Mesh Fixation in Lichtenstein Hernioplasty
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
2 other identifiers
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 17, 2020
December 1, 2020
6.6 years
May 3, 2012
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain
pain scores (VAS 0-10) preoperatively and after surgery
5 years
Secondary Outcomes (1)
costs
1 year
Study Arms (3)
glue fixation
EXPERIMENTALOptilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)
self-gripping
ACTIVE COMPARATORProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
suture fixation
ACTIVE COMPARATORUltrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures
Interventions
non-absorbable suture fixation 3-0
Eligibility Criteria
You may qualify if:
- primary or recurrent inguinal hernia
- unilateral or bilateral
You may not qualify if:
- femoral hernia
- massive scrotal hernia
- allergy to polypropylene
- patient's refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Paijat-Hame Hospital Districtcollaborator
- North Karelia Central Hospitalcollaborator
- East Savo Hospital Districtcollaborator
Study Sites (1)
Kuopio University Hospital
Kuopio, 70600, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannu EK Paajanen, MD, PhD
Kuopio University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
May 3, 2012
First Posted
May 7, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2019
Study Completion
December 1, 2021
Last Updated
December 17, 2020
Record last verified: 2020-12