Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of surgical interventions
研究概览
简要总结
comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser
详细描述
Randomized controlled double-blinded study. The study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or T1a-b,N0M0 squamous cell carcinoma.
Patients will undergo examination and treatment and at least 3 years of follow-up.
40 cancer patients will be included. The participants will be randomly divided into two groups: the first will be treated by KTP laser and the second by CO2 laser.
The patients will be blinded to the method of treatment. To enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. The investigator in charge of collecting the data after the operation will be blinded to the treatment method.
Each participant will undergo pre-operative evaluation and follow-up after surgery in both arms.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma).
排除标准
- •Patients who underwent previous significant vocal cords surgical intervention , or irradiation.
- •Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)
结局指标
主要结局
number of surgical interventions
时间窗: 3 years
total number of surgical interventions needed to eliminate the disease
Cure rates in terms of local, regional or distant recurrence events
时间窗: 3 years after last intervention
evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases
Overall survival and disease-dependent survival over a period of at least 3 years
时间窗: 3 years after last intervention
voice quality results In the short term
时间窗: 6 month after last intervention
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
voice quality results In the long term
时间窗: 3 years after last intervention
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Duration of surgery
时间窗: intraoperative
total time (minutes) of surgical procedure
Recovery time after surgery
时间窗: up to 3 years
recovery in terms of overall function, breathing, swallowing and vocal communication
次要结局
未报告次要终点
研究者
Dr Yonatan Lahav
Dr Yonatan Lahav
Kaplan Medical Center