search
Back to results

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

Primary Purpose

Umbilical Hernias, Ventral Hernias

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Proceed Ventral Patch placement
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Umbilical Hernias focused on measuring Umbilical and small ventral hernias less than 3cm diameter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imelda Hospital
  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proceed Ventral Patch placement

Arm Description

Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

Outcomes

Primary Outcome Measures

Percentage of adequately placed patches

Secondary Outcome Measures

Perioperative morbidity rate
Pre- and postoperative pain
Number of patients needed a repositioning of the patch
Reasons for inadequate positioning
Number of repositioning necessary
Complication ratio
Recurrence rate at 1 year

Full Information

First Posted
August 12, 2010
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson
search

1. Study Identification

Unique Protocol Identification Number
NCT01183325
Brief Title
Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernias, Ventral Hernias
Keywords
Umbilical and small ventral hernias less than 3cm diameter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proceed Ventral Patch placement
Arm Type
Experimental
Arm Description
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Intervention Type
Device
Intervention Name(s)
Proceed Ventral Patch placement
Intervention Description
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Primary Outcome Measure Information:
Title
Percentage of adequately placed patches
Time Frame
At T 0 days
Secondary Outcome Measure Information:
Title
Perioperative morbidity rate
Time Frame
Within 30 days
Title
Pre- and postoperative pain
Time Frame
At T 0 day, T 30 days and T 1 year
Title
Number of patients needed a repositioning of the patch
Time Frame
At T 0 days
Title
Reasons for inadequate positioning
Time Frame
At T 0 days
Title
Number of repositioning necessary
Time Frame
At T 0 days
Title
Complication ratio
Time Frame
At 1 year
Title
Recurrence rate at 1 year
Time Frame
At 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs