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Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Differentiated Thyroid Cancer

Treatments

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06671184
2024-KY-236(K)

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Difficult transoral and submental thyroidectomy
Description:
(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or recurrent laryngeal nerve injury
Treatment:
Other: Observations on clinicopathological factors influencing the difficulty of surgery
Normal transoral and submental thyroidectomy
Description:
the remaining of the entire study cases excluding the difficult cases
Treatment:
Other: Observations on clinicopathological factors influencing the difficulty of surgery

Trial contacts and locations

1

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Central trial contact

Ling Zhan, Doctor

Data sourced from clinicaltrials.gov

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