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

NCT01848184 | Completed Results DMC

• 1 other identifier: COVPCOV0293
• Study Type: observational
• Target: 126
• Locations: 4 countries
• Sites: 10

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.

Conditions

Hernia

Keywords

PARIETEX Composite Ventral Patch; PCO VP OR PCOVP; Primary ventral hernia repair; Panacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence Rate at 1, 6 and 12 Month Follow-up

  1, 6 and 12 month follow-up.

Other Outcomes (5)

• Pain Score 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

  Baseline

• Mesh Handling Ease of Use During Surgery

  Per- operative

Study Arms (1)

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

Interventions

PARIETEX™ Composite Ventral Patch DEVICE

PARIETEX™ Composite Ventral Patch for ventral hernia repair

PARIETEX™ Composite Ventral Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (10)

University of South Florida

Tampa, Florida, 33606, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 78080, United States

Location

Surgicare of Missouri

Jefferson City, Missouri, 65101, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Hernia Centers of Excellence

Yorktown, Virginia, 23692, United States

Location

General Surgery - Imelda Hospital

Bonheiden, 2820, Belgium

Location

Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Department of Surgery K, Bispebjerg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

Location

Dr. ERIC KULLMAN

Linköping, Östergötland County, 58224, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31311545 DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle DiSalvo
• Organization: Medtronic

michelle.v.disalvo@medtronic.com

774 284 6089

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2017-10

Locations

US (5); DK (1); BE (3); SE (1)