Mesh Fixation With Intraperitoneal Tisseel (MEFIXIT)

Herlev Hospital

Status: Completed

Conditions: Postoperative Pain; Ventral Hernia

Treatments: Procedure: tack fixation of mesh; Procedure: glue fixation of mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00842842

H-B-2008-147

Details and patient eligibility

About

The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-85 years and Danish speaking
• Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
• ASA group I-III

Exclusion criteria

• Former laparoscopic umbilical herniotomy
• Incarceration
• Drug/alcohol abuse/ongoing use of strong analgesic
• Bad compliance
• Liver disease Child-Pugh stage B/C
• Immunodeficiency (ex. steroid use)
• Pregnancy
• Other hernias recognized perop. and operated on at the same operation
• Lack of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

1: tacks

Active Comparator group

Description:

mesh fixation with tacks

Treatment:

Procedure: tack fixation of mesh

2: glue

Experimental group

Description:

mesh fixation with glue

Treatment:

Procedure: glue fixation of mesh