Clinical trial NCT06738888: Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
Official title: Renovated Prediction Model for Difficult. Transoral and Submental Endoscopic Thyroidectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Thyroid Diseases
Thyroid Nodule
Keywords: Endoscopic thyroidectomy
Transoral and submental approach
Prediction model
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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 renovate and validate the prediction model through a prospective study.

Detailed description: Male sex, age, BMI, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult thyroidectomy. The investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. Therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.

Eligibility criteria: 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 outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
measure: Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism Number of participants with hypoparathyroidism
timeFrame: through study completion, an average of 1 year
measure: Number of participants with mental nerve injury
timeFrame: through study completion, an average of 1 year
measure: operative time
timeFrame: immediately at the end of the surgery
Secondary outcomes:
measure: hospitalization
timeFrame: Length of stay from hospitalisation to discharge
measure: degree of pain
timeFrame: approximately 4 hours after surgery and on postoperative day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Ling Zhan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: