Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up
Sponsor study identifier
interventional
160
1 country
2
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 12, 2010
Actual (reported)August 17, 2010
Actual (reported)April 2011
Actual (reported)September 2013
Actual (reported)Percentage of adequately placed patches
At T 0 days
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
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Imelda Hospital
Bonheiden, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
Frederik Berrevoet, MD
University Hospital, Ghent
160 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2010
First Posted
August 17, 2010
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2011
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
December 5, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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