
• Ventral Hernia

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