跳至主要内容
临床试验/NCT06482632
NCT06482632尚未招募不适用

The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients Undergoing Multilevel Anterior Cervical Discectomy and Fusion

University of Puerto Rico2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Neck Disability Index

研究概览

简要总结

The investigators believe that the transection of the omohyoid during an anterior cervical discectomy and fusion decreases the incidence of dysphagia in patients who undergo this procedure when compared to patients who do not have the omohyoid transected.

详细描述

Dysphagia is a common postoperative complication in patients undergoing anterior cervical discectomy and fusion (ACDF). Although it is often transient, there have been cases of postoperative dysphagia lasting for several months or being permanent. The pathogenesis of this complication is poorly understood and likely multifactorial. There have been multiple risk factors described that may contribute to postoperative dysphagia, but there is a lack of clarity regarding these. The effect of transecting the omohyoid during a multilevel Anterior Cervical Discectomy and Fusion has been controversial. The transaction of this muscle is generally safe and is often used during the approach of the technique for improved visualization.

This research study aims to determine whether the transection of the omohyoid affects the incidence of dysphagia in patients who underwent multilevel ACDF and whether it should be routinely performed during a multilevel ACDF. The investigators plan to prospectively enroll 60 patients undergoing multilevel ACDF (C3-C7). Patients selected in the allotted time frame were treated by the orthopedic spine service of the University of Puerto Rico Orthopaedic Surgery Residency Program. Exclusion criteria include those patients with preoperative dysphagia, those with conditions that expose them to a high risk of postoperative dysphagia (such as motor neuron disease), and those with cervical non-degenerative pathology, such as tumor or trauma. Randomization was performed utilizing an online computer-generated sequence (www.graphpad.com/quickcalcs/randomN1.cfm). A request for the waiver of authorization to release health information will be completed. After the research committee approves, medical records will be reviewed to gather information such as age, gender, smoking status, diabetic status, body mass index (BMI), inpatient medications, and discharge medications. After discharge, patients undergoing this procedure are followed up at outpatient clinics (Clinicas Externas). Follow-up intervals include postoperative days 1 and 2, 4, and 8 weeks after surgical intervention. On the first postoperative day, and each of the follow-up visits we will collect dysphagia scores via a modified Swallowing Quality of Life Scale (Swal-QOL) and physician notes. Physician notes will also be evaluated for clear documentation of patient-reported outcomes. Results will be gathered to evaluate outcomes and complications.

The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion.

Patients with a history of preoperative dysphagia, those with conditions that expose them to high risk of postoperative dysphagia (such as motor neuron disease), and those with cervical non-degenerative pathology, such as tumor or trauma as well as those who have lost to follow up, will be excluded from the study.

The risks of participating in this study, though minimal, include a breach in confidentiality. The benefits of participation include contributing to the Orthopaedic Surgery research community to guide future pain management in fracture care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion.

排除标准

  • Patients with a history of preoperative dysphagia, those with conditions that expose them to high risk of postoperative dysphagia (such as motor neuron disease), and those with cervical non-degenerative pathology, such as tumor or trauma as well as those who have lost to follow up, will be excluded from the study.

结局指标

主要结局

Neck Disability Index

时间窗: 6 months

This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.

Dysphagia Short Questionnaire- "The Dysphagia Questionnaire

时间窗: 6 months

a 10-point rating scale, were 1 is the minimum value, 10 is the maximum value, and the higher scores means the worse outcome and lower scores are the better outcomes. In the Dysphagia questionnaire the patients provide an assessment of the severity of dysphagia symptoms experienced.

次要结局

  • Neck Circumference(Pre operation)
  • Body Mass Index(Pre Operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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