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

Study Overview
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Brief Summary
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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.

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

Conditions
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Umbilical Hernias, Ventral Hernias

Intervention / Treatment
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* Device: Proceed Ventral Patch placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proceed Ventral Patch placement<br>Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control | Device: Proceed Ventral Patch placement<br>* Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adequately placed patches |  | At T 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative morbidity rate |  | Within 30 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 | 
| Reasons for inadequate positioning |  | At T 0 days | 
| Number of repositioning necessary |  | At T 0 days | 
| Complication ratio |  | At 1 year | 
| Recurrence rate at 1 year |  | At 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical and small ventral hernias less than 3cm diameter