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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00572962
First received: December 11, 2007
Last updated: December 4, 2014
Last verified: December 2014
  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: 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:


Further study details as provided by University Hospital, Ghent:

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

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

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Study First Received: December 11, 2007
Last Updated: December 4, 2014

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

ClinicalTrials.gov processed this record on June 29, 2017