Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

May 2, 2026 updated by: Ling Zhan, Shanghai 6th People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • Shanghai sixth people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with FNA proven differentiated thyroid cancer, were willing to undergo total thyroidectomy and central lymph node dissection via transoral and submental approach. Patients were well informed about the transoral and submental approach and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Observations on clinicopathological factors influencing the difficulty of surgery
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
Other: Observations on clinicopathological factors influencing the difficulty of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrent laryngeal nerve injury
Time Frame: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
through study completion, an average of 1 year
Number of participants with hypoparathyroidism
Time Frame: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
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
a postoperative numbness in the lower lip and submental area
through study completion, an average of 1 year
operative time
Time Frame: 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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization
Time Frame: through study completion, an average of 1 year
days of hospitalization
through study completion, an average of 1 year
degree of pain
Time Frame: 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
approximately 4 hours after surgery and on postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: Ling Zhan, Doctor, Shanghai 6th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-236(K)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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