ChiCTR2500109629 版本V1.1 版本创建时间2025/09/27 18:55:19 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：

 ChiCTR2500109629 

最近更新日期：

Date of Last Refreshed on：

 2025-09-23 11:35:33 

注册时间：

Date of Registration：

 2025-09-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

肝脏切除术后早期下床活动安全评估指标的临床应用研究

Public title：

Clinical Application Research on Safety Evaluation Indicators for Early Ambulation after Hepatectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肝脏切除术后早期下床活动安全评估指标的临床应用研究

Scientific title：

Clinical Application Research on Safety Evaluation Indicators for Early Ambulation after Hepatectomy

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：

范明嫄 

研究负责人：

马洁 

Applicant：

Fan Mingyuan 

Study leader：

Ma Jie 

申请注册联系人电话：

Applicant telephone：

 +86 132 2491 4790

研究负责人电话：

Study leader's
telephone：

+86 158 9708 2597

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：

 f13224914790@163.com

研究负责人电子邮件：

Study leader's E-mail：

 f13224914790@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 青海大学

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：

青海省西宁市城西区同仁路29号

研究负责人通讯地址：

青海省西宁市城西区同仁路29号

Applicant address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

Study leader's address：

My name is Ma Jie. [Name: Ma Jie] As the principal investigator of the clinical trial titled "Clinical Study on the Safety Assessment of Early Out-of-Bed Activity in Patients after Liver Resection", I hereby declare: We abide by the Helsinki Declaration, Chinese GCP and relevant laws/guidelines. This trial protocol has been approved by the Ethics Committee of Qinghai University Affiliated Hospital (EC Approval Number: [SL-202420]; Date: [2024/02/20]). Any modification to the protocol without EC approval is prohibited. All registration information (trial design, intervention measures, outcome indicators, etc.) is true, accurate and complete. We will promptly update the trial progress, protocol modifications and results on the registration platform. The rights and safety of the subjects are the top priority. We will conduct standardized informed consent, monitor safety, and report serious adverse events (SAEs) as required. The trial will follow the approved protocol and GCP; the original data will be updated promptly, traceable and verified. We will cooperate with monitoring/inspection. We promise to complete the trial as planned and submit the final results (including negative/uncertain results) to the platform as required.

申请注册联系人邮政编码：

Applicant postcode：

 810000

研究负责人邮政编码：

Study leader's postcode：

 810000

申请人所在单位：

青海大学研究生院

Applicant's institution：

Graduate School of Qinghai University

研究负责人所在单位：

青海大学附属医院

Affiliation of the Leader：

Qinghai University Affiliated 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：

 SL-202420

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：

青海大学附属医院科研伦理委员会

Name of the ethic committee：

The Research Ethics Committee of Qinghai University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-24 00:00:00

伦理委员会联系人：

赵延礼

Contact Name of the ethic committee：

Zhao Yanli

伦理委员会联系地址：

青海省西宁市城西区同仁路29号

Contact Address of the ethic committee：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 971 616 2033

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：

青海大学附属医院

Primary sponsor：

Qinghai University Affiliated Hospital

研究实施负责（组长）单位地址：

青海省西宁市城西区同仁路29号

Primary sponsor's address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai 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)：

青海省

市(区县)：

西宁市

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

青海大学附属医院

具体地址：

青海省西宁市城西区同仁路29号

Institution
hospital：

Qinghai University Affiliated Hospital

Address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

经费或物资来源：

青海大学附属医院

Source(s) of funding：

Qinghai university affiliated hospital

研究疾病：

肝癌、肝包虫、肝血管瘤等肝切除  

Target disease：

hepatectomy

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

建立一套科学、准确的肝脏切除术后患者早期下床活动的安全评估指标，并进一步探索其在临床应用中的效果。将为改善患者术后康复质量和降低并发症风险提供有效的科学依据，并为临床医生提供指导和决策的参考。  

Objectives of Study：

Promote early ambulation for patients undergoing liver resection to accelerate the recovery process, shorten the hospital stay, and reduce hospital costs.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

主要包括开腹及腹腔镜下肝部分切除术、肝段切除术、肝叶切除术、半肝切除术的患者。

Inclusion criteria

The patients mainly include those who have undergone open and laparoscopic partial liver resection, segmental liver resection, hepatic lobe resection, and hemi-liver resection.

