The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Primary; Unilateral; Inguinal Hernia

Treatments: Device: Open inguinal hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01026935

231268

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary unilateral inguinal hernia

Exclusion criteria

• not willing to participate
• not capable to understand or fill in the questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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398 participants in 2 patient groups

sutured mesh

Experimental group

Description:

200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)

Treatment:

Device: Open inguinal hernia repair

non-sutured mesh

Experimental group

Description:

200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures

Treatment:

Device: Open inguinal hernia repair