A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Voice Quality
研究概览
简要总结
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.
Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for a fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
详细描述
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.
Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are surgically and medically fit for undergoing a total laryngectomy +/- partial pharyngectomy.
- •Patients who have already undergone total laryngectomy +/- partial pharyngectomy and are willing for a secondary voice rehabilitation procedure.
- •Patient signing the informed consent for procedure after understanding the details
排除标准
- •Partial laryngectomy
- •Near total laryngectomy
- •Patient unfit for the procedure
- •Patients not consenting for the procedure
- •Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for secondary insertion)
- •Patients with stricture in pharynx (for secondary insertion)
- •Partial pharyngectomy reconstruction, not permitting insertion of TEP
结局指标
主要结局
Change in Voice Quality
时间窗: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
Change in Presence / Absence of Fluid Leak
时间窗: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
Clinical assessment of modified TEP leak after a test fluid feed
次要结局
未报告次要终点
研究者
Vishal U S Rao
Head, Dept of Head & Neck Surgery
HealthCare Global Enterprise Ltd.