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Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07713693
Enrollment
36
Registered
2026-07-20
Start date
2019-11-30
Completion date
2021-12-30
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cervical Spinal Surgery, Dysphagia After Anterior Cervical Decompression and Fusion of the Spine, Dysphonia

Keywords

Dysphagia, Dysphonia, Anterior Cervical Spinal Surgery

Brief summary

Introduction: The anterior cervical approach is used to treat a variety of spinal disorders; among these, the Smith-Robinson approach is the most commonly used, as it allows access to discs, bony structures, and anterior lesions without directly affecting the spinal cord. Its use has increased as anterior discectomies and fusions are performed more frequently. Among the complications, dysphonia and dysphagia are the most common. Objectives: To describe the prevalence of dysphagia and dysphonia in patients with narrow cervical canal who were treated using an anterior cervical approach at the National Institute of Rehabilitation Materials and Methods: This study will consecutively enroll patients diagnosed with a narrow cervical canal who are treated using an anterior cervical approach at the INRLGII. The presence of dysphagia and dysphonia will be assessed in the postoperative period, at three months, and one year after surgery. Patients will be given rating scales to assess the presence and severity of symptoms during these three time periods. Study design: A prospective, longitudinal, observational, descriptive cohort study. Proposed statistical analysis: Clinical and demographic data will be described using summary measures (mean and median) for quantitative data and measures of dispersion (standard deviation, maximum, and minimum). The normality of the data will be tested using the Shapiro-Wilk test. The t-test will be applied to compare quantitative variables, and Pearson's chi-square test will be used for qualitative variables.

Detailed description

First Stage: Upon admission of patients to the Spine Surgery Service with a prior diagnosis of cervical spinal stenosis, each patient will be informed about the surgical procedure, the type of approach, as well as the surgical risks and possible complications. Second Phase: Once patients agree to participate in the protocol, they will be given two scales. The first will be a vocal disability index, consisting of a 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life. The higher the score, the greater the disability. The second questionnaire is the EAT-10, a verbal, unidimensional, direct-scoring analog self-assessment scale designed to evaluate specific symptoms of dysphagia. It is a five-point scale (0-4 points), where zero (0) indicates the absence of the problem and four (4) indicates that the subject considers it a serious problem; higher scores will indicate a greater perception of dysphagia. Third Phase: This will take place during the postoperative period, approximately on the second or third day of recovery and before the patient begins eating solid foods. The questionnaires will be administered again to identify any differences and/or possible postoperative complications. Afterward, the patient will undergo a swallowing test, which involves inserting an endoscope (similar to a probe) through the nasal passage to the glottis, allowing visualization of the vocal cords. Subsequently, patients will swallow various food consistencies-liquid (water), semisolid (baby food), and solid (1/4 of a cookie)-viewed through a camera, reveal the state of the anatomical structures involved before and after swallowing. Prior to swallowing, the endoscope must be positioned on the soft palate, between the soft palate and the epiglottis, to visualize the base of the tongue and assess the passage of the food bolus into the pharynx; all of this is performed by a speech-language pathologist.

Interventions

Involves inserting an endoscope (similar to a probe) through the nasal passage to the glottis, allowing visualization of the vocal cords. Subsequently, patients will swallow various food consistencies-liquid (water), semisolid (baby food), and solid (1/4 of a cookie)-viewed through a camera, reveal the state of the anatomical structures involved before and after swallowing. Prior to swallowing, the endoscope must be positioned on the soft palate, between the soft palate and the epiglottis, to visualize the base of the tongue and assess the passage of the food bolus into the pharynx; all of this is performed by a speech-language pathologist.

DIAGNOSTIC_TEST30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life

The higher the score, the greater the disability.

DIAGNOSTIC_TESTEAT-10 questionnaire

It is a five-point scale (0-4 points), where zero (0) indicates the absence of the problem and four (4) indicates that the subject considers it a serious problem; higher scores will indicate a greater perception of dysphagia.

Sponsors

Instituto Nacional de Rehabilitacion
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any age. * Any gender. * Diagnosis of narrow cervical canal; candidates for surgical management via an anterior cervical approach. * Patients treated in the spinal surgery department. * Patients who have signed an informed consent form. * Complete medical records.

Exclusion criteria

* History of previous cervical surgery. * Psychiatric disorders. * ASA III and IV. * Smoking. * BMI \> 30. * History of esophageal and/or laryngeal diseases (Barrett's syndrome, chronic esophagitis, laryngeal trauma, recurrent laryngitis, malformations). * History of ankylosing spondylitis or any other rheumatic disease. * History of neurological disease. * Previous phoniatric condition.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.24 hours after surgery, 3 months after surgery, and 12 months after surgeryNumber and percentage of participants presenting postoperative dysphagia after anterior cervical spine surgery, assessed using the Eating Assessment Tool-10, Bazaz Dysphagia Score, Dysphagia Short Questionnaire, and Flexible Endoscopic Evaluation of Swallowing when applicable.

Secondary

MeasureTime frameDescription
Postoperative pain assessed using the Visual Analog Scale24 hours after surgery, 3 months after surgery, and 12 months after surgeryPostoperative pain intensity measured using the Visual Analog Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Cervical disability assessed using the Neck Disability IndexPreoperative baseline, 3 months after surgery, and 12 months after surgeryCervical disability measured using the Neck Disability Index. Scores range from 0 to 50, with higher scores indicating greater disability.
Myelopathy severity assessed using the modified Japanese Orthopaedic Association scorePreoperative baseline, 3 months after surgery, and 12 months after surgeryScale used to determine the degree of cervical spine disability according to upper-limb, lower-limb, and sphincter function. Scores range from 0 to 18, with lower scores indicating greater neurologic impairment.
Voice handicap assessed using the Voice Handicap IndexPreoperative baseline, 3 months after surgery, and 12 months after surgery.Thirty-item questionnaire with a 0 to 4 scale for each item. It evaluates the impact of voice dysfunction on daily life; higher scores indicate greater disability
Dysphagia-related handicap assessed using the Eating Assessment Tool-10Preoperative baseline, 24 hours after surgery, 3 months after surgery, and 12 months after surgery.Dysphagia-related symptoms measured using the Eating Assessment Tool-10. Scores range from 0 to 40, with higher scores indicating greater swallowing-related symptom burden.
Length of hospital stayFrom date of surgery to date of hospital discharge, up to 30 daysNumber of days from surgery to hospital discharge.
Postoperative complicationsFrom surgery to 12 months after surgery.Number and percentage of participants with postoperative complications after anterior cervical spine surgery.
Quality of life assessed using the Short Form-36 Health SurveyPreoperative baseline, 3 months after surgery, and 12 months after surgery.Health-related quality of life measured using the Short Form-36 Health Survey. Higher scores indicate better health-related quality of life.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026