Trial Outcomes & Findings for Parietex Progrip Study (NCT NCT00827944)
NCT ID: NCT00827944
Last Updated: 2016-11-17
Results Overview
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
603 participants
Primary outcome timeframe
M3, M12 after surgery
Results posted on
2016-11-17
Participant Flow
Study period: 42 months First patient in: 13 October 2008 Last patient in: 27 April 2011 Last Patient visit: 8 May 2012 Follow-up duration: 1 year
Participant milestones
| Measure |
Progrip Group
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
299
|
|
Overall Study
COMPLETED
|
241
|
240
|
|
Overall Study
NOT COMPLETED
|
63
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parietex Progrip Study
Baseline characteristics by cohort
| Measure |
Progrip Group
n=304 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=299 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
Total
n=603 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
304 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
92 participants
n=5 Participants
|
89 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
87 participants
n=5 Participants
|
86 participants
n=7 Participants
|
173 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: M3, M12 after surgeryPopulation: The analysis were performed on an As Treated (AT)population, with a 5% significance level.
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Outcome measures
| Measure |
Progrip Group
n=241 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=240 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
VAS - 3 months
|
7.48 units on a scale
Standard Deviation 15.82
|
6.76 units on a scale
Standard Deviation 17.05
|
|
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
VAS - 12 months
|
4.62 units on a scale
Standard Deviation 10.81
|
5.27 units on a scale
Standard Deviation 13.27
|
PRIMARY outcome
Timeframe: M3, M12 after surgeryPopulation: The analysis were performed on an As Treated population (AT), with a 5% significance level.
Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).
Outcome measures
| Measure |
Progrip Group
n=241 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=240 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
Surgical Pain - 3 months
|
6.62 units on a scale
Standard Deviation 15.42
|
7.85 units on a scale
Standard Deviation 15.52
|
|
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
Surgical Pain - 12 months
|
5.51 units on a scale
Standard Deviation 15.12
|
4.37 units on a scale
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: M1, M3, M12 months after surgeryPopulation: The analysis were performed on an As Treated population, with a 5% significance level.
Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.
Outcome measures
| Measure |
Progrip Group
n=304 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=299 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Foreign Body Sensation
FBS General Feeling - M1 (Answer : No)
|
144 participants
|
151 participants
|
|
Foreign Body Sensation
FBS at Rest - M1 (Answer : No)
|
159 participants
|
173 participants
|
|
Foreign Body Sensation
FBS Normal Activities - M1 (Answer: No)
|
139 participants
|
148 participants
|
|
Foreign Body Sensation
FBS Doing exercise - M1 (Answer : No)
|
121 participants
|
128 participants
|
|
Foreign Body Sensation
FBS at Rest - M3 (Answer : No)
|
186 participants
|
198 participants
|
|
Foreign Body Sensation
FBS Normal Activities - M3 (Answer: No)
|
166 participants
|
177 participants
|
|
Foreign Body Sensation
FBS Doing exercise - M3 (Answer : No)
|
140 participants
|
155 participants
|
|
Foreign Body Sensation
FBS General feeling - M3 (Answer : No)
|
172 participants
|
189 participants
|
|
Foreign Body Sensation
FBS at Rest - M12 (Answer : No)
|
178 participants
|
196 participants
|
|
Foreign Body Sensation
FBS Normal Activities - M12 (Answer: No)
|
169 participants
|
197 participants
|
|
Foreign Body Sensation
FBS Doing exercise - M12 (Answer : No)
|
171 participants
|
165 participants
|
|
Foreign Body Sensation
FBS General Feeling - M12 (Answer : No)
|
176 participants
|
199 participants
|
SECONDARY outcome
Timeframe: 3 months after surgeryChronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Outcome measures
| Measure |
Progrip Group
n=241 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=240 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: M12 after surgeryPopulation: The analysis were performed on an As Treated (AT) population, with a 5% significance level.
Outcome measures
| Measure |
Progrip Group
n=262 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=267 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Wound Complications and Hernia Recurrences
Seroma
|
4 participants
|
6 participants
|
|
Wound Complications and Hernia Recurrences
Hematoma
|
13 participants
|
5 participants
|
|
Wound Complications and Hernia Recurrences
Site Surgical Infection
|
9 participants
|
14 participants
|
|
Wound Complications and Hernia Recurrences
Recurrence
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Effective datePopulation: The analysis were performed on an As Treated (AT) population, with a 5% significance level.
