Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to renovate and validate the prediction model through a prospective study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

NCT06671184

Differentiated Thyroid Cancer

RECRUITING

A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

NCT05735054

Thyroid Diseases

UNKNOWN

Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

NCT00993837

Thyroid Carcinoma

UNKNOWN NA

Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)

NCT06730321

Thyroid Cancer Thyroid Nodule Thyroid Diseases +2 more

RECRUITING

Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients

NCT06468696

Papillary Thyroid Cancer Lymph Node Metastasis Carcinogenesis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Male sex, age, BMI, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult thyroidectomy. The investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. Therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer Thyroid Diseases Thyroid Nodule

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Difficult transoral and submental thyroidectomy

(1) operative time more than 75% of the overall study cases (2) severe intraoperative injuries :: vascular injury, recurrent laryngeal nerve injury, trachea injury, esophagus injury

Observations on clinicopathological factors influencing the difficulty of surgery

Intervention Type OTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data, thyromental distance, neck circumference, sternomental distance, ratio of height-to-thyromental distance, RHTMD, ratio of height-to-sternomental distance, RHSMD

Normal transoral and submental thyroidectomy

the remaining of the entire study cases excluding the difficult cases

Observations on clinicopathological factors influencing the difficulty of surgery

Intervention Type OTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data, thyromental distance, neck circumference, sternomental distance, ratio of height-to-thyromental distance, RHTMD, ratio of height-to-sternomental distance, RHSMD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observations on clinicopathological factors influencing the difficulty of surgery

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data, thyromental distance, neck circumference, sternomental distance, ratio of height-to-thyromental distance, RHTMD, ratio of height-to-sternomental distance, RHSMD

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
* Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
* Absence of suspicious lateral lymph nodes or distant metastases

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 and/or jaw

Eligible Sex

ALL

Accepts Healthy Volunteers

No