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

NCT01842204 | Completed

• 1 other identifier: 2013/234
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernias

Keywords

inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesic requirement after 1 week.

  Evaluation through Questionnaires, VAS, euraHS QOL, diary.

  1 week after the surgery.

Secondary Outcomes (1)

• chronic pain at 3 months post-surgery.

  3 months post surgery.

Study Arms (2)

active kit

EXPERIMENTAL

Patient receives an active kit with pulsed electromagnetic field over wound surface area.

Device: Magnetic field therapy device

non-active kit

PLACEBO COMPARATOR

Patient receives a non-active kit.

Device: Non magnetic field therapy device.

Interventions

Magnetic field therapy device DEVICE

Therapy device for 1 week.

Also known as: Post-surgical and wound care recovery kit.

active kit

Non magnetic field therapy device. DEVICE

Non-active device for 1 week.

Also known as: Post-surgical and Wound care recovery kit.

non-active kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent from the patient
• Primary, unilateral and bilateral groin hernias

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• BioElectronics Corporation: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik Berrevoet, MD, PhD, FACS

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)