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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00572962
First received: December 11, 2007
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose
  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 Intervention
Ventral Hernia
 Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity rate [ Time Frame: perioperative ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: within 1 week ] [ Designated as safety issue: No ]
  • long term complication rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00572962     History of Changes
Other Study ID Numbers: 2007/268
Study First Received: December 11, 2007
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013