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Risk Factors for Morbidity After Parastomal Hernia Repair (PAHEREP)

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ClinicalTrials.gov Identifier: NCT01484743
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, Zealand University Hospital

Brief Summary:
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 or disease Intervention/treatment
Parastomal Hernia Procedure: differences in surgical techniques

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.

Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair
Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



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



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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

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
Zealand University Hospital
Investigators
Principal Investigator: Frederik Helgstrand, MD Dept. surgery Koege hospital

Responsible Party: Frederik Helgstrand, MD, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01484743     History of Changes
Other Study ID Numbers: Parastoma
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical