Self-Expanding Multi-Layered Partially Resorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment of Small and Medium Umbilical Ventral Hernias
Meshes-devices using dual-sided mesh technology have been developed for the specific indication of small ventral hernias. The design of these meshes allows introduction of a mesh of appropriate size to cover the hernia defect, through a small incision. This technique is very attractive for the surgeon and the patients because the mesh usually can be introduced through a nearly invisible scar in the umbilicus. The avoidance of fixation sutures omits the pain related to these sutures. Short-term results and patient satisfaction are very favorable, encouraging the surgeons to continue with the technique, although long-term results of these meshes in good quality studies are lacking.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Multicenter Prospective Clinical Registry To Evaluate The Safety And Efficacy Of A Self-Expanding Multi-Layered Partially Resorbable Absorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment Of Small And Medium Umbilical Ventral Hernias|
- Hernia recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
The aim of this study is to evaluate the safety and efficacy at 12 months after repair of small and medium ventral hernias using PVP™. All patients operated between March 2009 and February 2011 at the participating centers, will be evaluated and described. Patients will be evaluated by clinical investigation, questioning and ultrasound. The investigators' main focus will be the incidence of complications related to the use of the device, during the first year. Also the investigators look at recurrence rate at 12 months, occurrence of pain at 12 months and foreign body feeling. The trial can be seen as a quality control of a cohort of patients treated with an innovative mesh device. No sponsoring from the company J&J will be asked or accepted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307696
|AZ Maria Middelares|
|Ghent, Oost Vlaanderen, Belgium, 9000|
|Principal Investigator:||Jan Bontinck||Algemeen Ziekenhuis Maria Middelares|