ChiCTR2500106218 版本V1.0 版本创建时间2025/07/21 09:35:35 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：

 ChiCTR2500106218 

最近更新日期：

Date of Last Refreshed on：

 2025-07-21 09:35:31 

注册时间：

Date of Registration：

 2025-07-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

信息化预警系统在留置输尿管支架患者中的应用效果评价

Public title：

Effectiveness Evaluation of Information-based Early Warning System Applied to Patients with Indwelling Ureteral Stents

注册题目简写：

English Acronym：

研究课题的正式科学名称：

信息化预警系统在留置输尿管支架患者中的应用效果评价

Scientific title：

Effectiveness Evaluation of Information-based Early Warning System Applied to Patients with Indwelling Ureteral Stents

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：

黄文 

研究负责人：

黄文 

Applicant：

Wen Huang 

Study leader：

Wen Huang 

申请注册联系人电话：

Applicant telephone：

 +86 187 8011 0945

研究负责人电话：

Study leader's
telephone：

+86 187 8011 0945

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：

 1154676682@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1154676682@qq.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：

四川省成都市青白江区凤凰东四路 15 号

研究负责人通讯地址：

四川省成都市青白江区凤凰东四路 15 号

Applicant address：

No.15, East Fenghuang 4th Road, Qingbaijiang District, Chengdu, Sichuan

Study leader's address：

No.15, East Fenghuang 4th Road, Qingbaijiang District, Chengdu, Sichuan

申请注册联系人邮政编码：

Applicant postcode：

 610106

研究负责人邮政编码：

Study leader's postcode：

 610106

申请人所在单位：

成都市青白江区人民医院

Applicant's institution：

Chengdu Qingbaijiang District People’s Hospital

研究负责人所在单位：

成都市青白江区人民医院

Affiliation of the Leader：

Chengdu Qingbaijiang District People’s Hospital

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：

 2025 年 审(4)号

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：

成都市青白江区人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chengdu Qingbaijiang District People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-13 00:00:00

伦理委员会联系人：

乔洪图

Contact Name of the ethic committee：

Hongtu Qiao

伦理委员会联系地址：

四川省成都市青白江区凤凰东四路 15 号

Contact Address of the ethic committee：

No.15, East Fenghuang 4th Road, Qingbaijiang District, Chengdu, Sichuan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 182 6385 6731

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

成都市青白江区人民医院

Primary sponsor：

Chengdu Qingbaijiang District People's Hospital

研究实施负责（组长）单位地址：

四川省成都市青白江区凤凰东四路 15 号

Primary sponsor's address：

No.15, East Fenghuang 4th Road, Qingbaijiang District, Chengdu, Sichuan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都市青白江区人民医院

具体地址：

四川省成都市青白江区凤凰东四路 15 号

Institution
hospital：

Chengdu Qingbaijiang District People's Hospital

Address：

No.15, East Fenghuang 4th Road, Qingbaijiang District, Chengdu, Sichuan

经费或物资来源：

自筹经费

Source(s) of funding：

Self-financing

研究疾病：

泌尿系结石  

Target disease：

Urologic Calculi

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

系统评价基于信息化预警系统的延续护理在泌尿系结石术后留置输尿管支架患者中的应用效果，重点验证其在减少支架逾期留置时间、提高患者按时拔除输尿管支架的依从性、缓解输尿管支架相关症状方面的优势。具体而言:① 比较传统护理组、微信群护理组与信息化预警系统护理组在中文版输尿管支架相关症状调查问卷（USSQ）总分及各维度（泌尿系统症状、身体疼痛、总体健康状况及附加问题维度）得分的差异，明确信息化预警系统对改善患者生理症状的作用。② 评估三组患者在支架逾期留置率、成年人健康自我管理能力测评量表（AHSMRS )、焦虑自评量表（SAS）及抑郁自评量表（SDS）评分及延续护理满意度上的差异，分析信息化预警系统对提升患者依从性及身心健康的影响。  

