Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

NCT07713693 | Completed

• 1 other identifier: 02/21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dysphagia; Dysphonia; Anterior Cervical Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.

  Number 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.

  24 hours after surgery, 3 months after surgery, and 12 months after surgery

Secondary Outcomes (8)

• Postoperative pain assessed using the Visual Analog Scale

  24 hours after surgery, 3 months after surgery, and 12 months after surgery

• Cervical disability assessed using the Neck Disability Index

  Preoperative baseline, 3 months after surgery, and 12 months after surgery

• Myelopathy severity assessed using the modified Japanese Orthopaedic Association score

  Preoperative baseline, 3 months after surgery, and 12 months after surgery

• Voice handicap assessed using the Voice Handicap Index

  Preoperative baseline, 3 months after surgery, and 12 months after surgery.

• Dysphagia-related handicap assessed using the Eating Assessment Tool-10

  Preoperative baseline, 24 hours after surgery, 3 months after surgery, and 12 months after surgery.

Interventions

Fiberoptic Endoscopic Evaluation of Swallowing PROCEDURE

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.

EAT-10 questionnaire DIAGNOSTIC_TEST

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.

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

The higher the score, the greater the disability.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

Location

Related Publications (18)

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MeSH Terms

Conditions

Dysphonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 20, 2026
• Study Start: November 30, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2021
• Last Updated: July 20, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)