Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst
- Conditions
- Vocal Cord Cyst
- Registration Number
- NCT06703515
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
The aim of the study is to prospectively compare the functional and clinical outcomes of TNLS under local anesthesia and MLS under general anesthesia in managing vocal cord cysts.
Office-based awake transnasal laser-assisted surgery (TNLS) has been gaining popularity in treating different laryngeal lesions, with the advantages of avoiding general anesthetic risks and minimizing healthcare-related costs. In addition, the general waiting time for surgeries under general anesthesia in public hospitals is getting longer due to the increasing population and limited resources. The investigators have recently conducted a novel randomized controlled trial in 2021-2022 comparing the functional and cost-effectiveness of traditional microlaryngeal surgery (MLS) under general anesthesia and TNLS for benign laryngeal lesions (vocal cord polyps, nodules, cysts, granuloma and Reinke's edema), and found that TNLS was superior to MLS in terms of length of stay, intraoperative complications, perioperative throat discomfort and hospital costs; while it was equivalent to MLS in terms of functional outcome, operative time and recurrence rate. However, since the previous study's main goal was to compare TNLS to MLS in a macroscopic perspective in terms of functional outcomes and cost-effectiveness, it had included a wide variety of benign laryngeal lesions, and different vocal cord lesions may respond differently to laser surgery.
Vocal cord cyst is a fluid-filled sac inside the vocal cord, with 2 subtypes: 1) Epidermoid cyst due to epithelial inclusion 2) Mucous retention cyst due to glandular ductal obstruction. Vocal cord cysts typically do not resolve with voice therapy, and are traditionally excised with microlaryngeal surgery with microflap technique or marsupialization. In our previous RCT study, subgroup analysis did not show a significant difference of vocal cord cyst recurrence in both TNLS and MLS group. However, the investigators' cohort had a higher overall vocal cord cyst recurrence rate (13.8%) compared to historic cohort rate of 2.2-8.7% , which may be accounted by that the vocal cord cysts were ablated and marsupialized instead of removed in the TNLS group. Nevertheless, a recent case series by Gao and colleagues showed a good functional outcome of awake KTP-laser marsupialization in selected cases. A larger cohort is warranted to compare TNLS to MLS for vocal cord cyst. Therefore, the investigators would like to conduct a randomized controlled trial to compared tradition MLS surgery to TNLS, with hypothesis that TNLS would be non-inferior to traditional microlaryngeal surgery in benign laryngeal lesions, and with its additional benefits on minimization of anesthetic risks and hospital expenses, hopefully to expand its further application.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Patients with vocal cord cysts
- older than 18-year-old
- able to independently provide consent
- able to tolerate flexible laryngoscopy would be recruited
- under 18-year-old
- unable to independently give an informed consent
- unable to tolerate flexible laryngoscopy
- allergic to local anesthesia
- had unfavorable anatomy such as prolapsing epiglottis precluding adequate visualization, extensive lesions and an expected difficult operation as judged by the surgeons
- with pathologies other than vocal cord cyst
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Voice-Handicap Index (VHI-30) From enrolment to post-operative 1year 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 Outcome Measures
Name Time Method Procedure-oriented outcomes - Operation time From perioperative period to post-operative 1 year Comparison of the operation time between two groups in terms of minute.
Patient-oriented outcomes Perioperative period Patient-oriented outcomes included peri-operative throat, nose, and overall discomfort in visual analogue scale, a 10-point scale with 0 (least uncomfortable) to 10 (most uncomfortable).
Perceptual evaluation of voice From enrolment to post-operative 1year 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) From enrolment to post-operative 1year 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 From enrolment to post-operative 1year Acoustic voice analysis will be performed using PRATT program; Jitter refers to variation of voice frequency.
Acoustic voice analysis - Shimmer From enrolment to post-operative 1year Acoustic voice analysis will be performed using PRATT program; Shimmer refers to variation of intensity of the voice.
Aerodynamic measure of voice From enrolment to post-operative 1year Aerodynamic measure, maximal phonation time (MPT) would be measured by instructing patients to phonate /a:/ sound for as long as possible after maximal inspiration, at a spontaneous, comfortable pitch and loudness level, for three consequent trials.
Visual analog scale (VAS) From enrolment to post-operative 1year In VAS, patients would be asked to self-rate their voice quality on a visual analog scale of 0 (best) to 10 (worst).
Videostroboscopy - Mucosal wave pattern From enrolment to post-operative 1year Videostroboscopy would be conducted on all patients to look for any impaired mucosal wave form.
Videostroboscopy - Vocal fold closure From enrolment to post-operative 1year Videostroboscopy would be conducted on all patients to compare the degree of vocal fold closure.
Procedure-oriented outcomes - Reoperation From perioperative period to post-operative 1 year Comparison of the rate of reoperation for recurrence vocal cord cyst between two groups.
Procedure-oriented outcomes - Disease recurrence From perioperative period to post-operative 1 year Comparison of the rate of vocal cord cyst recurrence between two groups.
Procedure-oriented outcomes - Length of hospital stay From perioperative period to post-operative 1 year Comparison of the length of hospital stay (number of day) between two groups.
Procedure-oriented outcomes - Surgical complications in Clavien-Dindo classification From perioperative period to post-operative 1 year Clavien-Dindo classification is a commonly used surgical complication grading system, from grade I-V with grade V indicating worst outcome (death).
Procedure-oriented outcomes - Completeness of lesion removal From perioperative period to post-operative 1 year Indicates if the vocal fold pathology has been completely removed
Medical costs From enrolment to post-operative 1year Medical costs of both interventions would be also calculated respectively, including costs for inpatient hospital stay, medical staff, operating theater and consumable.
Trial Locations
- Locations (1)
The Chinese University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong