Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)

May 2, 2026 updated by: Ling Zhan, Shanghai 6th People's Hospital
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200233
        • Recruiting
        • Shanghai sixth people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients underwent robotic thyroidectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrent laryngeal nerve injury
Time Frame: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
through study completion, an average of 1 year
Number of participants with hypoparathyroidism
Time Frame: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
through study completion, an average of 1 year
Operative time
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
through study completion, an average of 1 year
Score for surgical competence
Time Frame: at the end of robotic thyroidectomy
score evaluated by the proposed assessment system
at the end of robotic thyroidectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization
Time Frame: through study completion, an average of 1 year
days of hospitalization
through study completion, an average of 1 year
degree of pain
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
approximately 4 hours after surgery and on postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: Ling Zhan, Doctor, Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-245(K)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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