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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
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, Zealand University Hospital

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 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
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederik Helgstrand, MD, Zealand University Hospital
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, Zealand University Hospital:
ventral hernia
repair
clinical
reoperation

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