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Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT01325246
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Ventral Hernia

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 945 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair
Study Start Date : September 2010
Primary Completion Date : March 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Clinical recurrence after ventral hernia repair [ Time Frame: up to 4 years ]

Secondary Outcome Measures :
  1. explanations for not having a recurrence repair [ Time Frame: up to 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1200 patients who had a ventral hernia repair in 2007

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325246

Dept. of surgery, Køge Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
University Hospital Koge
Principal Investigator: Frederik Helgstrand, MD dept. of surgery, Køge Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederik Helgstrand, MD, University Hospital Koge
ClinicalTrials.gov Identifier: NCT01325246     History of Changes
Other Study ID Numbers: FH-1
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Frederik Helgstrand, University Hospital Koge:
ventral hernia

Additional relevant MeSH terms:
Hernia, Ventral
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Hernia, Abdominal