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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848184
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hernia
Intervention Device: PARIETEX™ Composite Ventral Patch
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PARIETEX™ Composite Ventral Patch
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PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra‐peritoneal positioning

PARIETEX™ Composite Ventral Patch for ventral hernia repair
Period Title: Overall Study
Started 126
Completed 100
Not Completed 26
Arm/Group Title PARIETEX™ Composite Ventral Patch
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PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra‐peritoneal positioning

PARIETEX™ Composite Ventral Patch for ventral hernia repair
Overall Number of Baseline Participants 126
Hide Baseline Analysis Population Description
Consented and enrolled population 126 (100.0) Completed Study 100 (79.4) Discontinued early 26 (20.6)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
<=18 years
0
   0.0%
Between 18 and 65 years
107
  84.9%
>=65 years
19
  15.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants
51.2  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
Female
39
  31.0%
Male
87
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 126 participants
Sweden 15
Belgium 40
United States 33
Denmark 16
Italy 11
Netherlands 11
1.Primary Outcome
Title Primary Hernia Recurrence Rate at 24 Month Follow‐up.
Hide Description The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.
Time Frame 24 month follow‐up
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Hide Analysis Population Description
101 patients returned for 24 month Follow-Up Visit.
Arm/Group Title PARIETEX™ Composite Ventral Patch
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PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra‐peritoneal positioning

PARIETEX™ Composite Ventral Patch for ventral hernia repair
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.0%
2.Secondary Outcome
Title Recurrence Rate at 1, 6 and 12 Month Follow‐up
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed reflects the number of participants who returned for 1 month, 6 month and 12 month follow-up visits.
Arm/Group Title Patients Undergoing Primary Ventral Hernia Repair
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Patients undergoing primary ventral hernia repair using PARIETEX™ Composite Ventral Patch (PCO-VP)
Overall Number of Participants Analyzed 126
Measure Type: Count of Participants
Unit of Measure: Participants
1 month follow-up Number Analyzed 122 participants
0
   0.0%
6 month follow-up Number Analyzed 114 participants
2
   1.8%
12 month follow-up Number Analyzed 111 participants
3
   2.7%
3.Other Pre-specified Outcome
Title Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed includes participants who completed the NRS pain scale
Arm/Group Title Hernia Patients Receiving Surgery
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Number of participants receiving surgery with PARIETEX™ Composite Ventral Patch for primary ventral hernia repair
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 120 participants
2.1  (2)
Discharge Number Analyzed 123 participants
2.9  (1.91)
Day 10 Number Analyzed 125 participants
1.5  (1.48)
1 Month Number Analyzed 123 participants
0.5  (0.74)
6 Months Number Analyzed 107 participants
0.4  (0.73)
12 Months Number Analyzed 111 participants
0.2  (0.4)
24 Months Number Analyzed 103 participants
0.1  (0.63)
4.Other Pre-specified Outcome
Title Summary of Risk Factors at Baseline
Hide Description 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
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Hide Analysis Population Description
Number of patients with risk factors at baseline
Arm/Group Title Hernia Patients Enrolled at Baseline
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All patients enrolled at Baseline and assessed for risk factors
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: participants
Smoker 54
Obesity (BMI>=30) 43
Diabetes Type 1 0
Diabetes Type 2 10
Cancer 8
Cardiovascular Disease 19
Hypertension 36
COPD 9
Chronic Disease-Analgesic Consumption 4
Chronic Disease-Corticoid consumption 3
5.Other Pre-specified Outcome
Title Mesh Handling Ease of Use During Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Overal patients treated with PCO Ventral patch
Arm/Group Title Ease of Use
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Ease of use (mesh handling and manipulability, comfort of use …)
Overall Number of Participants Analyzed 126
Measure Type: Count of Participants
Unit of Measure: Participants
Completely satisfied
78
  61.9%
Satisfied
42
  33.3%
Unsatisfied
5
   4.0%
Completely dissatisfied
1
   0.8%
6.Other Pre-specified Outcome
Title Other Relevant Data: Operative Time
Hide Description Operative time during surgery for all patient receiving PCO ventral patch
Time Frame Per- operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative Time
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Operative time during surgery
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: min
36.2  (15.57)
7.Other Pre-specified Outcome
Title Other Relevant Data: Time of Mesh Positioning
Hide Description The time of the mesh positioning during surgery
Time Frame Per- operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Time Mesh Positioning
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Time positioning of the mesh
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: min
8.1  (3.35)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PARIETEX™ Composite Ventral Patch
Hide Arm/Group Description

