Department of Otolaryngology Head Neck Surg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fiberoptic laryngoscope evaluation of swallowing
研究概览
简要总结
Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.
详细描述
There were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma. At least these patients need several months to recover. Few people required surgery of total laryngectomy to maintain normal swallowing function. The swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia. Factors that influenced the swallowing function recovery, for example, the time of nasogastric feeding and tracheostomy tube removal, were affected by age and diabetes.
On the other hand, the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy. But those are not directly related to swallowing motion, although they are predictors of dysphagia. The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagia's recovery early.
Subglottic pressure is a protective factor that can reduce aspiration risk. This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders. Specific objectives were to verify the effect of laryngectomy on subglottic pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Age: 18-80 years
- •Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma
- •Availability of clinical data
- •Validity of normal swallowing of thin liquids
排除标准
- •Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease
- •Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
- •Radiotherapy histology
- •Swallowing disorder or trachea aspiration before surgery.
结局指标
主要结局
Fiberoptic laryngoscope evaluation of swallowing
时间窗: Pre-operation, one week post-operation, two months post-operation, six months post-operation
The patient, in a sitting position, had to swallow liquid. The tip of a flexible endoscope was positioned beyond the soft palate, and the pharyngeal phase of swallowing was studied, recording videos and images for further analysis. In particular, according to the severity scale, the scores ranged from 1 point (no materials entered the airway) to 8 points (the material penetrated below the vocal cords, but no effort was made to eject the material), representing the severity of risk for penetration
EAT-10 questionnaire
时间窗: At one day before surgery, two months after surgery, six months after surgery
The EAT-10 questionnaire consists of a 10-item questionnaire with a maximum total score of 40 points. All items are rated on a 5-point scale in which 0 indicates no problem, and 4 indicates a severe problem in swallowing function. An EAT-10 score of over 3 is abnormal and indicates a higher self-perception of the presence of dysphagia.
direct subglottic pressure
时间窗: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Subglottic pressure was measured while swallowing a thinned solution with and without airflow delivery through the subglottic puncture needle. The unit of subglottic pressure is cmH20.
Swallowing ability to four different textures
时间窗: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
An early 5-point scoring system (score one corresponding to the early postoperative assessment) was applied to each patient depending on his ability to swallow one to four different textures (liquid, semi-liquid, semi-solid, and solid). A score of 0 is poor (no power to swallow), while a score of 4 is good.
次要结局
- Voice acoustic analysis(At one day before surgery, six months after surgery)
- The time in weeks of nasogastric feeding(At two months after surgery, six months after surgery)