Inguinal HerniasELEFANTNCT01842204
Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
A study testing Magnetic field therapy device and Non magnetic field therapy device. in people with Inguinal Hernias, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- Magnetic field therapy device and Non magnetic field therapy device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent from the patient
- Primary, unilateral and bilateral groin hernias
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Magnetic field therapy device, Non magnetic field therapy device.
- Keywords
- inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic field therapy deviceDevice
Also called Post-surgical and wound care recovery kit.
Therapy device for 1 week.
Non magnetic field therapy device.Device
Also called Post-surgical and Wound care recovery kit.
Non-active device for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| active kit | Experimental | Patient receives an active kit with pulsed electromagnetic field over wound surface area. Receives: Device: Magnetic field therapy device |
| non-active kit | Placebo comparator | Patient receives a non-active kit. Receives: Device: Non magnetic field therapy device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic requirement after 1 week.
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
Measured: 1 week after the surgery.
Secondary outcomes (1)
chronic pain at 3 months post-surgery.
Clinical evaluation and VAS.
Measured: 3 months post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniasStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- BioElectronics Corporation
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, FACS, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842204
- Sponsor's protocol ID
- 2013/234
- Acronym
- ELEFANT
- Status last verified
- Jul 2024
- First submitted
- 24 Apr 2013
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
- ClinicalTrials.gov ID
- NCT01842204
- Acronym / sponsor ID
- ELEFANT / 2013/234
- Conditions
- Inguinal Hernias
- Keywords
- inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- BioElectronics Corporation
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active kit | Experimental | Device: Magnetic field therapy devicePatient receives an active kit with pulsed electromagnetic field over wound surface area. |
| non-active kit | Placebo comparator | Device: Non magnetic field therapy device.Patient receives a non-active kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent from the patient
- Primary, unilateral and bilateral groin hernias
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic field therapy deviceAlso: Post-surgical and wound care recovery kit.Therapy device for 1 week. | Device | active kit |
| Non magnetic field therapy device.Also: Post-surgical and Wound care recovery kit.Non-active device for 1 week. | Device | non-active kit |
Primary outcome
Postoperative analgesic requirement after 1 week.
Time frame: 1 week after the surgery.
Evaluation through Questionnaires, VAS, euraHS QOL, diary.
1 secondary outcome
chronic pain at 3 months post-surgery.
Time frame: 3 months post surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Berrevoet, MD, PhD, FACS principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic field therapy device and Non magnetic field therapy device. in people with Inguinal Hernias, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic requirement after 1 week. (time frame: 1 week after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.