Phase 4
N=603
Parietex Progrip Study
Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT00827944 ↗Enrolled (actual)
603
Serious AEs
6.5%
Results posted
Nov 2016
Primary outcome: Primary: Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) — 7.48; 6.76; 4.62; 5.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Parietex Progrip (Device); Low weight polypropylene mesh (Device)
- Age
- Adult, Older Adult · 31+ yrs
- Sex
- Male
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) |
7.48; 6.76; 4.62; 5.27 | — |
| PRIMARY Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) |
6.62; 7.85; 5.51; 4.37 | — |
| SECONDARY Foreign Body Sensation |
159; 173; 139; 148; 121; 128 | — |
| SECONDARY Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score |
9; 12 | — |
| SECONDARY Wound Complications and Hernia Recurrences |
4; 6; 13; 5; 9; 14 | — |
| SECONDARY Return to Work and to Normal Daily Activities |
14.61; 14.79; 7.99; 8.426 | — |
| SECONDARY Other Post-operative Complications |
23; 29 | — |
Summary
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
Eligibility Criteria
Inclusion Criteria
- All male patients at participating centers with a primary, uncomplicated inguinal hernia.
- Collar of the defect ≤ 4 cm
- Signed informed consent
Exclusion Criteria
- 30 years ≥ Age ≥ 75 years
- Emergency procedure
- Inclusion in other trials
- Bilateral inguinal hernia
- Recurrence
Data sourced from ClinicalTrials.gov (NCT00827944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.