Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Voice Handicap Index - 10
研究概览
简要总结
Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.
详细描述
The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.
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
- Single (Investigator)
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 benign mid membranous vocal fold lesions such as the following:
- •Sub-epithelial fibrous mass
- •Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
- •Age 18 and older
排除标准
- •Patients with any of the following will be excluded from the study:
- •Reinke's edema
- •Active smokers
- •Ligamentous mid membranous vocal fold lesions
- •RRP (Recurrent Respiratory Papillomatosis)
- •CIS (Carcinoma-in-situ)
- •SCC (squamous cell carcinoma)
- •Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
- •Previous vocal fold surgery
- •Systemic steroids
- •History of systemic illness that could affect wound healing
结局指标
主要结局
Voice Handicap Index - 10
时间窗: 1 month post op
次要结局
- Cepstral Peak Prominence (CPP)(1 month and 3 months post op)
- video stroboscopy findings(1 month and 3 months post op)
- Average phonatory airflow in all voiced sentence(1 month and 3 months post op)
研究者
Libby Smith DO
Associate Professor
University of Pittsburgh