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Mesh Fixation in Lichtenstein Hernioplasty

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ClinicalTrials.gov Identifier: NCT01592942
Recruitment Status : Recruiting
First Posted : May 7, 2012
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
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

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.

Condition or disease Intervention/treatment
Inguinal Hernia Device: Histoacryl Device: Progrip Device: sutures (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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : August 2012
Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. pain [ Time Frame: 5 years ]
    pain scores (VAS 0-10) preoperatively and after surgery


Secondary Outcome Measures :
  1. costs [ Time Frame: 1 year ]
    operative cost-effectiveness



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
East Savo Hospital District
Investigators
Principal Investigator: Hannu EK Paajanen, MD, PhD Kuopio University Hospital

Responsible Party: Hannu Paajanen, PhD, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01592942     History of Changes
Other Study ID Numbers: KUH5200627
KUH 31//2012 ( Registry Identifier: KUH 31//2012 )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: October 2016

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

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