Mesh Fixation in Lichtenstein Hernioplasty

December 16, 2020 updated by: Hannu Paajanen, Kuopio University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary or recurrent inguinal hernia
  • unilateral or bilateral

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glue fixation
Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)
Device: Histoacryl
cyanoacrylate glue fixation of mesh 1 ml
Other Names:
  • Histoacryl glue
Active Comparator: self-gripping
ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
Device: Progrip
self-gripping mesh
Other Names:
  • Parietex Progrip
Active Comparator: suture fixation
Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures
Device: sutures (prolene 3-0)
non-absorbable suture fixation 3-0
Other Names:
  • prolene 3-0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 5 years
pain scores (VAS 0-10) preoperatively and after surgery
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
costs
Time Frame: 1 year
operative cost-effectiveness
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Helsinki University Central Hospital
North Karelia Central Hospital
Paijat-Hame Hospital District
East Savo Hospital District

Investigators

  • Principal Investigator: Hannu EK Paajanen, MD, PhD, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5200627
  • KUH 31//2012 (Registry Identifier: KUH 31//2012)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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