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

NCT ID: NCT03524703

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-28

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

chewing gum

Intervention Type OTHER

Chewing gum four times per day for 5 days, 15 minutes each time.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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chewing gum

Chewing gum four times per day for 5 days, 15 minutes each time.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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YunBing Chang

Head of Spine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

86-020-83827812 ext. 61011

Facility Contacts

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

Role: primary

086-020-83827812 ext. 61011

Guoyan Liang, M.D., Ph.D.

Role: backup

086-020-83827812 ext. 61011

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GDREC 2018151H

Identifier Type: -

Identifier Source: org_study_id

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