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

Inguinal Hernias Clinical Trial

— ELEFANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842204
• Other study ID #: 2013/234
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: August 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2023
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernias

Intervention

Device:
• Magnetic field therapy device
Therapy device for 1 week.
• Non magnetic field therapy device.
Non-active device for 1 week.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	BioElectronics Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesic requirement after 1 week.	Evaluation through Questionnaires, VAS, euraHS QOL, diary.	1 week after the surgery.
Secondary	chronic pain at 3 months post-surgery.	Clinical evaluation and VAS.	3 months post surgery.

External Links

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