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

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ClinicalTrials.gov Identifier: NCT01026935
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : July 20, 2011
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by:
Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Primary Unilateral Device: Open inguinal hernia repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.
Study Start Date : February 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: sutured mesh
200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)
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
Other Names:
  • Parietene Light
  • Parietene ProGrip

Experimental: non-sutured mesh
200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures
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
Other Names:
  • Parietene Light
  • Parietene ProGrip




Primary Outcome Measures :
  1. postoperative complaints [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary unilateral inguinal hernia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026935


Locations
Finland
HUCH Jorvi Hospital, department of Surgery
Espoo, Finland, 02480
HUCH Surgical Hospital, Dept of Surgery
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Medtronic - MITG
Investigators
Principal Investigator: Jaana Vironen, MD PhD HUCH Jorvi Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaana Vironen, MD PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01026935     History of Changes
Other Study ID Numbers: 231268
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: December 2009

Keywords provided by Helsinki University Central Hospital:
open mesh repair
sutured
non-sutured
pro-grip
postoperative pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal