The Comparison of Voice and Swallowing Parameters After Endoscopic Total and Partial Arytenoidectomy Using Medially Based Mucosal Advancement Flap Technique for Bilateral Abductor Vocal Fold Paralysis: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Decannulation
研究概览
简要总结
Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.
详细描述
Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral vocal fold paralysis
排除标准
- •Previously operated patients
研究组 & 干预措施
Total arytenoidectomy
Endoscopic total arytenoidectomy was performed on patients.
干预措施: Total arytenoidectomy (Procedure)
Partial arytenoidectomy
Endoscopic partial arytenoidectomy was performed on patients.
干预措施: Partial arytenoidectomy (Procedure)
结局指标
主要结局
Decannulation
时间窗: From the day of operation until 52 weeks after arytenoidectomy
Preoperative examinations were repeated 1 year after surgery.
次要结局
- Duration of operation(At the day of operation)
研究者
Taner Yilmaz
Prof. Dr.
Hacettepe University