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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-oriented outcomes | Operation time | Intraoperative |
| Procedure-oriented outcomes | Completeness of lesion removal | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
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This is a prospective randomised controlled trial
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non
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| Microlaryngeal surgery (MLS) | Procedure | For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach. |
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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 |
| 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 |