ChiCTR2600124953 版本V1.0 版本创建时间2026/05/19 16:56:09 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：

 ChiCTR2600124953 

最近更新日期：

Date of Last Refreshed on：

 2026-05-19 16:56:02 

注册时间：

Date of Registration：

 2026-05-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于肠道准备失败预测模型构建全麻结肠镜检查风险分层个性化肠道准备方案及有效性评价

Public title：

Construction of a Risk-Stratified Personalized Bowel Preparation Regimen for Colonoscopy Under General Anesthesia Based on a Predictive Model for Bowel Preparation Failure and Evaluation of Its Effectiveness

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于肠道准备失败预测模型构建全麻结肠镜检查风险分层个性化肠道准备方案及有效性评价

Scientific title：

Construction of a Risk-Stratified Personalized Bowel Preparation Regimen for Colonoscopy Under General Anesthesia Based on a Predictive Model for Bowel Preparation Failure and Evaluation of Its Effectiveness

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：

郭晶晶 

研究负责人：

郭晶晶 

Applicant：

Guo Jingjing 

Study leader：

Guo Jingjing 

申请注册联系人电话：

Applicant telephone：

 +86 20 3915 1810

研究负责人电话：

Study leader's
telephone：

+86 20 3915 1810

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：

 421432199@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 421432199@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：

中国广东省广州市番禺区兴南大道521号

研究负责人通讯地址：

中国广东省广州市番禺区兴南大道521号

Applicant address：

521 Xingnan Avenue, Panyu District, Guangzhou, Guangdong, China

Study leader's address：

521 Xingnan Avenue, Panyu District, Guangzhou, Guangdong, China

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：

广东省妇幼保健院

Applicant's institution：

Guangdong Women and Children Hospital

研究负责人所在单位：

广东省妇幼保健院

Affiliation of the Leader：

Guangdong Women and Children 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：

 广东省妇幼保健院医伦第[20250098]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：

广东省妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Guangdong Women and Children Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-18 00:00:00

伦理委员会联系人：

尹爱华

Contact Name of the ethic committee：

Yin Aihua

伦理委员会联系地址：

中国广东省广州市番禺区兴南大道521号

Contact Address of the ethic committee：

521 Xingnan Avenue, Panyu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3915 1602

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gdsfyec@163.com

研究实施负责（组长）单位：

广东省妇幼保健院

Primary sponsor：

Guangdong Women and Children Hospital

研究实施负责（组长）单位地址：

中国广东省广州市番禺区兴南大道521号

Primary sponsor's address：

521 Xingnan Avenue, Panyu District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东省妇幼保健院

具体地址：

中国广东省广州市番禺区兴南大道521号

Institution
hospital：

Guangdong Women and Children Hospital

Address：

521 Xingnan Avenue, Panyu District, Guangzhou, Guangdong, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

消化系统疾病  

Target disease：

Gastrointestinal diseases

研究疾病代码：

H0323

Target disease code：

H0323

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：

随机平行对照 

Study design：

Parallel 

研究目的：

旨在评估与标准方案相比，基于预测模型引导的个性化干预模式能否提高高危受检者的结肠镜检查质量。  

Objectives of Study：

The aim is to assess whether a personalized intervention model guided by predictive models can improve the quality of colonoscopy in high-risk subjects compared with the standard protocol.

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. 有结肠镜检查适应证，无禁忌证； 2. 年龄18~65岁； 3. 经本研究预测模型风险分层评估＞0.5的高风险人群； 4. 能够熟练使用微信并配合反馈； 5. 自愿参与本研究并签署知情同意书。

Inclusion criteria

1. Have indications for colonoscopy and no contraindications; 2. Aged 18–65 years; 3. Classified as high-risk population with a risk stratification assessment score >0.5 by the predictive model of this study; 4. Proficient in using WeChat and able to provide feedback accordingly; 5. Voluntarily participate in this study and sign the informed consent form.

排除标准：

1. 妊娠期或哺乳期女性； 2. 肠道清洁剂或麻醉药物过敏者； 3. 近期（3个月内）接受过腹部手术或肠道放射治疗； 4. 既往结直肠切除术史（阑尾、痔疮除外）； 5. 存在消化道梗阻、穿孔或出血或患有消化系统肿瘤、炎症性肠病； 6. 合并严重肝、肾、心功能不全，或活动性恶性肿瘤，或严重血液系统疾病者； 7. 存在严重认知障碍、精神疾患或语言沟通困难，无法配合评估者； 8. 吞咽反射减弱； 9. 关键临床资料缺失，影响风险分层评估者； 10. 既往有服用过泻药，进行过肠道准备； 11. 难以控制的高血压（收缩压＞170 mmHg；舒张压＞100 mmHg）； 12. 低血糖（血糖值＜3.9 mmol/L）或高血糖（血糖值大于13.9 mmol/L）； 13. 电解质紊乱或者脱水者； 14. 处于月经期女性； 15. 拒绝参与本研究。

