Pre-and Post-operative Risk Factors Affecting the Incidence and Severity of Dysphagia Following Total Thyroidectomy: An International Multi-centric Prospective Randomized Controlled Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
研究概览
简要总结
The most common and feared complications of total thyroidectomy are vocal cord paralyses and hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important consequences on the quality of life (QoL). It should be taken seriously by all clinicians.
详细描述
Dysphagia is a possible complication that can be observed in patients undergoing thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN), tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy to be detected. Therefore, a subjective feeling of dysphagia is more common.
Dysphagia has important consequences on the QoL in postoperative period, and should be addressed by the primary surgeon/clinician, regardless of whether it is objective or subjective.
The goal of the present study is to better understand the incidence of postoperative dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme will also be employed and results will be shared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
THE STUDY IS OPEN TO ALL SURGICAL CLINICS OVER THE WORLD EAGER TO JOIN; EXCEL WITH FORMS TO BE FILLED ARE AVAILABLE, please contact the principle/co-investigators by phone/e-mail.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma)
- •Patients with total thyroidectomy (TT) indication
- •Patients over 17 year-old
排除标准
- •Patients without thyroid disease
- •Patients with thyroid disorder, but prepared for surgery other than TT
- •Healthy volunteers
- •Patients below 17 y/o
结局指标
主要结局
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
时间窗: 6 weeks
Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
Evaluation of Dysphagia- ENT Consultation
时间窗: 12 months
Flexible fiberoptic laryngoscopy (any anatomic explanation for dysphagia? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
Evaluation of Dysphagia- Neurology Consultation
时间窗: 12 months
EMG-electromyography test (any anatomic and/or physiologic dysfunction? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
Evaluation of Dysphagia-Subjective Survey Form
时间窗: 12 months
Subjective survey form to be filled- a self-evaluation questionnaire-to evaluate 'Change from baseline postoperative (po) day 1-3 to week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control. assessing common dysphagia symptoms- includes 6 items scored within a range of 0 (without swallowing alterations) to 24 (maximum swallowing dysfunction).
Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)
时间窗: 12 months
Objective survey form to be filled- a clinician-oriented questionnaire assessing the swallowing function objectively, from stage I (normal function) to stage V (no oral intake). To evaluate change in dysphagia from baseline po day 1-3 to .po week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.
次要结局
- Evaluation of Standard Dysphagia Rehabilitation(12 weeks)
研究者
Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
Associated Professor of General Surgery and Surgical Oncology
Umraniye Education and Research Hospital