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

Medtronic

Status: Completed

Conditions: Hernia

Treatments: Device: PARIETEX™ Composite Ventral Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT01848184

COVPCOV0293

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 1 patient group

PARIETEX™ Composite Ventral Patch

Description:

PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning

Treatment:

Device: PARIETEX™ Composite Ventral Patch