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Risk Factors for Morbidity After Incisional Hernia Repairs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01430676
First received: September 5, 2011
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after incisional hernia repair.


Condition Intervention
Incisional Hernia
 Procedure: differences in surgical techniques

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Morbidity After Incisional Hernia Repairs

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:
  • Recurrence repair [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Risk factors for recurrence repair after incisional hernia repair

  • Readmission [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
    Riskfactors for readmission within 30 days after incisional hernia repair

  • Reoperation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Riskfactors for reoperation (any procedure) within 30 days after incisional hernia repair

  • Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Riskfactors for death within 30 days after incisional hernia repair


Enrollment: 3460
Study Start Date: January 2007
Study Completion Date: November 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Danish Ventral Hernia Database
Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010
 Procedure: differences in surgical techniques
follow the risk for morbidity after incisional hernia repair

Detailed Description:

All principal incisional hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

  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

All incisional hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Criteria

Inclusion Criteria:

  • Incisional hernia repair
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430676

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

No publications provided

Responsible Party: Frederik Helgstrand, MD., University Hospital Koge
ClinicalTrials.gov Identifier: NCT01430676     History of Changes
Other Study ID Numbers: FH-2
Study First Received: September 5, 2011
Last Updated: November 30, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by University Hospital Koge:
Incisional hernia
recurrence
longterm

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 18, 2013