The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
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.
1 other identifier
interventional
398
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 4, 2009
CompletedFirst Posted
Study publicly available on registry
December 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJuly 20, 2011
December 1, 2009
1.9 years
December 4, 2009
July 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative complaints
One year
Secondary Outcomes (1)
Recurrence rate
One year
Study Arms (2)
sutured mesh
EXPERIMENTAL200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)
non-sutured mesh
EXPERIMENTAL200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures
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 Criteria
You may qualify if:
- primary unilateral inguinal hernia
You may not qualify if:
- not willing to participate
- not capable to understand or fill in the questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Medtronic - MITGcollaborator
Study Sites (2)
HUCH Jorvi Hospital, department of Surgery
Espoo, 02480, Finland
HUCH Surgical Hospital, Dept of Surgery
Helsinki, Finland
Related Publications (1)
Pierides G, Scheinin T, Remes V, Hermunen K, Vironen J. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg. 2012 May;99(5):630-6. doi: 10.1002/bjs.8705. Epub 2012 Feb 23.
PMID: 22362035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaana Vironen, MD PhD
HUCH Jorvi Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 4, 2009
First Posted
December 7, 2009
Study Start
February 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2011
Last Updated
July 20, 2011
Record last verified: 2009-12