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

NCT05665829 | Completed

• 1 other identifier: CREC Ref. No. 2021.170
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Procedure-oriented outcomes

  Intraoperative

• Procedure-oriented outcomes

  Intraoperative

• Procedure-oriented outcomes

  Intraoperative

• Procedure-oriented outcomes

  Perioperative

• Procedure-oriented outcomes

  Post-op 2 week, 6 week, 3 month, 6 month, 1 year

Study Arms (2)

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

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.

Procedure: Awake transnasal laser-assisted surgery (TNLS)

Interventions

Awake transnasal laser-assisted surgery (TNLS) PROCEDURE

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.

Awake transnasal laser-assisted surgery (TNLS)

Microlaryngeal surgery (MLS) PROCEDURE

For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.

Microlaryngeal surgery (MLS)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: non
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Tutor (honorary)

Model Details: This is a prospective randomised controlled trial

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 27, 2022
• Study Start: May 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

HK (1)