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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

May 3, 2012
May 7, 2012
March 8, 2017
August 2012
October 2016   (Final data collection date for primary outcome measure)
pain [ Time Frame: 5 years ]
pain scores (VAS 0-10) preoperatively and after surgery
Same as current
Complete list of historical versions of study NCT01592942 on ClinicalTrials.gov Archive Site
costs [ Time Frame: 1 year ]
operative cost-effectiveness
Same as current
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Inguinal Hernia
  • Device: Histoacryl
    cyanoacrylate glue fixation of mesh 1 ml
    Other Name: Histoacryl glue
  • Device: Progrip
    self-gripping mesh
    Other Name: Parietex Progrip
  • Device: sutures (prolene 3-0)
    non-absorbable suture fixation 3-0
    Other Name: prolene 3-0
  • Experimental: glue fixation
    Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)
    Intervention: Device: Histoacryl
  • Active Comparator: self-gripping
    ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
    Intervention: Device: Progrip
  • Active Comparator: suture fixation
    Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures
    Intervention: Device: sutures (prolene 3-0)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
Same as current
December 2017
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary or recurrent inguinal hernia
  • unilateral or bilateral

Exclusion Criteria:

  • femoral hernia
  • massive scrotal hernia
  • allergy to polypropylene
  • patient's refusal
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Hannu EK Paajanen, MD, PhD +358-40-3589905 hannu.paajanen@kuh.fi
Contact: Kirsi Rönkä, MD kirsi.ronka@kuh.fi
Finland
 
 
NCT01592942
KUH5200627
KUH 31//2012 ( Registry Identifier: KUH 31//2012 )
No
Not Provided
Not Provided
Hannu Paajanen, Kuopio University Hospital
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
Kuopio University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP