Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Modified Strap-Muscle Dissection Technique
Procedure/SurgeryA 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Conventional TOaST0 interventions
Group B: Modified Strap-Muscle Dissection TOaST1 intervention
Trial outcomes
Primary outcomes
1
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 surgery2
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 months3
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 monthsSecondary outcomes
1
hospitalization
days of hospitalization
Time frame
Length of stay from hospitalisation to discharge2
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 13
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 year4
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 yearSponsors and contacts
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Source ClinicalTrials.gov