Developing a scoring tool for robotic thyroid surgery performance
Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
This study is trying to create a scoring tool to help doctors measure how well they perform robotic thyroid surgeries, with the aim of improving patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06730321 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create and validate a structured scoring tool known as the Robotic Thyroidectomy Assessment Score (RTAS) to evaluate surgical competency in robotic thyroidectomy procedures. The study is conducted in two phases, with the first phase focusing on breaking down the surgical process into nine key steps and using the Delphi method for content validation. Experts assess each step using a Likert scale to ensure the scoring system accurately reflects surgical performance. The goal is to enhance the assessment of surgical skills in robotic thyroidectomy, ultimately improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with differentiated thyroid cancer or benign thyroid nodules who meet specific size criteria and have high cosmetic expectations.
Not a fit: Patients with a history of neck surgery or radiation, vocal fold fixation, or signs of distant invasion may not benefit from this study.
Why it matters
Potential benefit: If successful, this scoring tool could lead to improved surgical training and outcomes for patients undergoing robotic thyroidectomy.
How similar studies have performed: While the specific approach of developing a scoring tool for robotic thyroidectomy is novel, similar competency assessment tools have shown success in other surgical fields.
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 nodules with a maximum diameter not exceeding 6 cm * Participants with high cosmetic expectations * Participants underwent robotic thyroidectomy without open conversion Exclusion Criteria: * Participants with history of neck surgery or radiation * Participants with vocal fold fixation by preoperative fibrolaryngoscope * Participants with preoperative examination suggestive of distant invasion * Participants with fusion or fixed of lymph nodes in the neck
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.