Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •History of previous cervical surgery.
- •Psychiatric disorders.
- •ASA III and IV.
- •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.
结局指标
主要结局
Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.
时间窗: 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.
次要结局
- 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.)
- Length of hospital stay(From date of surgery to date of hospital discharge, up to 30 days)
- Postoperative complications(From surgery to 12 months after surgery.)
- Quality of life assessed using the Short Form-36 Health Survey(Preoperative baseline, 3 months after surgery, and 12 months after surgery.)
研究者
Carla Lisette Garcia Ramos
Principal investigator
Instituto Nacional de Rehabilitacion