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