An observational study in Differentiated Thyroid Cancer, sponsored by Shanghai 6th People's Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Shanghai 6th People's Hospital · Observational
No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.
Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.
Shanghai 6th People's Hospital is the lead sponsor of 69 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with FNA proven differentiated thyroid cancer, were willing to undergo total thyroidectomy and central lymph node dissection via transoral and submental approach. Patients were well informed about the transoral and submental approach and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.
Exclusion Criteria:
(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury
Other: Observations on clinicopathological factors influencing the difficulty of surgery
the remaining of the entire study cases excluding the difficult cases
Other: Observations on clinicopathological factors influencing the difficulty of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
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
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
Number of participants with mental nerve injury
a postoperative numbness in the lower lip and submental area
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: through study completion, an average of 1 year
hospitalization
days of hospitalization
Time frame: through study completion, an average of 1 year
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
Plan to share: Undecided — Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.
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Shanghai 6th People's Hospital