Awake LaserNCT05665829

Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

A study testing Awake transnasal laser-assisted surgery (TNLS) and Microlaryngeal surgery (MLS) in people with Awake Laser and Microlaryngeal Surgery, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, single-cluster randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based transnasal laser-assisted surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery (MLS) under general… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Awake Laser, Microlaryngeal Surgery, Benign Laryngeal Lesion
What is being tested?: Awake transnasal laser-assisted surgery (TNLS) and Microlaryngeal surgery (MLS)
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteHong Kong
Study dates: 1 May 2021to 1 Dec 2022
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

older than 18-year-old
mentally competent to give an informed consent
operable benign laryngeal lesions
able to tolerate transnasal flexible laryngoscopy

Who cannot join

under 18-year old
unable to give an informed consent
unable to tolerate flexible laryngoscopy under local anesthesia
allergy to local anesthesia
unfavourable anatomy precluding adequate visualization
with extensive lesions with expected difficult operation
with pathologies suspicious of or confirmed malignancy

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Prince of Wales Hospital
Shatin

Other trials in Hong Kong

About this study

Official title: Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

Read the detailed description

Patients with benign laryngeal lesions were block-randomized to either TNLS or traditional MLS group. Pre-operative diagnosis and post-operative follow-up were conducted in a multidisciplinary voice clinic. All patients were followed up at 2-week, 6-week, 3-month, 6-month and 1-year post-operation. Primary outcome included functional vocal measures using Voice-Handicap index (VHI-30). Secondary outcomes included length of stay, patient-perceived procedural discomfort, complications, operative time, recurrence rate, reoperation rate, and medical cost.

Conditions: Awake Laser, Microlaryngeal Surgery, Benign Laryngeal Lesion, Transnasal Laser Surgery
Being tested: Awake transnasal laser-assisted surgery (TNLS), Microlaryngeal surgery (MLS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Awake transnasal laser-assisted surgery (TNLS)Procedure or surgery
The experimental intervention would be awake transnasal laser-assisted surgery under local anesthesia, carried out in minor operation theater as a day-case basis in ENT ambulatory center.
Microlaryngeal surgery (MLS)Procedure or surgery
For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.

Study groups in NCT05665829
Study group	Role	What they receive
Microlaryngeal surgery (MLS)	Active comparator	For traditional MLS under general anesthesia, after intubation with microlaryngeal tube, a laryngoscope will be inserted transorally under direct vision and suspended. Laryngeal lesions are visualized with either microscope or endoscope, and removed with microsurgery instruments and sent for routine section Receives: Procedure: Microlaryngeal surgery (MLS)
Awake transnasal laser-assisted surgery (TNLS)	Experimental	For TNLS, a transnasal channel flexible laryngoscope is used with prior trans-nasal, trans-oral and trans-laryngeal local anesthesia application. A 445nm blue laser is introduced via a working channel of laryngoscope, with a lesion-specific laser setting. Biopsy can be performed by devascularizing and thinning the lesion down to a pedicle, then removed with biopsy forcep. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. Patients are discharged on same day of procedure after close observation for 2 hours in day center. Receives: Procedure: Awake transnasal laser-assisted surgery (TNLS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Voice-Handicap Index (VHI-30)
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Measured: Post-op 2 week
Voice-Handicap Index (VHI-30)
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Measured: Post-op 6 week
Voice-Handicap Index (VHI-30)
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Measured: Post-op 3 month
Voice-Handicap Index (VHI-30)
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Measured: Post-op 6 month
Voice-Handicap Index (VHI-30)
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Measured: Post-op 1 year

Secondary outcomes (8)

Procedure-oriented outcomes
Operation time
Measured: Intraoperative
Procedure-oriented outcomes
Completeness of lesion removal
Measured: Intraoperative
Procedure-oriented outcomes
Complications in Clavien-Dindo classification
Measured: Intraoperative
Procedure-oriented outcomes
Length of hospital stay
Measured: Perioperative
Procedure-oriented outcomes
Recurrence rate
Measured: Post-op 2 week, 6 week, 3 month, 6 month, 1 year
Procedure-oriented outcomes
Reoperation
Measured: 1 year
Cost
Medical costs including surgery-related and hospitalization-related costs are estimated.
Measured: Peri-operative
Patient-perceived procedural discomfort
Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable.
Measured: Immediate post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20211 Dec 2022

