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

• 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: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Tracking Information

• First Submitted Date: May 2, 2013
• First Posted Date: May 7, 2013
• Results First Submitted Date: October 4, 2017
• Results First Posted Date: July 20, 2018
• Last Update Posted Date: July 20, 2018
• Study Start Date: May 2013
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2017)

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.

Original Primary Outcome Measures (submitted: May 2, 2013)

Primary Hernia Recurrence Rate at 24 Month Follow-up. [ Time Frame: 24 month follow-up ]

The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography.

Current Secondary Outcome Measures (submitted: October 4, 2017)

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.

Original Secondary Outcome Measures (submitted: May 2, 2013)

Recurrence Rate at 1, 6 and 12 Month Follow-up [ Time Frame: 1, 6 and 12 month follow-up. ]

The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography.

Current Other Pre-specified Outcome Measures (submitted: October 4, 2017)

• 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

Original Other Pre-specified Outcome Measures (submitted: May 2, 2013)

Safety Parameters [ Time Frame: at 10 days, 1, 6 and 12 month follow-up ]

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)

Descriptive Information

• Brief Title: 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.
• 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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Hernia

Intervention

Device: PARIETEX™ Composite Ventral Patch

PARIETEX™ Composite Ventral Patch for ventral hernia repair

Study Groups/Cohorts

PARIETEX™ Composite Ventral Patch

PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning

Intervention: Device: PARIETEX™ Composite Ventral Patch

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 4, 2017): 126
• Original Estimated Enrollment (submitted: May 2, 2013): 100
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Denmark, Sweden, United States

Administrative Information

• NCT Number: NCT01848184
• Other Study ID Numbers: COVPCOV0293
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Medtronic - MITG
• Study Sponsor: Medtronic - MITG
• Collaborators: Not Provided

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)

• PRS Account: Medtronic - MITG
• Verification Date: October 2017