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Risk Factors for Morbidity After Parastomal Hernia Repair (PAHEREP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01484743
First received: November 30, 2011
Last updated: December 1, 2011
Last verified: December 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 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:

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 after operation ] [ Designated as safety issue: No ]
    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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Frederik Helgstrand, MD, University Hospital Koge
ClinicalTrials.gov Identifier: NCT01484743     History of Changes
Other Study ID Numbers: Parastoma
Study First Received: November 30, 2011
Last Updated: December 1, 2011
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013