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Mesh Fixation in Lichtenstein Hernioplasty

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Histoacryl
Progrip
sutures (prolene 3-0)
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, mesh fixation, glue, Lichtenstein

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary or recurrent inguinal hernia
  • unilateral or bilateral

Exclusion Criteria:

  • femoral hernia
  • massive scrotal hernia
  • allergy to polypropylene
  • patient's refusal

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

glue fixation

self-gripping

suture fixation

Arm Description

Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)

ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)

Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures

Outcomes

Primary Outcome Measures

pain
pain scores (VAS 0-10) preoperatively and after surgery

Secondary Outcome Measures

costs
operative cost-effectiveness

Full Information

First Posted
May 3, 2012
Last Updated
December 16, 2020
Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, Paijat-Hame Hospital District, North Karelia Central Hospital, East Savo Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT01592942
Brief Title
Mesh Fixation in Lichtenstein Hernioplasty
Official Title
A Randomized Multi-center Study of Tissue Glue Fixation of Optilene™ Mesh With Histoacryl™ or Self-gripping Parietex ProGrip™ Compared to Conventional Non-absorbable Suture Fixation of Ultrapro™ Mesh
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, Paijat-Hame Hospital District, North Karelia Central Hospital, East Savo Hospital District

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.
Detailed Description
Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, mesh fixation, glue, Lichtenstein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
glue fixation
Arm Type
Experimental
Arm Description
Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)
Arm Title
self-gripping
Arm Type
Active Comparator
Arm Description
ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
Arm Title
suture fixation
Arm Type
Active Comparator
Arm Description
Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures
Intervention Type
Device
Intervention Name(s)
Histoacryl
Other Intervention Name(s)
Histoacryl glue
Intervention Description
cyanoacrylate glue fixation of mesh 1 ml
Intervention Type
Device
Intervention Name(s)
Progrip
Other Intervention Name(s)
Parietex Progrip
Intervention Description
self-gripping mesh
Intervention Type
Device
Intervention Name(s)
sutures (prolene 3-0)
Other Intervention Name(s)
prolene 3-0
Intervention Description
non-absorbable suture fixation 3-0
Primary Outcome Measure Information:
Title
pain
Description
pain scores (VAS 0-10) preoperatively and after surgery
Time Frame
5 years
Secondary Outcome Measure Information:
Title
costs
Description
operative cost-effectiveness
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary or recurrent inguinal hernia unilateral or bilateral Exclusion Criteria: femoral hernia massive scrotal hernia allergy to polypropylene patient's refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannu EK Paajanen, MD, PhD
Phone
+358-40-3589905
Email
hannu.paajanen@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsi Rönkä, MD
Email
kirsi.ronka@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70600
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Phone
+358-40-3589905
Email
hannu.paajanen@kuh.fi
First Name & Middle Initial & Last Name & Degree
Kirsi Rönkä, MD
Email
kirsi.ronka@kuh.fi
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD

12. IPD Sharing Statement

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Mesh Fixation in Lichtenstein Hernioplasty

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