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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842204
First Posted: April 29, 2013
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BioElectronics Corporation
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

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.


Condition Intervention Phase
Inguinal Hernias Device: Magnetic field therapy device Device: Non magnetic field therapy device. Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Postoperative analgesic requirement after 1 week. [ Time Frame: 1 week after the surgery. ]
    Evaluation through Questionnaires, VAS, euraHS QOL, diary.


Secondary Outcome Measures:
  • chronic pain at 3 months post-surgery. [ Time Frame: 3 months post surgery. ]
    Clinical evaluation and VAS.


Estimated Enrollment: 75
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Post-surgical and Wound care recovery kit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842204


Contacts
Contact: Frederik Berrevoet, MD, PhD, FACS Frederik.Berrevoet@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD, PhD, FACS       Frederik.Berrevoet@ugent.be   
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS         
Sub-Investigator: Aude Vanlnander, MD         
Sponsors and Collaborators
University Hospital, Ghent
BioElectronics Corporation
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01842204     History of Changes
Other Study ID Numbers: 2013/234
First Submitted: April 24, 2013
First Posted: April 29, 2013
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Ghent:
inguinal hernia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal