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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
The modified procedure consists of cranial limited opening of the linea alba cervicalis with intentional preservation of the caudal linea alba-strap muscle fascial bridge. Bilateral symmetric suspension of the strap muscles is performed to maintain a centered operative window for thyroid lobectomy and, when indicated, ipsilateral central compartment lymph node dissection. If exposure is inadequate, the caudal linea alba may be further opened for safety.
Shanghai Sixth People's Hospital
Shanghai, China
RECRUITINGPostoperative neck functional recovery at 1 month
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.
Time frame: 1 month after surgery
Anterior neck tightness score
Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
Time frame: Postoperative 1 week, 1 month, and 3 months
Swallowing-related traction discomfort
Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.
Time frame: Postoperative 1 week, 1 month, and 3 months
hospitalization
days of hospitalization
Time frame: Length of stay from hospitalisation to discharge
degree of pain
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
Number of participants with recurrent laryngeal nerve injury
Impaired vocal cord mobility confirmed by postoperative laryngoscopy
Time frame: Through study completion, an average of 1 year
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Number of participants with hypoparathyroidism
A postoperative parathyroid hormone level of less than 10 pg/ml
Time frame: Through study completion, an average of 1 year
Operative time
Operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Time frame: Immediately at the end of the surgery
Central compartment lymph node yield
For participants undergoing central compartment lymph node dissection, the number of retrieved central compartment lymph nodes will be recorded and compared between groups.
Time frame: At the time of pathological assessment after surgery