Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

NCT06738888 | Recruiting

• 1 other identifier: 2025-KY-029(K)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Thyroid Diseases; Thyroid Nodule

Keywords

Endoscopic thyroidectomy; Transoral and submental approach; Prediction model

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• hospitalization

  Length of stay from hospitalisation to discharge

• degree of pain

  approximately 4 hours after surgery and on postoperative day 1

Study Arms (2)

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

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Normal transoral and submental thyroidectomy

the remaining of the entire study cases excluding the difficult cases

Other: Observations on clinicopathological factors influencing the difficulty of surgery

Interventions

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

Difficult transoral and submental thyroidectomy; Normal transoral and submental thyroidectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Study Officials

• Ling Zhan, Doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhan, Doctor

CONTACT

08615821120972; rebecca0428zhan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)