Today is 2022-05-21

MERT in laparoscopic Burch procedure
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注册号:

Registration number:

ChiCTR2100054368 

最近更新日期:

Date of Last Refreshed on:

2021-12-16 

注册时间:

Date of Registration:

2021-12-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

MERT in laparoscopic Burch procedure 

Public title:

MERT in laparoscopic Burch procedure 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Multiple Endoclip Retraction Technique (MERT) in Laparoscopic Burch 

Scientific title:

Multiple Endoclip Retraction Technique (MERT) in Laparoscopic Burch 

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:

Mert Ali Karadag 

研究负责人:

Mert Ali Karadag 

Applicant:

Mert Ali Karadag 

Study leader:

Mert Ali Karada 

申请注册联系人电话:

Applicant telephone:

+90 5054509445 

研究负责人电话:

Study leader's telephone:

+90 5054509445 

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:

karadagmert@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

karadagmert@yahoo.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:

Kayseri Sehir Hastanesi Kocasinan, Kayseri, Turkey 

研究负责人通讯地址:

Kayseri Sehir Hastanesi Kocasinan, Kayseri, Turkey 

Applicant address:

Kayseri Sehir Hastanesi Kocasinan, Kayseri, Turkey 

Study leader's address:

Kayseri Sehir Hastanesi Kocasinan, Kayseri, Turkey 

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:

土耳其Kayseri City Hospital, Department of Urology 

Applicant's institution:

Kayseri City Hospital, Department of Urology 

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:

487 

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:

Kayseri City Hospital Ethics Committee 

Name of the ethic committee:

Kayseri City Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-10-07 

伦理委员会联系人:

Kayseri City Hospital Ethics Committee 

Contact Name of the ethic committee:

Kayseri City Hospital Ethics Committee 

伦理委员会联系地址:

Kayseri ehir Hastanesi Kocasinan/Kayseri /Turkey 

Contact Address of the ethic committee:

Kayseri ehir Hastanesi Kocasinan/Kayseri /Turkey 

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:

None 

Primary sponsor:

None 

研究实施负责(组长)单位地址:

None 

Primary sponsor's address:

None 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

None 

Source(s) of funding:

None 

研究疾病:

Stress Urinary Incontinence 

Target disease:

Stress Urinary Incontinence 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

Multiple endoclip retraction technique (MERT) was developed depending on our experience in renal parenchyma suturing in laparoscopic partial nephrectomy. Herein, we will try to evaluate the results of cases that will be treated by laparoscopic retroperitoneal-transperitoneal Burch with MERT. 

Objectives of Study:

Multiple endoclip retraction technique (MERT) was developed depending on our experience in renal parenchyma suturing in laparoscopic partial nephrectomy. Herein, we will try to evaluate the results of cases that will be treated by laparoscopic retroperitoneal-transperitoneal Burch with MERT. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

The patients having symptomatic pure SUI without symptoms of urgency or urge incontinence. 

Inclusion criteria

The patients having symptomatic pure SUI without symptoms of urgency or urge incontinence. 

排除标准:

The patients who have bleeding diathesis, concomitant pelvic organ prolapse, neurologic disorders, medical conditions that prevent surgical intervention and previous surgical treatment for urinary incontinence will be excluded. 

Exclusion criteria:

The patients who have bleeding diathesis, concomitant pelvic organ prolapse, neurologic disorders, medical conditions that prevent surgical intervention and previous surgical treatment for urinary incontinence will be excluded. 

研究实施时间:

Study execute time:

From2022-01-03To 2023-01-15 

征募观察对象时间:

Recruiting time:

From2021-12-16To 2023-09-15 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

Burch Laparoscopic

干预措施代码:

Intervention:

Burch Laparoscopic

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

土耳其 

省(直辖市):

Kocasinan 

市(区县):

Kayseri 

Country:

Turkey 

Province:

Kocasinan 

City:

Kayseri 

单位(医院):

Kayseri City Hospital 

单位级别:

三级医院 

Institution
hospital:

Kayseri City Hospital  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

Being full dry

指标类型:

主要指标 

Outcome:

Being full dry

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:

No

组织:

Sample Name:

None

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 40 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):

None

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

None

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

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):

None

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:

Yes

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

Clinical and demographic data, as well as perioperative findings and post‐operative complications will be recorded.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-16
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