Awake Laser, Benign Laryngeal Lesion, Microlaryngeal Surgery, Transnasal Laser Surgery
Conditions
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.
Interventions
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.
PROCEDUREMicrolaryngeal surgery (MLS)
For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
non
Intervention model description
This is a prospective randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voice-Handicap Index (VHI-30) | Post-op 2 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-oriented outcomes | Intraoperative | Operation time |
| Cost | Peri-operative | Medical costs including surgery-related and hospitalization-related costs are estimated. |
| Patient-perceived procedural discomfort | Immediate post-operation | Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable. |
Countries
Hong Kong
Outcome results
None listed