Objectives of Study：

To systematically evaluate the application effect of continuous care based on the informatization early - warning system in patients with indwelling ureteral stents after urologic calculi surgery, with a focus on verifying its advantages in reducing the overdue indwelling time of stents, improving patients' compliance with timely removal of ureteral stents, and alleviating symptoms related to ureteral stents. Specifically: ① Compare the differences in the total scores and dimension scores (urinary system symptoms, physical pain, general health status, and additional problem dimensions) of the Chinese version of the Ureteral Stent - related Symptom Questionnaire (USSQ) among the traditional nursing group, the WeChat group nursing group, and the informatization early - warning system nursing group, so as to clarify the role of the informatization early - warning system in improving patients' physiological symptoms. ② Evaluate the differences among the three groups of patients in the stent overdue indwelling rate, scores of the Adult Health Self - management Ability Rating Scale (AHSMRS), Self - Rating Anxiety Scale (SAS), Self - Rating Depression Scale (SDS), and continuous care satisfaction, and analyze the impact of the informatization early - warning system on improving patients' compliance, physical and mental health.

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. 年龄≥18 周岁的成年患者。 2. 因泌尿系结石接受上尿路内镜碎石术（如输尿管镜、经皮肾镜碎石术），术后留置输尿管支架。 3. 输尿管支架预计留置时间≤1个月； 4. 意识清晰，具备正常沟通能力，能配合完成量表评估； 5. 患者本人或其家属具备基本的手机使用能力（如扫码、接收短信、使用微信）； 6. 自愿参与本研究并签署知情同意书。

Inclusion criteria

1. Adult patients aged >= 18 years. 2. Patients who have undergone upper urinary tract endoscopic lithotripsy (such as ureteroscopy, percutaneous nephrolithotomy) due to urologic calculi and have indwelling ureteral stents after surgery. 3. The expected indwelling time of the ureteral stent is <= 1 month. 4. Patients with clear consciousness, normal communication ability, and able to cooperate in completing scale assessments. 5. Patients themselves or their family members have basic mobile phone operation skills (such as scanning codes, receiving text messages, using WeChat). 6. Patients voluntarily participate in this study and sign the informed consent form.

排除标准：

1. 合并严重心脑血管疾病、肝肾功能衰竭、恶性肿瘤等基础疾病。 2. 患有精神疾病（如抑郁症、焦虑症）或认知障碍（如阿尔茨海默病），无法配合干预。 3. 上尿路内镜碎石术失败或术后即刻出现严重并发症（如大出血、输尿管穿孔）需再次手术。 4. 凝血功能异常（如血小板＜50×10?/L、凝血酶原时间延长＞3 秒）。 5. 对信息化工具（如手机、微信）严重抵触或无法使用。

Exclusion criteria：

1. Complicated with severe underlying diseases such as cardiovascular and cerebrovascular diseases, hepatic and renal failure, and malignant tumors. 2. Suffering from mental illnesses (such as depression, anxiety) or cognitive impairments (such as Alzheimer's disease), and unable to cooperate with interventions. 3. Failure of upper urinary tract endoscopic lithotripsy or occurrence of severe complications immediately after surgery (such as massive hemorrhage, ureteral perforation) requiring reoperation. 4. Abnormal coagulation function (e.g., platelets < 50×10?/L, prothrombin time prolonged > 3 seconds). 5. Severe resistance to or inability to use information tools (such as mobile phones, WeChat).

研究实施时间：

Study execute time：

从 From 2025-08-20 00:00:00至 To 2025-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-20 00:00:00 至 To 2025-12-30 00:00:00

干预措施：

Interventions：

组别：

传统护理组

样本量：

 50

Group：

Traditional Care Group

Sample size：

干预措施：

出院当天发放纸质健康宣教手册（含支架护理、并发症处理、拔管时间），登记患者电话及地址，研究护士记录宣教内容及患者知情确认。术后1周、2周、3周及第4周（如输尿管支架留置时间超过2周时）进行电话随访：询问症状（腰痛、血尿、尿频等）、拔除输尿管支架管准备情况，记录随访时间及内容（形成纸质随访记录单）。

干预措施代码：

 TC - 01

Intervention：

On the day of discharge, a paper - based health education manual (including stent care, complication management, and stent removal time) is distributed. The patient's phone number and address are registered, and the research nurse records the health education content and the patient's informed confirmation. Telephone follow - ups are conducted 1 week, 2 weeks, 3 weeks, and 4 weeks after surgery (if the indwelling time of the ureteral stent exceeds 2 weeks): Inquire about symptoms (low back pain, hematuria, frequent urination, etc.), the preparation status for ureteral stent removal, and record the follow - up time and content (to form a paper - based follow - up record sheet).

Intervention code：

组别：

微信群护理组

样本量：

 50

Group：

WeChat Group Nursing Group

Sample size：

干预措施：

完成传统护理组所有措施，额外由研究护士协助患者加入专属微信群（群成员含泌尿外科主任1名、泌尿外科主治医师及副主任医师各1名、泌尿外科护士长1名，泌尿外科护士1名、护理在读研究生1名）。群内干预：每周在群内转发推送健康教育图文一次（如输尿管支架留置期间饮食、饮水及运动指导、腰痛及血尿等常见支架相关症状的处理措施、按时拔除输尿管支架的重要性及延迟拔管的危害）；医务人员及时回复患者信息以解答疑惑。

干预措施代码：

 WC - 01

Intervention：

All measures of the Traditional Care Group are completed. Additionally, the research nurse assists patients in joining an exclusive WeChat group (group members include 1 director of the Department of Urology, 1 attending physician and 1 associate chief physician of the Department of Urology, 1 head nurse of the Department of Urology, 1 nurse of the Department of Urology, and 1 nursing postgraduate student). Interventions within the group: Health education pictures and texts are forwarded and pushed in the group once a week (such as diet, drinking water and exercise guidance during ureteral stent indwelling, treatment measures for common stent - related symptoms like low back pain and hematuria, the importance of timely ureteral stent removal and the hazards of delayed stent removal); Medical staff reply to patients' messages in a timely manner to answer their doubts.

Intervention code：

组别：

信息化预警系统护理组

样本量：

 50

Group：

Informatization Early - warning System Nursing Group

Sample size：

干预措施：

完成传统护理组所有措施，额外由研究护士协助患者通过微信扫码登录或网页直接登录网址进入信息化预警系统，在护士的指导下录入姓名、住院号、置管时间及数量、预计拔管日期等信息，演示系统功能（查看科普教育、医患健康咨询互动、患患留言互动）。系统自动干预：拔管前5天、1天向患者手机发送短信提醒内容包括饮食饮水运动指导及按时拔管提醒；逾期未拔管时，分别在逾期后1天、4天、7天追加提醒。医护人员每日9:00，12点及16点登录系统查看患者咨询或留言并及时给予患者处理建议。

干预措施代码：

 ICS - 01

Intervention：

All measures of the Traditional Care Group are completed. Additionally, the research nurse assists patients in logging into the informatization early - warning system either by scanning the QR code via WeChat or directly logging in through the web address. Under the nurse's guidance, patients enter information such as name, hospital admission number, catheterization time and quantity, and expected stent removal date, and the system functions (viewing popular science education, doctor - patient health consultation interaction, patient - patient message interaction) are demonstrated. Automatic system intervention: 5 days and 1 day before stent removal, text messages are sent to patients' mobile phones with reminders including diet, drinking water, exercise guidance, and reminders for timely stent removal; When the stent is not removed overdue, additional reminders are sent 1 day, 4 days, and 7 days after the overdue date respectively. Medical staff log in to the system at 9:00, 12:00, and 16:00 every day to check patients' consultations or messages and give patients treatment suggestions in a timely manner.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

 成都市青白江区人民医院 

单位级别：

 三甲 

Institution
hospital：

Chengdu Qingbaijiang District People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

输尿管支架相关症状调查问卷

指标类型：

主要指标

Outcome：

The Ureteral Stent - Related Symptom Questionnaire

Type：

Primary indicator

测量时间点：

术后第二天及返院拔除支架时

测量方法：

Measure time point of outcome：

On the second day after surgery and when returning to the hospital for stent removal

