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Risk Factors for Morbidity After Parastomal Hernia Repair (PAHEREP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484743
First Posted: December 2, 2011
Last Update Posted: December 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge
  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 parastomal hernia repair.

Condition Intervention
Parastomal Hernia Procedure: differences in surgical techniques

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Frederik Helgstrand, University Hospital Koge:

Primary Outcome Measures:
  • Recurrence repair [ Time Frame: up to 4 years after operation ]
    Surgical risk factors for recurrence repair after parastomal hernia repair.


Enrollment: 199
Study Start Date: January 2007
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with parastomal hernia repair
Patients registered in the Danish Ventral Hernia database
Procedure: differences in surgical techniques
follow the risk for morbidity after incisional hernia repair

Detailed Description:
All principal parastomal 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All incisional hernia repairs registered in the Danish National Hernia Database from January 1st 2007 to December 31st 2010
Criteria

Inclusion Criteria:

  • All parastomal hernia repairs registered in the Danish National Ventral Hernia Database
  Contacts and Locations
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): NCT01484743


Locations
Denmark
Køge Hospital
Køge, Region Sjælland, Denmark, 4600
Sponsors and Collaborators
University Hospital Koge
Investigators
Principal Investigator: Frederik Helgstrand, MD Dept. surgery Koege hospital
  More Information

Responsible Party: Frederik Helgstrand, MD, University Hospital Koge
ClinicalTrials.gov Identifier: NCT01484743     History of Changes
Other Study ID Numbers: Parastoma
First Submitted: November 30, 2011
First Posted: December 2, 2011
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by Frederik Helgstrand, University Hospital Koge:
recurrence
readmission
reoperation
mortality
morbidity

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical