Mesh Fixation in Lichtenstein Hernioplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Kuopio University Hospital
Helsinki University Central Hospital
Paijat-Hame Hospital District
North Karelia Central Hospital
East Savo Hospital District
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital Identifier:
First received: May 3, 2012
Last updated: March 20, 2016
Last verified: August 2015
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.

Condition Intervention
Inguinal Hernia
Device: Histoacryl
Device: Progrip
Device: sutures (prolene 3-0)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • pain [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    pain scores (VAS 0-10) preoperatively and after surgery

Secondary Outcome Measures:
  • costs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    operative cost-effectiveness

Estimated Enrollment: 650
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Histoacryl glue
Active Comparator: self-gripping
ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
Device: Progrip
self-gripping mesh
Other Name: 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 Name: prolene 3-0

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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary or recurrent inguinal hernia
  • unilateral or bilateral

Exclusion Criteria:

  • femoral hernia
  • massive scrotal hernia
  • allergy to polypropylene
  • patient's refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01592942

Contact: Hannu EK Paajanen, MD, PhD +358-40-3589905
Contact: Kirsi Rönkä, MD

Kuopio University Hospital Recruiting
Kuopio, Finland, 70600
Contact: Hannu EK Paajanen, MD, PhD    +358-40-3589905   
Contact: Kirsi Rönkä, MD   
Principal Investigator: Hannu EK Paajanen, MD, PhD         
Sponsors and Collaborators
Kuopio University Hospital
Helsinki University Central Hospital
Paijat-Hame Hospital District
North Karelia Central Hospital
East Savo Hospital District
Principal Investigator: Hannu EK Paajanen, MD, PhD Kuopio University Hospital
  More Information

Responsible Party: Hannu Paajanen, PhD, MD, Kuopio University Hospital Identifier: NCT01592942     History of Changes
Other Study ID Numbers: KUH5200627  KUH 31//2012 
Study First Received: May 3, 2012
Last Updated: March 20, 2016
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
inguinal hernia
mesh fixation

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical processed this record on May 26, 2016