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
  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 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
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: 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 September 11, 2014