COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

This study has been terminated.
(patients had to be converted to the other study arm)
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00498810
First received: July 9, 2007
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.


Condition Intervention
Incisional Hernia
Procedure: complete repair
Procedure: partial repair of the abdominal wall

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Perioperative morbidity rate
  • Postoperative pain
  • Long term complication rate
  • Recurrence rate [ Time Frame: 3 years ]

Estimated Enrollment: 160
Study Start Date: September 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent from the patient or his/her legal representative
  • Incisional hernia requiring elective surgical repair

Exclusion Criteria:

  • No written informed consent
  • Emergency surgery (incarcerated hernia)
  • All incisional or parastomal hernias not originating at the midline
  • All recurrent hernias
  • All patients with mesh placed intra-abdominally during surgery have to be withdrawn
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498810

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Frederik Berrevoet, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00498810     History of Changes
Other Study ID Numbers: 2007/241
Study First Received: July 9, 2007
Last Updated: January 27, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 22, 2014