Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair. (ELEFANT)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Inguinal Hernias

Treatments: Device: Non magnetic field therapy device.; Device: Magnetic field therapy device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01842204

2013/234

Details and patient eligibility

About

A monocentric interventional randomized placebo controlled trial evaluating the efficacy of the post surgical and wound care recovery kit.

It's a small device that consists of a thin metal ring that is placed on the skin surface, non-invasively. It's connected with a small battery. When the plastic tag is removed and the button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is created. It influences the receptor-ligand binding at the cell surface and might improve wound healing by diminishing wound edema and inflammation. It possibly helps reducing the inflammatory reaction induced by surgery.

Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at the time of bandage, a kit will be applied at the level of the incision. One group will at random receive a working device, the other half will have a kit without active electromagnetic field.

Postoperative analgesic consumption will be measured in a diary and pain and quality of life will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.

The aim of this study is to evaluate whether the placement of the device reduces the acute postoperative pain and whether it reduces the incidence of chronic groin pain.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent from the patient
• Primary, unilateral and bilateral groin hernias

Exclusion criteria

• No written informed consent
• Recurrent hernias
• 'Incarcerated' hernias
• pregnant women: reaction of a Pulsed Electromagnetic Field on the foetus is unknown
• Patients with pacemaker or Internal defibrillator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

active kit

Experimental group

Description:

Patient receives an active kit with pulsed electromagnetic field over wound surface area.

Treatment:

Device: Magnetic field therapy device

non-active kit

Placebo Comparator group

Description:

Patient receives a non-active kit.

Treatment:

Device: Non magnetic field therapy device.