ChiCTR2400089700 版本V1.0 版本创建时间2024/09/13 10:13:39 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400089700 

最近更新日期：

Date of Last Refreshed on：

 2024-09-13 10:13:06 

注册时间：

Date of Registration：

 2024-09-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

国产腔镜手术机器人系统远程手术服务模式与产品配置方案研究

Public title：

Research on the remote surgical service mode and product configuration scheme of domestic laparoscopic surgical robot system

注册题目简写：

English Acronym：

研究课题的正式科学名称：

国产腔镜手术机器人系统远程手术服务模式与产品配置方案研究

Scientific title：

Research on Remote Surgical Service Mode and Product Configuration Scheme of Domestic Laparoscopic Surgical Robot System

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

牛海涛 

研究负责人：

牛海涛 

Applicant：

Haitao Niu 

Study leader：

Haitao Niu 

申请注册联系人电话：

Applicant telephone：

 +86 18661805829

研究负责人电话：

Study leader's
telephone：

+86 532 82911330

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 niuht0532@126.com

研究负责人电子邮件：

Study leader's E-mail：

 niuht0532@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

山东省青岛市市南区江苏路16号

研究负责人通讯地址：

山东省青岛市市南区江苏路16号

Applicant address：

No. 16, Jiangsu Road, Shinan District, Qingdao City, Shandong Province

Study leader's address：

No. 16, Jiangsu Road, Shinan District, Qingdao, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

青岛大学附属医院

Applicant's institution：

The Affiliated Hospital of Qingdao University

研究负责人所在单位：

青岛大学附属医院

Affiliation of the Leader：

The Affiliated Hospital of Qingdao University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 【临研】伦审QYFYEC2024-71

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

青岛大学附属医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of the Affiliated Hospital of Qingdao University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-15 00:00:00

伦理委员会联系人：

张小蕾

Contact Name of the ethic committee：

Zhang Xiaolei

伦理委员会联系地址：

山东省青岛市市南区江苏路16号

Contact Address of the ethic committee：

No. 16, Jiangsu Road, Shinan District, Qingdao, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 532 82912611

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 qingyilunli@126.com

研究实施负责（组长）单位：

青岛大学附属医院

Primary sponsor：

The Affiliated Hospital of Qingdao University

研究实施负责（组长）单位地址：

山东省青岛市市南区江苏路16号

Primary sponsor's address：

No. 16, Jiangsu Road, Shinan District, Qingdao, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

青岛大学附属医院

具体地址：

山东省青岛市市南区江苏路16号

Institution
hospital：

The Affiliated Hospital of Qingdao University

Address：

No. 16, Jiangsu Road, Shinan District, Qingdao, Shandong Province

经费或物资来源：

诊疗装备与生物医用材料

Source(s) of funding：

Diagnosis and treatment equipment and biomedical materials

研究疾病：

泌尿系统肿瘤如膀胱癌、肾癌、前列腺癌等  

Target disease：

Urinary system tumors such as bladder cancer, kidney cancer, prostate cancer, etc

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

基于已有苏州康多、山东威高远程手术机器人系统及其前期研究，开展国产腔镜远程手术机器人系统的临床队列研究。针对目前远程手术流程尚无统一标准以及应用和推广等瓶颈问题,构建远程手术示范基地，建立本地和远程培训工具，开展高精准、高速率的培训、指导和远程手术新服务模式:构建我国医疗资源分布模型，提出兼顾中心医院承载能力与对卫星医院支撑效率的医疗资源远程星网式布局共享方案,开展满足真实需求的分布式远程节点设计及应用范式;同时在远程手术临床实践探索和应用的基础上开展远程手术系统稳健性研究、手术机器人适应化改进、通信体系高效智能配置等一系列远程手术核心技术测评和改进研究。进而从整体布局、应用模式、标准化流程等多个纬度支撑和促进远程手术的应用和推广,助力优质医疗资源下沉。  

Objectives of Study：

Based on the existing Suzhou Kangduo and Shandong Weigao remote surgical robot systems and their preliminary research, a clinical cohort study of domestic laparoscopic remote surgical robot systems was carried out. In view of the bottlenecks such as the lack of unified standards for the current remote surgery process and the application and promotion, a remote surgery demonstration base was constructed, local and remote training tools were established, and a new service model of high-precision and high-speed training, guidance and remote surgery was carried out: the distribution model of medical resources in China was constructed, a remote satellite network layout and sharing scheme of medical resources that took into account the carrying capacity of central hospitals and the support efficiency of satellite hospitals was proposed, and the design and application paradigm of distributed remote nodes to meet real needs were carried out. At the same time, on the basis of the exploration and application of remote surgery clinical practice, a series of core technology evaluation and improvement studies of remote surgery are carried out, such as the robustness of the remote surgery system, the adaptability improvement of surgical robots, and the efficient and intelligent configuration of the communication system. In addition, the application and promotion of remote surgery are supported and promoted from multiple dimensions such as overall layout, application mode, and standardized process, so as to help the sinking of high-quality medical resources.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1）18-80周岁，男女不限； 2）美国麻醉医师协会（ASA）一级、二级或三级； 3）体重指数18-30Kg/m2； 4）拟行拟行泌尿系肿瘤切除患者，即:肾上腺肿瘤切除患者（无功能腺瘤，直径小于5cm）；I或II期拟行肾癌根治术、肾部分切除术患者；无功能肾切除患者；肾盂肿瘤根治术患者；输尿管肿瘤根治术患者；膀胱肿瘤根治术患者；前列腺肿瘤根治术患者；盆腔肿瘤切除术患者； 5）受试者（或其法定代理人/监护人）自愿参加临床研究，并已签署知情同意书。

Inclusion criteria

1) 18-80 years old, male or female; 2) United States Society of Anesthesiologists (ASA) Level I, II or III; 3) Body mass index 18-30Kg/m2; 4) Patients who are to be resected for urinary tumors, i.e., patients with adrenal tumor resection (non-functional adenoma, less than 5cm in diameter); Patients with stage I or II radical nephrectomy or partial nephrectomy; Patients with non-functional nephrectomy; Patients undergoing radical renal pelvic tumor resection; Patients undergoing radical ureteral tumor resection; Patients undergoing radical bladder tumor resection; Patients undergoing radical prostatectomy; Patients undergoing pelvic tumor resection; 5) The subject (or his/her legal representative/guardian) voluntarily participates in the clinical study and has signed the informed consent form.

排除标准：

1.在签署知情同意书前30天内参与任何其他临床试验或临床研究并应用过试验药物、试验器械等试验产品；
2.妊娠期或哺乳期女性；
3.有癫痫或精神病史；
4.有既往胃穿孔、肠穿孔、肠粘连松懈术、本次手术目标部位既往有手术史；
5.严重的心脑血管疾病伴纽约心功能分级III-IV级和肺功能不全，无法耐受该手术者；
6.肝硬化、肾衰竭等严重肝肾功能不全者（ALT、AST超过正常值上限3倍，Cr超过正常值上限1.5倍）；有全身性出血倾向，以及凝血功能障碍者（凝血酶原活动度PTA＜25%）；肝炎、艾滋病活动期患者；未纠正的糖尿病患者（随机血糖>11.1mmol/l）和高血压患者（160/100mmHg以上）；
7.严重过敏体质及怀疑或确定有酒精、药物或毒品成瘾性者；
8.严重心、肺、肝、肾功能不全；
9.腹腔感染，腹膜炎，膈疝；泌尿系或全身严重感染患者；弥漫性腹膜炎伴肠梗阻、腹腔广泛粘连；
10.研究者认为不宜参加本临床研究的其他情况；

Exclusion criteria：

1.Participated in any other clinical trials or clinical studies within 30 days before signing the informed consent form and applied investigational drugs, investigational devices and other investigational products;
2.Pregnant or lactating females;
3.Has a history of epilepsy or psychiatric illness;
4.Previous gastric perforation, intestinal perforation, intestinal adhesion laxity, and previous surgery at the target site of this surgery;
5.Patients with severe cardiovascular and cerebrovascular disease with New York cardiac function class III-IV and pulmonary insufficiency, unable to tolerate this surgery;
6.Patients with severe liver and kidney dysfunction such as liver cirrhosis and renal failure (ALT and AST exceed the upper limit of normal by 3 times, and Cr exceeds the upper limit of normal by 1.5 times<); Patients with active hepatitis and AIDS; Patients with uncorrected diabetes mellitus (random blood glucose > 11.1 mmol/l) and hypertensive patients (above 160/100 mmHg);
7.Those with severe allergies and those who are suspected or confirmed to have alcohol, drugs or drug addiction;
8.Severe heart, lung, liver, and kidney insufficiency;
9.intra-abdominal infection, peritonitis, diaphragmatic hernia; Patients with severe urinary tract or systemic infections; Diffuse peritonitis with intestinal obstruction and extensive abdominal adhesions;
10.Other conditions that are considered inappropriate by the investigator to participate in this clinical study;

研究实施时间：

Study execute time：

从 From 2023-11-11 00:00:00至 To 2026-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-16 00:00:00 至 To 2025-06-01 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 60

Group：

Experimental group

Sample size：

干预措施：

远程机器人辅助腔镜手术

干预措施代码：

Intervention：

Remote robotic-assisted laparoscopic surgery

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 青岛大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The Affiliated Hospital of Qingdao University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

手术成功率

指标类型：

主要指标

Outcome：

Surgical success rate

Type：

Primary indicator

测量时间点：

手术完成后

测量方法：

手术成功的受试者例数/接受手术的受试者例数*100%

Measure time point of outcome：

After the surgery is completed

Measure method：

The number of subjects who succeeded in surgery/the number of subjects who underwent surgery * 100%

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Duration of surgery

Type：

Secondary indicator

测量时间点：

手术完成后

测量方法：

自机器人安装完毕开始手术至手术切口缝合完毕的时间长度。单位：分钟

Measure time point of outcome：

After the surgery is completed

Measure method：

The length of time from the start of surgery after the robot is installed to the completion of the suture of the surgical incision. Unit: minutes

指标中文名：

术中出血量

指标类型：

次要指标

Outcome：

Intraoperative blood loss

Type：

Secondary indicator

测量时间点：

手术完成后

测量方法：

机器人安装完毕手术开始至手术切口缝合完毕期间的总出血量，手术结束时计算，采用称重法估算，失血量（g）=揩净全部失血后的纱布重量-干纱布重量，1g计为1ml。单位：ml。

Measure time point of outcome：

After the surgery is completed

Measure method：

The total amount of blood loss during the period from the start of the operation to the completion of the surgical incision and suturing after the robot is installed, calculated at the end of the operation, and estimated by the weighing method, the blood loss (g) = the weight of the gauze after all the blood loss is wiped - the weight of the dry gauze, and 1g is counted as 1ml. Unit: ml.

指标中文名：

术后疼痛

指标类型：

次要指标

Outcome：

Postoperative pain

Type：

Secondary indicator

测量时间点：

术后24±2小时

测量方法：

患者术后24±2小时根据视觉模拟量表（VAS）评估术后疼痛，评估范围为：0（无疼痛）至10（最大疼痛）

Measure time point of outcome：

24±2 hours postoperatively

Measure method：

Patients were assessed for postoperative pain according to the Visual Analogue Scale (VAS) 24±2 hours postoperatively, and the assessment ranged from: 0 (no pain) to 10 (maximum pain)

指标中文名：

平均网络延迟时间

指标类型：

次要指标

Outcome：

Average network latency

Type：

Secondary indicator

测量时间点：

实时监控，全程跟踪复现。

测量方法：

平均网络延迟时间：使用相关通信监控软件、设备，实时监控，全程跟踪复现。单位：分钟。

Measure time point of outcome：

Real-time monitoring, full tracking and reproduction.

Measure method：

Average network latency time: Real-time monitoring with relevant communication monitoring software and equipment, tracking and reproduction throughout the process. Unit: minutes.

指标中文名：

人体工程学

指标类型：

次要指标

Outcome：

Ergonomics

Type：

Secondary indicator

测量时间点：

手术完成后

测量方法：

基于有效问卷（任务负荷指数量表（NASA-TLX表））的人体工程学显示远程手术与达芬奇手术对比优劣。手术结束时评估，主刀医生填写。

Measure time point of outcome：

After the surgery is completed

Measure method：

Ergonomics based on a valid questionnaire (Task Load Index Scale (NASA-TLX Scale)) shows the advantages and disadvantages of telesurgery compared to da Vinci surgery. At the end of the operation, the surgeon fills in.

