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

This study has been completed.
Sponsor:
Collaborators:
Research Foundation of Helsinki University Central Hospital
Covidien
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01026935
First received: December 4, 2009
Last updated: July 19, 2011
Last verified: December 2009
History of Changes
  Purpose

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 Intervention
Inguinal Hernia
Primary
Unilateral
 Device: Open inguinal hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • postoperative complaints [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 398
Study Start Date: February 2008
Study Completion Date: January 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Research Foundation of Helsinki University Central Hospital
Covidien
Investigators
Principal Investigator: Jaana Vironen, MD PhD HUCH Jorvi Hospital
  More Information

No publications provided by Helsinki University Central Hospital

Additional 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
Study First Received: December 4, 2009
Last Updated: July 19, 2011
Health Authority: Finland: Data Protection Board
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Finland: Ministry of Social Affairs and Health
Finland: National Advisory Board on Health Care Ethics

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

ClinicalTrials.gov processed this record on May 19, 2013