NCT05542680已完成不适用
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2022年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Reflux symptoms
研究概览
简要总结
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
详细描述
- Make application-oriented achievement transformation products to provide new special semi recumbent auxiliary tools for patients with esophageal cancer after operation. Summarize the clinical experience and evidence, sign the project cooperation intention agreement with the manufacturer with production qualification, connect with the professional designer of the manufacturer and refine and improve the design scheme; The angle range, materials, fabrics and connection methods of the semi reclining cushion are closely combined with the clinical treatment and patient needs to meet the effectiveness, comfort and practicality of the patient's application; To produce semi reclining cushion products to provide semi reclining cushion for patients after esophageal cancer surgery that can be adjusted from multiple angles and take into account the skin protection function, which is conducive to preventing and alleviating reflux symptoms, improving the quality of life and reducing the risk of skin stress injury.
- Implement and evaluate the effectiveness of the special semi reclining cushion after esophageal cancer surgery, apply the product to patients after esophageal cancer surgery, and evaluate the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reflux symptoms
时间窗: 1 to 30 days after surgery
Reflux Diagnostic Questionnaire RDQ The Reflux Diagnostic Questionnaire includes four symptoms: heartburn, acid reflux, regurgitation, and pain behind the sternum. The frequency and severity of symptoms range from 0 to 5 points. The highest score for symptom frequency and severity is 40 points. A higher score indicates more severe reflux, and a score exceeding 12 points indicates a preliminary diagnosis of gastroesophageal reflux disease
次要结局
- Postoperative quality of life QLQ-C30(7 days after surgery)
- Postoperative quality of life QLQ-OES18(7 days after surgery)
- Skin pressure injury(7 to 180 days after surgery)
研究者
研究点 (1)
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