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
研究组 & 干预措施
Microlaryngeal surgery (MLS)
For traditional MLS under general anesthesia, after intubation with microlaryngeal tube, a laryngoscope will be inserted transorally under direct vision and suspended. Laryngeal lesions are visualized with either microscope or endoscope, and removed with microsurgery instruments and sent for routine section
干预措施: Microlaryngeal surgery (MLS) (Procedure)
Awake transnasal laser-assisted surgery (TNLS)
For TNLS, a transnasal channel flexible laryngoscope is used with prior trans-nasal, trans-oral and trans-laryngeal local anesthesia application. A 445nm blue laser is introduced via a working channel of laryngoscope, with a lesion-specific laser setting. Biopsy can be performed by devascularizing and thinning the lesion down to a pedicle, then removed with biopsy forcep. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. Patients are discharged on same day of procedure after close observation for 2 hours in day center.
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: 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.
Voice-Handicap Index (VHI-30)
时间窗: Post-op 2 week
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.
Voice-Handicap Index (VHI-30)
时间窗: Post-op 6 week
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.
Voice-Handicap Index (VHI-30)
时间窗: Post-op 3 month
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.
Voice-Handicap Index (VHI-30)
时间窗: Post-op 6 month
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)
- Procedure-oriented outcomes(Intraoperative)
- Procedure-oriented outcomes(Perioperative)
- Procedure-oriented outcomes(Post-op 2 week, 6 week, 3 month, 6 month, 1 year)
研究者
Tam Aurora Ka Yue
Clinical Tutor (honorary)
Chinese University of Hong Kong