ChiCTR2600122869 版本V1.0 版本创建时间2026/04/20 08:49:54 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：

 ChiCTR2600122869 

最近更新日期：

Date of Last Refreshed on：

 2026-04-20 08:49:49 

注册时间：

Date of Registration：

 2026-04-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

小肠减压状态下滋养型口服营养补充对梗阻性结肠癌患者术后肠屏障和临床结局的影响：一项随机对照研究

Public title：

Effect of Nutrient Oral Nutritional Supplementation During Small Bowel Decompression on Postoperative Intestinal Barrier Function and Clinical Outcomes in Patients with Obstructive Colorectal Cancer: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

小肠减压状态下滋养型口服营养补充对梗阻性结肠癌患者术后肠屏障和临床结局的影响：一项随机对照研究

Scientific title：

Effect of Nutrient Oral Nutritional Supplementation During Small Bowel Decompression on Postoperative Intestinal Barrier Function and Clinical Outcomes in Patients with Obstructive Colorectal Cancer: A Randomized Controlled Trial

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：

孙大力 

研究负责人：

孙大力 

Applicant：

Sun Dali 

Study leader：

Sun Dali 

申请注册联系人电话：

Applicant telephone：

 +86 135 7704 7806

研究负责人电话：

Study leader's
telephone：

+86 135 7704 7806

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：

 945341793@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 945341793@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：

云南省昆明市五华区滇缅大道374号昆明医科大学第二附属医院胃肠外科

研究负责人通讯地址：

云南省昆明市五华区滇缅大道374号昆明医科大学第二附属医院胃肠外科

Applicant address：

Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China

Study leader's address：

Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China

申请注册联系人邮政编码：

Applicant postcode：

 650032

研究负责人邮政编码：

Study leader's postcode：

 650032

申请人所在单位：

昆明医科大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Kunming Medical University

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：

 PJ-KY-2026-20

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：

昆明医科大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of The Second Affiliated Hospital of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-07 00:00:00

伦理委员会联系人：

张敏

Contact Name of the ethic committee：

Zhang Min

伦理委员会联系地址：

云南省昆明市五华区滇缅大道374号昆明医科大学第二附属医院医学伦理委员会

Contact Address of the ethic committee：

Medical Ethics Committee of The Second Affiliated Hospital of Kunming Medical University No. 374 Dianmian Avenue, Wuhua District, Kunming, Yunnan Province, 650101, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 63402346

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：

昆明医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

云南省昆明市五华区滇缅大道374号昆明医科大学第二附属医院胃肠外科

Primary sponsor's address：

Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 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)：

云南省

市(区县)：

昆明市

Country：

China

Province：

Yunnan Province

City：

Kunming

单位(医院)：

昆明医科大学第二附属医院

具体地址：

云南省昆明市五华区滇缅大道374号昆明医科大学第二附属医院胃肠外科

Institution
hospital：

The Second Affiliated Hospital of Kunming Medical University

Address：

Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

研究疾病：

梗阻性结肠癌  

Target disease：

Obstructive Colorectal Cancer

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：

 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：

本研究通过在小肠减压状态下行滋养型口服营养补充，应用HE染色、IHC、16S rRNA测序、ELISA法等观察肠屏障、肠道微生物群、术后肠功能恢复、感染性并发症和住院时间等指标，系统评估小肠减压状态下给予滋养性口服营养补充对临床结局的影响。  

Objectives of Study：

This study systematically evaluated the effects of trophic oral nutritional supplementation (ONS) during small bowel decompression on clinical outcomes. By administering trophic ONS in the decompressed state, we observed multiple indicators—including intestinal barrier function, gut microbiota, postoperative bowel function recovery, infectious complications, and length of hospital stay—using H&E staining, immunohistochemistry (IHC), 16S rRNA sequencing, and enzyme-linked immunosorbent assay (ELISA).

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岁以上； 2.经腹部X线平片及腹部CT检查确诊为结直肠癌伴不完全性肠梗阻患者，已放置经鼻肠梗阻导管，并通过腹部立位平片确认导管头端到达回肠末端，近端肠管未见明显液气平面，后接受择期根治性切除； 3.自愿参与研究并签署知情同意书。

Inclusion criteria

1.Aged 18 years or older. 2. Patients diagnosed with colorectal cancer accompanied by incomplete intestinal obstruction via abdominal X-ray and abdominal CT examination, who had undergone placement of a transnasal intestinal decompression tube; the tube tip was confirmed to have reached the terminal ileum by abdominal upright radiography, with no significant air-fluid levels observed in the proximal bowel, followed by elective radical resection. 3. Voluntarily participated in the study and provided written informed consent.

排除标准：

1.需紧急手术的患者，包括但不限于因结肠癌伴肠梗阻导致的急性完全性肠梗阻、肠穿孔、严重腹膜炎或败血症等需立即手术干预的急症情况； 2.妊娠期或哺乳期妇女； 3.长期使用大量激素的患者。

Exclusion criteria：

1. Patients requiring emergency surgery, including but not limited to acute complete intestinal obstruction, bowel perforation, severe peritonitis, or sepsis secondary to colon cancer with obstruction necessitating immediate surgical intervention. 2.Pregnant or lactating women. 3.Patients on long-term high-dose corticosteroid therapy.

研究实施时间：

Study execute time：

从 From 2026-04-13 00:00:00至 To 2029-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-20 00:00:00 至 To 2029-12-01 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 30

Group：

Experimental Group

Sample size：

干预措施：

患者在放置肠梗阻导管后，接受滋养型口服营养补充干预至少5天，滋养型营养补充方案参考2016年发表的美国成人重症营养指南和2023年发表的中国成人患者肠外肠内营养临床应用指南，用短肽类肠内营养制剂“百普力”，嘱患者每次口服30ml，每日4次[8-9]，同时予肠外营养（25 kcal/kg/日）。若出现不耐受(如恶心、呕吐、腹胀)，则减量或暂停干预。干预持续至术前24小时停止。并予抑酸护胃、抗感染、补液等对症处理。

干预措施代码：

Intervention：

Following placement of the intestinal decompression tube, patients in the intervention group received trophic oral nutritional supplementation (ONS) for a minimum of 5 days. The trophic nutritional regimen was based on the 2016 American guidelines for nutrition support in critically ill adults and the 2023 Chinese guidelines for parenteral and enteral nutrition in adult patients. A short peptide-based enteral nutrition formula ("Peptisorb" / "Baipuli") was administered orally at a dose of 30 mL, four times daily [8-9]. Concurrent parenteral nutrition was provided at 25 kcal/kg/day. In cases of intolerance (e.g., nausea, vomiting, or abdominal distension), the ONS dose was reduced or temporarily withheld. The intervention was continued until 24 hours prior to surgery. All patients received standard supportive care, including gastric acid suppression, anti-infective therapy, and fluid resuscitation.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control Group

Sample size：

干预措施：

禁食，予全胃肠外营养（25 kcal/kg/日），并予抑酸护胃、抗感染、补液等对症处理。

干预措施代码：

Intervention：

Patients in the control group were kept nil per os (NPO) and received total parenteral nutrition (TPN) at 25 kcal/kg/day. Standard supportive care was provided, including gastric acid suppression, anti-infective therapy, and fluid resuscitation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南省 

市(区县)：

 昆明市 

Country：

China

Province：

Yunnan Province

City：

Kunming

单位(医院)：

 昆明医科大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Kunming Medical University

Level of the institution：

Grade III, Class A Hospital

测量指标：

Outcomes：

指标中文名：

感染性并发症的发生率

指标类型：

主要指标

Outcome：

Incidence of Infectious Complications

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清肠屏障标志物

指标类型：

次要指标

Outcome：

Serum Intestinal Barrier Markers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肠屏障功能

指标类型：

主要指标

Outcome：

Intestinal Barrier Function

Type：

Primary 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：

主要指标

Outcome：

Postoperative Length of Hospital Stay

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：

血液

组织：

结肠

Sample Name：

Blood

Tissue：

Colon

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 90 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）：

随机分配序列由一名不参与患者招募和干预实施的独立统计人员使用 SPSS 27.0 软件生成。采用区组随机化方法，区组长度设为 4，按 1:1 比例将受试者分配至干预组或对照组。

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

The random allocation sequence was generated by an independent statistician who was not involved in patient recruitment or intervention delivery, using SPSS software (version 27.0; IBM Corp., Armonk, NY, USA). Block randomization with a block size of 4 was employed to assign participants to either the intervention group or the control group in a 1:1 ratio.

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：

结局评估者盲法

Blinding：

Assessor-Blind

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：

数据采集采用纸质病例记录表与电子数据采集系统相结合的方式。研究团队依据方案设计标准CRF，由培训合格的研究人员实时填写。所有CRF数据经核查后，由两名数据管理员独立双份录入至ResMan电子数据采集平台。系统设有自动逻辑核查程序，数据管理过程中产生的质疑由研究者在线答复确认。全部数据操作过程均由系统稽查轨迹完整记录。数据清理完成后锁定数据库，导出标准化数据集供统计分析使用。

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

Data were collected using a combination of paper Case Report Forms (CRFs) and an Electronic Data Capture (EDC) system. Standardized CRFs were designed based on the study protocol and completed in real time by trained research personnel. Following source data verification, data were independently double-entered into the ResMan EDC platform by two data managers. The system incorporated automated logic checks, and queries raised during data management were resolved online by the investigators. All data operations were documented with a complete audit trail. After data cleaning, the database was locked, and a standardized dataset was exported for statistical analysis.

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：

  2026-04-20 08:49:49