Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion

Not Applicable

• Conditions: Dysphagia
• Interventions: Other: chewing gum

• Registration Number: NCT03524703
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2018-04-11
• Study Start: 2018-04-28
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-15
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing Gum Group	chewing gum	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China