Mesh Fixation in Lichtenstein Hernioplasty
This study is currently recruiting participants.
Verified November 2012 by Kuopio University Hospital
Sponsor:
Kuopio University Hospital
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: November 12, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (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
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: | November 12, 2012 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Kuopio University Hospital:
|
inguinal hernia mesh fixation glue Lichtenstein |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 23, 2013