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
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
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
NCT ID
NCT01183325
First Posted
August 12, 2010
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson
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
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