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

Not Applicable

Completed

• Conditions: Awake Laser; Microlaryngeal Surgery; Benign Laryngeal Lesion; Transnasal Laser Surgery
• Interventions: Procedure: Microlaryngeal surgery (MLS); Procedure: Awake transnasal laser-assisted surgery (TNLS)

• Registration Number: NCT05665829
• Lead Sponsor: Chinese University of Hong Kong

Brief 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 anesthesia.

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 Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microlaryngeal surgery (MLS)	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)	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.

Primary Outcome Measures

Name	Time	Method
Voice-Handicap Index (VHI-30)	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.

Secondary Outcome Measures

Name	Time	Method
Cost	Peri-operative	Medical costs including surgery-related and hospitalization-related costs are estimated.
Patient-perceived procedural discomfort	Immediate post-operation	Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable.
Procedure-oriented outcomes	1 year	Reoperation

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong