Hernia
Conditions
Keywords
PARIETEX Composite Ventral Patch, PCO VP OR PCOVP, Primary ventral hernia repair, Panacea
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
Interventions
DEVICEPARIETEX™ Composite Ventral Patch
PARIETEX™ Composite Ventral Patch for ventral hernia repair
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Hernia Recurrence Rate at 24 Month Follow-up. | 24 month follow-up | The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate at 1, 6 and 12 Month Follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mesh Handling Ease of Use During Surgery | 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 |
| 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) | 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 |
| Other Relevant Data: Time of Mesh Positioning | Per- operative | The time of the mesh positioning during surgery |
| Other Relevant Data: Operative Time | Per- operative | Operative time during surgery for all patient receiving PCO ventral patch |
| Summary of Risk Factors at Baseline | 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 |
Countries
Belgium, Denmark, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PARIETEX™ Composite Ventral Patch PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair | 126 |
| Total | 126 |
Baseline characteristics
| Characteristic | PARIETEX™ Composite Ventral Patch |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Age, Continuous | 51.2 years STANDARD_DEVIATION 12.21 |
| Region of Enrollment Belgium | 40 participants |
| Region of Enrollment Denmark | 16 participants |
| Region of Enrollment Italy | 11 participants |
| Region of Enrollment Netherlands | 11 participants |
| Region of Enrollment Sweden | 15 participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 126 |
| other Total, other adverse events | 41 / 126 |
| serious Total, serious adverse events | 21 / 126 |
Outcome results
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.
Time frame: 24 month follow-up
Population: 101 patients returned for 24 month Follow-Up Visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PARIETEX™ Composite Ventral Patch | Primary Hernia Recurrence Rate at 24 Month Follow-up. | 3 Participants |
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.
Time frame: 1, 6 and 12 month follow-up.
Population: The number analyzed reflects the number of participants who returned for 1 month, 6 month and 12 month follow-up visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Recurrence Rate at 1, 6 and 12 Month Follow-up | 1 month follow-up | 0 Participants |
| PARIETEX™ Composite Ventral Patch | Recurrence Rate at 1, 6 and 12 Month Follow-up | 6 month follow-up | 2 Participants |
| PARIETEX™ Composite Ventral Patch | Recurrence Rate at 1, 6 and 12 Month Follow-up | 12 month follow-up | 3 Participants |
Other Pre-specified
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
Time frame: Per- operative
Population: Overal patients treated with PCO Ventral patch
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Mesh Handling Ease of Use During Surgery | Completely satisfied | 78 Participants |
| PARIETEX™ Composite Ventral Patch | Mesh Handling Ease of Use During Surgery | Satisfied | 42 Participants |
| PARIETEX™ Composite Ventral Patch | Mesh Handling Ease of Use During Surgery | Unsatisfied | 5 Participants |
| PARIETEX™ Composite Ventral Patch | Mesh Handling Ease of Use During Surgery | Completely dissatisfied | 1 Participants |
Other Pre-specified
Other Relevant Data: Operative Time
Operative time during surgery for all patient receiving PCO ventral patch
Time frame: Per- operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Other Relevant Data: Operative Time | 36.2 min | Standard Deviation 15.57 |
Other Pre-specified
Other Relevant Data: Time of Mesh Positioning
The time of the mesh positioning during surgery
Time frame: Per- operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Other Relevant Data: Time of Mesh Positioning | 8.1 min | Standard Deviation 3.35 |
Other Pre-specified
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
Time frame: Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)
Population: The number analyzed includes participants who completed the NRS pain scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | Baseline | 2.1 units on a scale | Standard Deviation 2 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | Discharge | 2.9 units on a scale | Standard Deviation 1.91 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | Day 10 | 1.5 units on a scale | Standard Deviation 1.48 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | 1 Month | 0.5 units on a scale | Standard Deviation 0.74 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | 6 Months | 0.4 units on a scale | Standard Deviation 0.73 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | 12 Months | 0.2 units on a scale | Standard Deviation 0.4 |
| PARIETEX™ Composite Ventral Patch | Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months | 24 Months | 0.1 units on a scale | Standard Deviation 0.63 |
Other Pre-specified
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
Time frame: Baseline
Population: Number of patients with risk factors at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Smoker | 54 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Obesity (BMI>=30) | 43 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Diabetes Type 1 | 0 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Diabetes Type 2 | 10 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Cancer | 8 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Cardiovascular Disease | 19 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Hypertension | 36 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | COPD | 9 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Chronic Disease-Analgesic Consumption | 4 participants |
| PARIETEX™ Composite Ventral Patch | Summary of Risk Factors at Baseline | Chronic Disease-Corticoid consumption | 3 participants |