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

The Chinese University of Hong Kong

Status: Completed

Conditions: Awake Laser; Benign Laryngeal Lesion; Microlaryngeal Surgery; Transnasal Laser Surgery

Treatments: Procedure: Awake transnasal laser-assisted surgery (TNLS); Procedure: Microlaryngeal surgery (MLS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05665829

CREC Ref. No. 2021.170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Microlaryngeal surgery (MLS)

Active Comparator group

Description:

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

Treatment:

Procedure: Microlaryngeal surgery (MLS)

Awake transnasal laser-assisted surgery (TNLS)

Experimental group

Description:

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.

Treatment:

Procedure: Awake transnasal laser-assisted surgery (TNLS)