Outcome measures
| Measure |
Progrip Group
n=304 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=299 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Return to Work and to Normal Daily Activities
Return to work
|
14.61 days
Standard Error 11.61
|
14.79 days
Standard Error 11.51
|
|
Return to Work and to Normal Daily Activities
Return to daily activities
|
7.99 days
Standard Error 8.78
|
8.426 days
Standard Error 8.145
|
SECONDARY outcome
Timeframe: M12 after surgeryPopulation: As Treated population
Outcome measures
| Measure |
Progrip Group
n=262 Participants
Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=267 Participants
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Other Post-operative Complications
|
23 participants
|
29 participants
|
Adverse Events
Progrip Group
Serious events: 18 serious events
Other events: 23 other events
Deaths: 0 deaths
Lichtenstein Group
Serious events: 21 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Progrip Group
n=304 participants at risk
Parietex ProGrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=299 participants at risk
Low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Reproductive system and breast disorders
Ischemic left testis
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
General disorders
High pain just after surgery, ilioinguinal nerve trapped in suture
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Surgical and medical procedures
Inguinal hernia recurrence
|
1.3%
4/304 • Number of events 4 • 12 months after surgery
|
1.7%
5/299 • Number of events 5 • 12 months after surgery
|
|
Surgical and medical procedures
Right Total Hip Replacement
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
General disorders
inguinal pain after lifting a heavy weight, suspected hernia recurrence
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Renal and urinary disorders
Acute retention of urine
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Renal and urinary disorders
prostate adenocarcinoma
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Injury, poisoning and procedural complications
Hand Tendon Injury
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Renal and urinary disorders
Ureter transection left, direct suture
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Blood and lymphatic system disorders
Melena red blood loss per anum Hospitalisation
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoïdosis
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Vascular disorders
atrial flutter
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Vascular disorders
Atrial fibrillation
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Respiratory, thoracic and mediastinal disorders
lungmetastasis dorsolateral right lung
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Cardiac disorders
necrotic defect 0,5cm scar pace maker
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Lung Embol
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Reproductive system and breast disorders
Elective trans-urethral resection of prostate
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
General disorders
edema, poor kidney function, decompensation cordes, pneumonia
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Reproductive system and breast disorders
enlarged prostate gland resulting in surgical intervention
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Surgical and medical procedures
HERNIA RECURRENCE ADMISSION FOR REPAIR
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
General disorders
NEURALGIC PAIN RIGHT GROIN (post-op)
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Surgical and medical procedures
hospitalization surgery umbilical hernia
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Gastrointestinal disorders
Cancer colon + metastasis liver and spleen
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
|
Infections and infestations
Wound infection
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.66%
2/304 • Number of events 2 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
General disorders
Increasing pain in the inguinal area
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Gastrointestinal disorders
Gastric Ulcus Perforation
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Eye disorders
neuronitis vestibularis left
|
0.33%
1/304 • Number of events 1 • 12 months after surgery
|
0.00%
0/299 • 12 months after surgery
|
|
Renal and urinary disorders
acute on chronic renal insufficiency
|
0.00%
0/304 • 12 months after surgery
|
0.33%
1/299 • Number of events 1 • 12 months after surgery
|
Other adverse events
| Measure |
Progrip Group
n=304 participants at risk
Parietex ProGrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
|
Lichtenstein Group
n=299 participants at risk
Low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Seroma
|
1.3%
4/304 • Number of events 4 • 12 months after surgery
|
2.0%
6/299 • Number of events 6 • 12 months after surgery
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
4.3%
13/304 • Number of events 13 • 12 months after surgery
|
1.7%
5/299 • Number of events 5 • 12 months after surgery
|
|
Skin and subcutaneous tissue disorders
Site Surgical Infection
|
3.0%
9/304 • Number of events 9 • 12 months after surgery
|
4.7%
14/299 • Number of events 14 • 12 months after surgery
|
|
Skin and subcutaneous tissue disorders
Recurrence
|
1.3%
4/304 • Number of events 4 • 12 months after surgery
|
2.7%
8/299 • Number of events 8 • 12 months after surgery
|
Additional Information
Pr. Andrew KINGSNORTH
Derriford Hospital, Department of Surgery
Phone: +44 175 276 3017
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60