Exclusion criteria：

1. Pregnant or breastfeeding women; 2. Those allergic to bowel cleansing agents or anesthetic drugs; 3. Those who have undergone abdominal surgery or abdominal radiotherapy within the past 3 months; 4. History of colorectal resection (excluding appendix or hemorrhoid surgery); 5. Presence of gastrointestinal obstruction, perforation, or bleeding, or diagnosis of digestive system tumors or inflammatory bowel disease; 6. Those with severe liver, kidney, or cardiac dysfunction, active malignant tumors, or severe hematological disorders; 7. Those with severe cognitive impairment, mental illness, or language communication difficulties that prevent compliance with assessment; 8. Diminished swallowing reflex; 9. Missing key clinical data that may affect risk stratification assessment; 10. Previous use of laxatives for bowel preparation; 11. Uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg); 12. Hypoglycemia (blood glucose <3.9 mmol/L) or hyperglycemia (blood glucose >13.9 mmol/L); 13. Electrolyte imbalance or dehydration; 14. Women who are menstruating; 15. Those who refuse to participate in this study.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 66

Group：

Control group

Sample size：

干预措施：

接受标准化纸质与视频宣教及统一3L复方聚乙二醇电解质散分次服用方案。在此基础上，于预约后24小时、检查前一天中午及检查当天早晨分别接收三次预设的统一推送提醒（短信或微信）；于检查前一天晚间接受一次结构化电话随访，护士仅按标准答案回答患者提问，不给予个体化指导，不要求上传任何照片或运动记录，不启动动态补救。

干预措施代码：

Intervention：

All patients received standardized paper and video education and a unified 3L compound polyethylene glycol electrolyte powder in divided doses. On this basis, they received three preset unified push reminders (SMS or wechat) 24 hours after the appointment, at noon on the day before the examination, and on the morning of the examination. During a structured telephone call, which took place the evening before the test, nurses responded to patients' questions with standard answers and did not provide individualized instructions, require uploads of any photographs or exercise recordings, or initiate dynamic remediation.

Intervention code：

组别：

干预组

样本量：

 66

Group：

Intervention group

Sample size：

干预措施：

在对照组相同基础方案上，实施基于微信平台的护士主导动态闭环精准导航护理模式。患者预约后24小时内由责任护士建立专属微信群（患者+家属），患者确认掌握宣教内容后进入动态管理。护士鼓励但不强制患者上传低渣饮食照片（无时间水印要求）；患者以文字或步数截图报告运动（≥6900步，不要求视频），通过Bristol粪便性状图示自评或自愿上传排便照片报告排便性状（取消强制水印，仅第二次服药后末次排便为关键上传节点，无法拍照者可用语音替代）。护士根据患者信息进行分级响应：Bristol 6~7型表扬鼓励；3~5型推送标准化建议（如增加温水、腹部按摩）；1~2型或严重不适者15分钟内启动语音/视频紧急干预，评估是否追加饮水、开塞露塞肛或联系医生推迟检查。所有评估与干预记录均录入动态日志。检查前2小时若排便仍未达清亮标准，启动紧急补救（开塞露、追加饮水等），患者仍按计划行结肠镜检查，数据纳入意向性分析。

干预措施代码：

Intervention：

On the same basis of the control group, the nurse-led dynamic closed-loop precise navigation nursing model based on wechat platform was implemented. An exclusive wechat group (patients + family members) was established by the responsible nurses within 24 hours after the patient's appointment, and the patients entered the dynamic management after confirming that they had mastered the education content. Patients were encouraged but not required to upload photos of low-residue diet (no time watermark required). Patients reported their bowel movements using text or screenshots of their steps (≥6900 steps, no video required), and reported their bowel movements through self-evaluation of Bristol stool Form chart or voluntary upload of photos of bowel movements (the mandatory watermark was removed, and only the last bowel movement after the second dose was used as the key upload node, and voice could be used to replace those who could not take photos). Nurses graded response according to patients' information: Bristol 6-7 type praise and encouragement; Type 3 to 5 push standardized recommendations (such as adding warm water and abdominal massage); For patients with type 1-2 or severe discomfort, voice/video emergency intervention was initiated within 15 minutes to evaluate whether to add water, open the anal dew, or contact the doctor to postpone the examination. All assessment and intervention records were entered into a dynamic diary. If bowel movements did not reach the clear standard 2 hours before the examination, emergency remedial measures (enema, additional water, etc.) were initiated, and the patients still underwent colonoscopy as planned. The data were included in the intention-to-treat analysis.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广东省妇幼保健院 

单位级别：

 三级甲等 

Institution
hospital：

Guangdong Women and Children Hospital

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

肠道准备合格率

指标类型：

主要指标

Outcome：

Bowel preparation adequacy rate

Type：

Primary indicator

测量时间点：

结肠镜检查时

测量方法：

波士顿肠道准备量表（BBPS）

Measure time point of outcome：

During colonoscopy

Measure method：

Boston Bowel Preparation Scale (BBPS)

指标中文名：

波士顿肠道准备量表（BBPS）各段及总的评分

指标类型：

主要指标

Outcome：

Boston Bowel Preparation Scale (BBPS) scores by segment and total score

Type：

Primary indicator

测量时间点：

结肠镜检查时

测量方法：

波士顿肠道准备量表（BBPS）

Measure time point of outcome：

During colonoscopy

Measure method：

Boston Bowel Preparation Scale (BBPS)

指标中文名：

结肠镜检查时间

指标类型：

次要指标

Outcome：

Colonoscopy procedure time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腺瘤检出率

指标类型：

次要指标

Outcome：

Adenoma detection rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病人的依从性

指标类型：

次要指标

Outcome：

Patient adherence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病人的耐受性

指标类型：

次要指标

Outcome：

Patient tolerability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病人的可接受性

指标类型：

次要指标

Outcome：

Patient acceptability

Type：

Secondary indicator

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

 使用后销毁  

说明

Fate of sample：

Destruction 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 65 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）：

使用 IBM SPSS Statistics 26.0 软件（IBM公司，美国）生成分组，设定固定值2000000，利用函数组将1-108生成新的随机数，再进行可视化分箱按照1:1生成两组，组别数字1代表干预组，2代表对照组。

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

BM SPSS Statistics 26.0 software (IBM Corporation, USA) was used to generate groups, set a fixed value of 2000000, use the function group to generate a new random number from 1-108, and then visual bins were divided into two groups according to 1:1. The number 1 of the group represents the intervention group, and the number 2 represents the control group.

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：

在研究过程中，所有负责执行结肠镜检查及进行初步镜下评估的内镜医师、内镜护士及进行数据录入者在检查完成前后不清楚患者的分组。同时，不允许受试患者向上述结肠镜检查医师、 护士及研究者透露与其所接受肠道准备方案相关的任何内容。

Blinding：

All the endoscopists who performed colonoscopies and initial endoscopic assessments, the endoscopy nurses, and the data entry personnel were unaware of the group assignments before and after the procedures were completed. Participants were not allowed to disclose anything about their bowel preparation protocol to the colonoscopists, nurses, and investigators.

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

否No

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）：

无

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

None

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：

在预约结肠镜检查当天，一名经过培训的研究人员收集了参与者的人口统计学资料，如年龄、性别、体重、学历、手术史、基础疾病史、腹部和/或盆腔手术史、预测模型评分等，检查当天收集肠道准备相关变量（如 PEG的实际服用量、行走步数、末次大便排泄颜色、末次服药到结肠镜检查的时间间隔、服药期间/结肠镜检查期间的不良反应和满意度等）。末次大便排泄物颜色由研究人员使用患者提供的照片进行评估，从无色透明到深褐色的等级来描述。肠道准备评分由内镜中心结肠镜检查例数大于1000例的内镜医师进行肠道Boston大便评分，如对结果有异议，有两名有经验检查医生共同讨论，达成一致意见。研究者在检查结束后录入BBPS 评分。需要患者填写问卷所需时间不超过15min，结果均记录在预先建立的数据库中。

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

On the day of the colonoscopy appointment, a trained research staff member collected demographic data such as age, sex, weight, education, history of surgery, history of underlying medical conditions, history of abdominal and/or pelvic surgery, score of the prediction model, etc. On the day of examination, the variables related to bowel preparation (such as actual dose of PEG, number of steps taken, color of the last stool, interval between the last dose and colonoscopy, adverse reactions during medication/colonoscopy, and satisfaction, etc.) were collected. The final stool excreta color was assessed by the researcher using photographs provided by the patient and described on a scale from colorless transparent to dark brown. The Boston stool score was scored by the endoscopists who had performed more than 1000 cases of colonoscopy in the endoscopy center. If there was any disagreement with the results, two experienced endoscopists discussed and reached a consensus. Investigators entered BBPS scores at the end of the examination. It took no more than 15 minutes for patients to fill out the questionnaire, and the results were recorded in a pre-established database.

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：

  2026-05-19 16:56:02