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

PARIETEX™ Composite Ventral Patch for ventral hernia repair
All-Cause Mortality
PARIETEX™ Composite Ventral Patch
Affected / at Risk (%)
Total   1/126 (0.79%)    
Hide Serious Adverse Events
PARIETEX™ Composite Ventral Patch
Affected / at Risk (%) # Events
Total   21/126 (16.67%)    
Cardiac disorders   
Acute myocardial infarction * 1  1/126 (0.79%)  1
Cardiac failure * 1  1/126 (0.79%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/126 (0.79%)  1
Umbilical hernia * 1  1/126 (0.79%)  1
General disorders   
Cyst * 1  1/126 (0.79%)  1
Multi-organ failure * 1  1/126 (0.79%)  1
Pyrexia * 1  1/126 (0.79%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/126 (0.79%)  1
Infections and infestations   
Device related infection * 1  1/126 (0.79%)  1
Gastroenteritis * 1  1/126 (0.79%)  1
Pneumonia * 1  1/126 (0.79%)  1
Pneumonia legionella * 1  1/126 (0.79%)  1
Urinary tract infection * 1  1/126 (0.79%)  1
Injury, poisoning and procedural complications   
Ligament rupture * 1  1/126 (0.79%)  1
Multiple fractures * 1  1/126 (0.79%)  1
Post procedural fistula * 1  1/126 (0.79%)  1
Postoperative ileus * 1  1/126 (0.79%)  1
Procedural pain * 1  1/126 (0.79%)  1
Pubis fracture * 1  1/126 (0.79%)  1
Traumatic fracture * 1  1/126 (0.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lipoma * 1  1/126 (0.79%)  1
Malignant melanoma * 1  1/126 (0.79%)  1
Teratoma * 1  1/126 (0.79%)  1
Reproductive system and breast disorders   
Rectocele * 1  1/126 (0.79%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/126 (0.79%)  1
Psoriasis * 1  1/126 (0.79%)  1
Vascular disorders   
Intermittent claudication * 1  1/126 (0.79%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PARIETEX™ Composite Ventral Patch
Affected / at Risk (%) # Events
Total   41/126 (32.54%)    
Gastrointestinal disorders   
Abdominal hernia * 1  1/126 (0.79%)  1
Constipation * 1  1/126 (0.79%)  1
Nausea * 1  1/126 (0.79%)  1
Umbilical hernia * 1  2/126 (1.59%)  2
General disorders   
Local swelling * 1  1/126 (0.79%)  1
Pyrexia * 1  1/126 (0.79%)  1
Infections and infestations   
Postoperative wound infection * 1  3/126 (2.38%)  3
Wound infection * 1  2/126 (1.59%)  2
Injury, poisoning and procedural complications   
Incision site haematoma * 1  2/126 (1.59%)  2
Post procedural discomfort * 1  1/126 (0.79%)  1
Procedural intestinal perforation * 1  1/126 (0.79%)  1
Procedural nausea * 1  1/126 (0.79%)  1
Procedural pain * 1  26/126 (20.63%)  26
Seroma * 1  2/126 (1.59%)  2
Wound secretion * 1  1/126 (0.79%)  1
Investigations   
Haemoglobin decreased * 1  1/126 (0.79%)  1
Reproductive system and breast disorders   
Vaginal haemorrhage * 1  1/126 (0.79%)  1
Skin and subcutaneous tissue disorders   
Skin irritation * 1  1/126 (0.79%)  1
Vascular disorders   
Hypotension * 1  1/126 (0.79%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle DiSalvo
Organization: Medtronic
Phone: 774 284 6089
EMail: michelle.v.disalvo@medtronic.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01848184    
Other Study ID Numbers: COVPCOV0293
First Submitted: May 2, 2013
First Posted: May 7, 2013
Results First Submitted: October 4, 2017
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018