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  • All patients with mesh placed intra-abdominally during surgery have to be withdrawn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
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: 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 August 20, 2014