Learning curve of trans-areola single-site endoscopic thyroidectomy in a high-volume center: A CUSUM-based assessment.
Ling Zhan, Ming Xuan, Hao Ding...
https://pubmed.ncbi.nlm.nih.gov/37395126Actively Recruiting
Led by Shanghai 6th People's Hospital · Updated on 2026-05-07
500
Participants Needed
1
Research Sites
N/A
Total Duration
The trial investigates factors influencing the difficulty of performing transoral and submental thyroidectomy (TOaST) in patients with differentiated thyroid cancer. This type of thyroid cancer is common and often treated with thyroidectomy. The study aims to identify preoperative indicators of surgical difficulty and develop a predictive model, addressing a current gap in understanding how various factors affect the complexity and safety of this minimally invasive procedure. Participants undergo observation of clinicopathological factors including age, body mass index, gender, thyroid function, lesion size and location, and ultrasound findings. The study categorizes cases as difficult or normal based on operative time and occurrence of severe intraoperative complications such as vascular or nerve injury. No treatment is assigned; the study is observational, analyzing outcomes during and after surgery. Participants will be monitored for up to one year, with evaluations of operative time and complications like recurrent laryngeal nerve injury, hypoparathyroidism, and mental nerve injury. Additional assessments include hospitalization duration and pain levels shortly after surgery. This comprehensive follow-up helps researchers measure surgical difficulty and related outcomes to build and validate the predictive model.
CONDITIONS
Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo transoral or submental endoscopic thyroidectomy and receive immediate care following surgery.
1 surgical visit and immediate post-operative monitoring
Duration - Up to 1 year after surgery
Participants are monitored for complications such as nerve injury and hypoparathyroidism, and evaluated for pain and hospitalization outcomes.
Multiple follow-up visits over 1 year
Total: 1 location
1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
L
Ling Zhan, Doctor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Ling Zhan, Ming Xuan, Hao Ding...
https://pubmed.ncbi.nlm.nih.gov/37395126Juyong Liang, Ling Zhan, Ming Xuan...
https://pubmed.ncbi.nlm.nih.gov/33782758