An observational study in Thyroid Cancer, Thyroid Nodule and Thyroid Diseases, sponsored by Shanghai 6th People's Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Shanghai 6th People's Hospital · Observational
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).
This study was conducted in two phases. In the first phase, the content development and validation phase, the key elements of robotic thyroidectomy with central neck dissection were broken down into 9 key steps for assessing the technical skills required to complete the procedure: creating the surgical area, exposing the thyroid gland, dissecting the upper pole of the thyroid gland with preservation of the superior laryngeal nerve (SLN), identifying and protecting the upper pole of the parathyroid glands, protecting the retractor laryngeal nerve (RLN), identifying and protecting the lower pole of the parathyroid glands, removing the thyroid, dissection of the central neck region and hemostasis.
The Delphi method was used for content validation of the 9 key steps. Each item was described using a Likert scale: 1 for worst and 5 for best. Experts were invited to evaluate each of the 9 key steps in terms of the description of the items and the agreement of the items with the assigned scores. Based on the Delphi method, the opinions of the experts were collected and consensus on the entry was indicated by determining that a content validity index (CVI) > 0.75 (CVI measure: the proportion of experts who scored each entry 4 or 5. Consensus is considered to have been reached when the CVI reaches 0.75. For entries where consensus was not reached entries were revised to reflect any changes suggested by the expert group and the revised scoring system was recirculated for reassessment. This process is repeated until all entries have reached consensus.
In the second phase of the study, the structural validation phase, two consecutive 50 robotic by the same operator after a learning curve were scored. The aim was to analyze whether the scoring system developed in the first phase could assess operator progress and steps for improvement. In addition, the time taken to complete the procedure was recorded and compared. It was also analyzed whether there were any differences in the baseline (tumor size, location, age, gender, etc.) of the patients in the two groups (1st 50 cases and 2nd 50 cases).
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 200 is above the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Shanghai 6th People's Hospital is the lead sponsor of 70 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were well informed about the robotic thyroidectomy and were aware of the potential benefits and risks. Patients underwent robotic thyroidectomy during the study period. Patient consented for us to use perioperative data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients underwent robotic thyroidectomy without conversion during the study period
Other: Observations on clinicopathological factors influencing the assessment score of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Number of participants with recurrent laryngeal nerve injury
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Time frame: through study completion, an average of 1 year
Number of participants with hypoparathyroidism
a postoperative parathyroid hormone level of less than 10 pg/ml
Time frame: 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
Time frame: through study completion, an average of 1 year
Score for surgical competence
score evaluated by the proposed assessment system
Time frame: at the end of robotic thyroidectomy
hospitalization
days of hospitalization
Time frame: through study completion, an average of 1 year
degree of pain
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.
Of 103 non-industry observational studies under Thyroid Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 311. This study's planned 36 months is below that.
Counting every sponsor, half of 112 studies reached it within 63 months; a quarter within 26 and three quarters within 311.
How these figures are worked out, and which studies are left out of them.
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Shanghai 6th People's Hospital