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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sofradim Production
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Sofradim Production
ClinicalTrials.gov Identifier:
NCT01848184
First received: May 2, 2013
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Hernia
Device: PARIETEX™ Composite Ventral Patch for ventral hernia repair
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sofradim Production:

Primary Outcome Measures:
  • Primary hernia recurrence rate at 24 month follow‐up. [ Time Frame: 24 month follow‐up ] [ Designated as safety issue: No ]
    The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography.


Secondary Outcome Measures:
  • Recurrence rate at 1, 6 and 12 month follow‐up [ Time Frame: 1, 6 and 12 month follow‐up. ] [ Designated as safety issue: No ]
    The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography.


Other Outcome Measures:
  • Safety Parameters [ Time Frame: at 10 days, 1, 6 and 12 month follow‐up ] [ Designated as safety issue: Yes ]
    Deep and superficial infection Pain / Chronic pain Other post‐operative complications (complications related to visceral adhesions, Ileus, seroma, hematoma...) Analgesics consumption Risk factors (severity and treatment)


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 for ventral hernia repair

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848184

Contacts
Contact: Corinne MARTINELLA, PhD +33 04 74 08 90 00 ext 13 34 Corinne.Martinella@covidien.com
Contact: Traci Frye Traci.Frye@covidien.com

Locations
United States, Louisiana
Our Lady of the Lake Regional Medical Center Not yet recruiting
Baton Rouge, Louisiana, United States, 78080
Contact: Karl Leblanc, MD    225-769-5656      
Principal Investigator: Karl Leblanc, MD         
United States, Missouri
Surgicare of Missouri Not yet recruiting
Jefferson City, Missouri, United States, 65101
Contact: Carl Doerhoff, MD    573-659-5500      
Principal Investigator: Carl Doerhoff, MD         
United States, New Jersey
Monmouth Medical Center Not yet recruiting
Long Branch, New Jersey, United States, 07740
Contact: Mark Schwartz, MD    732-923-6300      
Principal Investigator: Mark Schwartz, MD         
United States, Virginia
Hernia Centers of Excellence Not yet recruiting
Yorktown, Virginia, United States, 23692
Contact: Steven Hopson, MD    757-846-4335      
Principal Investigator: Steven Hopson, MD         
Belgium
General Surgery - Imelda Hospital Recruiting
Bonheiden, Belgium, 2820
Contact: Tim Tollens, MD    0032474806828.    algheelkunde1@imelda.be   
Principal Investigator: Tim Tollens, MD         
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium, 9000
Principal Investigator: Frederik BERREVOET, MD         
Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent Not yet recruiting
Ghent, Belgium, 9000
Contact: Filip E Muysoms, MD    003292607181    filip.muysoms@azmmsj.be   
Principal Investigator: Filip E Muysoms, MD         
Denmark
Department of Surgery K, Bispebjerg Hospital, University of Copenhagen Recruiting
Copenhagen, Denmark, 2400
Contact: Lars N Jørgensen, MD    +45 35316441    LNJ01@bbh.regionh.dk   
Principal Investigator: Lars N Jørgensen, MD         
Sweden
Dr. ERIC KULLMAN Recruiting
Linköping, Östergötland, Sweden, 58224
Contact: ERIC KULLMAN, Dr.    +46 13 460 10 00    eric.kullman@medcentrum.se   
Principal Investigator: ERIC KULLMAN, DR         
Sponsors and Collaborators
Sofradim Production
Covidien
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)
  More Information

No publications provided

Responsible Party: Sofradim Production
ClinicalTrials.gov Identifier: NCT01848184     History of Changes
Other Study ID Numbers: COVPCOV0293
Study First Received: May 2, 2013
Last Updated: July 26, 2013
Health Authority: Belgium: Ethics Committee
Sweden: Regional Ethical Review Board
Netherlands: Medical Ethics Review Committee (METC)
Italy: Ethics Committee
Denmark: Ethics Committee
United States: Institutional Review Board

Keywords provided by Sofradim Production:
PARIETEX Composite Ventral Patch
PCO VP OR PCOVP
Primary ventral hernia repair
Panacea

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 21, 2014