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Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT00572962
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2007
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
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: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
Study Start Date : January 2008
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair



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 ]


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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): NCT00572962


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00572962     History of Changes
Other Study ID Numbers: 2007/268
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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