Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

Ghent University Hospital (UZ)

Status: Completed

Conditions: Ventral Hernias; Umbilical Hernias

Treatments: Device: Proceed Ventral Patch placement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01183325

2009/291

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient
• Written informed consent
• Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion criteria

• Hernias larger than 3cm
• Recurrence
• Children
• Emergency cases
• Incisional hernias

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Proceed Ventral Patch placement

Experimental group

Description:

Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

Treatment:

Device: Proceed Ventral Patch placement