Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Differentiated Thyroid Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Difficult transoral and submental thyroidectomy

(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury

Observations on clinicopathological factors influencing the difficulty of surgery

Intervention Type OTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Normal transoral and submental thyroidectomy

the remaining of the entire study cases excluding the difficult cases

Observations on clinicopathological factors influencing the difficulty of surgery

Intervention Type OTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Interventions

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Observations on clinicopathological factors influencing the difficulty of surgery

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No