Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observations on clinicopathological factors influencing the difficulty of surgery.
- Who it may be relevant to
- Registry conditions: Differentiated Thyroid Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Observations on clinicopathological factors influencing the difficulty of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Primary outcome measures
- Number of participants with recurrent laryngeal nerve injury [Time frame: through study completion, an average of 1 year]
- Number of participants with hypoparathyroidism [Time frame: through study completion, an average of 1 year]
- Number of participants with mental nerve injury [Time frame: through study completion, an average of 1 year]
- operative time [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- hospitalization [Time frame: through study completion, an average of 1 year]
- degree of pain [Time frame: approximately 4 hours after surgery and on postoperative day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Sixth People's Hospital — Shanghai
Publications
- Zhan L, Xuan M, Ding H, Liang J, Zhao Q, Chen L, Yang Z, Cheng X, Kuang J, Yan J, Cai W, Qiu W. Learning curve of trans-areola single-site endoscopic thyroidectomy in a high-volume center: A CUSUM-based assessment. Cancer Med. 2023 Aug;12(16):16846-16858. doi: 10.1002/cam4.6307. Epub 2023 Jul 3. PMID 37395126
- Liang J, Zhan L, Xuan M, Zhao Q, Chen L, Yan J, Kuang J, Tan J, Qiu W. Thyroidectomy for thyroid cancer via transareola single-site endoscopic approach: results of a case-match study with large-scale population. Surg Endosc. 2022 Feb;36(2):1394-1406. doi: 10.1007/s00464-021-08424-y. Epub 2021 Mar 29. PMID 33782758
Identifiers
NCT: NCT06671184 · 2024-KY-236(K)