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

Helsinki University Central Hospital398 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

398

Conditions

Inguinal Hernia Primary Unilateral

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * primary unilateral inguinal hernia Exclusion Criteria: * not willing to participate * not capable to understand or fill in the questionnaires

Locations (2)

HUCH Jorvi Hospital, department of Surgery

Espoo, Finland

HUCH Surgical Hospital, Dept of Surgery

Helsinki, Finland

Outcomes

Primary Outcomes

postoperative complaints

Time frame: One year

Secondary Outcomes

Recurrence rate

Time frame: One year

Data from ClinicalTrials.gov

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