NCT01592942

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	Histoacryl	cyanoacrylate glue fixation of mesh 1 ml
DEVICE	Progrip	self-gripping mesh
DEVICE	sutures (prolene 3-0)	non-absorbable suture fixation 3-0

Timeline

• Start date: 2012-08-01
• Primary completion: 2019-03-01
• Completion: 2021-12-01
• First posted: 2012-05-07
• Last updated: 2020-12-17

Locations

1 site across 1 country: Finland