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

Not Applicable

Completed

• Conditions: Ventral Hernias; Umbilical Hernias
• Interventions: Device: Proceed Ventral Patch placement

• Registration Number: NCT01183325
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2011-04
• Study Completion: 2013-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of adequately placed patches	At T 0 days

Secondary Outcome Measures

Name	Time	Method
Reasons for inadequate positioning	At T 0 days
Perioperative morbidity rate	Within 30 days
Number of patients needed a repositioning of the patch	At T 0 days
Number of repositioning necessary	At T 0 days
Complication ratio	At 1 year
Pre- and postoperative pain	At T 0 day, T 30 days and T 1 year
Recurrence rate at 1 year	At 1 year

Trial Locations

Locations (2)

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium