Inguinal Hernia, Primary, Unilateral
Conditions
Keywords
open mesh repair, sutured, non-sutured, pro-grip, postoperative pain
Brief summary
For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.
Interventions
Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks
Sponsors
Medtronic - MITG
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary unilateral inguinal hernia
Exclusion criteria
* not willing to participate * not capable to understand or fill in the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative complaints | One year |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate | One year |
Countries
Finland
Outcome results
None listed