Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair. (ELEFANT)
Primary Purpose
Inguinal Hernias
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Magnetic field therapy device
Non magnetic field therapy device.
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernias focused on measuring inguinal hernia
Eligibility 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
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
active kit
non-active kit
Arm Description
Patient receives an active kit with pulsed electromagnetic field over wound surface area.
Patient receives a non-active kit.
Outcomes
Primary Outcome Measures
Postoperative analgesic requirement after 1 week.
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
Secondary Outcome Measures
chronic pain at 3 months post-surgery.
Clinical evaluation and VAS.
Full Information
NCT ID
NCT01842204
First Posted
April 24, 2013
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
Collaborators
BioElectronics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01842204
Brief Title
Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
Acronym
ELEFANT
Official Title
Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
August 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
BioElectronics Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernias
Keywords
inguinal hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active kit
Arm Type
Experimental
Arm Description
Patient receives an active kit with pulsed electromagnetic field over wound surface area.
Arm Title
non-active kit
Arm Type
Placebo Comparator
Arm Description
Patient receives a non-active kit.
Intervention Type
Device
Intervention Name(s)
Magnetic field therapy device
Other Intervention Name(s)
Post-surgical and wound care recovery kit.
Intervention Description
Therapy device for 1 week.
Intervention Type
Device
Intervention Name(s)
Non magnetic field therapy device.
Other Intervention Name(s)
Post-surgical and Wound care recovery kit.
Intervention Description
Non-active device for 1 week.
Primary Outcome Measure Information:
Title
Postoperative analgesic requirement after 1 week.
Description
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
Time Frame
1 week after the surgery.
Secondary Outcome Measure Information:
Title
chronic pain at 3 months post-surgery.
Description
Clinical evaluation and VAS.
Time Frame
3 months post surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD, FACS
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
We'll reach out to this number within 24 hrs