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

Study Description

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

Study Design

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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

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 :

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:

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
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
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
Other Relevant Data: Operative Time [ Time Frame: Per- operative ]
Operative time during surgery for all patient receiving PCO ventral patch
Other Relevant Data: Time of Mesh Positioning [ Time Frame: Per- operative ]
The time of the mesh positioning during surgery

Eligibility Criteria

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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

Contacts and Locations

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)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berrevoet F, Doerhoff C, Muysoms F, Hopson S, Muzi MG, Nienhuijs S, Kullman E, Tollens T, Schwartz M, Leblanc K, Velanovich V, Jørgensen 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.

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Responsible Party:	Medtronic - MITG
ClinicalTrials.gov Identifier:	NCT01848184
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

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