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
  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:


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
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: 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 August 18, 2014