基于转录组测序探讨五达颗粒治疗结直肠癌患者术后肠麻痹的潜在干预机制

注册号:

Registration number:

ITMCTR2025000265

最近更新日期:

Date of Last Refreshed on:

2025-02-14

注册时间:

Date of Registration:

2025-02-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于转录组测序探讨五达颗粒治疗结直肠癌患者术后肠麻痹的潜在干预机制

Public title:

Exploring the Potential Mechanisms of Wuda Granules in Treating Postoperative Ileus in Patients with Colorectal Cancer Based on Transcriptome Sequencing

注册题目简写:

基于转录组测序探讨五达颗粒治疗结直肠癌患者术后肠麻痹的潜在干预机制

English Acronym:

Exploring the Potential Mechanisms of Wuda Granules in Treating Postoperative Ileus in Patients with Colorectal Cancer Based on Transcriptome Sequencing

研究课题的正式科学名称:

基于转录组测序探讨五达颗粒治疗结直肠癌患者术后肠麻痹的潜在干预机制

Scientific title:

Exploring the Potential Mechanisms of Wuda Granules in Treating Postoperative Ileus in Patients with Colorectal Cancer Based on Transcriptome Sequencing

研究课题的正式科学名称简写:

基于转录组测序探讨五达颗粒治疗结直肠癌患者术后肠麻痹的潜在干预机制

Scientific title acronym:

Exploring the Potential Mechanisms of Wuda Granules in Treating Postoperative Ileus in Patients with Colorectal Cancer Based on Transcriptome Sequencing

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:

李星

研究负责人:

蒋志

Applicant:

lixing

Study leader:

jiangzhi

申请注册联系人电话:

Applicant telephone:

17708347911

研究负责人电话:

Study leader's telephone:

15011937399

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:

lixing428x@163.com

研究负责人电子邮件:

Study leader's E-mail:

2000jiangzhi@163.com

申请单位网址(自愿提供):

Study leader's 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:

广东省广州市番禺区小谷围街道大学城内环西路92号广东省中医药科学院

研究负责人通讯地址:

广东省广州市番禺区小谷围街道大学城内环西路92号广东省中医药科学院

Applicant address:

Guangdong Provincial Academy of Traditional Chinese Medicine No. 92 Inner Ring West Road University Town Xiaoguwei Street Panyu District Guangzhou City Guangdong Province

Study leader's address:

Guangdong Provincial Academy of Traditional Chinese Medicine No. 92 Inner Ring West Road University Town Xiaoguwei Street Panyu District Guangzhou City Guangdong 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:

广东省中医院

Applicant's institution:

Guangdong Provincial Hospital of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

广东省中医院伦理委员会YF-2024-390-01-

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/12/9 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

lixiaoyan

伦理委员会联系地址:

广东省中医院大德路总院

Contact Address of the ethic committee:

Guangdong Provincial Hospital of Traditional Chinese Medicine Dadelong Main Campus

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-88187233转35943

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@gzucm.edu.cn

研究实施负责(组长)单位:

广东省中医院

Primary sponsor:

Guangdong Provincial Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市番禺区小谷围街道大学城内环西路92号广东省中医药科学院

Primary sponsor's address:

Guangdong Provincial Academy of Traditional Chinese Medicine No. 92 Inner Ring West Road University Town Xiaoguwei Street Panyu District Guangzhou City Guangdong 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市番禺区小谷围街道大学城内环西路92号广东省中医药科学院

Institution
hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine

Address:

Guangdong Provincial Academy of Traditional Chinese Medicine No. 92 Inner Ring West Road University Town Xiaoguwei Street Panyu District Guangzhou City Guangdong Province

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

术后肠麻痹

研究疾病代码:

Target disease:

Postoperative Ileus

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

(1)通过转录组测序分析患者服用五达颗粒前后的肠道样本,观察肠道基因表达的变化,从而揭示五达颗粒对肠道功能的调节作用; (2)识别五达颗粒作用的分子靶点:分析服用五达颗粒后,哪些基因的表达发生了显著变化,以及这些基因如何与肠麻痹的病理机制相关联; (3) 通过对五达颗粒作用机制的研究,为中医药在结直肠癌术后肠麻痹治疗中的应用提供分子层面的证据; (4)通过对转录组数据的深入分析,可能会发现不同的患者对五达颗粒的反应存在差异,从而为个体化治疗策略提供参考。

Objectives of Study:

(1) By analyzing the intestinal samples of patients before and after taking Wuda Granules through transcriptome sequencing observe the changes in intestinal gene expression to reveal the regulatory effects of Wuda Granules on intestinal function; (2) Identify the molecular targets of Wuda Granules: Analyze which genes show significant changes in expression after taking Wuda Granules and how these genes are associated with the pathophysiological mechanisms of postoperative ileus; (3) Study the mechanism of action of Wuda Granules to provide molecular evidence for the application of traditional Chinese medicine in the treatment of postoperative ileus in colorectal cancer; (4) Through in-depth analysis of transcriptome data it may be possible to discover differences in the response of different patients to Wuda Granules thus providing a reference for personalized treatment strategies.

药物成份或治疗方案详述:

①基础治疗:包括抗生素治疗、补液支持治疗等,及术后快速康复护理管理。 1)抗生素:依据国家卫健委公布的《抗生素应用指导原则》,规范使用抗生素。 2)补液:维持体内水、电解质与酸碱平衡以及营养支持。按照快速康复原则控制输液。 3)若出现术后肠麻痹,则给予结直肠癌手术后患者肠麻痹的常规治疗,如静脉补液和电解质补充治疗、胃肠道减压、限制饮食、中医药治疗包括封包热敷、穴位贴敷、针灸、益气通腑中药等。 4)镇痛药使用时间不超过48小时。 5)术后72小时内不使用灌肠治疗。 6)其他护理管理措施。 ②五达颗粒治疗。 五达颗粒由于广东省中医院制剂室提供,术前2天开始服用,服用时间为早上9:00、下午4:00服用,每包温开水100ml冲服,每次1包,每日2包,至术后首次排便或出院。

Description for medicine or protocol of treatment in detail:

Basic treatment: Including antibiotic therapy fluid support therapy etc. and postoperative rapid recovery nursing management. Antibiotics: Antibiotics are used in accordance with the "Guiding Principles for the Clinical Application of Antibiotics" published by the National Health Commission ensuring standardized use. Fluid replenishment: Maintaining the balance of water electrolytes and acid-base within the body as well as providing nutritional support. Fluid administration is controlled according to the principles of rapid recovery. In case of postoperative ileus routine treatment for ileus after colorectal cancer surgery is provided including intravenous fluid and electrolyte supplementation gastrointestinal decompression dietary restriction and traditional Chinese medicine treatments such as fomentation acupoint application acupuncture and Qi-tonifying and bowel-regulating herbal medicine. The use of analgesics does not exceed 48 hours. Enema treatment is not used within 72 hours after surgery. Other nursing management measures. Wuda Granules treatment. Wuda Granules are provided by the Preparation Room of Guangdong Provincial Hospital of Traditional Chinese Medicine. They are taken starting 2 days before surgery at 9:00 AM and 4:00 PM with each packet dissolved in 100ml of warm boiled water one packet per time twice daily until the first bowel movement after surgery or discharge.

纳入标准:

1)择期行腹腔镜辅助下肠切除术患者; 2)年龄:18岁≤年龄≤80岁; 3)性别:性别不限,男女均可; 4)签署知情同意者。

Inclusion criteria

1)Patients undergoing elective laparoscopic-assisted bowel resection; 2)Age: 18 years ≤ age ≤ 80 years; 3)Gender: No gender restriction both male and female are eligible; 4)Individuals who have signed the informed consent.

排除标准:

1)恶性肿瘤需行扩大根治术或行肠造口术; 2)有精神疾病不能配合者; 3)孕妇或哺乳期者; 4)再次腹部手术并肠粘连严重者; 5)术中出血量超过400 mL者,或术中需输血者; 6)术后6小时内出现严重并发症者,或术后转ICU者; 7)术后必须使用对胃肠功能有明显影响的药物或治疗者,如术后需行热灌注治疗; 8)目前正在参加或在本研究前1个月内参加过其它临床试验的患者; 9)研究者认为不宜进行此项临床研究。

Exclusion criteria:

1.Patients with malignant tumors requiring extended radical surgery or ostomy surgery; 2.Individuals with mental disorders who cannot cooperate; 3.Pregnant or breastfeeding women; 4.Patients with severe intestinal adhesions due to repeated abdominal surgeries; 5.Patients with intraoperative blood loss exceeding 400 mL or those requiring blood transfusion during surgery; 6.Patients who develop serious complications within 6 hours postoperatively or those transferred to the ICU after surgery; 7.Patients who must use medications or treatments that significantly affect gastrointestinal function postoperatively such as those requiring hyperthermic intraperitoneal chemotherapy; 8.Patients who are currently participating in or have participated in other clinical trials within the last month before this study; 9.Patients whom the investigator deems unsuitable for this clinical research.

研究实施时间:

Study execute time:

From 2025-02-20

To      2026-12-09

征募观察对象时间:

Recruiting time:

From 2025-02-21

To      2026-12-09

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

基础治疗:包括抗生素治疗、补液支持治疗等,及术后快速康复护理管理。

干预措施代码:

Intervention:

Basic treatment: Including antibiotic therapy fluid support therapy etc. and postoperative rapid recovery nursing management.

Intervention code:

组别:

五达颗粒组

样本量:

20

Group:

Wuda Granules group

Sample size:

干预措施:

①基础治疗:包括抗生素治疗、补液支持治疗等,及术后快速康复护理管理。②五达颗粒治疗。

干预措施代码:

Intervention:

1.Basic treatment: Including antibiotic therapy, fluid support therapy, etc., and postoperative rapid recovery nursing management.2.Wuda Granules treatment.

Intervention code:

样本总量 Total sample size : 40

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

单位级别:

三级甲等医院

Institution/hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary Hospital Grade A

测量指标:

Outcomes:

指标中文名:

首次排便、排气时间

指标类型:

次要指标

Outcome:

First bowel movement 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:

结直肠癌旁正常组织基因表达

指标类型:

次要指标

Outcome:

Gene expression in normal tissue adjacent to colorectal cancer

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠道症状评分

指标类型:

次要指标

Outcome:

Gastrointestinal symptom 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:

肠鸣音恢复正常时间

指标类型:

次要指标

Outcome:

Bowel sounds return to normal 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:

POI的发生率

指标类型:

主要指标

Outcome:

the incidence rate of POI

Type:

Primary 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:

癌旁正常组织

组织:

Sample Name:

normal tissue adjacent to tumor

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由研究员用随机数字表法选取随机序列

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

Random sequences selected by researchers using the random number table method

盲法:

Blinding:

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):

http://www.medresman.org.cn/uc/index.aspx

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

http://www.medresman.org.cn/uc/index.aspx

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

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

CRF

数据管理委员会:

Data Managemen Committee:

No

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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