Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01183325
First received: August 12, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.

About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).

With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.

The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.


Condition Intervention
Umbilical Hernias
Ventral Hernias
Device: Proceed Ventral Patch placement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Percentage of adequately placed patches [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative morbidity rate [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Pre- and postoperative pain [ Time Frame: At T 0 day, T 30 days and T 1 year ] [ Designated as safety issue: No ]
  • Number of patients needed a repositioning of the patch [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Reasons for inadequate positioning [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Number of repositioning necessary [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Complication ratio [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Recurrence rate at 1 year [ Time Frame: At 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Device: Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient
  • Written informed consent
  • Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion Criteria:

  • Hernias larger than 3cm
  • Recurrence
  • Children
  • Emergency cases
  • Incisional hernias
  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: NCT01183325

Locations
Belgium
Imelda Hospital
Bonheiden, 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01183325     History of Changes
Other Study ID Numbers: 2009/291
Study First Received: August 12, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Umbilical and small ventral hernias less than 3cm diameter

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Hernia, Ventral
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 01, 2014