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

This study has been terminated.
(patients had to be converted to the other study arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498810
First Posted: July 10, 2007
Last Update Posted: January 28, 2011
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.
Information provided by:
University Hospital, Ghent
July 9, 2007
July 10, 2007
January 28, 2011
September 2007
January 2008   (Final data collection date for primary outcome measure)
recurrence rate [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00498810 on ClinicalTrials.gov Archive Site
  • Perioperative morbidity rate
  • Postoperative pain
  • Long term complication rate
  • Recurrence rate [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Incisional Hernia
  • Procedure: complete repair
  • Procedure: partial repair of the abdominal wall
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
January 2008
January 2008   (Final data collection date for primary outcome measure)

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  • All patients with mesh placed intra-abdominally during surgery have to be withdrawn
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00498810
2007/241
No
Not Provided
Not Provided
Frederik Berrevoet, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
University Hospital, Ghent
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP