ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors for Morbidity After Incisional Hernia Repairs

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.
ClinicalTrials.gov Identifier: NCT01430676
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : December 1, 2011
Sponsor:
Information provided by (Responsible Party):
Frederik Helgstrand, University Hospital Koge

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 incisional hernia repair.

Condition or disease Intervention/treatment
Incisional Hernia Procedure: differences in surgical techniques

Detailed Description:
All principal incisional 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 : 3460 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Morbidity After Incisional Hernia Repairs
Study Start Date : January 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Group/Cohort Intervention/treatment
Danish Ventral Hernia Database
Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010
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 ]
    Risk factors for recurrence repair after incisional hernia repair

  2. Readmission [ Time Frame: 30 days after operation ]
    Riskfactors for readmission within 30 days after incisional hernia repair

  3. Reoperation [ Time Frame: 30 days ]
    Riskfactors for reoperation (any procedure) within 30 days after incisional hernia repair

  4. Death [ Time Frame: 30 days ]
    Riskfactors for death within 30 days after incisional hernia repair



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 tha Danish National Hernia Database from January 1st 2007 to December 31st 2010
Criteria

Inclusion Criteria:

  • Incisional hernia repair

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): NCT01430676


Locations
Denmark
Køge Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
Principal Investigator: Frederik Helgstrand, MD dept. surgery, Køge sygehus, Denmark

Responsible Party: Frederik Helgstrand, MD., University Hospital Koge
ClinicalTrials.gov Identifier: NCT01430676     History of Changes
Other Study ID Numbers: FH-2
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by Frederik Helgstrand, University Hospital Koge:
Incisional hernia
recurrence
longterm

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes