Clinical trial NCT06730321: Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
Official title: Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Thyroid Nodule
Thyroid Diseases
Thyroid Cancer, Papillary
Thyroid Cancer, Follicular
Keywords: Robotic thyroidectomy
Surgical competency
Robotic thyroidectomy assessment score
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with recurrent laryngeal nerve injury
timeFrame: through study completion, an average of 1 year
measure: Number of participants with hypoparathyroidism
timeFrame: through study completion, an average of 1 year
measure: Operative time
timeFrame: through study completion, an average of 1 year
measure: Score for surgical competence
timeFrame: at the end of robotic thyroidectomy
Secondary outcomes:
measure: hospitalization
timeFrame: through study completion, an average of 1 year
measure: degree of pain
timeFrame: approximately 4 hours after surgery and on postoperative day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Ling Zhan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: