Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Thyroid Diseases; Thyroid Nodule; Thyroid Cancer

Treatments: Other: Observations on clinicopathological factors influencing the difficulty of surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06738888

2025-KY-029(K)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Difficult transoral and submental thyroidectomy

Description:

(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

Treatment:

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Normal transoral and submental thyroidectomy

Description:

the remaining of the entire study cases excluding the difficult cases

Treatment:

Other: Observations on clinicopathological factors influencing the difficulty of surgery