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Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01325246
First received: September 14, 2010
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Ventral Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • Clinical recurrence after ventral hernia repair [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • explanations for not having a recurrence repair [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 945
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

1200 patients who had a ventral hernia repair in 2007

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325246

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

No publications provided by University Hospital Koge

Additional 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
Study First Received: September 14, 2010
Last Updated: November 30, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Koge:
ventral hernia
repair
clinical
reoperation

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

ClinicalTrials.gov processed this record on May 23, 2013