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Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01665859
First received: August 13, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.

The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.


Condition
Umbilical Hernia
Epigastric Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Epigastric and Umbilical 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:
  • readmission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair


Secondary Outcome Measures:
  • reoperation for recurrence [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Risk factors for recurrence repair after umbilical or epigastric hernia repair


Enrollment: 6783
Study Start Date: January 2007
Study Completion Date: July 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Danish Ventral Hernia Database
Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010

Detailed Description:

All elective umbilical or epigastric 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 elective umbilical or epigastric hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Criteria

Inclusion Criteria:

  • Umbilical or epigastric hernia repair

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665859

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: NCT01665859     History of Changes
Other Study ID Numbers: FH09
Study First Received: August 13, 2012
Last Updated: August 13, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University Hospital Koge:
readmission
recurrence
umbilical
epigastric
 hernia
outcome
morbidity

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Hernia, Umbilical
 Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral

ClinicalTrials.gov processed this record on May 19, 2013