Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 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, 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
non
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18-year-old
- •mentally competent to give an informed consent
- •operable benign laryngeal lesions
- •able to tolerate transnasal flexible laryngoscopy
排除标准
- •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
结局指标
主要结局
Voice-Handicap Index (VHI-30)
时间窗: Post-op 1 year
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.
次要结局
- Cost(Peri-operative)
- Patient-perceived procedural discomfort(Immediate post-operation)
- Procedure-oriented outcomes(1 year)
研究者
Tam Aurora Ka Yue
Clinical Tutor (honorary)
Chinese University of Hong Kong