Mesh Fixation in Lichtenstein Hernioplasty

Kuopio University Hospital

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Device: Progrip; Device: sutures (prolene 3-0); Device: Histoacryl

Study type: Interventional

Funder types: Other

Identifiers

NCT01592942

KUH5200627

KUH 31//2012 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 3 patient groups

glue fixation

Experimental group

Description:

Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)

Treatment:

Device: Histoacryl

self-gripping

Active Comparator group

Description:

ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)

Treatment:

Device: Progrip

suture fixation

Active Comparator group

Description:

Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures

Treatment:

Device: sutures (prolene 3-0)