Phase 4
Completed N=603
Parietex Progrip Study
Hernia, Inguinal
Source: ClinicalTrials.gov NCT00827944 ↗
Enrolled (actual)
603
Serious AEs
6.5%
Results posted
Nov 2016
Primary outcomePrimary: 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
◆ Published Evidence
Established
68citations · ~6 / year
Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair.
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.
Linked Publications
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Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.