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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01592942

Enrollment

650

Registered

2012-05-07

Start date

2012-08-31

Completion date

2021-12-31

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

inguinal hernia, mesh fixation, glue, Lichtenstein

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.

Interventions

DEVICEHistoacryl

cyanoacrylate glue fixation of mesh 1 ml

DEVICEProgrip

self-gripping mesh

DEVICEsutures (prolene 3-0)

non-absorbable suture fixation 3-0

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* primary or recurrent inguinal hernia * unilateral or bilateral

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
pain	5 years	pain scores (VAS 0-10) preoperatively and after surgery

Secondary

Measure	Time frame	Description
costs	1 year	operative cost-effectiveness

Countries

Finland

Contacts

Primary ContactHannu EK Paajanen, MD, PhD

hannu.paajanen@kuh.fi+358-40-3589905

Backup ContactKirsi Rönkä, MD

kirsi.ronka@kuh.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026