中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100046897
最近更新日期： Date of Last Refreshed on：	2022-01-11 02:59:18
注册时间： Date of Registration：	2021-05-29 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	the effect of early stone surgery on kidney function
Public title：	the effect of early stone surgery on kidney function
注册题目简写：
English Acronym：
研究课题的正式科学名称：	The effect of timing of surgery on renal functions in unilateral ureteral stones.
Scientific title：	The effect of timing of surgery on renal functions in unilateral ureteral stones.
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：	Dr. Ahmet Semih Güleser	研究负责人：	Dr. Mert Ali Karadag
Applicant：	Dr. Ahmet Semih Güleser	Study leader：	Dr. Mert Ali Karadag
申请注册联系人电话： Applicant telephone：	+90 54 48303949	研究负责人电话： Study leader's telephone：	+90 54 48303949
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：	aseguleser@gmail.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 City Hospital General Hospital P6 uroloji 7	研究负责人通讯地址：	Kayseri City Hospital General Hospital P6 uroloji 7
Applicant address：	Kayseri City Hospital General Hospital P6 uroloji 7	Study leader's address：	Kayseri City Hospital General Hospital P6 uroloji 7
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, General Hospital
Applicant's institution：	Kayseri City Hospital, General Hospital
研究负责人所在单位：	土耳其Kayseri City Hospital, General Hospital
Affiliation of the Leader：	Kayseri City Hospital, General Hospital

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：	47	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 Ethic Commitee
Name of the ethic committee：	Kayseri City Hospital Ethic Commitee
伦理委员会批准日期： Date of approved by ethic committee：	2021-02-12 00:00:00
伦理委员会联系人：	Dr. Emin Silay
Contact Name of the ethic committee：	Dr. Emin Silay
伦理委员会联系地址：	Kayseri City Education Hospital Anestezi ve reaminasyon anabilim dal TALAS/ Kayseri TURKEY
Contact Address of the ethic committee：	Kayseri City Education Hospital Anestezi ve reaminasyon anabilim dal TALAS/ 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：

国家：	土耳其	省(直辖市)：	Kayseri	市(区县)：
Country：	Turkey	Province：	Kayseri	City：
单位(医院)：	Kayseri City Hospital	具体地址：	Erkilet mevki kayseri ?ehir hastanesi ?eker mah. Kocasinan Kayseri Turkey
Institution hospital：	Kayseri City Hospital	Address：	Erkilet mevki kayseri ?ehir hastanesi ?eker mah. Kocasinan Kayseri Turkey

经费或物资来源：

the researcher himself

Source(s) of funding：

the researcher himself

研究疾病：

Unilateral ureteral stone

Target disease：

Unilateral ureteral stone

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：

回顾性研究

Study phase：

Retrospective study

研究设计：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

To examine the effect of ureterorenoscopy timing on kidney function in unilateral ureteral stones.

Objectives of Study：

To examine the effect of ureterorenoscopy timing on kidney function in unilateral ureteral stones.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

74 patients were excluded forum study because stone localization and size could not be determined in preoperative radiological imaging and 48 patients were excluded from the study because various data were missing
Patients were excluded from the study if their serum creatinine and glomerular filtration rate (GFR) measures were unknown during the preoperative period, if computed tomography had not been used to diagnose their unilateral ureteral stones, if their GFR measures were ≤ 60, or if their stone sizes were > 10mm.

Exclusion criteria：

74 patients were excluded forum study because stone localization and size could not be determined in preoperative radiological imaging and 48 patients were excluded from the study because various data were missing
Patients were excluded from the study if their serum creatinine and glomerular filtration rate (GFR) measures were unknown during the preoperative period, if computed tomography had not been used to diagnose their unilateral ureteral stones, if their GFR measures were ≤ 60, or if their stone sizes were > 10mm.

研究实施时间：

Study execute time：

从 From 2017-05-02 00:00:00至 To 2021-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-03-02 00:00:00 至 To 2021-05-01 00:00:00

干预措施：

Interventions：

组别：	1	样本量：	98
Group：	1	Sample size：	98
干预措施：	ureterorenoscopy	干预措施代码：
Intervention：	ureterorenoscopy	Intervention code：

组别：	2	样本量：	39
Group：	2	Sample size：	39
干预措施：	creatinin, GFR, blod urea nitrogen	干预措施代码：
Intervention：	creatinin, GFR, blod urea nitrogen	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	土耳其	省(直辖市)：	Kayseri	市(区县)：
Country：	Turkey	Province：	Kayseri	City：
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：	Serum Creatinin	指标类型：	主要指标
Outcome：	Serum Creatinin	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	GFR	指标类型：	主要指标
Outcome：	GFR	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	blood urea nitrogen	指标类型：	次要指标
Outcome：	blood urea nitrogen	Type：	Secondary 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：	blood	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	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）：

Since the study was conducted retrospectively, patients with glomerular filtration rate below 60, patients over 65 years of age and patients with stone size greater than 10 mm were excluded for randomization of the groups.

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

Since the study was conducted retrospectively, patients with glomerular filtration rate below 60, patients over 65 years of age and patients with stone size greater than 10 mm were excluded for randomization of the groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	N/A
Blinding：	N/A

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）：	By mail if requested
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	By mail if requested
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：	data were obtained by retrospective archive scanning method.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	data were obtained by retrospective archive scanning method.
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：	2021-05-30 00:00:49