NCT01848184

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Hernia

Interventions

Type	Name	Description
DEVICE	PARIETEX™ Composite Ventral Patch	PARIETEX™ Composite Ventral Patch for ventral hernia repair

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-05-07
• Last updated: 2018-07-20
• Results posted: 2018-07-20

Locations

10 sites across 4 countries: United States, Belgium, Denmark, Sweden