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

August 31, 2023 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active kit
Patient receives an active kit with pulsed electromagnetic field over wound surface area.
Device: Magnetic field therapy device
Therapy device for 1 week.
Other Names:
  • Post-surgical and wound care recovery kit.
Placebo Comparator: non-active kit
Patient receives a non-active kit.
Device: Non magnetic field therapy device.
Non-active device for 1 week.
Other Names:
  • Post-surgical and Wound care recovery kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesic requirement after 1 week.
Time Frame: 1 week after the surgery.
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
1 week after the surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic pain at 3 months post-surgery.
Time Frame: 3 months post surgery.
Clinical evaluation and VAS.
3 months post surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

BioElectronics Corporation

Investigators

  • Principal Investigator: Frederik Berrevoet, MD, PhD, FACS, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimated)

April 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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