A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch

Study Overview
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Brief Summary
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The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.

Detailed Description
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Prospective, multicenter, multinational non-comparative study. Primary Endpoint: Primary hernia recurrence* rate at 24 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography. Secondary Endpoints: Primary hernia recurrence* rate at 1, 6 and 12 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography. (*Recurrence is defined as a clinically manifested bulge or a protrusion exacerbated by a Valsalva maneuver.) Safety Parameters: Deep and superficial infection (A Surgical Site Infection (SSI) will be defined in the study according to the Centers for Disease Control and Prevention (CDC) criteria for diagnosis of SSI). Pain / Chronic pain Other post-operative complications (complications related to visceral adhesions, Ileus, seroma, hematoma...) Analgesics consumption Risk factors (severity and treatment) Efficacy Parameters: Recurrence of primary ventral hernia Operative time Time of the mesh positioning Length of Hospital Stay Ease of use (Mesh handling and manipulability, comfort of use …) Return to daily activities/ work Patient satisfaction Patient comfort (Carolina's™ Comfort scale (CCS) - QoL questionnaire) Visit Schedule: Baseline visit (Preoperative) & Operative/Discharge visit Post-Op: Phone call Day 10 1 month 6 months 12 months 24 months Duration: 12 months recruitment and 24 months follow-up Up to 12 sites in Europe and the United States will be included in this study

Official Title
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A Multicentre Prospective Study in Patients Undergoing Ventral Hernia Repair by Open Approach With Intraperitoneal Positioning Using Parietex™ Composite Ventral Patch - Panacea Study.

Conditions
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Hernia

Intervention / Treatment
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* Device: PARIETEX™ Composite Ventral Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach Signed informed consent form by the patient or the legally authorized representative Intraoperative inclusion criteria :Size of the defect: ≤ 4 cm Exclusion Criteria: Emergency procedure Current participation in other trials History of previous hernia at the same location. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period Patient < 18 years BMI > 35 ASA score ≥ 4 The investigator determined that the patient will not be able to comply with the required follow-up visits

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PARIETEX™ Composite Ventral Patch<br>PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning | Device: PARIETEX™ Composite Ventral Patch<br>* PARIETEX™ Composite Ventral Patch for ventral hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Hernia Recurrence Rate at 24 Month Follow-up. | The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography. | 24 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate at 1, 6 and 12 Month Follow-up | The number of participants with hernia recurrence at 1 month, 6 month and 12 month follow-up visit. | 1, 6 and 12 month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PARIETEX Composite Ventral Patch, PCO VP OR PCOVP, Primary ventral hernia repair, Panacea