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

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ClinicalTrials.gov Identifier: NCT01848184
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hernia 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


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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. Primary Hernia Recurrence Rate at 24 Month Follow‐up. [ Time Frame: 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 :
  1. Recurrence Rate at 1, 6 and 12 Month Follow‐up [ Time Frame: 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.


Other Outcome Measures:
  1. Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months [ Time Frame: Various (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

  2. Summary of Risk Factors at Baseline [ Time Frame: 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

  3. Mesh Handling Ease of Use During Surgery [ Time Frame: Per- operative ]
    Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied

  4. Other Relevant Data: Operative Time [ Time Frame: Per- operative ]
    Operative time during surgery for all patient receiving PCO ventral patch

  5. Other Relevant Data: Time of Mesh Positioning [ Time Frame: Per- operative ]
    The time of the mesh positioning during surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848184


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 78080
United States, Missouri
Surgicare of Missouri
Jefferson City, Missouri, United States, 65101
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
United States, Virginia
Hernia Centers of Excellence
Yorktown, Virginia, United States, 23692
Belgium
General Surgery - Imelda Hospital
Bonheiden, Belgium, 2820
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent
Ghent, Belgium, 9000
Denmark
Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
Copenhagen, Denmark, 2400
Sweden
Dr. ERIC KULLMAN
Linköping, Östergötland, Sweden, 58224
Sponsors and Collaborators
Medtronic - MITG
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01848184     History of Changes
Other Study ID Numbers: COVPCOV0293
First Posted: May 7, 2013    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Medtronic - MITG:
PARIETEX Composite Ventral Patch
PCO VP OR PCOVP
Primary ventral hernia repair
Panacea

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