Trial Outcomes & Findings for A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch (NCT NCT01848184)
NCT ID: NCT01848184
Last Updated: 2018-07-20
Results Overview
The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.
Recruitment status
COMPLETED
Target enrollment
126 participants
Primary outcome timeframe
24 month follow-up
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
126
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
Baseline characteristics by cohort
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 12.21 • n=93 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
|
Region of Enrollment
Sweden
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
40 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
16 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 24 month follow-upPopulation: 101 patients returned for 24 month Follow-Up Visit.
The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=101 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Primary Hernia Recurrence Rate at 24 Month Follow-up.
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of participants with hernia recurrence at 1 month, 6 month and 12 month follow-up visit.
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Recurrence Rate at 1, 6 and 12 Month Follow-up
1 month follow-up
|
0 Participants
|
|
Recurrence Rate at 1, 6 and 12 Month Follow-up
6 month follow-up
|
2 Participants
|
|
Recurrence Rate at 1, 6 and 12 Month Follow-up
12 month follow-up
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)Population: The number analyzed includes participants who completed the NRS pain scale
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
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months
Baseline
|
2.1 units on a scale
Standard Deviation 2
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: BaselinePopulation: Number of patients with 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
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Summary of Risk Factors at Baseline
Smoker
|
54 participants
|
|
Summary of Risk Factors at Baseline
Obesity (BMI>=30)
|
43 participants
|
|
Summary of Risk Factors at Baseline
Diabetes Type 1
|
0 participants
|
|
Summary of Risk Factors at Baseline
Diabetes Type 2
|
10 participants
|
|
Summary of Risk Factors at Baseline
Cancer
|
8 participants
|
|
Summary of Risk Factors at Baseline
Cardiovascular Disease
|
19 participants
|
|
Summary of Risk Factors at Baseline
Hypertension
|
36 participants
|
|
Summary of Risk Factors at Baseline
COPD
|
9 participants
|
|
Summary of Risk Factors at Baseline
Chronic Disease-Analgesic Consumption
|
4 participants
|
|
Summary of Risk Factors at Baseline
Chronic Disease-Corticoid consumption
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Per- operativePopulation: Overal patients treated with PCO Ventral patch
Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Mesh Handling Ease of Use During Surgery
Completely satisfied
|
78 Participants
|
|
Mesh Handling Ease of Use During Surgery
Satisfied
|
42 Participants
|
|
Mesh Handling Ease of Use During Surgery
Unsatisfied
|
5 Participants
|
|
Mesh Handling Ease of Use During Surgery
Completely dissatisfied
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Per- operativeOperative time during surgery for all patient receiving PCO ventral patch
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=124 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Other Relevant Data: Operative Time
|
36.2 min
Standard Deviation 15.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Per- operativeThe time of the mesh positioning during surgery
Outcome measures
| Measure |
PARIETEX™ Composite Ventral Patch
n=124 Participants
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Other Relevant Data: Time of Mesh Positioning
|
8.1 min
Standard Deviation 3.35
|
Adverse Events
PARIETEX™ Composite Ventral Patch
Serious events: 21 serious events
Other events: 41 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 participants at risk
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
General disorders
Cyst
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
General disorders
Multi-organ failure
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
General disorders
Pyrexia
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Device related infection
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Pneumonia
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Pneumonia legionella
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Rectocele
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Vascular disorders
Intermittent claudication
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/126 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
PARIETEX™ Composite Ventral Patch
n=126 participants at risk
PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning
PARIETEX™ Composite Ventral Patch for ventral hernia repair
|
|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.6%
2/126 • Number of events 2 • 24 months
|
|
General disorders
Local swelling
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
General disorders
Pyrexia
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Infections and infestations
Postoperative wound infection
|
2.4%
3/126 • Number of events 3 • 24 months
|
|
Infections and infestations
Wound infection
|
1.6%
2/126 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
1.6%
2/126 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.6%
26/126 • Number of events 26 • 24 months
|
|
Injury, poisoning and procedural complications
Seroma
|
1.6%
2/126 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Investigations
Haemoglobin decreased
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.79%
1/126 • Number of events 1 • 24 months
|
|
Vascular disorders
Hypotension
|
0.79%
1/126 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place