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Completed

NCT Number: NCT01842204

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic field therapy device

Device

Therapy device for 1 week.

Other names: Post-surgical and wound care recovery kit.

Non magnetic field therapy device.

Device

Non-active device for 1 week.

Other names: Post-surgical and Wound care recovery kit.

Primary outcomes

  1. Postoperative analgesic requirement after 1 week.

    Time frame: 1 week after the surgery.

    Evaluation through Questionnaires, VAS, euraHS QOL, diary.

Secondary outcomes

  1. chronic pain at 3 months post-surgery.

    Time frame: 3 months post surgery.

    Clinical evaluation and VAS.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • BioElectronics Corporation

Registry information

Acronym: ELEFANT

Important dates

Study start
2013
Primary completion
2015
Study completion
2023
First posted
Apr 29, 2013
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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