指标中文名：

患者对远程手术的接受度

指标类型：

次要指标

Outcome：

Patient acceptance of telesurgery

Type：

Secondary indicator

测量时间点：

术前一天开始

测量方法：

患者对远程手术的接受度：根据标准量表（远程手术/远程医疗服务患者接受度调查问卷（TPSQ表））进行患者接受度评估。术前一天开始评估。患者焦虑指数：通过国际标准焦虑自测量表（TP-SAS表）进行远程手术患者焦虑研究。

Measure time point of outcome：

Started the day before surgery

Measure method：

Patient acceptance of telesurgery: Patient acceptance assessment was performed according to a standard scale (Telesurgery/Telemedicine Services Patient Acceptance Questionnaire (TPSQ Form)). Assessments began the day before surgery. Patient Anxiety Index: Remote surgical patient anxiety study by the International Standard Anxiety Self-Measurement Scale (TP-SAS Scale).

指标中文名：

同行医生的远程手术认可度

指标类型：

次要指标

Outcome：

Recognition of telesurgery by fellow doctors

Type：

Secondary indicator

测量时间点：

手术完成后

测量方法：

根据各项手术指标对比，通过调查表（远程手术/远程医疗服务同行医生患者认可度调查问卷（TAKA表））综合评估远程手术的情况，得出同行医生的认可程度。手术结束时评估。

Measure time point of outcome：

After the surgery is completed

Measure method：

Based on the comparison of various surgical indicators, the status of telesurgery was comprehensively evaluated through a questionnaire (Telesurgery/Telemedicine Service Peer Physician Patient Recognition Questionnaire (TAKA form)) to obtain the degree of recognition of peer doctors. Assessed at the end of surgery.

指标中文名：

远程手术操作者及助手焦虑指数

指标类型：

次要指标

Outcome：

Anxiety index for remote surgical operators and assistants

Type：

Secondary indicator

测量时间点：

术前一天开始

测量方法：

远程手术操作者及助手焦虑指数：通过标准量表（远程手术操作者及助手焦虑自测量表（T0-SAS表））评估远程手术对操作者和助手的心态影响。

Measure time point of outcome：

Started the day before surgery

Measure method：

Remote Operator and Assistant Anxiety Index: The impact of remote surgery on the mentality of operators and assistants was assessed by a standard scale (Remote Operator and Assistant Anxiety Self-Measure Scale (T0-SAS Form)).

指标中文名：

装机时间

指标类型：

次要指标

Outcome：

Installation time

Type：

Secondary indicator

测量时间点：

从机器人启动直至Trocar与机械臂连接完毕的时间。单位：分钟。

测量方法：

从机器人启动直至Trocar与机械臂连接完毕的时间。单位：分钟。

Measure time point of outcome：

The time between the start of the robot and the completion of the connection between the Trocar and

Measure method：

The time between the start of the robot and the completion of the connection between the Trocar and the robotic arm. Unit: minutes.

指标中文名：

从手术到出院时间

指标类型：

次要指标

Outcome：

Time from surgery to discharge

Type：

Secondary indicator

测量时间点：

患者康复出院后

测量方法：

患者从手术至出院的时间。计算方法：从手术到出院时间=患者出院日期-患者手术日期+1，规定出院时间均为上午出院。单位：天。

Measure time point of outcome：

After the patient recovers and is discharged from the hospital

Measure method：

The patient's time from surgery to hospital discharge. Calculation method: from surgery to discharge time = patient discharge date - patient surgery date + 1, the specified discharge time is morning discharge. Unit: days.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

泌尿系统肿瘤组织

组织：

Sample Name：

Urinary tract tumor tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

国家重点研发计划科技计划项目科学数据交汇计划，由国家人口健康科学数据中心管理

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The scientific data exchange plan of the science and technology program of the National Key R&D Program is managed by the National Population Health Science Data Center

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-09-13 10:13:06