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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Bioelectronics Corp.
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01842204
First received: April 24, 2013
Last updated: December 12, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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. ] [ Designated as safety issue: No ]
    Evaluation through Questionnaires, VAS, euraHS QOL, diary.


Secondary Outcome Measures:
  • chronic pain at 3 months post-surgery. [ Time Frame: 3 months post surgery. ] [ Designated as safety issue: No ]
    Clinical evaluation and VAS.


Estimated Enrollment: 75
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Corp.
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01842204     History of Changes
Other Study ID Numbers: 2013/234
Study First Received: April 24, 2013
Last Updated: December 12, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
inguinal hernia

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

ClinicalTrials.gov processed this record on October 22, 2014