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Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

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ClinicalTrials.gov Identifier: NCT00573105
Recruitment Status : Terminated (slow inclusion rate)
First Posted : December 13, 2007
Last Update Posted : January 26, 2011
Sponsor:
Collaborator:
C. R. Bard
Information provided by:
University Hospital, Ghent

Brief Summary:
  1. General

    - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery

  2. Laparoscopic surgery

    • at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
    • with or without anchoring transparietal sutures or double crown technique

Condition or disease Intervention/treatment Phase
Ventral Hernia Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Study Start Date : February 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight Hernia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Laparoscopic Ventral hernia repair by heavy weight mesh
Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by heavy weight mesh
Experimental: 2
Laparoscopic Ventral hernia repair by lighter weight mesh
Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh
Laparoscopic Ventral hernia repair by lighter weight mesh



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

Secondary Outcome Measures :
  1. morbidity rate [ Time Frame: perioperative ]
  2. quality of life [ Time Frame: after 1 year ]
  3. postoperative pain [ Time Frame: within 1 week ]
  4. long term complication rate [ Time Frame: after 1 year ]


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
  • ventral hernia requiring elective surgical repair

Exclusion Criteria:

  • no written informed consent
  • 'hostile' abdomen; open abdomen treatment
  • contraindication to pneumoperitoneum
  • emergency surgery (incarcerated hernia)
  • parastomal hernia

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): NCT00573105


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

Additional Information:
Responsible Party: Frederik Berrevoet, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00573105     History of Changes
Other Study ID Numbers: 2007/421
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal