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Completed
NCT07713693
Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery
Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine, Dysphonia, Anterior Cervical Spinal Surgery
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Instituto Nacional de Rehabilitacion
Location: National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra Mexico City Mexico City
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07713693). StuddyBuddy aggregates publicly available trial information.