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排尿动作缓解软性膀胱镜检查相关尿道疼痛的临床研究
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注册号:

Registration number:

ChiCTR-INR-17013294 

最近更新日期:

Date of Last Refreshed on:

2018-03-17 

注册时间:

Date of Registration:

2017-11-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

排尿动作缓解软性膀胱镜检查相关尿道疼痛的临床研究 

Public title:

Clinical study of urination action to relieve urethral pain associated with flexible cystoscopy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

排尿动作缓解软性膀胱镜检查相关尿道疼痛的临床研究 

Scientific title:

Clinical study of urination action to relieve urethral pain associated with flexible cystoscopy 

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:

谢英伟 

研究负责人:

刘跃新 

Applicant:

Xie Yingwei 

Study leader:

Liu Yuexin 

申请注册联系人电话:

Applicant telephone:

+86 18210141880 

研究负责人电话:

Study leader's telephone:

+86 010-58268509 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 010-58268509 

申请注册联系人电子邮件:

Applicant E-mail:

1262795619@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

doctorlyx@126.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:

北京市东城区东交民巷1号 

研究负责人通讯地址:

北京市东城区东交民巷1号 

Applicant address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, China 

Study leader's address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100730 

研究负责人邮政编码:

Study leader's postcode:

100730 

申请人所在单位:

首都医科大学附属北京同仁医院 

Applicant's institution:

Beijing Tongren Hospital, Capital 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:

trecky2017-034 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tongren Hospital, Capital Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-19 

伦理委员会联系人:

常灏 

Contact Name of the ethic committee:

Chang Hao 

伦理委员会联系地址:

北京市东城区同仁医院行政楼104房间 

Contact Address of the ethic committee:

Executive Building 104 rooms,Tongren Hospital, Dongcheng District, Beijing  

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-58265755 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

trkyec@126.com 

研究实施负责(组长)单位:

首都医科大学附属北京同仁医院 

Primary sponsor:

Beijing Tongren Hospital, Capital Medical University  

研究实施负责(组长)单位地址:

北京市东城区同仁医院泌尿外科医生办公室 

Primary sponsor's address:

Department of Urology, Tongren Hospital, Dongcheng District, Beijing  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区同仁医院

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University

Address:

Tongren Hospital, Dongcheng District, Beijing

经费或物资来源:

患者本人自付所有费用 

Source(s) of funding:

Patients pay for themselves 

研究疾病:

软性膀胱镜检查 

Target disease:

Flexible cystoscopy 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

寻找一种简便易行,可以明显减轻软性膀胱镜检查相关尿道疼痛的方法。 

Objectives of Study:

Objective to find a simple and convenient method to reduce the urethral pain associated with flexible cystoscopy.  

药物成份或治疗方案详述:

所有患者在检查前,向尿道中注入11ml 4℃的2%利多卡因凝胶,用阴茎钳夹住龟头10分钟。然后用软性膀胱镜通过尿道进入膀胱做检查。灌注使用的是室温生理盐水。实验组为膀胱镜通过尿道过程中患者做排尿动作,对照组为膀胱镜通过尿道过程中嘱患者做深呼吸并放松的常规动作;所有的操作过程由泌尿外科高年资医生单独完成。 

Description for medicine or protocol of treatment in detail:

All patients were injected with 11 ml of 2% lidocaine gel at 4 degree C into the urethra before the examination and the penis was held for 10 minutes with the penis forceps.Then use a flexible cystoscope to enter the bladder through the urethra for examination.The perfusion was normal saline at room temperature. Patients in the experimental group had urination during cystoscopy through the urethra, while patients in the control group received routine deep breath and relaxation during the urethra through the urethra. All operations were performed independently by senior urology surgeons. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

于我院门诊就诊因血尿、膀胱癌术后复查、输尿管支架术后等拟行膀胱镜检查,要求男性,年龄在18-70岁之间。 

Inclusion criteria

Male patients aged 18-70 years old, due to hematuria, bladder cancer postoperative review, ureteral stenting and other need cystoscopy. 

排除标准:

在24小时之内使用任何镇痛药者,已知尿道狭窄者,既往有尿道扩张史者,有前列腺切除等尿道手术者,急性期尿道感染者,留置导尿管者,预先存在的尿道疼痛(如患者有慢性盆腔炎和间质性膀胱炎等),或者由于精神障碍无法配合进行疼痛评估者。 

Exclusion criteria:

Used of any analgesics within the previous 24 hours, known urethral stricture, past urethral dilatation, History of urethral surgery,active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis) or inability to cooperate with pain assessment due to mental disorders  

研究实施时间:

Study execute time:

From2017-12-01To 2018-02-28 

征募观察对象时间:

Recruiting time:

From2017-12-01To 2017-02-28 

干预措施:

Interventions:

组别:

试验组

样本量:

48

Group:

experimental group

Sample size:

干预措施:

排尿动作

干预措施代码:

Intervention:

Urination action

Intervention code:

组别:

对照组

样本量:

48

Group:

Control group

Sample size:

干预措施:

膀胱镜通过尿道过程中嘱患者做深呼吸并放松的常规动作

干预措施代码:

Intervention:

Routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

VAS疼痛评分

指标类型:

主要指标 

Outcome:

VAS pain score

Type:

Primary indicator 

测量时间点:

膀胱镜检查结束后

测量方法:

视觉模拟评分法

Measure time point of outcome:

After flexible cystoscopy

Measure method:

VAS pain score

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

专门的研究员根据患者纳入的先后顺序,采用随机数字表的方法将患者分为两组,该研究员不参与病人的纳入,也不参与试验操作等其他环节,并严格保存分配表。

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

Special researcher according to the order of the patients included, randomly divided the patients into two groups, the researchers did not participate in the patients included, do not participate in the test operation and other aspects, and strictly preserved allocation table.

盲法:

Blinding:

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

是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):

2018-6-30起通过ResMan提供原始数据查询(www.medresman.org)

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

IPD will be public accessable via ResMan from 06-30-2018 (www.medresman.org)

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:

数据的采集:建立病例记录表(Case Record Form, CRF),记录每一位受试者的数据;数据管理:利用EpiData软件建立专门的数据库,对信息进行录入、核查,储存等。

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

Data collection: The Case Record Form (CRF) was set up to record the data of each subject. Data Management: EpiData software was used to set up a special database to record, check and store information.

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:

 2017-11-08
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