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: December 3, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 3, 2013
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 August 28, 2014