Mesh Fixation in Lichtenstein Hernioplasty

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01592942
• Other study ID #: KUH5200627
• Secondary ID: KUH 31//2012
• Status: Recruiting
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Kuopio University Hospital
• Contact: Hannu EK Paajanen, MD, PhD
• Phone: +358-40-3589905
• Email: hannu.paajanen[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 2021
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary or recurrent inguinal hernia

• unilateral or bilateral

Exclusion Criteria:

• femoral hernia

• massive scrotal hernia

• allergy to polypropylene

• patient's refusal

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Histoacryl
cyanoacrylate glue fixation of mesh 1 ml
• Progrip
self-gripping mesh
• sutures (prolene 3-0)
non-absorbable suture fixation 3-0

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (5)

Lead Sponsor	Collaborator
Kuopio University Hospital	East Savo Hospital District, Helsinki University Central Hospital, North Karelia Central Hospital, Paijat-Hame Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	pain scores (VAS 0-10) preoperatively and after surgery	5 years
Secondary	costs	operative cost-effectiveness	1 year