An observational study in Thyroid Cancer, Thyroid Diseases and Thyroid Nodule, sponsored by Shanghai 6th People's Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Shanghai 6th People's Hospital · Observational
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.
This study is a prospectively registered cohort study evaluating postoperative neck functional recovery after TOaST. As a procedure refinement, a modified strap-muscle dissection technique will be introduced during transoral and submental endoscopic thyroidectomy. In the modified approach, the midline separation of the superficial sternohyoid muscle layer will be limited to the upper central neck, approximately to the level of the thyroid cartilage. The deeper sternothyroid muscle layer will be adequately dissected inferiorly as required to maintain sufficient surgical working space. Appropriate lateral retraction of the strap muscles will be used to achieve adequate exposure of the thyroid gland without extending the superficial midline dissection. This refinement is intended to reduce unnecessary disruption of the superficial anterior neck musculature and soft tissues while maintaining satisfactory operative exposure.
Surgical feasibility and safety will be assessed using operative time, intraoperative blood loss, drainage volume, number of central lymph nodes retrieved, recurrent laryngeal nerve events, parathyroid-related outcomes, postoperative complications, and the rate of technical conversion.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 300 is above the median of 161 across 82 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Shanghai 6th People's Hospital is the lead sponsor of 70 studies on the registry; 41 are open to participants now.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, the midline separation of the strap muscles, including the superficial sternohyoid layer, was extended inferiorly toward the suprasternal notch to obtain operative exposure
In this group, midline separation of the superficial sternohyoid muscle layer is limited to the upper central neck, approximately to the level of the thyroid cartilage, while adequate dissection of the deeper sternothyroid muscle layer is maintained as required for operative exposure. Lateral retraction of the strap muscles is used to provide sufficient visualization and working space without extending the superficial midline separation to the suprasternal notch.
Procedure: 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.
Postoperative neck functional recovery at 1 month
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.
Time frame: 1 month after surgery
Anterior neck tightness score
Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.
Time frame: Postoperative 1 week, 1 month, and 3 months
Swallowing-related traction discomfort
Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.
Time frame: Postoperative 1 week, 1 month, and 3 months
hospitalization
days of hospitalization
Time frame: Length of stay from hospitalisation to discharge
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
Time frame: approximately 4 hours after surgery and on postoperative day 1
Number of participants with recurrent laryngeal nerve injury
Impaired vocal cord mobility confirmed by postoperative laryngoscopy
Time frame: Through study completion, an average of 1 year
Number of participants with hypoparathyroidism
A postoperative parathyroid hormone level of less than 10 pg/ml
Time frame: 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
Time frame: Immediately at the end of the surgery
Central compartment lymph node yield
For participants undergoing central compartment lymph node dissection, the number of retrieved central compartment lymph nodes will be recorded and compared between groups.
Time frame: At the time of pathological assessment after surgery
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Dec 2027, 43 months after the start.
Of 38 observational studies under Thyroid Nodule, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32. This study's planned 43 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shanghai 6th People's Hospital