Clinical Trials Directory

Trials / Completed

CompletedNCT01842204

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMagnetic field therapy deviceTherapy device for 1 week.
DEVICENon magnetic field therapy device.Non-active device for 1 week.

Timeline

Start date
2013-05-01
Primary completion
2015-12-01
Completion
2023-08-01
First posted
2013-04-29
Last updated
2024-07-03

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT01842204. Inclusion in this directory is not an endorsement.