Идёт набор NCT06730321

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

— Наблюдательное Thyroid Cancer Thyroid Nodule Thyroid Diseases Thyroid Cancer, Papillary

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Observations on clinicopathological factors influencing the assessment score of surgery.
Кому может быть актуально: Состояния в реестре: Thyroid Cancer, Thyroid Nodule, Thyroid Diseases, Thyroid Cancer, Papillary. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).

Подробное описание

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).

Вмешательства

Другое Observations on clinicopathological factors influencing the assessment score of surgery
Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Первичные конечные точки

Number of participants with recurrent laryngeal nerve injury [Срок оценки: through study completion, an average of 1 year]
Number of participants with hypoparathyroidism [Срок оценки: through study completion, an average of 1 year]
Operative time [Срок оценки: through study completion, an average of 1 year]
Score for surgical competence [Срок оценки: at the end of robotic thyroidectomy]

Вторичные конечные точки (2)

hospitalization [Срок оценки: through study completion, an average of 1 year]
degree of pain [Срок оценки: approximately 4 hours after surgery and on postoperative day 1]

Критерии участия

Критерии включения

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