ACTRN12624000568516尚未招募Unknown
Efficacy of cricopharyngeal peroral endoscopic myotomy (C-POEM) as a treatment for dysphagia attributable to impaired cricopharyngeal relaxation in Parkinson’s disease: a multicentre randomised controlled trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •Diagnosis of Parkinson’s disease
- •Self-reported symptoms of oropharyngeal dysphagia
- •Abnormal Sydney Swallow Questionnaire (SSQ) score (>234)
- •Manometric evidence of failed upper oesophageal sphincter relaxation defined as an abnormally raised Integrated Relaxation Pressure
排除标准
- •Deep brain stimulator (DBS) – monopolar diathermy is contraindicated in DBS.
- •Severe oropharyngeal dysphagia that had led to a previous or current recommendation to stay completely nil-by-mouth.
- •Significant co-morbidities and/or advanced Parkinson’s Disease where risk of general anaesthesia is deemed unacceptably high.
- •Hypopharyngeal structural disorders known to cause pharyngeal dysfunction (e.g., Zenker’s diverticulum, radiotherapy-related CP stricture)
- •Oesophageal disorders known to cause dysphagia (e.g., achalasia cardia, peptic oesophageal stricture, eosinophilic oesophagitis etc).
- •Insufficient cognitive capability to follow clinicians’ instruction or to provide informed consent (e.g., dementia).
研究者
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