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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia Primary Unilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sutured mesh

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

Group Type EXPERIMENTAL

Open inguinal hernia repair

Intervention Type DEVICE

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

non-sutured mesh

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

Group Type EXPERIMENTAL

Open inguinal hernia repair

Intervention Type DEVICE

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

Interventions

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Open inguinal hernia repair

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

Intervention Type DEVICE