Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Whether the participant successfully received the allocated operation (yes/no)
研究概览
简要总结
The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.
There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.
详细描述
Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study
Short title: VOCALIST
Trial medication: Not Applicable
Phase of trial: Phase IIb
Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- •Age from 18 to 70 years old
- •Male or female
- •Able to provide informed consent
- •A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score >16)
- •Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.
排除标准
- •Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- •Severe lung disorders
- •Structural vocal fold lesions such as polyp
- •Previous laryngeal framework surgery
- •Cricoarytenoid joint fixation (CAJF)
- •Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- •Previous Level 2, 3 or 4 thyroid neck dissection
- •Previous ipsilateral surgical neck dissection
- •Previous radiotherapy to the head and neck
- •Laryngeal injection of a rapidly absorbable material in the last 6 months.
- •Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics, VOX)
- •Neuromuscular disease affecting the larynx or multiple cranial nerve palsies
研究组 & 干预措施
Thyroplasty
This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.
干预措施: Thyroplasty (Procedure)
Reinnervation
For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).
干预措施: Reinnervation (Procedure)
结局指标
主要结局
Whether the participant successfully received the allocated operation (yes/no)
时间窗: 24 months
From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)
Whether the participant was randomised (yes/no)
时间窗: 24 months
From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)
Whether the participant completed the trial (yes/no)
时间窗: 24 months
From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)
次要结局
- Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.(24 months)
- The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.(Baseline, 6 months and 12 month post surgery)
- Perceptual voice quality analysis will be determined using the GRBAS scale.(Baseline, 6 months and 12 month post surgery)
- Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures(24 months)
- The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.(Baseline, 6 months and 12 month post surgery)
- The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.(Baseline, 6 months and 12 month post surgery)
- The validated 100ml Water Swallow test will be used to measure the participants' swallowing.(Baseline, 6 months and 12 month post surgery)
- Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.(24 months)
- The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life(Baseline, 6 months and 12 month post surgery)
- Laryngeal EMG will be used to detect laryngeal muscle activity.(Baseline, 6 months and 12 month post surgery)
- Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments(24 months)
- Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes(24 months)
- The OperaVOX™ system will also be used to perform the acoustic voice analysis.(Baseline, 6 months and 12 month post surgery)
- Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.(24 months)
- Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.(24 months)
研究者
Professor Martin Birchall
Professor
Royal National Throat, Nose and Ear Hospital