Plain English Summary
Background and study aims
Recurrent or chronic inflammation of the tonsils (tonsillitis) is currently a global public health issue which can severely impair an individual’s quality of life.
Tonsillectomy is a 3000-year-old operation. Tonsillectomy is a surgical procedure to remove the tonsils. Tonsils are two small glands located in the back of your throat. Although tonsillectomy is performed less often than it once was, it is still among the most common surgical procedures performed in children anywhere in the world. The main indication of tonsillectomy is the recurrent throat infection. Tonsillitis and the need for tonsillectomies are more common in children than adults. However, people of any age can experience trouble with their tonsils and require surgery.
There are several different ways to remove tonsils. Most common method is called “cold knife (steel) dissection.” In this case, your surgeon removes your tonsils with a scalpel. Another common method for tonsillectomy involves burning away the tissues through a process called cauterization, CO2 laser etc. However, like with other surgeries, there are some risks with this procedure: swelling, intraoperational and postoperational bleeding, postoperational pain and delayed healing. Tonsillectomy with Thulium RevoLix laser usage could minimize the listed risks and thus improve the patient’s quality of life after tonsillectomy surgery, as it is surgical laser available for soft tissue surgery which unifies all advantageous properties of existing laser principles in a single unit.
Who can participate?
Adults over 18 years with chronic or recurrent tonsillitis
What does the study involve?
Patients due to have tonsils removed surgically will have the right side tonsils removed using the Thilium RevoLix laser and the left side with the cold steel method. Patients will be followed up for 10 days to assess the difference between the two methods.
What are the possible benefits and risks of participating?
Improved quality of life: Having the tonsils removed, as an adult, can help prevent a recurring sore throat, or tonsillitis (inflammation of the tonsils), that may force you to miss work. By having the tonsils removed, patients should no longer experience uncomfortable symptoms, such as pain and a sore throat related to tonsillitis
Fewer infections: As the tonsils will be removed and general health improved, those who experience tonsillitis caused by bacteria should have fewer infections.
Less use of medication: If patients have fewer tonsillitis infections, they may be prescribed less medication, such as antibiotics. Although antibiotics have many benefits, they kill off good bacteria as well as the bad.
There is no specific risk of operation regarding the technique of the operation. There are standard risks of operation tonsillectomy:
Reactions to anesthetics. Swelling, bleeding during surgery, bleeding during healing, infection.
Where is the study run from?
"Heratsi" #1 Hospital complex (Armenia)
When is the study starting and how long is it expected to run for?
May 2020 to November 2020 (updated 10/07/2020, previously: June 2020)
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Anna Poghosyan (scientific)
anna.yu.poghosyan@gmail.com
Dr Manana Baghdasaryan (scientific)
m.baghdasaryan@yahoo.com
Dr Gurgen Mkhitaryan (scientific)
Mkhitaryan_GK@yahoo.com
Dr Vahe Vermishyan (public)
vahevermishyan@gmail.com
Dr Martin Misakyan (scientific)
