Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing Gum Group | Experimental | 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. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chewing gum | Other | Chewing gum four times per day for 5 days, 15 minutes each time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia Short Questionnaire (DSQ) score | 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. | Change from the 1st day after surgery to the 7th day after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Bazaz grading system | 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. | Change from the 1st day after surgery to the 7th day after surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunbing Chang, M.D., Ph.D. | Contact | 86-020-83827812 | 61011 | cspine@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunbing Chang, M.D., Ph.D. | Guangdong Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2018 | May 2, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prevertebral soft tissue swelling | 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. | The 3rd days after surgery. |
| D010038 | Otorhinolaryngologic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |