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 renovate and validate the prediction model through a prospective study.
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
Observations on clinicopathological factors influencing the difficulty of surgery
Other interventionAge, 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
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Difficult transoral and submental thyroidectomy1 intervention
Group B: Normal transoral and submental thyroidectomy1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 1 year2
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
Time frame
through study completion, an average of 1 year3
Number of participants with mental nerve injury
a postoperative numbness in the lower lip and submental area
Time frame
through study completion, an average of 1 year4
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 surgerySecondary 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 1Sponsors and contacts
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Source ClinicalTrials.gov