Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient's evaluation of his own voice
研究概览
简要总结
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. The investigators will divide the patients into 2 groups: the first group will be instructed for a postoperative voice rest and the second group will not. Later the investigators will compare the results and conclude whether voice rest had any significance.
详细描述
The prevailing view among laryngologists is that voice rest after laryngeal surgery is important to ensure a good recovery of the epithelium and lamina propria layers of the vocal cord. Speaking immediately after surgery leads to the formation of an irregular collagen in large quantities of the vocal cords - namely the creation scar tissue. The scarred vocal cords leads to a decrease in its elasticity, which is reflected in poor speech quality. Although this theory, not many works were published in the literature proving the necessity for voice rest after vocal cord surgery.
Several studies have been recently published which claim that there is no need for vocal rest and stress the importance of a moderate voice effort straight after surgery. This need is based on the idea that early mobilization of tissue after surgery led to the creation of a healthy soft tissue architecture.
The investigators hypothesize that there is no role for vocal rest after surgery to remove benign lesions from the vocal cords.
Patients candidate for laryngeal surgery that include removal of a benign vocal cord lesion will be divided into two groups:
- Patients instructed for the conventional post operative voice rest, namely absolute voice rest for a week and another week of relative voice rest (speaking is allowed for 20 minutes a day).
- Patients instructed to speak freely without restrictions after the surgery. those are the study phases: * first visit- preoperative visit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel.
排除标准
- •A patient under
- •Demented patient.
- •Deaf patient.
结局指标
主要结局
Patient's evaluation of his own voice
时间窗: 6 months post operative
VHI questionnaire score
doctors evaluation of the patient's voice
时间窗: 6 month post operative
GRABS scale score
voice analysis by a software
时间窗: 6 month post operative
jitter score, shrimmer score, harmonic to noise ration
次要结局
- Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)(6 month post operative)