Condition category
Respiratory
Date applied
23/03/2020
Date assigned
25/03/2020
Last edited
10/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional contact

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

Additional contact

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

Additional contact

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

Additional contact

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 number

Nil known

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

03/02/2020

Overall trial 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

Patient

Age group

Adult

Gender

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

Trial 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

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 is planning on March 2021. The researchers are intending to publish the results of pilot study of comparative assessment of Thulium Revolix Laser usage for tonsillectomy in compare with cold steel dissection with bipolar electrocautery.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/07/2020: The following changes were made to the trial record: 1. The overall end date was changed from 01/10/2020 to 01/11/2020. 2. The intention to publish date was changed from 01/11/2020 to 01/11/2021. 3. The plain English summary was updated to reflect these changes. 24/03/2020: Trial’s existence confirmed by Yerevan State Medical University.