Mesh Fixation in Lichtenstein Hernioplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Kuopio University Hospital
Sponsor:
Collaborators:
Helsinki University Central Hospital
Paijat-Hame Hospital District
North Karelia Central Hospital
Hospital of Eastern Savo
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01592942
First received: May 3, 2012
Last updated: September 10, 2014
Last verified: August 2013
  Purpose

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 2014
Primary Completion Date: December 2013 (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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01592942

Contacts
Contact: Hannu EK Paajanen, MD, PhD +358-40-3589905 hannu.paajanen@kuh.fi
Contact: Kirsi Rönkä, MD kirsi.ronka@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70600
Contact: Hannu EK Paajanen, MD, PhD    +358-40-3589905    hannu.paajanen@kuh.fi   
Contact: Kirsi Rönkä, MD       kirsi.ronka@kuh.fi   
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
Hospital of Eastern Savo
Investigators
Principal Investigator: Hannu EK Paajanen, MD, PhD Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Hannu Paajanen, PhD, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01592942     History of Changes
Other Study ID Numbers: KUH5200627, KUH 31//2012
Study First Received: May 3, 2012
Last Updated: September 10, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
inguinal hernia
mesh fixation
glue
Lichtenstein

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 01, 2014