A Functional-oriented Modification of TOaST Based on Partial Preservation of the Lines Alba Cervical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 1.Number of participants with recurrent laryngeal nerve injury 1.Number of participants with recurrent laryngeal nerve injury Number of participants with recurrent laryngeal nerve injury
研究概览
简要总结
The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to refine the procedure through a prospective study.
详细描述
This study is a prospectively registered cohort study evaluating postoperative neck functional recovery after TOaST. As a procedure refinement, the study will further evaluate whether partial preservation of the caudal linea alba cervicalis during TOaST is associated with improved postoperative neck functional recovery without compromising surgical exposure or central compartment dissection.
The main purpose of this technical refinement is to determine whether preserving the caudal anterior cervical fascial continuity may reduce postoperative anterior neck tightness, swallowing-related traction discomfort, pain, and limitation of neck range of motion. Surgical feasibility and safety will be assessed using operative time, intraoperative blood loss, drainage volume, number of central lymph nodes retrieved, recurrent laryngeal nerve events, parathyroid-related outcomes, postoperative complications, and the rate of technical conversion.
In addition, male sex, age, BMI, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult TOaST. The investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. Therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
- •Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
- •Absence of suspicious lateral lymph nodes or distant metastases
排除标准
- •Participants with fusion or fixation of lymph nodes in the neck
- •Participants with history of neck surgery or radiation
- •Participants with vocal fold fixation by preoperative fibrolaryngoscope
- •Participants with preoperative examination suggestive of extrathyroidal invasion
- •Participants with a significantly restricted neck and/or jaw
研究组 & 干预措施
Conventional TOaST with bilateral strap muscle suspension
Participants undergoing conventional transoral and submental thyroidectomy. In this group, the linea alba cervicalis is opened caudally toward the suprasternal notch to establish the operative working space. Bilateral symmetric suspension of the strap muscles is performed to standardize surgical exposure.
Modified TOaST with caudal linea alba preservation
Participants undergoing modified transoral and submental thyroidectomy. In this group, the linea alba cervicalis is opened only in its cranial portion, with intentional preservation of a visible caudal linea alba-strap muscle fascial bridge. Bilateral symmetric suspension of the strap muscles is performed to create a centered operative window. If exposure is inadequate, the caudal linea alba opening may be extended and the case will be recorded as technical conversion to conventional TOaST.
干预措施: Modified TOaST with caudal linea alba preservation (Procedure)
结局指标
主要结局
1.Number of participants with recurrent laryngeal nerve injury 1.Number of participants with recurrent laryngeal nerve injury Number of participants with recurrent laryngeal nerve injury
时间窗: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism
时间窗: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml a postoperative parathyroid hormone level of less than 10 pg/ml a postoperative parathyroid hormone level of less than 10 pg/ml
Number of participants with mental nerve injury
时间窗: through study completion, an average of 1 year
a postoperative numbness in the lower lip and submental area
operative time
时间窗: immediately at the end of the surgery
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Postoperative neck functional recovery at 1 month
时间窗: 1 month after surgery
Postoperative neck functional recovery will be assessed 1 month after surgery using a standardized neck function assessment, including neck discomfort, anterior neck tightness, swallowing-related traction discomfort, and neck range of motion. Higher impairment scores indicate worse neck functional recovery.
Anterior neck tightness score
时间窗: Postoperative 1 week, 1 month, and 3 months
Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
Swallowing-related traction discomfort
时间窗: Postoperative 1 week, 1 month, and 3 months
Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.
次要结局
- hospitalization(Length of stay from hospitalisation to discharge)
- degree of pain(approximately 4 hours after surgery and on postoperative day 1)
- Number of participants with recurrent laryngeal nerve injury(Through study completion, an average of 1 year)
- Number of participants with hypoparathyroidism(Through study completion, an average of 1 year)
- Operative time(Immediately at the end of the surgery)
- Central compartment lymph node yield(At the time of pathological assessment after surgery)
研究者
Ling Zhan
Principal Investigator
Shanghai 6th People's Hospital