Clinical trial NCT01848184: A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Keywords: PARIETEX Composite Ventral Patch
PCO VP OR PCOVP
Primary ventral hernia repair
Panacea
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients eligible for a primary ventral hernia repair with mesh by open approach (scheduled for non-emergent elective surgery with PCO VP) will be assessed for potential study participation (screening) and will be recorded in the patient log.

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

Eligibility criteria: 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

Primary outcomes:
measure: Primary Hernia Recurrence Rate at 24 Month Follow-up.
timeFrame: 24 month follow-up
Secondary outcomes:
measure: Recurrence Rate at 1, 6 and 12 Month Follow-up
timeFrame: 1, 6 and 12 month follow-up.
Other outcomes:
measure: Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months
timeFrame: Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)
measure: Summary of Risk Factors at Baseline
timeFrame: Baseline
measure: Mesh Handling Ease of Use During Surgery
timeFrame: Per- operative
measure: Other Relevant Data: Operative Time
timeFrame: Per- operative
measure: Other Relevant Data: Time of Mesh Positioning
timeFrame: Per- operative
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Jefferson City
country: United States
facility: Surgicare of Missouri
state: Missouri
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Yorktown
country: United States
facility: Hernia Centers of Excellence
state: Virginia
city: Bonheiden
country: Belgium
facility: General Surgery - Imelda Hospital
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Ghent
country: Belgium
facility: Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent
city: Copenhagen
country: Denmark
facility: Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
city: Linköping
country: Sweden
facility: Dr. ERIC KULLMAN
state: Östergötland
Study officials:
affiliation: University Hospital Ghent (Belgium)
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital, University of Copenhagen (Denmark)
name: Lars N Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgicare of MO (United States)
name: Carl Doerhoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hernia Centers of Excellence, VA (United States)
name: Steven Hopson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicinskt Centrum i Linköping (Sweden)
name: Eric KULLMAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, University Hospital Tor Vergata, Roma (Italy)
name: Marco G MUZI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis, EJ EINDHOVEN (The Netherlands)
name: Simon NIENHUIJS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Algemene Heelkunde, AZ Maria Middelares Ghent (Belgium)
name: Filip E Muysoms, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imelda Hospital, Bonheiden (Belgium)
name: Tim Tollens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Our Lady of the Lake Regional Medical Center, LA (United States)
name: Karl Leblanc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monmouth Medical Center, NJ (United States)
name: Mark Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida (United States)
name: Vic Velanovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berrevoet F, Doerhoff C, Muysoms F, Hopson S, Muzi MG, Nienhuijs S, Kullman E, Tollens T, Schwartz M, Leblanc K, Velanovich V, Jorgensen LN. Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study. BMC Surg. 2019 Jul 16;19(1):93. doi: 10.1186/s12893-019-0555-z.