ChiCTR2500103062 版本V1.0 版本创建时间2025/05/23 10:42:48 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：

ChiCTR2500103062 

最近更新日期：

Date of Last Refreshed on：

2025-05-23 10:42:42 

注册时间：

Date of Registration：

2025-05-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

预康复干预对内镜黏膜下剥离术患者的干预效果

Public title：

Effect of pre-rehabilitation intervention on patients undergoing ESD treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

预康复干预对内镜黏膜下剥离术患者的干预效果

Scientific title：

Effect of pre-rehabilitation intervention on patients undergoing ESD treatment

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：

陆晟迪 

研究负责人：

蒋碧鋆 

Applicant：

Lu Shengdi 

Study leader：

Jiang Biyun 

申请注册联系人电话：

Applicant telephone：

+86 139 1648 2184

研究负责人电话：

Study leader's telephone：

+86 137 6425 3887

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：

lushendi0828@163.com

研究负责人电子邮件：

Study leader's E-mail：

mj_yuan1988@163.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：

上海市宜山路600号

研究负责人通讯地址：

上海市宜山路600号

Applicant address：

600 Yishan Road, Shanghai

Study leader's address：

600 Yishan Road, Shanghai

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：

上海交通大学医学院附属第六人民医院

Applicant's institution：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海交通大学医学院附属第六人民医院

Affiliation of the Leader：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2022-KY-046(K)

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：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2022-03-05 00:00:00

伦理委员会联系人：

曾炳方

Contact Name of the ethic committee：

Zeng Bingfang

伦理委员会联系地址：

上海市宜山路600号

Contact Address of the ethic committee：

600 Yishan Road, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6436 9181

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：

上海交通大学医学院附属第六人民医院

Primary sponsor：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市宜山路600号

Primary sponsor's address：

600 Yishan Road, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属第六人民医院

具体地址：

宜山路600号

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

600 Yishan Road

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Postopertive condition of Endoscopic Submucosal Dissection

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：

探究术前康复干预（prehabilitation）相较于传统健康宣教对内镜黏膜下剥离术（ESD）患者术后恢复的影响  

Objectives of Study：

To explore the effect of prehabilitation compared with traditional health education on postoperative recovery of patients undergoing endoscopic submucosal dissection (ESD)

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

接受ESD的成人患者：年龄≥18岁，计划接受择期内镜黏膜下剥离术（ESD），病变部位位于上消化道或下消化道（例如早期胃癌、结肠息肉、早期结直肠肿瘤或食管病变）。ESD适应证需经内镜或外科团队确认（例如病变大小和组织学类型符合ESD标准，且术前检查未发现病变存在深层浸润或转移迹象）。 术前充足准备时间：患者的手术日期距离入组时至少有4周以上，以确保有充分的时间实施为期4周的术前康复干预。这意味着患者接受的ESD为择期手术，能够安全地等待数周的术前准备。 具备运动能力：患者在基线时功能状态允许进行轻到中等强度的运动训练。这并不意味着患者必须具有良好的运动基础，事实上低于平均体能水平的患者更符合本研究的目标人群，但患者应具备基础的行走能力和进行简单体力活动的能力（即使目前耐力较差）。例如，患者需能够爬上一层楼梯或步行至少一个街区（允许休息后继续），才适合参与本研究。研究将采用简单的功能评估工具（如Duke活动状态指数[DASI]问卷或6分钟步行测试）对患者基线运动能力进行评估，以确保患者能够参加运动训练。 知情同意：患者自愿参加本研究，能够理解研究随机分组的要求并同意接受随机分配结果（术前康复干预或标准护理），并能够配合研究流程，签署书面知情同意书。

Inclusion criteria

Adult patients undergoing ESD: >=18 years of age, scheduled to undergo elective endoscopic submucosal dissection (ESD) for lesions in the upper or lower digestive tract (e.g., early gastric cancer, colon polyps, early colorectal tumors, or esophageal lesions). ESD indications need to be confirmed by the endoscopic or surgical team (for example, the size and histological type of the lesion meet ESD criteria, and preoperative examination does not show signs of deep infiltration or metastasis of the lesion). Adequate pre-operative preparation time: Patients had surgery at least 4 weeks prior to enrollment to ensure sufficient time to implement the 4-week pre-operative rehabilitation intervention. This means that patients receive ESD as elective surgery and can safely wait several weeks for preoperative preparation. Exercise capacity: Patient's functional status at baseline allows for light to moderate intensity exercise training. This does not mean that patients must have a good exercise foundation, in fact, patients with lower than average fitness level are more suitable for the target population of this study, but patients should have basic walking ability and the ability to perform simple physical activities (even if the current endurance is poor). For example, patients were required to be able to climb a flight of stairs or walk at least one block (allowed to continue after rest) in order to participate in the study. A simple functional assessment tool, such as the Duke Activity State Index [DASI] questionnaire or the 6-minute walking test, will be used to assess baseline motor capacity to ensure that patients are able to participate in exercise training. Informed consent: Patients voluntarily participate in the study, are able to understand the study randomization requirements and agree to receive randomized outcomes (preoperative rehabilitation intervention or standard care), and are able to cooperate with the study process and sign a written informed consent.

排除标准：

需急诊或紧急实施ESD者：病情紧急，无法等待4周进行术前康复干预的患者（例如高度怀疑存在快速进展的恶性肿瘤，需要立即手术干预，尽管此类情况在早期病变中较少见）。所有因ESD手术延迟可能造成患者严重健康风险的病例均不予纳入。 严重合并症，不适合运动干预者：存在严重的内科疾病或健康问题，使患者无法安全或有效参与运动训练。例如：不稳定的心血管疾病（如未控制的心绞痛、近期心肌梗死、严重主动脉瓣狭窄）、未控制的充血性心力衰竭、严重的慢性阻塞性肺疾病（COPD）导致运动无法进行，或未控制的高血压。此外，存在严重肌肉骨骼疾病或神经系统疾病导致患者不能行走（如依赖轮椅且无法完成指定训练动作）的患者也不予纳入。如有必要，将对患者进行运动前医学评估以确认安全性。 认知障碍或精神障碍者：患有明显的认知功能障碍、痴呆或严重精神疾病（如未控制的精神病、重度抑郁症影响日常功能）的患者，这些状况会妨碍患者参与结构化的干预方案，或无法可靠地遵循训练指导、填写研究问卷。患者需具备正常交流能力，能够与训练指导人员有效沟通。 目前正在参加结构化的术前康复或运动训练者：已参加其他正式术前康复计划或高强度运动训练计划的患者，或近期刚刚完成类似计划的患者不纳入，以防止研究干预效果的交叉污染。此外，体能特别优秀且已有规律性训练习惯（如竞技运动员）的患者也不予纳入，因为本研究的术前康复干预对这类患者的额外获益可能较小（不过这种情况在常规ESD患者中并不多见）。 存在其他未控制的医学疾病者：患有其他可能显著干扰干预措施或研究结局的未控制疾病的患者，例如活动性感染或发热，或预期寿命小于6个月的终末期疾病患者。接受姑息治疗路径或同期需接受其他重大手术干预（如其他外科手术）的患者，也将排除，以确保评估ESD及术前康复的干预效应不受其他因素干扰。 妊娠患者：由于高强度运动对妊娠可能存在未知风险，且妊娠期间ESD本身即属特殊情形，妊娠患者不予纳入研究。对于具有妊娠可能的女性患者，将在术前例行询问妊娠情况，并可按标准护理流程进行妊娠检测。一般而言，除非绝对必要，妊娠患者通常推迟ESD手术。

Exclusion criteria：

Patients in need of emergency or emergency ESD: patients with an urgent condition who cannot wait 4 weeks for preoperative rehabilitation intervention (for example, the presence of a rapidly progressing malignancy is highly suspected and requires immediate surgical intervention, although this is less common in early stage lesions). All cases in which a delay in ESD surgery could pose a serious health risk to the patient were excluded. Severe comorbidities, not suitable for exercise intervention: There is a serious medical disease or health problem that prevents the patient from safely or effectively participating in exercise training. Examples include unstable cardiovascular disease (such as uncontrolled angina, recent myocardial infarction, severe aortic stenosis), uncontrolled congestive heart failure, severe chronic obstructive pulmonary disease (COPD) that prevents exercise, or uncontrolled high blood pressure. In addition, patients with severe musculoskeletal or neurological conditions that prevent them from walking (such as being wheelchair-dependent and unable to complete specified training movements) are not included. If necessary, the patient will undergo a pre-exercise medical assessment to confirm safety. Cognitive or psychiatric impairment: Patients with significant cognitive impairment, dementia, or serious mental illness (e.g., uncontrolled psychosis, major depressive disorder) that interferes with daily functioning and prevents them from participating in structured intervention programs or from reliably following training instructions or completing research questionnaires. The patient should have normal communication skills and be able to communicate effectively with the trainer. Patients currently participating in structured preoperative rehabilitation or exercise training: Patients who had participated in other formal preoperative rehabilitation programs or high-intensity exercise training programs, or who had recently completed similar programs, were excluded to prevent cross-contamination of the effects of the study intervention. In addition, patients with exceptional physical fitness and regular training habits (such as competitive athletes) were not included, because the additional benefit of preoperative rehabilitation intervention in this study may be small for these patients (although this situation is not common in conventional ESD patients). People with other uncontrolled medical conditions: Patients with other uncontrolled conditions that may significantly interfere with interventions or study outcomes, such as active infections or fever, or patients with end-stage conditions with a life expectancy of less than 6 months. Patients receiving palliative care pathways or requiring other major surgical interventions (such as other surgical procedures) at the same time will also be excluded to ensure that the intervention effects of ESD and preoperative rehabilitation are evaluated without interference from other factors. Pregnant patients: Due to the possible unknown risks of high-intensity exercise to pregnancy, and ESD itself is a special situation during pregnancy, pregnant patients were not included in the study. For women with a possibility of pregnancy, pregnancy will be routinely asked before surgery and pregnancy testing may be performed according to standard care procedures. In general, pregnant patients usually postpone ESD surgery unless absolutely necessary.

研究实施时间：

Study execute time：

从 From 2022-03-05 00:00:00至 To 2024-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-03-08 00:00:00 至 To 2024-01-31 00:00:00  

干预措施：

Interventions：

组别：

术前康复干预组

样本量：

25

Group：

Pre-habilitation Group

Sample size：

干预措施：

被随机分配至术前康复组的患者，将在内镜黏膜下剥离术前接受为期4周的结构化术前康复干预。干预内容涉及多个方面，以全面优化患者在术前的身体和心理状态（术前运动康复，营养干预，心理支持和干预，术前教育）

干预措施代码：

Intervention：

Patients randomly assigned to the preoperative rehabilitation group will receive a structured preoperative rehabilitation intervention for 4 weeks before endoscopic submucosal dissection. The intervention involves multiple aspects to comprehensively optimize the patient's physical and psychological state before surgery (preoperative exercise rehabilitation, nutritional intervention, psychological support and intervention, preoperative education).

Intervention code：

组别：

对照组

样本量：

25

Group：

Control Group

Sample size：

干预措施：

对照组患者将接受本院针对内镜黏膜下剥离术（ESD）患者常规提供的标准术前教育及常规护理措施，具体内容通常包括：术前指导，术后恢复指导，风险预警教育

干预措施代码：

Intervention：

Patients in the control group will receive standard preoperative education and routine nursing measures routinely provided by our hospital for patients with endoscopic submucosal dissection (ESD), which usually includes preoperative guidance, postoperative recovery guidance, and risk warning education

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属第六人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

六分钟步行试验

指标类型：

主要指标

Outcome：

6-minutes walk test

Type：

Primary indicator

测量时间点：

ESD治疗前4周，治疗后当天，治疗后4周，治疗后12周，治疗后24周

测量方法：

患者在平坦地面上尽可能地步行6分钟，并记录所步行的距离

Measure time point of outcome：

Four weeks before ESD treatment, on the same day after treatment, four weeks after treatment, twelve weeks after treatment, and twenty-four weeks after treatment

Measure method：

The patient walked as much as possible on a flat ground for 6 minutes and recorded the distance walked

指标中文名：

术后并发症发生率

指标类型：

次要指标

Outcome：

Number of Complications

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后住院时间

指标类型：

次要指标

Outcome：

Length of Hospital Stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

非计划再入院率

指标类型：

次要指标

Outcome：

Number of Re-hospitalization

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

EuroQol5维量表

指标类型：

次要指标

Outcome：

EuroQol five dimensions questionnaire, EQ-5D-5L

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital axiety and depression score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

干预成本

指标类型：

次要指标

Outcome：

cost of intervention

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

 其它  

说明

Fate of sample：

0thers  

Note：

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 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）：

在SAS/STAT 9.3 (SAS Institute, Cary, North Carolina)中使用SAS Proc Plan创建计算机生成的随机列表。统计学家准备了这份清单，并将其放在一系列密封的信封中分发给每个站点的临床协调员。随后，研究协调员在患者在场的情况下进行随机分组。

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

A computer-generated randomization list was created using SAS Proc Plan in SAS/STAT 9.3 (SAS Institute, Cary, North Carolina). The statistician prepared this list and distributed it to each site's clinical coordinator in a series of sealed envelopes. Subsequently, the study coordinator conducted the randomization in the presence of the patient.

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：

负责分析数据的个人也将对分组分配进行盲法。数据将在分析前匿名化，以确保在统计评估过程中不泄露治疗分配。

Blinding：

The individuals responsible for analyzing the data will be blinded to the group allocation as well. Data will be anonymized prior to analysis, ensuring that the treatment allocation is not revealed during the statistical evaluation.

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

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）：

研究主要论文发表一年后以授权访问形式共享原始数据库http://www.medresman.org.cn/login.aspx

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

Share the original database with authorized access one year after publication of the main research paper

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：

数据采集和管理由病例记录表（Case Record Form, CRF）和电子数据采集和管理系统（Electronic Data Capture, EDC）两部分共同实施。研究者在患者访视时根据研究方案规范填写纸质CRF，内容包括人口学信息、基线特征、治疗方案、随访评估指标以及不良事件等各项数据。完成填写后，研究人员在规定的时限内，将纸质CRF中的信息准确录入至EDC系统。数据录入完成后，质控人员通过EDC系统内置的逻辑检查、范围核查、数据一致性比对等功能，及时发现问题并进行数据质疑，研究人员核实后予以修正和确认。所有数据均通过定期备份确保安全存储，且严格限制访问权限。整个过程中，由专人负责数据备份和管理，确保数据的安全性、完整性和可追溯性。

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

Data collection and management are implemented by the Case Record Form (CRF) and the Electronic Data Capture and Management System (EDC). At the time of patient visit, researchers filled in paper CRF according to the study protocol specification, including demographic information, baseline characteristics, treatment regimen, follow-up evaluation indicators, adverse events and other data. After completing the filling, the researchers accurately input the information in the paper CRF into the EDC system within the prescribed time limit. After the data entry is completed, the quality control personnel will find the problem in time and question the data through the built-in functions of the EDC system such as logic check, scope check and data consistency comparison, and the researchers will correct and confirm it after verification. All data is stored securely with regular backups, and access is strictly restricted. During the whole process, a dedicated person is responsible for data backup and management to ensure data security, integrity and traceability.

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：

  2025-05-23 10:42:42