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

Completed

Conditions: Hernia

Interventions: Device: PARIETEX™ Composite Ventral Patch

Registration Number: NCT01848184

Lead Sponsor: Medtronic - MITG

Brief 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recurrence Rate at 1, 6 and 12 Month Follow-up	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.

Trial Locations

Locations (10): Surgicare of Missouri
🇺🇸
Jefferson City, Missouri, United States
Hernia Centers of Excellence
🇺🇸
Yorktown, Virginia, United States
Dr. ERIC KULLMAN
🇸🇪
Linköping, Östergötland, Sweden
Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
🇩🇰
Copenhagen, Denmark
Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent
🇧🇪
Ghent, Belgium
University of South Florida
🇺🇸
Tampa, Florida, United States
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
General Surgery - Imelda Hospital
🇧🇪
Bonheiden, Belgium
Our Lady of the Lake Regional Medical Center
🇺🇸
Baton Rouge, Louisiana, United States
Monmouth Medical Center
🇺🇸
Long Branch, New Jersey, United States