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

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ClinicalTrials.gov Identifier: NCT00498810
Recruitment Status : Terminated (patients had to be converted to the other study arm)
First Posted : July 10, 2007
Last Update Posted : January 28, 2011
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment
Incisional Hernia Procedure: complete repair Procedure: partial repair of the abdominal wall

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
Study Start Date : September 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Perioperative morbidity rate
  2. Postoperative pain
  3. Long term complication rate
  4. Recurrence rate [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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  • All patients with mesh placed intra-abdominally during surgery have to be withdrawn

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): NCT00498810


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

Additional Information:
Responsible Party: Frederik Berrevoet, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00498810     History of Changes
Other Study ID Numbers: 2007/241
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

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