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

Study Overview
=================
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.

Official Title
-----------------
Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

Conditions
-----------------
Awake Laser, Microlaryngeal Surgery, Benign Laryngeal Lesion, Transnasal Laser Surgery

Intervention / Treatment
-----------------
* Procedure: Awake transnasal laser-assisted surgery (TNLS)
* Procedure: Microlaryngeal surgery (MLS)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microlaryngeal surgery (MLS)<br>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)<br>* For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.<br>|
| Experimental: Awake transnasal laser-assisted surgery (TNLS)<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-oriented outcomes | Operation time | Intraoperative | 
| Procedure-oriented outcomes | Completeness of lesion removal | Intraoperative | 
| Procedure-oriented outcomes | Complications in Clavien-Dindo classification | Intraoperative | 
| Procedure-oriented outcomes | Length of hospital stay | Perioperative | 
| Procedure-oriented outcomes | Recurrence rate | Post-op 2 week, 6 week, 3 month, 6 month, 1 year | 
| Procedure-oriented outcomes | Reoperation | 1 year | 
| Cost | Medical costs including surgery-related and hospitalization-related costs are estimated. | Peri-operative | 
| Patient-perceived procedural discomfort | Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable. | Immediate post-operation |