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

NCT ID: NCT01848184

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-07-31

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

Conditions

Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PARIETEX™ Composite Ventral Patch

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

PARIETEX™ Composite Ventral Patch

Intervention Type: DEVICE

PARIETEX™ Composite Ventral Patch for ventral hernia repair

Interventions

PARIETEX™ Composite Ventral Patch

PARIETEX™ Composite Ventral Patch for ventral hernia repair

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederik Berrevoet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent (Belgium)

Lars N Jørgensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, University of Copenhagen (Denmark)

Carl Doerhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Surgicare of MO (United States)

Steven Hopson, MD

Role: PRINCIPAL_INVESTIGATOR

Hernia Centers of Excellence, VA (United States)

Eric KULLMAN, MD

Role: PRINCIPAL_INVESTIGATOR

Medicinskt Centrum i Linköping (Sweden)

Marco G MUZI, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University Hospital Tor Vergata, Roma (Italy)

Simon NIENHUIJS, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis, EJ EINDHOVEN (The Netherlands)

Filip E Muysoms, MD

Role: PRINCIPAL_INVESTIGATOR

Algemene Heelkunde, AZ Maria Middelares Ghent (Belgium)

Tim Tollens, MD

Role: PRINCIPAL_INVESTIGATOR

Imelda Hospital, Bonheiden (Belgium)

Karl Leblanc, MD

Role: PRINCIPAL_INVESTIGATOR

Our Lady of the Lake Regional Medical Center, LA (United States)

Mark Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Monmouth Medical Center, NJ (United States)

Vic Velanovich, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida (United States)

Locations

University of South Florida

Tampa, Florida, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Surgicare of Missouri

Jefferson City, Missouri, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Hernia Centers of Excellence

Yorktown, Virginia, United States

General Surgery - Imelda Hospital

Bonheiden, , Belgium

Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent

Ghent, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Department of Surgery K, Bispebjerg Hospital, University of Copenhagen

Copenhagen, , Denmark

Dr. ERIC KULLMAN

Linköping, Östergötland County, Sweden

Countries

United States; Belgium; Denmark; Sweden

References

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.

Reference Type: DERIVED

PMID: 31311545 (View on PubMed)

Other Identifiers

COVPCOV0293

Identifier Type: -

Identifier Source: org_study_id