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Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06671184
Enrollment
500
Registered
2024-11-04
Start date
2021-01-01
Completion date
2027-12-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Differentiated Thyroid Cancer

Keywords

Differentiated thyroid cancer, Transoral and submental thyroidectomy, Surgical difficulty

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.

Interventions

OTHERObservations on clinicopathological factors influencing the difficulty of surgery

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

Sponsors

Shanghai 6th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with recurrent laryngeal nerve injurythrough study completion, an average of 1 yearimpaired vocal cord mobility confirmed by postoperative laryngoscopy
Number of participants with hypoparathyroidismthrough study completion, an average of 1 yeara postoperative parathyroid hormone level of less than 10 pg/ml
Number of participants with mental nerve injurythrough study completion, an average of 1 yeara postoperative numbness in the lower lip and submental area
operative timethrough study completion, an average of 1 yearoperative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet

Secondary

MeasureTime frameDescription
hospitalizationthrough study completion, an average of 1 yeardays of hospitalization
degree of painapproximately 4 hours after surgery and on postoperative day 1pain 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

Countries

China

Contacts

CONTACTLing Zhan, Doctor
rebecca0428zhan@163.com08615821120972
PRINCIPAL_INVESTIGATORLing Zhan, Doctor

Shanghai 6th People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026