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

Hernia Clinical Trial

— Panacea  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848184
• Other study ID #: COVPCOV0293
• Status: Completed
• Start date: May 2013
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

Device:
• PARIETEX™ Composite Ventral Patch
PARIETEX™ Composite Ventral Patch for ventral hernia repair

Locations

Country	Name	City	State
Belgium	General Surgery - Imelda Hospital	Bonheiden
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent	Ghent
Denmark	Department of Surgery K, Bispebjerg Hospital, University of Copenhagen	Copenhagen
Sweden	Dr. ERIC KULLMAN	Linköping	Östergötland
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	University of South Florida	Tampa	Florida
United States	Hernia Centers of Excellence	Yorktown	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Score at 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	Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)
Other	Summary of Risk Factors at 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	Baseline
Other	Mesh Handling Ease of Use During Surgery	Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied	Per- operative
Other	Other Relevant Data: Operative Time	Operative time during surgery for all patient receiving PCO ventral patch	Per- operative
Other	Other Relevant Data: Time of Mesh Positioning	The time of the mesh positioning during surgery	Per- operative
Primary	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	Recurrence Rate at 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.	1, 6 and 12 month follow-up.