Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Awake transnasal laser-assisted surgery (TNLS)

    Procedure/Surgery

    For 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/Surgery

    For 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

54 Participants
are divided into 2 treatment groups
Group A: Microlaryngeal surgery (MLS)Active comparator 1 intervention
Group B: Awake transnasal laser-assisted surgery (TNLS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrolment to post-operative 1year

Secondary outcomes

1

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.

Time frame
From enrolment to post-operative 1year
2

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.

Time frame
From enrolment to post-operative 1year
3

Acoustic voice analysis - Jitter

Acoustic voice analysis will be performed using PRATT program; Jitter refers to variation of voice frequency.

Time frame
From enrolment to post-operative 1year
4

Acoustic voice analysis - Shimmer

Acoustic voice analysis will be performed using PRATT program; Shimmer refers to variation of intensity of the voice.

Time frame
From enrolment to post-operative 1year

Other outcomes

Sponsors and contacts

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