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
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
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
Typical duration for all trials
1 active site
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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 28, 2014
April 1, 2014
3.7 years
March 2, 2011
April 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hernia recurrence
1 year
Eligibility Criteria
All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011, are eligible for the trial.
You may qualify if:
- All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011.
You may not qualify if:
- no informed consent from the patient.
- patients lost to follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AZ Maria Middelares
Ghent, Oost Vlaanderen, 9000, Belgium
Related Publications (1)
Bontinck J, Kyle-Leinhase I, Pletinckx P, Vergucht V, Beckers R, Muysoms F. Single centre observational study to evaluate the safety and efficacy of the Proceed Ventral Patch to repair small ventral hernias. Hernia. 2014 Oct;18(5):671-80. doi: 10.1007/s10029-013-1140-5. Epub 2013 Jul 24.
PMID: 23881401RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Bontinck
Algemeen Ziekenhuis Maria Middelares
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 3, 2011
Study Start
August 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 28, 2014
Record last verified: 2014-04