ASSESSMENT OF VOICE QUALITY IN PATIENTS UNDERGOING MICROLARYNGEAL SURGERY FOR BENIGN VOCAL CORD LESIONS USING COBLATION VERSUS CONVENTIONAL METHOD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. GRBAS SCORE - Grade, Roughness, Breathiness, Asthenia, Strain and Voice
研究概览
简要总结
After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. (Annexure – 1A / 1B/ 1C)
Baseline investigations such as blood sugar levels, complete blood count, renal and liver function tests, HIV, HBsAg, HCV, will be done.
Patients will be screened by videolaryngoscopy under local anaesthesia to find out the pathology. Patients will be explained about the disease, the probable cause and its line of management.
Preoperative voice assessment will be done using GRBAS scoring and voice handicap index and PRAT software.
Patient will be randomized into two groups A and B based on random sequence generated by Statical Package for Social Sciences software, where Group A will include patients undergoing microlaryngeal surgery by conventional method and Group B will include patients undergoing microlaryngeal excision using coblation.
Patients will be followed up postoperatively at an interval of 1 week and 1month for voice assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •ENT outpatient department with complaints of hoarseness of voice and on videolaryngoscopy were found to have benign appearing vocal cord lesions.
排除标准
- •Malignant lesions
- •Vocal cord paralysis
- •Patients with severe cervical spondylosis.
- •Patients not willing to give informed consent.
结局指标
主要结局
1. GRBAS SCORE - Grade, Roughness, Breathiness, Asthenia, Strain and Voice
时间窗: one week and 4 weeks after sugery
handicap index 10
时间窗: one week and 4 weeks after sugery
2. Jitter and shimmer in prat software.
时间窗: one week and 4 weeks after sugery
3. Visual analogue score
时间窗: one week and 4 weeks after sugery
次要结局
- 2. Jitter and shimmer in prat software.(3. Visual analogue score)
研究者
BALAJI D
Bangalore Medical College and Research Institute