排除标准：

存在相关骨关节等疾病影响正常活动者；脑部疾患或精神障碍无法配合者；既往有活动性出血病史或凝血功能障碍者；病人及家属拒绝参加本次研究。

Exclusion criteria：

There are those with related bone and joint diseases that affect normal activities; those with brain disorders or mental impairments who cannot cooperate; those with a previous history of active bleeding or with coagulation disorders; and patients and their families who refuse to participate in this study.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-04 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 70

Group：

control group

Sample size：

干预措施：

采用常规护理措施，收集术后患者现状病案及临床资料

干预措施代码：

Intervention：

Adopt conventional nursing measures and collect the current medical records and clinical data of postoperative patients.

Intervention code：

组别：

干预组

样本量：

 80

Group：

Intervention group

Sample size：

干预措施：

用项目第一部分构建肝脏切除术后患者早期下床活动的安全评估指标（终稿）的体系去评估患者，根据指标的分级，对患者进行相应的评估和健康教育，指导患者早期下床活动。

干预措施代码：

Intervention：

Using the safety assessment index system for early ambulation of patients after liver resection constructed in the first part of the project (final version) to evaluate patients, and based on the grading of the indicators, conduct corresponding assessments and health education for patients, guiding them to engage in early ambul

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 青海省 

市(区县)：

 西宁市 

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

 青海大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Qinghai University Affiliated Hospital

Level of the institution：

university

测量指标：

Outcomes：

指标中文名：

术后首次下床活动的时间

指标类型：

主要指标

Outcome：

The time of the first postoperative ambulation, the distance of the first postoperative ambulation, the time of the first defecation, the time of the first defecation, the time of the first eating, the length of hospital stay, and the hospitalization cost.

Type：

Primary indicator

测量时间点：

患者首次下床活动至活动家属返回病床休息

测量方法：

用计时器记录时间

Measure time point of outcome：

The fifth day after the operation

Measure method：

The distance of getting out of bed and moving around is measured using a tape measure.

指标中文名：

术后首次下床活动的距离

指标类型：

主要指标

Outcome：

The distance of the first time getting out of bed after the surgery

Type：

Primary indicator

测量时间点：

以患者完成术后首次下床活动、返回病床或指定休息位置的时刻为测量时间点，精确记录至年、月、日、时，若活动中因不适（如头晕、乏力）中断，以患者停止活动并返回休息位置的时刻作为测量时间点，同时标注中断原因（如 2025-05-15 10:05，因患者诉头晕停止活动返回卧床）。记录时需同步关联 “活动起止时长”，即从患者起身下床到返回休息位置的总时长，辅助判断活动耐受度。

测量方法：

下床活动的距离用卷尺测量

Measure time point of outcome：

The measurement time point is set as the moment when the patient completes the first postoperative ambulation, returns to the bed or the designated rest position. The time should be accurately recorded down to year, month, day and hour. If the activity is interrupted due to discomfort (such as dizziness, fatigue), the moment when the patient stops the activity and returns to the rest position is taken as the measurement time point, and the reason for the interruption (such as 2025-05-15 10:05, d

Measure method：

Measure the distance for getting out of bed and moving around with a tape measure.

指标中文名：

术后首次进食时间

指标类型：

次要指标

Outcome：

The time of the first meal after surgery

Type：

Secondary indicator

测量时间点：

以患者开始摄入医生允许的第一口食物（如流质、半流质）的时刻为准，直接记录该时间点（精确到分钟）

测量方法：

无需额外测量工具，仅需观察并确认患者开始进食的时间

Measure time point of outcome：

Start timing from the moment when the patient begins to consume the first permitted food (such as liquid or semi-liquid) by the doctor, and directly record this time point (accurate to the minute)

Measure method：

No additional measuring tools are needed. All that is required is to observe and confirm the time when the patient starts to eat.

指标中文名：

术后首次排气时间

指标类型：

次要指标

Outcome：

The time of the first postoperative defecation

Type：

Secondary indicator

测量时间点：

以患者主动告知有气体从肛门排出，或医护人员通过听诊、观察患者表情及反馈确认排气的时刻为准，记录该时间点（精确到分钟）

测量方法：

无特殊测量方法，主要依赖患者主观感受与医护人员判断。

Measure time point of outcome：

Record the time (accurate to the minute) when the patient voluntarily informs that gas is being expelled from the anus, or when the medical staff confirm the expulsion through auscultation, observation of the patient's expression and feedback.

Measure method：

There is no specific measurement method. It mainly relies on the subjective feelings of the patients and the judgment of medical staff.

指标中文名：

术后首次排便时间

指标类型：

次要指标

Outcome：

The time of the first bowel movement after the surgery

Type：

Secondary indicator

测量时间点：

以患者完成第一次自主排便（无论排便量多少），且医护人员或家属确认粪便已排出体外的时刻为准，记录该时间点（精确到分钟）

测量方法：

测量方法为观察排便行为完成情况

Measure time point of outcome：

Start timing from the moment when the patient successfully achieves the first spontaneous defecation (regardless of the amount of stool), and the medical staff or family members confirm that the stool has been expelled from the body. Record this time point (accurate to the minute)

Measure method：

The measurement method is to observe the completion of defecation behavior.

指标中文名：

住院时间

指标类型：

次要指标

Outcome：

hospital stays

Type：

Secondary indicator

测量时间点：

从患者入院至出院的时间

测量方法：

His系统查询

Measure time point of outcome：

The period from the patient's admission to discharge

Measure method：

His system query

指标中文名：

住院费用

指标类型：

次要指标

Outcome：

hospitalization expenses

Type：

Secondary indicator

测量时间点：

患者住院期间的所有费用

测量方法：

His系统查询

Measure time point of outcome：

All the expenses incurred by the patient during the hospitalization period

Measure method：

His system query

指标中文名：

并发症发生率

指标类型：

次要指标

Outcome：

Complication occurrence rate

Type：

Secondary indicator

测量时间点：

以患者肝切除手术结束、返回病房开始计时，至术后 30 天（临床公认主要并发症高发期）为核心观测周期，重点记录并发症首次出现的具体时间（精确到日 / 时）

测量方法：

通过医护联合评估实现 —— 每日监测生命体征（体温、血压等）、肝功能（转氨酶、胆红素等）、血常规（白细胞、血红蛋白等），结合影像学检查（超声、CT），并记录患者症状（腹痛、黄疸、出血等），对照肝切除术后常见并发症（如出血、感染、胆瘘、肝功能衰竭等）诊断标准，确认并发症是否发生及类型，同步记录于病历系统。

Measure time point of outcome：

Starting from the moment the patient's liver resection surgery was completed and they returned to the hospital, the core observation period was set from this point until 30 days after the surgery (the period during which major complications are most likely to occur). The specific time (accurate to the day / hour) when the first occurrence of complications was recorded was given as the main focus.

Measure method：

Achieved through joint assessment by medical staff - daily monitoring of vital signs (body temperature, blood pressure, etc.), liver function (transaminase, bilirubin, etc.), blood routine (white blood cells, hemoglobin, etc.), combined with imaging examinations (ultrasound, CT), and recording of patient symptoms (abdominal pain, jaundice, bleeding, etc.), in accordance with the diagnostic criteria for common complications after liver resection (such as bleeding, infection, bile fistula, liver f

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

None

Sample Name：

None

Tissue：

None

人体标本去向

 使用后销毁  

说明

None

Fate of sample：

Destruction after use  

Note：

None

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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：

Blinding：

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）：

2025年12月、采用公共数据库Dryad、Figshare

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

It is planned to upload the de-identified IPD (including metadata) to the public database Dryad (website: https://datadryad.org/) and Figshare (https://figshare.com/) in December 2025. The data will be made available for open access in accordance with the platform's data usage agreement. Researchers can download and analyze the data after registration and agreement with the protocol.

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：

采用结构化病例记录表（CRF），涵盖人口学、基线信息、治疗过程、结局指标等模块；没有EDC系统，采用的纸质+Excel，“以纸质病例记录表（CRF）采集数据，双人核对无误，后续录入Excel表格管理，定期备份归档”。

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

The data are recorded in a standardized format according to the general reporting guidelines. Data are collected using paper case record forms (CRF), covering information such as demographics, baseline, and treatment process. They are then entered into an Excel table for management and regularly backed up for archiving. No professional electronic data collection (EDC) system was used; data quality was ensured through manual verification.

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：

  2025-09-23 11:35:23