Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up
1 other identifier
interventional
160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 5, 2014
December 1, 2014
1.6 years
August 12, 2010
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of adequately placed patches
At T 0 days
Secondary Outcomes (7)
Perioperative morbidity rate
Within 30 days
Pre- and postoperative pain
At T 0 day, T 30 days and T 1 year
Number of patients needed a repositioning of the patch
At T 0 days
Reasons for inadequate positioning
At T 0 days
Number of repositioning necessary
At T 0 days
- +2 more secondary outcomes
Study Arms (1)
Proceed Ventral Patch placement
EXPERIMENTALPlacement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Interventions
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Eligibility Criteria
You may qualify if:
- Adult patient
- Written informed consent
- Umbilical, primary ventral hernias smaller than 3cm diameter
You may not qualify if:
- Hernias larger than 3cm
- Recurrence
- Children
- Emergency cases
- Incisional hernias
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Johnson & Johnsoncollaborator
Study Sites (2)
Imelda Hospital
Bonheiden, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik Berrevoet, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
August 17, 2010
Study Start
September 1, 2009
Primary Completion
April 1, 2011
Study Completion
September 1, 2013
Last Updated
December 5, 2014
Record last verified: 2014-12