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COMPLETED
NCT07713693
NA

Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

Sponsor: Instituto Nacional de Rehabilitacion

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2019-11-30

Completion Date

2021-12-30

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

PROCEDURE

Fiberoptic Endoscopic Evaluation of Swallowing

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_TEST

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.

DIAGNOSTIC_TEST

EAT-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.

Locations (1)

National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, Mexico