Dysphagia
Conditions
Keywords
dysphagia, anterior cervical fusion, chewing gum
Brief summary
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.
Detailed description
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.
Interventions
OTHERchewing gum
Chewing gum four times per day for 5 days, 15 minutes each time.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia Short Questionnaire (DSQ) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bazaz grading system | Change from the 1st day after surgery to the 7th day after surgery. | Bazaz grading system is designed for the evaluation of swallowing difficulty after anterior cervical spine surgery. The patients are graded as having none, mild, moderate, or severe dysphagia based on their symptoms. A none or mild dysphagia is considered to be a better outcome. |
| Prevertebral soft tissue swelling | The 3rd days after surgery. | The measurement of the soft tissue space is made on the line parallel to the upper end plate from the midpoint of the anterior surface of each vertebral body to the border of the airway shadow. This scale ranges from 0 to approximately 30 mm for each vertebra, where a lower value represents a milder soft tissue swelling. |
Countries
China
Contacts
Primary ContactYunbing Chang, M.D., Ph.D.
Outcome results
None listed