Mesh Fixation in Lichtenstein Hernioplasty

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Device: Progrip; Device: Histoacryl; Device: sutures (prolene 3-0)

• Registration Number: NCT01592942
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Study Start: 2012-08
• Primary Completion: 2019-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• primary or recurrent inguinal hernia
• unilateral or bilateral

Exclusion Criteria

• femoral hernia
• massive scrotal hernia
• allergy to polypropylene
• patient's refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self-gripping	Progrip	ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)
glue fixation	Histoacryl	Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)
suture fixation	sutures (prolene 3-0)	Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures

Primary Outcome Measures

Name	Time	Method
pain	5 years	pain scores (VAS 0-10) preoperatively and after surgery

Secondary Outcome Measures

Name	Time	Method
costs	1 year	operative cost-effectiveness

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland