Predicting challenges in thyroid surgery
Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
Shanghai 6th People's Hospital · NCT06671184
This study is trying to find out which factors can help doctors predict how challenging thyroid surgery will be for patients with thyroid cancer so they can plan better and keep patients safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06671184 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify preoperative factors that indicate the difficulty of transoral and submental thyroidectomy (TOaST) for patients with differentiated thyroid cancer. By analyzing clinicopathological factors, the researchers intend to develop a predictive model that can help surgeons anticipate surgical challenges. The study focuses on understanding the complexities involved in endoscopic thyroid surgery, which is gaining popularity due to its cosmetic advantages. The findings could enhance surgical planning and patient safety by minimizing complications associated with difficult surgeries.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with differentiated thyroid cancer, with tumors not exceeding 4 cm and no signs of lymph node involvement or metastasis.
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 improve surgical outcomes and reduce complications for patients undergoing thyroid surgery.
How similar studies have performed: While there is limited research specifically on TOaST, studies on surgical difficulty in open thyroid surgery have shown that preoperative factors can be predictive of surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, 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: Differentiated Thyroid Cancer, Differentiated thyroid cancer, Transoral and submental thyroidectomy, Surgical difficulty