Thyroid CancerNCT06730321
Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
An observational study of Thyroid Cancer and Thyroid Nodule, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule, Thyroid Diseases
- What is being tested?
- Observations on clinicopathological factors influencing the assessment score of surgery
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Ling Zhan, Doctor, 08615821120972, 15821120972@163.com
About this study
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).
Read the 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).
- Conditions
- Thyroid Cancer, Thyroid Nodule, Thyroid Diseases, Thyroid Cancer, Papillary, Thyroid Cancer, Follicular
- Being tested
- Observations on clinicopathological factors influencing the assessment score of surgery
- Keywords
- Robotic thyroidectomy, Surgical competency, Robotic thyroidectomy assessment score
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule, Thyroid Diseases, Thyroid Cancer, Papillary, Thyroid cancer, follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations on clinicopathological factors influencing the assessment score of surgeryOther
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent robotic thyroidectomy | Patients underwent robotic thyroidectomy without conversion during the study period Receives: Other: Observations on clinicopathological factors influencing the assessment score of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrent laryngeal nerve injury
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Measured: through study completion, an average of 1 year
Number of participants with hypoparathyroidism
a postoperative parathyroid hormone level of less than 10 pg/ml
Measured: 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
Measured: through study completion, an average of 1 year
Score for surgical competence
score evaluated by the proposed assessment system
Measured: at the end of robotic thyroidectomy
Secondary outcomes (2)
hospitalization
days of hospitalization
Measured: 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
Measured: approximately 4 hours after surgery and on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start12 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Zhan, Shanghai 6th People's Hospital
- Investigators
- Ling Zhan, Doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730321
- Sponsor's protocol ID
- 2024-KY-245(K)
- Status last verified
- May 2026
- First submitted
- 9 Dec 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
- ClinicalTrials.gov ID
- NCT06730321
- Acronym / sponsor ID
- 2024-KY-245(K)
- Conditions
- Thyroid Cancer, Thyroid Nodule, Thyroid Diseases, Thyroid Cancer, Papillary, Thyroid Cancer, Follicular
- Keywords
- Robotic thyroidectomy, Surgical competency, Robotic thyroidectomy assessment score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent robotic thyroidectomy | – | Other: Observations on clinicopathological factors influencing the assessment score of surgeryPatients underwent robotic thyroidectomy without conversion during the study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observations on clinicopathological factors influencing the assessment score of surgeryAge, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data | Other | Patients underwent robotic thyroidectomy |
Primary outcome
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
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
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
Score for surgical competence
Time frame: at the end of robotic thyroidectomy
score evaluated by the proposed assessment system
2 secondary outcomes
hospitalization
Time frame: through study completion, an average of 1 year
degree of pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Zhan, Doctor principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Nodule, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhan, Doctor (08615821120972, rebecca0428zhan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrent laryngeal nerve injury (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.