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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 6th People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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