Measure method：

指标中文名：

成年人健康自我管理能力测评量表

指标类型：

次要指标

Outcome：

the rating scale of health self - management skill for adults

Type：

Secondary indicator

测量时间点：

术后第二天及返院拔除支架时

测量方法：

Measure time point of outcome：

On the second day after surgery and when returning to the hospital for stent removal

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self - Rating Anxiety Scale

Type：

Secondary indicator

测量时间点：

术后第二天及返院拔除支架时

测量方法：

Measure time point of outcome：

On the second day after surgery and when returning to the hospital for stent removal

Measure method：

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self - Rating Depression Scale

Type：

Secondary indicator

测量时间点：

术后第二天及返院拔除支架时

测量方法：

Measure time point of outcome：

On the second day after surgery and when returning to the hospital for stent removal

Measure method：

指标中文名：

延续护理满意度

指标类型：

次要指标

Outcome：

Continuous care satisfaction

Type：

Secondary indicator

测量时间点：

返院拔除支架时

测量方法：

Measure time point of outcome：

When returning to the hospital for stent removal

Measure method：

指标中文名：

按时拔除输尿管支架依从性

指标类型：

主要指标

Outcome：

Compliance with timely ureteral stent removal

Type：

Primary indicator

测量时间点：

返院拔除支架时

测量方法：

Measure time point of outcome：

When returning to the hospital for stent removal

Measure method：

指标中文名：

输尿管支架逾期留置时间

指标类型：

主要指标

Outcome：

Overdue indwelling time of ureteral stent

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

发热（体温＞38.5）

指标类型：

副作用指标

Outcome：

Fever (body temperature ≥38.5℃)

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

支架移位

指标类型：

副作用指标

Outcome：

Stent displacement (confirmed by imaging)

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

严重血尿

指标类型：

副作用指标

Outcome：

Severe hematuria (requiring emergency treatment)

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 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）：

随机数字表法

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

Random number table method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

采用单盲法（对数据收集者及统计分析者设盲）：因两组干预方式存在可感知差异，受试者知晓分组；数据收集者（负责记录支架拔除时间、依从性等指标）及统计分析者仅接触带唯一编号的去分组化数据，不知晓具体分组信息，直至数据分析完成后揭盲，以减少偏倚。

Blinding：

Single-blind method (blinding for data collectors and statisticians): Due to perceivable differences in interventions between groups, participants are aware of group allocation; data collectors (recording stent removal time, compliance, etc.) and statisticians only access de-identified data with unique numbers, unaware of specific groups, until unblinding after data analysis to reduce bias.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Clinical Study Data Request 平台：网址为https://www.clinicalstudydatarequest.com/，该平台由临床研究赞助商和资助者组成的联盟支持，致力于通过促进对临床研究患者水平数据的访问来推动科学创新和改善医疗保健。你可在研究结束后将数据上传至此平台，平台会对研究者的申请进行独立审查，在保护患者隐私和机密的前提下，实现数据共享。

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

Clinical Study Data Request platform: The website is https://www.clinicalstudydatarequest.com/. This platform is supported by a coalition of clinical research sponsors and funders, dedicated to advancing scientific innovation and improving healthcare by facilitating access to patient-level data from clinical studies. You can upload the raw data to this platform after the completion of the study. The platform will conduct an independent review of researchers' applications and enable data sharing under the premise of protecting patients' privacy and confidentiality.

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：

病例记录表（CRF）：采用结构化纸质 CRF 或电子 CRF，内容涵盖患者基线信息（年龄、诊断、支架类型等）、干预措施（信息化预警记录、随访方式等）、结局指标（支架留置时间、逾期情况、并发症发生时间及类型、预警系统响应数据等），所有数据由经过培训的研究人员按统一标准填写，确保记录完整、准确。

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

Case Record Form (CRF):Structured paper-based or electronic CRFs will be used, including patient baseline information (age, diagnosis, stent type, etc.), intervention measures (informatization alert records, follow-up methods, etc.), and outcome indicators (stent indwelling time, overdue status, occurrence time and type of complications, alert system response data, etc.). All data will be filled in by trained researchers according to unified standards to ensure completeness and accuracy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-07-21 09:35:31