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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
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.
For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.
Prince of Wales Hospital
Shatin, Hong Kong
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Post-op 1 year
Procedure-oriented outcomes
Operation time
Time frame: Intraoperative
Procedure-oriented outcomes
Completeness of lesion removal
Time frame: Intraoperative
Procedure-oriented outcomes
Complications in Clavien-Dindo classification
Time frame: Intraoperative
Procedure-oriented outcomes
Length of hospital stay
Time frame: Perioperative
Procedure-oriented outcomes
Recurrence rate
Time frame: Post-op 2 week, 6 week, 3 month, 6 month, 1 year
Procedure-oriented outcomes
Reoperation
Time frame: 1 year
Cost
Medical costs including surgery-related and hospitalization-related costs are estimated.
Time frame: Peri-operative
Patient-perceived procedural discomfort
Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable.
Time frame: Immediate post-operation