Clinical Trial: Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

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.


Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: Postoperative analgesic requirement after 1 week. [ Time Frame: 1 week after the surgery. ]

Evaluation through Questionnaires, VAS, euraHS QOL, diary.


Original Primary Outcome: Same as current

Current Secondary Outcome: chronic pain at 3 months post-surgery. [ Time Frame: 3 months post surgery. ]

Clinical evaluation and VAS.


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: April 24, 2013
Date Started: May 2013
Date Completion: December 2015
Last Updated: June 2, 2015
Last Verified: June 2015