Mesh Fixation With Intraperitoneal Tisseel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1: tacks

mesh fixation with tacks

Group Type ACTIVE_COMPARATOR

tack fixation of mesh

Intervention Type PROCEDURE

tack fixation of mesh

2: glue

mesh fixation with glue

Group Type EXPERIMENTAL

glue fixation of mesh

Intervention Type PROCEDURE

glue fixation of mesh

Interventions

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tack fixation of mesh

Intervention Type PROCEDURE

glue fixation of mesh

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No