Today is 2020-07-15

Effect of lower esophageal gastric tube implantation in postoperative enteral nutritional support in patients with laryngeal cancer: a study protocol for a randomized controlled trial
download

注册号:

Registration number:

ChiCTR2000030378 

最近更新日期:

Date of Last Refreshed on:

2020-02-29 

注册时间:

Date of Registration:

2020-02-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

食管下段胃管置入术在喉癌患者术后肠内营养支持中的效果:一项性随机对照试验方案 

Public title:

Effect of lower esophageal gastric tube implantation in postoperative enteral nutritional support in patients with laryngeal cancer: a study protocol for a randomized controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

食管下段胃管置入术在喉癌患者术后肠内营养支持中的效果:一项性随机对照试验方案 

Scientific title:

Effect of lower esophageal gastric tube implantation in postoperative enteral nutritional support in patients with laryngeal cancer: a study protocol for 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:

肖红英 

研究负责人:

肖红英 

Applicant:

Hongying Xiao 

Study leader:

Hongying Xiao 

申请注册联系人电话:

Applicant telephone:

+86 15883690003 

研究负责人电话:

Study leader's telephone:

+86 15883690003 

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:

1303186454@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1303186454@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:

四川德阳市泰山北路173号德阳市人民医院耳鼻喉头颈外科 

研究负责人通讯地址:

四川德阳市泰山北路173号德阳市人民医院耳鼻喉头颈外科 

Applicant address:

173 Taishan Road North, Deyang, Sichuan, China 

Study leader's address:

173 Taishan Road North, Deyang, Sichuan, China 

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:

德阳市人民医院 

Applicant's institution:

Department of Otolaryngology, head and neck, Deyang people's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

德阳市人民医院 

Primary sponsor:

Deyang People's Hospital 

研究实施负责(组长)单位地址:

德阳市泰山北路173号德阳市人民医院耳鼻喉头颈外科 

Primary sponsor's address:

173 Taishan Road North, Deyang, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

德阳市人民医院

具体地址:

德阳市泰山北路173号德阳市人民医院耳鼻喉头颈外科

Institution
hospital:

Deyang People's Hospital

Address:

173 Taishan Road North, Deyang

经费或物资来源:

德阳重点科学技术研究项目计划 

Source(s) of funding:

Deyang key science and technology research project plan 

研究疾病:

喉癌 

Target disease:

Laryngeal cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究喉癌患者围手术期胃管置入的合理深度,采取改良食管下段胃管置入法,模拟正常生理性进食,从而减轻长期留置胃管导致的胃部不适、膈肌痉挛等并发症,提高患者耐受力,增加舒适度,达到改善喉癌患者术后营养状况,促进快速康复的目的。 

Objectives of Study:

Study laryngeal cancer patients perioperative rational depth of gastric tube, taking improvement of lower esophagus stomach tube placement method, simulate the normal physiologic eating, so as to reduce the long-term indwelling gastric tube lead to complications such as upset stomach, diaphragmatic muscle spasms, improve patients' tolerance, increase comfort, to improve the nutritive condition of postoperative laryngeal cancer patients and promote a rapid recovery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.耳鼻咽喉头颈外科喉癌手术患者; 2.所有患者均否认既往消化系统疾病史; 3.具有正常的认知、行为、沟通能力; 4.自愿参加本次研究并签署知情同意书。 

Inclusion criteria

1. Patients need to undergo otolaryngology, head and neck surgery for laryngeal cancer; 2. Patients with no previous history of diseases of the digestive system; 3. Have normal cognitive, behavioral and communication skills; 4. Participate in the study voluntarily and sign the informed consent. 

排除标准:

1.下咽癌多数采取放化疗; 2.喉癌合并严重内外科疾病,如甲状腺功能亢进、高血压、心脏病、肝炎等; 3.文盲。 

Exclusion criteria:

1. Most patients who recieve radiotherapy and chemotherapy for hypopharyngeal cancer; 2. With laryngeal cancer complicated with serious internal and surgical diseases, such as hyperthyroidism, hypertension, heart disease, hepatitis, etc.; 3. Who are illiterates. 

研究实施时间:

Study execute time:

From2020-05-01To 2022-05-01 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

食管下段胃管置入

干预措施代码:

Intervention:

The lower esophagus is inserted into the gastric tube

Intervention code:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

常规胃管安置方式

干预措施代码:

Intervention:

Routine stomach tube placement

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

德阳市人民医院 

单位级别:

三甲医院 

Institution
hospital:

People's hospital of De Yang city  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

舒适状况量表

指标类型:

主要指标 

Outcome:

general comfort questionnaire GCQ

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:

胃液

组织:

Sample Name:

Gastric juice

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 105 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):

将患者按照数字表法随机分为对照组和试验组

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

Patients will be randomly divided into control group and experimental group according to the numerical table method

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

2022.05.06

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

2022.05.06

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:

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-29
return list