Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
ConditionDifferentiated Thyroid Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital
About this trial
No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
Absence of suspicious lateral lymph nodes or distant metastases
Participants with high cosmetic expectations
Participants who underwent total thyroidectomy and central lymph node dissection.
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 total 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
Treatment groups
500 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
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
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
through study completion, an average of 1 yearSecondary outcomes
1
hospitalization
days of hospitalization
Time frame
through study completion, an average of 1 year2
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov