跳至主要内容
临床试验/NCT06730321
NCT06730321招募中不适用

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

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Score for surgical competence

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Patients underwent robotic thyroidectomy

Patients underwent robotic thyroidectomy without conversion during the study period

干预措施: Observations on clinicopathological factors influencing the assessment score of surgery (Other)

结局指标

主要结局

Score for surgical competence

时间窗: at the end of robotic thyroidectomy

score evaluated by the proposed assessment system

Number of participants with recurrent laryngeal nerve injury

时间窗: through study completion, an average of 1 year

impaired vocal cord mobility confirmed by postoperative laryngoscopy

Number of participants with hypoparathyroidism

时间窗: through study completion, an average of 1 year

a postoperative parathyroid hormone level of less than 10 pg/ml

Operative time

时间窗: 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

次要结局

  • hospitalization(through study completion, an average of 1 year)
  • degree of pain(approximately 4 hours after surgery and on postoperative day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Zhan

Doctor

Shanghai 6th People's Hospital

研究点 (1)

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