Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dysphagia Short Questionnaire (DSQ) score
研究概览
简要总结
The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.
详细描述
Postoperative dysphagia is the most common complication of anterior cervical fusion surgery. Previous studies showed that chewing gum helped to improve swallow frequency and latency. However, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. A randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. Dysphagia severity will be assessed using dysphagia short questionnaire (DSQ) score in the chewing gum group and control group during 7 days after surgery, and the changes in DSQ score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 years to 80 years.
- •underwent anterior cervical fusion surgery for degenerative cervical disease.
- •diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using Bazaz scale.
排除标准
- •Patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease.
- •Patients with preoperative dysphagia.
- •Patients unable to chew, or unable to follow the directions for chewing gum.
- •Patients unable to attend follow-up visits or finish the dysphagia questionnaires.
研究组 & 干预措施
Chewing Gum Group
Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Chewing Gum Group are asked to chew gum four times a day for 5 days (15 minutes each time) after surgery in addition to standard cares. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.
干预措施: chewing gum (Other)
Control Group
Patients who receive anterior cervical fusion and have mild or moderate dysphagia postoperatively, will be randomized into two groups. Subjects assigned to the Control Group receive standard cares and are asked not to chew gum within 5 days after surgery. Standard cares include cleaning the wound every 2 days, wearing a collar, pain management, and education.
结局指标
主要结局
Dysphagia Short Questionnaire (DSQ) score
时间窗: Change from the 1st day after surgery to the 7th day after surgery.
DSQ is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. It is calculated by summing up the points given for each item, from 0 point to a maximum of 18 points, where lower scores represent milder symptoms and vice versa.
次要结局
- Bazaz grading system(Change from the 1st day after surgery to the 7th day after surgery.)
- Prevertebral soft tissue swelling(The 3rd days after surgery.)
研究者
YunBing Chang
Head of Spine Department
Guangdong Provincial People's Hospital