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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difficult transoral and submental thyroidectomy | (1) operative time more than 75% of the overall study cases (2) severe intraoperative injuries :: vascular injury, recurrent laryngeal nerve injury, trachea injury, esophagus injury |
| |
| Normal transoral and submental thyroidectomy | the remaining of the entire study cases excluding the difficult cases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observations on clinicopathological factors influencing the difficulty of surgery | Other | Age, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
| 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 | through study completion, an average of 1 year |
| Number of participants with mental nerve injury | a postoperative numbness in the lower lip and submental area | 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 | immediately at the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hospitalization | days of hospitalization | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Zhan, Doctor | Contact | 08615821120972 | rebecca0428zhan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Zhan, Doctor | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | 200233 | China |
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.
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D013959 | Thyroid Diseases |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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|
| approximately 4 hours after surgery and on postoperative day 1 |
| D004700 |
| Endocrine System Diseases |