Improving prediction for challenging thyroid surgeries
Renovated Prediction Model for Difficult. Transoral and Submental Endoscopic Thyroidectomy
Shanghai 6th People's Hospital · NCT06738888
This study is testing a new way to predict how challenging thyroid surgeries will be by looking at different health factors to help doctors perform the surgery better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06738888 on ClinicalTrials.gov |
What this trial studies
This study aims to renovate and validate a prediction model for difficult transoral and submental endoscopic thyroidectomy based on various clinical factors. The researchers will assess indicators such as male sex, age, BMI, neck length, and specific thyroid diseases to enhance surgical outcomes. By integrating innovative measurements like neck circumference and distances related to neck extension, the study seeks to improve the training and execution of this surgical approach. The ultimate goal is to promote the transoral and submental endoscopic technique for thyroid surgeries.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with differentiated thyroid cancer or benign thyroid nodules that meet specific size criteria.
Not a fit: Patients with prior neck surgeries, significant neck restrictions, or evidence of extrathyroidal invasion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing thyroid surgery.
How similar studies have performed: While previous studies have proposed prediction models for thyroid surgeries, this approach integrates novel measurements and is aimed at validating those models in a prospective manner.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Shanghai Sixth People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Ling Zhan, Doctor — Shanghai 6th People's Hospital
- Study coordinator: Ling Zhan, Doctor
- Email: rebecca0428zhan@163.com
- Phone: 08615821120972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer, Thyroid Diseases, Thyroid Nodule, Endoscopic thyroidectomy, Transoral and submental approach, Prediction model