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

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

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 anesthesia.

Study Overview

• Status: Completed
• Conditions: Awake Laser; Microlaryngeal Surgery; Benign Laryngeal Lesion; Transnasal Laser Surgery
• Intervention / Treatment: Procedure: Microlaryngeal surgery (MLS); Procedure: Awake transnasal laser-assisted surgery (TNLS)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Microlaryngeal surgery (MLS); For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Post-op 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CREC Ref. No. 2021.170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No