The Effect of Salt Water Gargling on Swallowing Dysfunction Following Multi-Level Anterior Cervical Discectomy and Fusion (ACDF): A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants with a SWAL-QOL Score of Greater Than 14
研究概览
简要总结
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is:
If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water.
Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery.
Patients in the control arm will be asked to:
- Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).
Patients in the experimental/interventional arm will be asked to:
- Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).
- Gargle with a warm saltwater solution once on POD 0, and thrice daily from POD 1 to POD 7.
详细描述
Background & Hypothesis:
Dysphagia, or difficulty swallowing, often signifies structural or functional abnormalities in any of the three phases of swallowing and contributes to higher self-reported disability and lower physical health status. Dysphagia is a common postoperative complication following anterior cervical discectomy and fusion (ACDF) procedures. While most experience mild and transient symptoms, some individuals endure severe dysphagia, leading to significant postoperative morbidity.
Several studies have demonstrated the efficacy of corticosteroids administered intraoperatively during ACDF procedures. One prospective, randomized, double-blinded study, showed favorable results with local corticosteroid administration, resulting in a significant decrease in dysphagia during the immediate postoperative period to 1-month postoperatively. Although other studies have also reported favorable outcomes with corticosteroid use, they are still associated with considerable risks of adverse events. Corticosteroids have been linked to a higher incidence of postoperative infection, impairment of wound healing, and a 2- to 5-fold increase in wound complications across a variety of surgical specialties.
Salt water, also known as saline is associated with anti-inflammatory, anti-bacterial, and wound healing properties. Warm salt water rinses offer a more accessible, cost-effective alternative to corticosteroids, without their associated adverse effects. The study aims to investigate the efficacy of gargling salt water in reducing the severity and symptoms of swallowing difficulties following multi-level ACDF procedures.
This study is a single-center, prospective, randomized control trial. Only patients ≥ 18 years of age who are undergoing a multi-level (2-, 3-, or 4-level ACDF) and meet the general inclusion criterion will be invited to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years of age
- •Patients undergoing a multi-level (2-, 3-, or 4-level) ACDF procedure
- •Single-approach (anterior only) ACDF - English or Spanish-speaking patients
- •Undergoing treatment at Keck Medical Center of USC
排除标准
- •Patients ≤ 18 years of age
- •Patients undergoing any revision ACDF procedure
- •Patients undergoing ACDF with combined approaches (i.e. anterior + posterior)
- •Patients with spinal pathologies or deformities that are non-degenerative or idiopathic (i.e. trauma, infection, malignancy, or tumor)
- •Patients with a prior diagnosis related to swallowing issues (i.e. esophagitis, Barrett's esophagus, Sjogren syndrome, multiple sclerosis (MS), or laryngitis)
- •Patients with an American Society of Anesthesiologists (ASA) score ≥ 4
结局指标
主要结局
Number of Participants with a SWAL-QOL Score of Greater Than 14
时间窗: 0 - 1 month
The Swallowing-Related Quality of Life (SWAL-QOL) questionnaire is a 44-question assessment that measures the severity of oropharyngeal dysphagia (difficulty swallowing) and the impact it has on quality of life. Patients with score of greater than or equal to 14 are indicative of have some sort of difficulty with swallowing. This will be used to assess if patients in the Salt Water Gargle arm (intervention) have any relief after completing the described intervention.
次要结局
- Neck Disability Index (NDI) Score of 30 to 100(0 - 1 month)
研究者
Ram Alluri
Assistant Professor of Clinical Orthopaedic Surgery
University of Southern California