Thyroid Cancer, Thyroid Cancer, Follicular, Thyroid Cancer, Papillary, Thyroid Diseases, Thyroid Nodule
Conditions
Keywords
Robotic thyroidectomy, Surgical competency, Robotic thyroidectomy assessment score
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).
Interventions
OTHERObservations on clinicopathological factors influencing the assessment score of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data
Sponsors
Shanghai 6th People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with recurrent laryngeal nerve injury | through study completion, an average of 1 year | impaired vocal cord mobility confirmed by postoperative laryngoscopy |
| Number of participants with hypoparathyroidism | through study completion, an average of 1 year | a postoperative parathyroid hormone level of less than 10 pg/ml |
| Operative time | 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 | at the end of robotic thyroidectomy | score evaluated by the proposed assessment system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospitalization | through study completion, an average of 1 year | days of hospitalization |
| degree of pain | 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 |
Countries
China
Contacts
CONTACTLing Zhan, Doctor
PRINCIPAL_INVESTIGATORLing Zhan, Doctor
Shanghai 6th People's Hospital
Outcome results
None listed