About this trial
This is a prospective randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based awake transnasal laser-assisted laryngeal surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery for vocal cord cyst under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with vocal cord cysts
older than 18-year-old
able to independently provide consent
able to tolerate flexible laryngoscopy would be recruited
Disqualifiers
under 18-year-old
unable to independently give an informed consent
unable to tolerate flexible laryngoscopy
allergic to local anesthesia
Trial design
Parallel
Treatments tested in this trial
Awake transnasal laser-assisted surgery (TNLS)
Procedure/SurgeryFor TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days.
Microlaryngeal surgery (MLS)
Procedure/SurgeryFor traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days.
Treatment groups
Trial outcomes
Primary outcomes
Voice-Handicap Index (VHI-30)
The primary outcome was to compare the pre- and post-operative Voice-Handicap Index 30 (VHI-30) of TNLS and MLS groups. The VHI-30 is a 30-item self-administered questionnaire, with score range from 0 to 120, and a score of 120 meaning worst voice score. It has been shown to be 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 a person's everyday functioning and experience.
Secondary outcomes
Perceptual evaluation of voice
Perceptual evaluation of voice using the GBRAS scale, in which patients would be required to produce sustained vowel and connected speech voice samples. Score range from 0 to 15, with 15 being the worst score. Two experienced speech-language pathologists blinded to the patient's information would rate the audio recordings.
Acoustic voice analysis - Noise-to-Harmonic ratio (NHR)
Acoustic voice analysis will be performed using PRATT program; Noise-to-Harmonic ratio refers to the ratio between periodic and non-periodic components of a speech sound. A lower NHR score may indicate a worse voice outcome.
Acoustic voice analysis - Jitter
Acoustic voice analysis will be performed using PRATT program; Jitter refers to variation of voice frequency.
Acoustic voice analysis - Shimmer
Acoustic voice analysis will be performed using PRATT program; Shimmer refers to variation of intensity of the voice.
Sponsors and contacts
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