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

December 4, 2014 updated by: University Hospital, Ghent

Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Imelda Hospital
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of adequately placed patches
Time Frame: At T 0 days
At T 0 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative morbidity rate
Time Frame: Within 30 days
Within 30 days
Pre- and postoperative pain
Time Frame: At T 0 day, T 30 days and T 1 year
At T 0 day, T 30 days and T 1 year
Number of patients needed a repositioning of the patch
Time Frame: At T 0 days
At T 0 days
Reasons for inadequate positioning
Time Frame: At T 0 days
At T 0 days
Number of repositioning necessary
Time Frame: At T 0 days
At T 0 days
Complication ratio
Time Frame: At 1 year
At 1 year
Recurrence rate at 1 year
Time Frame: At 1 year
At 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Johnson & Johnson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (ESTIMATE)

August 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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