HerniaPanaceaNCT01848184
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
An observational study of Hernia, run by Medtronic - MITG at 10 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- PARIETEX™ Composite Ventral Patch
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 10 sitesin 4 countries
- Study dates
- May 2013to Jul 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States5 sites
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 78080
Surgicare of Missouri
Jefferson City, Missouri, 65101
Monmouth Medical Center
Long Branch, New Jersey, 07740
University of South Florida
Tampa, Florida, 33606
Hernia Centers of Excellence
Yorktown, Virginia, 23692
Belgium3 sites
General Surgery - Imelda Hospital
Bonheiden, 2820
Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Denmark1 site
Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
Copenhagen, 2400
About this study
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.
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.
Read the 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
- Being tested
- PARIETEX™ Composite Ventral Patch
- Keywords
- PARIETEX Composite Ventral Patch, PCO VP OR PCOVP, Primary ventral hernia repair, Panacea
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARIETEX™ Composite Ventral PatchDevice
PARIETEX™ Composite Ventral Patch for ventral hernia repair
| Study group | Role | What they receive |
|---|---|---|
| PARIETEX™ Composite Ventral Patch | PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning Receives: Device: PARIETEX™ Composite Ventral Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 month follow-up
Secondary outcomes (1)
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.
Measured: 1, 6 and 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital Ghent (Belgium)Lars N Jørgensen, MD, Principal investigator, Bispebjerg Hospital, University of Copenhagen (Denmark)Carl Doerhoff, MD, Principal investigator, Surgicare of MO (United States)Steven Hopson, MD, Principal investigator, Hernia Centers of Excellence, VA (United States)Eric KULLMAN, MD, Principal investigator, Medicinskt Centrum i Linköping (Sweden)Marco G MUZI, MD, Principal investigator, Department of Surgery, University Hospital Tor Vergata, Roma (Italy)Simon NIENHUIJS, MD, Principal investigator, Catharina Ziekenhuis, EJ EINDHOVEN (The Netherlands)Filip E Muysoms, MD, Principal investigator, Algemene Heelkunde, AZ Maria Middelares Ghent (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848184
- Sponsor's protocol ID
- COVPCOV0293
- Acronym
- Panacea
- Status last verified
- Oct 2017
- First submitted
- 2 May 2013
- Last updated
- 20 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31311545
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01848184
- Acronym / sponsor ID
- Panacea / COVPCOV0293
- Conditions
- Hernia
- Keywords
- PARIETEX Composite Ventral Patch, PCO VP OR PCOVP, Primary ventral hernia repair, Panacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PARIETEX™ Composite Ventral Patch | – | Device: PARIETEX™ Composite Ventral PatchPARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARIETEX™ Composite Ventral PatchPARIETEX™ Composite Ventral Patch for ventral hernia repair | Device | PARIETEX™ Composite Ventral Patch |
Primary outcome
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.
1 secondary outcome
Recurrence Rate at 1, 6 and 12 Month Follow-up
Time frame: 1, 6 and 12 month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31311545Berrevoet 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hernia
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Berrevoet, MD principal investigator
University Hospital Ghent (Belgium)
Lars N Jørgensen, MD principal investigator
Bispebjerg Hospital, University of Copenhagen (Denmark)
Carl Doerhoff, MD principal investigator
Surgicare of MO (United States)
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by Medtronic - MITG at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belgium, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Hernia Recurrence Rate at 24 Month Follow-up. (time frame: 24 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.