Actively Recruiting

All Genders
ID06738888

Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

Led by Shanghai 6th People's Hospital · Updated on 2026-05-07

300

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a renovated prediction model to identify factors that make transoral and submental endoscopic thyroidectomy difficult. This study focuses on patients with thyroid cancer, benign thyroid nodules, or other thyroid diseases. The model integrates measurements such as neck circumference, thyromental distance, and ratios involving height to better predict surgical difficulty, which is important for improving the safety and training related to thyroid surgery. The study involves observing clinical and pathological factors including age, body mass index, gender, thyroid function, lesion size and location, and various neck measurements. Participants undergo transoral and submental endoscopic thyroidectomy, and cases are categorized as difficult or normal based on operative time and the occurrence of severe intraoperative injuries. The research team tracks outcomes such as nerve injuries and operative time immediately after surgery. Participants will be monitored through assessments of nerve injury, hypoparathyroidism, mental nerve injury, and postoperative pain levels, including hospitalization length. The study monitors outcomes for about one year following surgery to evaluate complications and surgical difficulty. This observational study will help refine and validate the prediction model to improve future thyroid surgeries.

CONDITIONS

Brief Title

Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo measurements of clinical and ultrasound parameters related to thyroid health and anatomy to assess factors influencing surgery difficulty.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo transoral or submental endoscopic thyroidectomy with monitoring for surgical outcomes and complications.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 1 year

Participants are monitored for recovery, including pain assessment and hospitalization duration, over approximately 1 year post-surgery.

Approximately 3 visits including 4 hours after surgery, postoperative day 1, and additional follow-ups

Trial Site Locations

Total: 1 location

1

Shanghai Sixth People's Hospital

Shanghai, China, 200233

Actively Recruiting

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Research Team

L

Ling Zhan, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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