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临床试验/NCT06703515
NCT06703515尚未招募不适用

Randomized Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
1
主要终点
Voice-Handicap Index (VHI-30)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with vocal cord cysts
  • older than 18-year-old
  • able to independently provide consent
  • able to tolerate flexible laryngoscopy would be recruited

排除标准

  • 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

研究组 & 干预措施

Microlaryngeal surgery (MLS)

Active Comparator

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.

干预措施: Microlaryngeal surgery (MLS) (Procedure)

Awake transnasal laser-assisted surgery (TNLS)

Experimental

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.

干预措施: Awake transnasal laser-assisted surgery (TNLS) (Procedure)

结局指标

主要结局

Voice-Handicap Index (VHI-30)

时间窗: 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.

次要结局

  • Perceptual evaluation of voice(From enrolment to post-operative 1year)
  • Acoustic voice analysis - Noise-to-Harmonic ratio (NHR)(From enrolment to post-operative 1year)
  • Acoustic voice analysis - Jitter(From enrolment to post-operative 1year)
  • Acoustic voice analysis - Shimmer(From enrolment to post-operative 1year)
  • Videostroboscopy - Mucosal wave pattern(From enrolment to post-operative 1year)
  • Aerodynamic measure of voice(From enrolment to post-operative 1year)
  • Visual analog scale (VAS)(From enrolment to post-operative 1year)
  • Videostroboscopy - Vocal fold closure(From enrolment to post-operative 1year)
  • Procedure-oriented outcomes - Reoperation(From perioperative period to post-operative 1 year)
  • Procedure-oriented outcomes - Disease recurrence(From perioperative period to post-operative 1 year)
  • Procedure-oriented outcomes - Length of hospital stay(From perioperative period to post-operative 1 year)
  • Procedure-oriented outcomes - Surgical complications in Clavien-Dindo classification(From perioperative period to post-operative 1 year)
  • Procedure-oriented outcomes - Completeness of lesion removal(From perioperative period to post-operative 1 year)
  • Procedure-oriented outcomes - Operation time(From perioperative period to post-operative 1 year)
  • Patient-oriented outcomes(Perioperative period)
  • Medical costs(From enrolment to post-operative 1year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tam Aurora Ka Yue

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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