Shanghai Sixth People's Hospital
Shanghai, 200233, China
Location status: Recruiting
NCT Number: NCT06730321
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).
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Observational
Shanghai, 200233, China
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Time frame: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Time frame: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
Time frame: through study completion, an average of 1 year
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Time frame: at the end of robotic thyroidectomy
score evaluated by the proposed assessment system
Time frame: through study completion, an average of 1 year
days of hospitalization
Time frame: approximately 4 hours after surgery and on postoperative day 1
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
Contact information is provided by the study sponsor or research team.
Shanghai 6th People's Hospital
Other
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