Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
NCT ID: NCT06730321
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-12-12
2025-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients underwent robotic thyroidectomy
Patients underwent robotic thyroidectomy without conversion during the study period
Observations on clinicopathological factors influencing the assessment score of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Interventions
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Observations on clinicopathological factors influencing the assessment score of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Shanghai 6th People's Hospital
OTHER
Responsible Party
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Ling Zhan
Doctor
Principal Investigators
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Ling Zhan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Locations
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Shanghai Sixth People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Ling Zhan, Doctor
Role: primary
Other Identifiers
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2024-KY-245(K)
Identifier Type: -
Identifier Source: org_study_id