Clinical Trial: Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome: Percentage of adequately placed patches [ Time Frame: At T 0 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Perioperative morbidity rate [ Time Frame: Within 30 days ]
- Pre- and postoperative pain [ Time Frame: 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 ]
- Reasons for inadequate positioning [ Time Frame: At T 0 days ]
- Number of repositioning necessary [ Time Frame: At T 0 days ]
- Complication ratio [ Time Frame: At 1 year ]
- Recurrence rate at 1 year [ Time Frame: At 1 year ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: August 12, 2010
Date Started: September 2009
Date Completion:
Last Updated: December 4, 2014
Last Verified: December 2014
