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

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Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Unknown

Conditions

Dysphagia

Treatments

Other: chewing gum

Study type

Interventional

Funder types

Other

Identifiers

NCT03524703
GDREC 2018151H

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Chewing Gum Group
Experimental group
Description:
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.
Treatment:
Other: chewing gum
Control Group
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Yunbing Chang, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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