今天是:2019-05-24 星期五

机械性肠道准备在良性妇科腔镜手术中的必要性评估
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注册号:

Registration number:

ChiCTR1900023181 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

机械性肠道准备在良性妇科腔镜手术中的必要性评估 

Public title:

The necessity of mechanical bowel preparation in benign gynecologic laparoscopic surgeries 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

机械性肠道准备在良性妇科腔镜手术中可能是不必要的——随机,单盲,对照试验 

Scientific title:

Mechanical bowel preparation may be not necessary in benign gynecologic laparoscopic surgeries: A Randomized, Single-Blind, 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:

邹佩君 

研究负责人:

李征宇 

Applicant:

Peijun Zou 

Study leader:

Zhengyu Li 

申请注册联系人电话:

Applicant telephone:

+86 18981352825 

研究负责人电话:

Study leader's telephone:

+86 15208212056 

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:

peggyiv0912@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zpj3722531@vip.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:

四川省成都市武侯区人民南路三段20号 

研究负责人通讯地址:

四川省成都市武侯区人民南路三段20号 

Applicant address:

20 Third Section of Renmin Road South, Chengdu, Sichuan, China 

Study leader's address:

20 Third Section of Renmin Road South, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西第二医院 

Applicant's institution:

West China Second University Hospital, Sichuan 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:

2019年申(56)号 

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:

四川大学华西第二医院伦理委员会 

Name of the ethic committee:

The ethic committee of West China Second University Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-08 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

四川省成都市武侯区人民南路20号 

Contact Address of the ethic committee:

20 Section 3, Renmin South Road, Chengdu, Sichuan, China 

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:

四川大学华西第二医院妇产科 

Primary sponsor:

Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区人民南路20号 

Primary sponsor's address:

20 Section 3, Renmin South Road, Chengdu, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西第二医院

具体地址:

四川省成都市武侯区人民南路20号

Institution
hospital:

West China Second University Hospital, Sichuan University

Address:

20 Section 3, Renmin South Road, Chengdu, Sichuan, China

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

良性,需要行腹腔镜手术的妇科疾病(如子宫肌瘤、卵巢良性肿瘤等) 

Target disease:

benign gynecologic diseases needing laparoscopic surgeries 

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:

其它 

Study phase:

N/A 

研究目的:

评估机械性肠道准备在良性妇科腔镜手术中的必要性 

Objectives of Study:

To evaluate the necessity of mechanical bowel preparation (MBP) with oral polyethene glycol (PEG) solution in patients undergoing benign gynecologic laparoscopic procedures. 

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:

年龄18-80岁的非妊娠妇女,患有良性妇科疾病并拟行腹腔镜手术治疗。 

Inclusion criteria

Non-pregnant women aged 18–80 years who needed laparoscopic surgeries for benign gynecologic diseases were identified prior to their operation dates.  

排除标准:

恶性肿瘤,妊娠,存在相关的胃肠道病变损害者,可疑深部浸润的子宫内膜异位症,一般条件不适宜手术者。有口服聚乙二醇的禁忌证者,如可疑肠梗阻、肠穿孔、胃潴留、消化道出血、中毒性肠炎、中毒性巨结肠、严重溃疡性结肠炎等。可疑的胃肠道感染。 

Exclusion criteria:

The exclusion criteria included suspected malignancy or pregnancy, associated lesions of gastrointestinal tracts, and suspected deep infiltrative endometriosis, poor performance status for operation. Patients with contraindications for oral polyethylene glycol agent were also excluded, such as intestinal obstruction, intestinal perforation, gastric retention, hemorrhage of digestive tract, toxic enteritis, severe ulcerative colitis and toxic megacolon. The patients who were suspected to have infection of gastrointestinal tracts were also under no consideration. 

研究实施时间:

Study execute time:

From2019-05-25To 2019-06-30 

干预措施:

Interventions:

组别:

Group 2

样本量:

110

Group:

Group 2

Sample size:

干预措施:

机械性肠道准备

干预措施代码:

Intervention:

bowel preparation, MBP

Intervention code:

组别:

Group 1

样本量:

121

Group:

Group 1

Sample size:

干预措施:

无机械性肠道准备

干预措施代码:

Intervention:

fasting only, no-MBP

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西第二医院 

单位级别:

三甲医院 

Institution
hospital:

West China Second University Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肛门排气时间

指标类型:

主要指标 

Outcome:

anal exhaust time

Type:

Primary indicator 

测量时间点:

术后

测量方法:

Measure time point of outcome:

postoperative

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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:

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 80 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

简单随机化,随机数生成程序产生

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

Simple randomization were made by using a random number generator (SPSS Inc., Chicago, IL, USA).

盲法:

手术医生及助手等研究实施者及数据采集者不知道分组情况。病人知道干预措施。

Blinding:

The primary surgeon and the assistant(s) were masked to the randomization assignments.

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成6月后,联系研究者邮箱获取

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

6 months after completing the trial, contact and aquire by email

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:

SPSS

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

SPSS

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-05-15
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