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Recruiting Observational

Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

NCT06738888 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-05-01
Last updated
2026-10-08

Condition(s) studied

Thyroid CancerThyroid DiseasesThyroid Nodule

Investigational drug(s) / intervention(s)

Modified Strap-Muscle Dissection Technique

Modified Strap-Muscle Dissection Technique: A refined endoscopic thyroidectomy technique characterized by limited midline separation of the superficial sternohyoid muscle layer, with preservation of adequate deep-layer sternothyroid dissection and lateral strap-muscle retraction to maintain surgical exposure.

Study summary

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 refine the procedure through a prospective study. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative neck functional recovery at 1 month — 1 month after surgery
    Postoperative neck functional recovery will be assessed 1 month after surgery using a standardized neck function assessment, including neck discomfort, anterior neck tightness, swallowing-related traction discomfort, and neck range of motion. Higher impairment scores indicate worse neck functional recovery.
  • Anterior neck tightness score — Postoperative 1 week, 1 month, and 3 months
    Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
  • Swallowing-related traction discomfort — Postoperative 1 week, 1 month, and 3 months
    Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Sixth People's Hospital Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06738888 on ClinicalTrials.gov ↗ ← All trials in China