misakyan86@inbox.ru
Study website
Contact information
Type
Scientific
Contact name
Prof Anna Poghosyan
ORCID ID
https://orcid.org/0000-0002-5116-5644
Contact details
Yerevan State Medical University
2 Koryun str.
Yerevan
0001
Armenia
+374 91474169
anna.yu.poghosyan@gmail.com
Type
Scientific
Contact name
Dr Manana Baghdasaryan
ORCID ID
https://orcid.org/0000-0003-1859-6685
Contact details
Yerevan State Medical University
2 Koryun str.
Yerevan
0001
Armenia
+374 91560125
m.baghdasaryan@yahoo.com
Type
Scientific
Contact name
Dr Gurgen Mkhitaryan
ORCID ID
https://orcid.org/0000-0002-8616-1133
Contact details
Yerevan State Medical University
2 Koryun str.
Yerevan
0014
Armenia
+374 77300180
Mkhitaryan_GK@yahoo.com
Type
Public
Contact name
Dr Vahe Vermishyan
ORCID ID
https://orcid.org/0000-0002-1745-4899
Contact details
Yerevan State Medical University
2 Koryun str.
Yerevan
0050
Armenia
+374 94661165
vahevermishyan@gmail.com
Type
Scientific
Contact name
Dr Martin Misakyan
ORCID ID
https://orcid.org/0000-0001-9151-6181
Contact details
Yerevan State Medical University
2 Koryun str.
Yerevan
0018
Armenia
+374 96044054
misakyan86@inbox.ru
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A pilot study of Thulium RevoLix laser usage for tonsillectomy
Acronym
Study hypothesis
The usage of Thulium laser for tonsillectomy could minimise intraoperational and postoperational hemorrhage, postoperational pain and swallowing difficulties, wound recovering period, compared with cold steel tonsillectomy method.
Ethics approval(s)
Approved 19/03/2020, The Ethics Committee of Yerevan State Medical University named after Mkhitar Heratsi (2 Koryun str., Yerevan, Armenia 0025; (+374)77 919111 ;ec@ysmu.am), ref: N 6-1/ 2020
Study design
Interventional non-randomized pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Recurrent or chronic tonsillitis
Intervention
Patient recruitment
Informed consent signing
All necessary diagnostics examination performing (blood analysis, urine analysis, chest XR, ECG)
Anesthesiologists examination
The right side tonsillectomy of all patients is performed with Thulium Revolix laser and the left side with cold steel tonsillectomy method
Hospital stay 2-4 days
Outpatient follow-up 12 days
End of participation from 13th postop day
Intervention type
Procedure/Surgery
Primary outcome measure
Postoperative wound healing measured by assessment of wound surface recovery in post-operational period to 12th post-operational day
Secondary outcome measures
1. Intraoperative blood loss quantified by measuring suction bottle fluid and weight measurement of surgical sponges
2. Time taken for surgery will be measured from the beginning and finishing of each side tonsillectomy
3. Postoperative pain will be measured by a numerical rating scale from 0-10 at 2, 5, 7 and 10 post-operational days
4. Postoperative bleeding will be assessed by the effectiveness of management strategy (no therapy, clot suction, direct pressure or electrocautery) at 2, 5, 7 and 10 post-operational days
5. Time taken for complete healing measured by comparing both tonsillectomy sides by serial direct clinical examinations at 2, 5, 7 and 10 post-operational days
Overall study start date
03/02/2020
Overall study end date
01/11/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic or recurrent tonsillitis
2. Age over 18 years
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
12
Participant exclusion criteria
1. Bleeding diathesis
2. Poor anesthetic risk
3. Uncontrolled medical illness
4. Anemia
5. Acute infection
Recruitment start date
01/05/2020
Recruitment end date
01/06/2020
Locations
Countries of recruitment
Armenia
Study participating centre
"Heratsi" #1 Hospital Complex
Yerevan State Medical University
60 Abovyan str.
Yerevan
0025
Armenia
Sponsor information
Organisation
Yerevan State Medical University
Sponsor details
"Heratsi" #1 Hospital complex
60 Abovyan str.
Yerevan
0025
Armenia
+374 (11) 621098
mfs.ent.dep@gmail.com
Sponsor type
Hospital/treatment centre
Website
http://www.hcplasticsurgery.com
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication and dissemination of trial results are planned for June 2022. The researchers are intending to publish the results of the pilot study of comparative assessment of Thulium Revolix Laser usage for tonsillectomy in comparison with cold steel dissection with bipolar electrocautery.
Intention to publish date
01/06/2022
Individual participant data (IPD) sharing plan
All data generated or analysed during this study will be included in the subsequent results publication.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | non-peer-reviewed results in preprint | 04/01/2023 | 09/01/2023 | No | No |