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

September 14, 2010
December 3, 2013
September 2010
March 2011   (final data collection date for primary outcome measure)
Clinical recurrence after ventral hernia repair [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01325246 on ClinicalTrials.gov Archive Site
explanations for not having a recurrence repair [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair
Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

1200 patients who had a ventral hernia repair in 2007

Ventral Hernia
Not Provided
Not Provided
Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T. Reoperation versus clinical recurrence rate after ventral hernia repair. Ann Surg. 2012 Dec;256(6):955-8. doi: 10.1097/SLA.0b013e318254f5b9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
945
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01325246
FH-1
No
Frederik Helgstrand, University Hospital Koge
University Hospital Koge
Not Provided
Principal Investigator: Frederik Helgstrand, MD dept. of surgery, Køge Hospital
University Hospital Koge
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP