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

Primary Purpose

Inguinal Hernia, Primary, Unilateral

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Open inguinal hernia repair
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring open mesh repair, sutured, non-sutured, pro-grip, postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary unilateral inguinal hernia

Exclusion Criteria:

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

Sites / Locations

  • HUCH Jorvi Hospital, department of Surgery
  • HUCH Surgical Hospital, Dept of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sutured mesh

non-sutured mesh

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative complaints

Secondary Outcome Measures

Recurrence rate

Full Information

First Posted
December 4, 2009
Last Updated
July 19, 2011
Sponsor
Helsinki University Central Hospital
Collaborators
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01026935
Brief Title
The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Primary, Unilateral
Keywords
open mesh repair, sutured, non-sutured, pro-grip, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sutured mesh
Arm Type
Experimental
Arm Description
200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)
Arm Title
non-sutured mesh
Arm Type
Experimental
Arm Description
200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures
Intervention Type
Device
Intervention Name(s)
Open inguinal hernia repair
Other Intervention Name(s)
Parietene Light, Parietene ProGrip
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative complaints
Time Frame
One year
Secondary Outcome Measure Information:
Title
Recurrence rate
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary unilateral inguinal hernia Exclusion Criteria: not willing to participate not capable to understand or fill in the questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaana Vironen, MD PhD
Organizational Affiliation
HUCH Jorvi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUCH Jorvi Hospital, department of Surgery
City
Espoo
ZIP/Postal Code
02480
Country
Finland
Facility Name
HUCH Surgical Hospital, Dept of Surgery
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22362035
Citation
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.
Results Reference
derived

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

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