Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

Renovated Prediction Model for Difficult. Transoral and Submental Endoscopic Thyroidectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Diseases; Thyroid Cancer; Thyroid Nodule
• Intervention / Treatment: Other: Observations on clinicopathological factors influencing the difficulty of surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ling Zhan, Doctor; Phone Number: 08615821120972; Email: rebecca0428zhan@163.com

Study Locations

• China
  • Shanghai, China, 200233
    • Recruiting
    • Shanghai sixth people's hospital
    • Contact: Ling Zhan, Doctor; Phone Number: 08615821120972; Email: 15821120972@163.com

Participation Criteria

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 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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, thyromental distance, neck circumference, sternomental distance, ratio of height-to-thyromental distance, RHTMD, ratio of height-to-sternomental distance, RHSMD
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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with mental nerve injury	a postoperative numbness in the lower lip and submental area	through study completion, an average of 1 year
1.Number of participants with recurrent laryngeal nerve injury 1.Number of participants with recurrent laryngeal nerve injury Number of participants with recurrent laryngeal nerve injury	impaired vocal cord mobility confirmed by postoperative laryngoscopy	through study completion, an average of 1 year
Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism	a postoperative parathyroid hormone level of less than 10 pg/ml a postoperative parathyroid hormone level of less than 10 pg/ml a postoperative parathyroid hormone level of less than 10 pg/ml	through study completion, an average of 1 year
operative time	operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet	immediately at the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of pain	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
hospitalization	days of hospitalization	Length of stay from hospitalisation to discharge

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 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: Prediction model; Endoscopic thyroidectomy; Transoral and submental approach
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule; Thyroid Neoplasms
• Other Study ID Numbers: 2025-KY-029(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