Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

July 14, 2026 updated by: Carla Lisette Garcia Ramos, Instituto Nacional de Rehabilitacion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14389
        • National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.
Time Frame: 24 hours after surgery, 3 months after surgery, and 12 months after 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessed using the Visual Analog Scale
Time Frame: 24 hours after surgery, 3 months after surgery, and 12 months after surgery
Postoperative pain intensity measured using the Visual Analog Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
24 hours after surgery, 3 months after surgery, and 12 months after surgery
Cervical disability assessed using the Neck Disability Index
Time Frame: Preoperative baseline, 3 months after surgery, and 12 months after surgery
Cervical disability measured using the Neck Disability Index. Scores range from 0 to 50, with higher scores indicating greater disability.
Preoperative baseline, 3 months after surgery, and 12 months after surgery
Myelopathy severity assessed using the modified Japanese Orthopaedic Association score
Time Frame: Preoperative baseline, 3 months after surgery, and 12 months after surgery
Scale 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.
Preoperative baseline, 3 months after surgery, and 12 months after surgery
Voice handicap assessed using the Voice Handicap Index
Time Frame: Preoperative 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
Preoperative baseline, 3 months after surgery, and 12 months after surgery.
Dysphagia-related handicap assessed using the Eating Assessment Tool-10
Time Frame: Preoperative 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.
Preoperative baseline, 24 hours after surgery, 3 months after surgery, and 12 months after surgery.
Length of hospital stay
Time Frame: From date of surgery to date of hospital discharge, up to 30 days
Number of days from surgery to hospital discharge.
From date of surgery to date of hospital discharge, up to 30 days
Postoperative complications
Time Frame: From surgery to 12 months after surgery.
Number and percentage of participants with postoperative complications after anterior cervical spine surgery.
From surgery to 12 months after surgery.
Quality of life assessed using the Short Form-36 Health Survey
Time Frame: Preoperative 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.
Preoperative baseline, 3 months after surgery, and 12 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Rehabilitacion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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