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

Umbilical Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307696
• Other study ID #: MM
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: April 25, 2014
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Hernia, Ventral
• Umbilical Hernia

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent	Oost Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

References & 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/s1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence		1 year	No