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

NCT ID: NCT05665829

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Awake Laser Microlaryngeal Surgery Benign Laryngeal Lesion Transnasal Laser Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective randomised controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

non

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Microlaryngeal surgery (MLS)

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Awake transnasal laser-assisted surgery (TNLS)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Microlaryngeal surgery (MLS)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Tam Aurora Ka Yue

Clinical Tutor (honorary)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CREC Ref. No. 2021.170

Identifier Type: -

Identifier Source: org_study_id