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

• 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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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