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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01183325

Enrollment

160

Registered

2010-08-17

Start date

2009-09-30

Completion date

2013-09-30

Last updated

2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Umbilical Hernias, Ventral Hernias

Keywords

Umbilical and small ventral hernias less than 3cm diameter

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.

Interventions

DEVICEProceed Ventral Patch placement

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of adequately placed patches	At T 0 days

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026