Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
- Conditions
- Differentiated Thyroid Cancer
- Registration Number
- NCT06671184
- Lead Sponsor
- Shanghai 6th People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
- Absence of suspicious lateral lymph nodes or distant metastases
- Participants with high cosmetic expectations
- Participants who underwent total thyroidectomy and central lymph node dissection.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Number of participants with mental nerve injury through study completion, an average of 1 year a postoperative numbness in the lower lip and submental area
operative time through study completion, an average of 1 year operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
- Secondary Outcome Measures
Name Time Method hospitalization through study completion, an average of 1 year 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
Trial Locations
- Locations (1)
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China