Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair. (ELEFANT)
Recruitment status was: Recruiting
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.
|Inguinal Hernias||Device: Magnetic field therapy device Device: Non magnetic field therapy device.||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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.|
- Postoperative analgesic requirement after 1 week. [ Time Frame: 1 week after the surgery. ]Evaluation through Questionnaires, VAS, euraHS QOL, diary.
- chronic pain at 3 months post-surgery. [ Time Frame: 3 months post surgery. ]Clinical evaluation and VAS.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842204
|Contact: Frederik Berrevoet, MD, PhD, FACS||Frederik.Berrevoet@ugent.be|
|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|
|Principal Investigator:||Frederik Berrevoet, MD, PhD, FACS||University Hospital, Ghent|