Clinical trial NCT01307696: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Hernia
Keywords: Umbilical Hernia Repair
PVP Mesh
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* no informed consent from the patient.
* patients lost to follow up.

Primary outcomes:
measure: Hernia recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: Oost Vlaanderen
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Jan Bontinck
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.