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

NCT01026935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2011-07-20

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia
  • Primary
  • Unilateral

Interventions

DEVICE

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

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Jaana Vironen, MD PhD · HUCH Jorvi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026935 on ClinicalTrials.gov