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

Ventral Hernias Clinical Trial

Official title:

Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183325
• Other study ID #: 2009/291
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: December 4, 2014
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Johnson & Johnson

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adequately placed patches		At T 0 days	No
Secondary	Perioperative morbidity rate		Within 30 days	No
Secondary	Pre- and postoperative pain		At T 0 day, T 30 days and T 1 year	No
Secondary	Number of patients needed a repositioning of the patch		At T 0 days	No
Secondary	Reasons for inadequate positioning		At T 0 days	No
Secondary	Number of repositioning necessary		At T 0 days	No
Secondary	Complication ratio		At 1 year	No
Secondary	Recurrence rate at 1 year		At 1 year	No

External Links

•   Website of University Hospital Ghent