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

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.

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Device: PARIETEX™ Composite Ventral Patch

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

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • General Surgery - Imelda Hospital
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Ghent, Belgium, 9000
    • Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent
• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58224
      • Dr. ERIC KULLMAN
• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Louisiana
    • Baton Rouge, Louisiana, United States, 78080
      • Our Lady of the Lake Regional Medical Center
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Surgicare of Missouri
  • New Jersey
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
  • Virginia
    • Yorktown, Virginia, United States, 23692
      • Hernia Centers of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PARIETEX™ Composite Ventral Patch; PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning	Device: PARIETEX™ Composite Ventral Patch; PARIETEX™ Composite Ventral Patch for ventral hernia repair

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Rate at 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.	1, 6 and 12 month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months	Pain evaluation as determined by a 10-point pain intensity numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Scores reported at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months	Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)
Summary of Risk Factors at Baseline	Summary of Risk factors at Baseline. Risk factors include: Smoker, Obesity, Diabetes T1 & T2, Cancer, Cardiovascular disease, Hypertension, COPD, Chronic desease requiring analgesic or corticoid consumption	Baseline
Mesh Handling Ease of Use During Surgery	Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied	Per- operative
Other Relevant Data: Operative Time	Operative time during surgery for all patient receiving PCO ventral patch	Per- operative
Other Relevant Data: Time of Mesh Positioning	The time of the mesh positioning during surgery	Per- operative

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Frederik Berrevoet, MD, University Hospital Ghent (Belgium); Principal Investigator: Lars N Jørgensen, MD, Bispebjerg Hospital, University of Copenhagen (Denmark); Principal Investigator: Carl Doerhoff, MD, Surgicare of MO (United States); Principal Investigator: Steven Hopson, MD, Hernia Centers of Excellence, VA (United States); Principal Investigator: Eric KULLMAN, MD, Medicinskt Centrum i Linköping (Sweden); Principal Investigator: Marco G MUZI, MD, Department of Surgery, University Hospital Tor Vergata, Roma (Italy); Principal Investigator: Simon NIENHUIJS, MD, Catharina Ziekenhuis, EJ EINDHOVEN (The Netherlands); Principal Investigator: Filip E Muysoms, MD, Algemene Heelkunde, AZ Maria Middelares Ghent (Belgium); Principal Investigator: Tim Tollens, MD, Imelda Hospital, Bonheiden (Belgium); Principal Investigator: Karl Leblanc, MD, Our Lady of the Lake Regional Medical Center, LA (United States); Principal Investigator: Mark Schwartz, MD, Monmouth Medical Center, NJ (United States); Principal Investigator: Vic Velanovich, MD, University of South Florida (United States)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (ESTIMATE): May 7, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: PARIETEX Composite Ventral Patch; PCO VP OR PCOVP; Primary ventral hernia repair; Panacea
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: COVPCOV0293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED