ChiCTR2500107896 版本V1.0 版本创建时间2025/08/20 16:38:12 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：

ChiCTR2500107896 

最近更新日期：

Date of Last Refreshed on：

2025-08-20 16:38:08 

注册时间：

Date of Registration：

2025-08-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

嚼口香糖对食管癌根治术后患者肠道活动的影响：一项随机对照研究

Public title：

The Impact of Chewing Gum on Intestinal Activity in Patients After Esophageal Cancer Radical Surgery: A Randomized Controlled Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

嚼口香糖对食管癌根治术后患者肠道活动的影响：一项随机对照研究

Scientific title：

The Impact of Chewing Gum on Intestinal Activity in Patients After Esophageal Cancer Radical Surgery: A Randomized Controlled Study

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：

钟美浓 

研究负责人：

张建 

Applicant：

Meinong Zhong 

Study leader：

JIan Zhang 

申请注册联系人电话：

Applicant telephone：

+86 139 2219 2727

研究负责人电话：

Study leader's telephone：

+86 139 2219 2727

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：

1261106574@qq.com

研究负责人电子邮件：

Study leader's E-mail：

Sumszhangjian@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

中山大学附属第三医院

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：

广州市天河区天河路600号

研究负责人通讯地址：

广州市天河区天河路600号

Applicant address：

No. 600, Tianhe Road, Tianhe District, Guangzhou

Study leader's address：

No. 600, Tianhe Road, Tianhe District, Guangzhou

申请注册联系人邮政编码：

Applicant postcode：

510630

研究负责人邮政编码：

Study leader's postcode：

510630

申请人所在单位：

中山大学附属第三医院

Applicant's institution：

The Third Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第三医院

Affiliation of the Leader：

The Third Affiliated Hospital of Sun Yat-sen University

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：

中大附三医伦 II2025-284-01

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：

中山大学附属第三医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of The Third Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-28 00:00:00

伦理委员会联系人：

黄凯琪

Contact Name of the ethic committee：

Kaiqi Huang

伦理委员会联系地址：

广东省广州市天河路 600 号

Contact Address of the ethic committee：

600# Tian He Road,Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8525 3302

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：

中山大学附属第三医院

Primary sponsor：

The Third Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省广州市天河路 600 号

Primary sponsor's address：

600# Tian He Road,Guangzhou

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)：

广东广州

Country：

China

Province：

Guangdong Province

City：

单位(医院)：

中山大学附属第三医院

具体地址：

广州市天河区天河路600号

Institution
hospital：

The Third Affiliated Hospital of Sun Yat-sen University

Address：

600# Tian He Road,Guangzhou

经费或物资来源：

自筹

Source(s) of funding：

self-funded

Target disease：

Esophageal cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索术后嚼口香糖能促进食管癌根治术后胃肠功能蠕动，提前首次排气时间和排便时间。  

Objectives of Study：

To explore whether chewing gum after surgery can promote gastrointestinal motility in patients who have undergone radical esophagectomy, and to advance the time of first flatus and defecation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

接受食管切除术和胃上提术治疗食管恶性肿瘤的患者；年龄在18至80岁之间的患者。

Inclusion criteria

Patients who underwent esophagectomy and gastric pull-up for the treatment of esophageal malignant tumors; patients aged between 18 and 80 years.

排除标准：

牙齿松动、慢性便秘、炎症性肠病、既往有肠道手术或新辅助化疗史；手术时间超过5小时或术后重症监护时间超过24小时的患者。本研究中包含的手术时间和重症监护时间限制为5小时和24小时，因为研究团队前期对医院所有接受食管切除术的患者进行回顾后发现，手术时间超过5小时或重症监护时间超过24小时的患者大多存在严重的术中或术后并发症。

Exclusion criteria：

Patients with loose teeth, chronic constipation, inflammatory bowel disease, or a history of previous intestinal surgery or neoadjuvant chemotherapy; patients with an operation time exceeding 5 hours or an intensive care unit (ICU) stay exceeding 24 hours after surgery. The surgery and ICU time limits included in this study are set at 5 hours and 24 hours, respectively. This is because the research team, after a retrospective review of all patients who underwent esophagectomy in the hospital, found that most patients with an operation time exceeding 5 hours or an ICU stay exceeding 24 hours had severe intraoperative or postoperative complications.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-09-01 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

25

Group：

Control group

Sample size：

干预措施：

对照组采用常规的食管癌围术期治疗与康复护理方法： 术前：所有患者在手术前一天接受了清流质饮食和肠道准备。 术中：在手术室中，所有患者在手术前30分钟接受了预防性静脉抗生素，并由三位资深麻醉师使用相同的麻醉技术提供全身麻醉。两位技术娴熟的外科医生以相同的方式进行了Ivor-Lewis食管切除术（分别进行开腹和右胸切口）、颈段吻合及双野淋巴结清扫。 术后：48小时内预防性使用抗生素，术后72小时内使用组胺H2受体阻滞剂预防应激性胃炎，术后72小时内采用患者自控硬膜外镇痛，拆除硬膜外导管后根据需要使用阿片类或非甾体镇痛药，以及使用甲氧氯普胺作为止吐药。镇痛处方记录详尽。如果胃肠道造影未发现异常，术后第7天会拔除鼻胃管和胸管。所有患者都根据患者的活动耐受性，鼓励予术后第一天协助或者下床活动，促进肠道恢复。所有患者均接受了标准化的术后喂养方案。所有患者在拔除鼻胃管前保持禁食。拔除鼻胃管后，患者先给予100毫升水，如耐受良好，则开始提供其他液体，直至首次排气。首次排气后，开始半流质饮食。患者持 续摄入半流质饮食直至排便。

干预措施代码：

Intervention：

The control group received the conventional perioperative treatment and rehabilitation nursing methods for esophageal cancer: Preoperatively: All patients were given a clear liquid diet and bowel preparation the day before surgery. Intraoperatively: In the operating room, all patients received prophylactic intravenous antibiotics 30 minutes before surgery and were administered general anesthesia using the same technique by three senior anesthesiologists. The Ivor-Lewis esophagectomy (with separate abdominal and right thoracic incisions), cervical anastomosis, and two-field lymphadenectomy were performed in the same manner by two highly skilled surgeons. Postoperatively: Prophylactic antibiotics were used within 48 hours, histamine H2-receptor antagonists were administered within 72 hours to prevent stress gastritis, and patient-controlled epidural analgesia was used within 72 hours. After the epidural catheter was removed, opioids or nonsteroidal analgesics were given as needed, and metoclopramide was used as an antiemetic. The analgesic prescriptions were meticulously recorded. Nasogastric and chest tubes were removed on postoperative day 7 if no abnormalities were found on gastrointestinal radiography. All patients were encouraged to engage in or get out of bed on the first postoperative day, according to their activity tolerance, to promote intestinal recovery. All patients received a standardized postoperative feeding protocol. All patients were kept fasting until the nasogastric tube was removed. After the nasogastric tube was removed, patients were first given 100 ml of water; if well-tolerated, other liquids were provided until the first flatus. After the first flatus, a semi-liquid diet was started. Patients continued on a semi-liquid diet until defecation.

Intervention code：

组别：

嚼口香糖组

样本量：

25

Group：

Gum-chewing group

Sample size：

干预措施：

嚼口香糖组：在对照组术后康复护理方法的基础上，嘱患者从术后第一天早晨开始咀嚼无糖口香糖，口香糖由课题组提供，均为绿箭牌无糖原味口香糖，在患者术前一天下发，指导患者术后第一天开始使用，每天三次，每次咀嚼1颗口香糖，每次咀嚼20分钟，咀嚼频率不作规定，直至首次放屁

干预措施代码：

Intervention：

Gum-chewing group: On the basis of the postoperative rehabilitation nursing methods of the control group, patients were instructed to start chewing sugar-free gum on the morning of the first day after surgery. The gum was provided by the research team, all of which were Wrigley's sugar-free original flavor gum. It was distributed to the patients one day before the surgery, and they were instructed to start using it on the first day after surgery. Patients chewed one piece of gum three times a day for 20 minutes each time. There was no specification on the frequency of chewing, and this continued until the first flatus.

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)：

中山大学附属第三医院 

单位级别：

三甲 

Institution
hospital：

The Third Affiliated Hospital of Sun Yat-sen University

Level of the institution：

A tertiary Class-A hospital

测量指标：

Outcomes：

指标中文名：

术后首次排气时间和排便时间

指标类型：

主要指标

Outcome：

Time to first flatus and time to first defecation after surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

额外止痛药需求

指标类型：

次要指标

Outcome：

Additional analgesic requirements

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后肠梗阻率

指标类型：

次要指标

Outcome：

Incidence rate of postoperative intestinal obstruction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

吻合口漏发生率

指标类型：

次要指标

Outcome：

Incidence rate of anastomotic leakage

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院时长

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：

咀嚼口香糖的耐受

指标类型：

副作用指标

Outcome：

Tolerance to Chewing Gum

Type：

Adverse events

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 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）：

由研究者通过计算机生成代码使用随机化方法产生随机化编号

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

Randomization numbers were generated by the researchers using a computer-based randomization method.

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：

本研究为开放试验，受试者和研究者均知晓干预方法。

Blinding：

This study is an open-label trial, meaning that both the participants and the researchers are aware of the intervention methods

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）：

于本研究完成发表研究论文后，将共享原始数据至中山大学数据共享平台

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

After the completion and publication of this study, the raw data will be shared on the Sun Yat-sen University Data Sharing Platform.

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：

（1）数据收集：由经过培训的研究者负责收集数据。在患者入组时收集其一般资料（如年龄、性别、体重、ASA 分级等）；术中收集出血量；术后每天定时记录患者的观察指标数据，直至患者出院。所有数据均记录在预先设计好的病例报告表（CRF）中。 （2）数据管理：将收集到的数据录入到电子数据库（如 Excel 或 SPSS）中，进行双人录入校对，确保数据的准确性。对数据进行整理、清洗，剔除不符合要求的数据。所有数据将严格保密，仅用于本研究分析。

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

(1) Data Collection: Data collection was conducted by trained researchers. General information of the patients (such as age, gender, weight, ASA classification, etc.) was collected at the time of enrollment. Intraoperative blood loss was collected during the surgery. Postoperatively, the observational index data of the patients were recorded on a regular basis every day until the patients were discharged from the hospital. All data were recorded in the pre-designed Case Report Form (CRF). (2) Data Management: The collected data were entered into an electronic database (such as Excel or SPSS) and double-entered for verification to ensure the accuracy of the data. The data were then organized and cleaned, with data that did not meet the requirements being excluded. All data will be strictly confidential and used solely for the analysis of this study.

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：

  2025-08-20 16:38:08