Completed

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

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What is being tested

Magnetic field therapy device

+ Non magnetic field therapy device.

Device
Who is being recruted

Hernia+2

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity Hospital, Ghent
Last updated: July 3, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Hospital, Ghent
Last updated: July 3, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HerniaPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, AbdominalHernia, Inguinal

Criteria

2 inclusion criteria required to participate
Primary, unilateral and bilateral groin hernias

Written informed consent from the patient

5 exclusion criteria prevent from participating
Incarcerated' hernias

No written informed consent

Patients with pacemaker or Internal defibrillator

Recurrent hernias

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
Patient receives a non-active kit.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ghent University Hospital

Ghent, BelgiumOpen Ghent University Hospital in Google Maps
CompletedOne Study Center