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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inguinal Hernias

Intervention / Treatment
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* Device: Magnetic field therapy device
* Device: Non magnetic field therapy device.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active kit<br>Patient receives an active kit with pulsed electromagnetic field over wound surface area. | Device: Magnetic field therapy device<br>* Therapy device for 1 week.<br>* Other names: Post-surgical and wound care recovery kit.;|
| Placebo Comparator: non-active kit<br>Patient receives a non-active kit. | Device: Non magnetic field therapy device.<br>* Non-active device for 1 week.<br>* Other names: Post-surgical and Wound care recovery kit.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic requirement after 1 week. | Evaluation through Questionnaires, VAS, euraHS QOL, diary. | 1 week after the surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain at 3 months post-surgery. | Clinical evaluation and VAS. | 3 months post surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia