Thyroid Cancer, Thyroid Diseases, Thyroid Nodule
Conditions
Keywords
Endoscopic thyroidectomy, Transoral and submental approach, Prediction model
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREModified TOaST with caudal linea alba preservation
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.
Sponsors
Shanghai 6th People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative neck functional recovery at 1 month | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospitalization | Length of stay from hospitalisation to discharge | days of hospitalization |
| degree of pain | approximately 4 hours after surgery and on postoperative day 1 | 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 |
| Number of participants with recurrent laryngeal nerve injury | Through study completion, an average of 1 year | Impaired vocal cord mobility confirmed by postoperative laryngoscopy |
| Number of participants with hypoparathyroidism | Through study completion, an average of 1 year | A postoperative parathyroid hormone level of less than 10 pg/ml |
| Operative time | 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 |
| Central compartment lymph node yield | At the time of pathological assessment after surgery | For participants undergoing central compartment lymph node dissection, the number of retrieved central compartment lymph nodes will be recorded and compared between groups. |
Countries
China
Contacts
CONTACTLing Zhan, Doctor
PRINCIPAL_INVESTIGATORLing Zhan, Doctor
Shanghai 6th People's Hospital
Outcome results
None listed