First posted27 Dec 2022
Study start1 May 2021
Primary completion1 Dec 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Awake LaserStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective randomised controlled trial
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05665829
Sponsor's protocol ID: CREC Ref. No. 2021.170
Status last verified: Dec 2022
First submitted: 6 Dec 2022
Last updated: 27 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions
ClinicalTrials.gov ID: NCT05665829
Acronym / sponsor ID: CREC Ref. No. 2021.170
Conditions: Awake Laser, Microlaryngeal Surgery, Benign Laryngeal Lesion, Transnasal Laser Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 27 Dec 2022 (actual)
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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a prospective randomised controlled trial

Arm	Type	Receives
Microlaryngeal surgery (MLS)	Active comparator	Procedure: Microlaryngeal surgery (MLS)For traditional MLS under general anesthesia, after intubation with microlaryngeal tube, a laryngoscope will be inserted transorally under direct vision and suspended. Laryngeal lesions are visualized with either microscope or endoscope, and removed with microsurgery instruments and sent for routine section
Awake transnasal laser-assisted surgery (TNLS)	Experimental	Procedure: Awake transnasal laser-assisted surgery (TNLS)For TNLS, a transnasal channel flexible laryngoscope is used with prior trans-nasal, trans-oral and trans-laryngeal local anesthesia application. A 445nm blue laser is introduced via a working channel of laryngoscope, with a lesion-specific laser setting. Biopsy can be performed by devascularizing and thinning the lesion down to a pedicle, then removed with biopsy forcep. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. Patients are discharged on same day of procedure after close observation for 2 hours in day center.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

older than 18-year-old
mentally competent to give an informed consent
operable benign laryngeal lesions
able to tolerate transnasal flexible laryngoscopy

Key exclusion criteria (7 listed)

under 18-year old
unable to give an informed consent
unable to tolerate flexible laryngoscopy under local anesthesia
allergy to local anesthesia
unfavourable anatomy precluding adequate visualization

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
Awake transnasal laser-assisted surgery (TNLS)The experimental intervention would be awake transnasal laser-assisted surgery under local anesthesia, carried out in minor operation theater as a day-case basis in ENT ambulatory center.	Procedure or surgery	Awake transnasal laser-assisted surgery (TNLS)
Microlaryngeal surgery (MLS)For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.	Procedure or surgery	Microlaryngeal surgery (MLS)

Primary outcome

Voice-Handicap Index (VHI-30)
Time frame: Post-op 2 week
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Voice-Handicap Index (VHI-30)
Time frame: Post-op 6 week
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Voice-Handicap Index (VHI-30)
Time frame: Post-op 3 month
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Voice-Handicap Index (VHI-30)
Time frame: Post-op 6 month
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.
Voice-Handicap Index (VHI-30)
Time frame: Post-op 1 year
The VHI-30 is a 30-item self-administered questionnaire, which is a reliable measure for voice treatment outcome.It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

8 secondary outcomes

Procedure-oriented outcomes
Time frame: Intraoperative
Procedure-oriented outcomes
Time frame: Intraoperative
Procedure-oriented outcomes
Time frame: Intraoperative
Procedure-oriented outcomes
Time frame: Perioperative
Procedure-oriented outcomes
Time frame: Post-op 2 week, 6 week, 3 month, 6 month, 1 year
Procedure-oriented outcomes
Time frame: 1 year
Cost
Time frame: Peri-operative
Patient-perceived procedural discomfort
Time frame: Immediate post-operation

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 27 Dec 2022.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 27 Dec 2022. 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 Hong Kong. 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. 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?

Voice-Handicap Index (VHI-30) (time frame: Post-op 2 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665829.

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 27 Dec 2022.