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Outcomes of different donor and recipient vessel and ureteral anastomoses in en-bloc kidney transplantation from paediatric deceased donors: a retrospective cohort
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注册号：

Registration number：

 ChiCTR2300075184 

最近更新日期：

Date of Last Refreshed on：

 2023-08-29 09:24:18 

注册时间：

Date of Registration：

 2023-08-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Outcomes of different donor and recipient vessel and ureteral anastomoses in en-bloc kidney transplantation from paediatric deceased donors: a retrospective cohort

Public title：

Outcomes of different donor and recipient vessel and ureteral anastomoses in en-bloc kidney transplantation from paediatric deceased donors: a retrospective cohort

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Comparison of outcomes in en-bloc kidney transplantation from deceased pediatric donors to adult recipients based on different anastomotic techniques

Scientific title：

Comparison of outcomes in en-bloc kidney transplantation from deceased pediatric donors to adult recipients based on different anastomotic techniques

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：

Abbas Basiri 

研究负责人：

Abbas Basiri 

Applicant：

Abbas Basiri 

Study leader：

Abbas Basiri 

申请注册联系人电话：

Applicant telephone：

 +98 912 389 0339

研究负责人电话：

Study leader's
telephone：

+98 912 389 0339

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：

 basiri@unrc.ir

研究负责人电子邮件：

Study leader's E-mail：

 basiri@unrc.ir

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：

Pasdaran avenue

研究负责人通讯地址：

Pasdaran avenue

Applicant address：

Pasdaran avenue

Study leader's address：

Pasdaran avenue

申请注册联系人邮政编码：

Applicant postcode：

 1666697751

研究负责人邮政编码：

Study leader's postcode：

 1666697751

申请人所在单位：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Applicant's institution：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

研究负责人所在单位：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Affiliation of the Leader：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

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：

 IR.SBMU.UNRC.REC.1401.014

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：

Research Ethics Committees of Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences

Name of the ethic committee：

Research Ethics Committees of Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-07-02 00:00:00

伦理委员会联系人：

Shabnam Golshan, MsC.

Contact Name of the ethic committee：

Shabnam Golshan, MsC.

伦理委员会联系地址：

Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Contact Address of the ethic committee：

Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +98 21 2277 0954

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：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Primary sponsor：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

研究实施负责（组长）单位地址：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Primary sponsor's address：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iran

省(直辖市)：

Tehran

市(区县)：

Country：

Iran

Province：

Tehran

City：

单位(医院)：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

具体地址：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Institution
hospital：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Address：

Urology and Nephrology Research Centre, Shahid Labbafinejad Medical Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran

经费或物资来源：

NO FUNDING WAS RECEIVED FOR THIS STUDY

Source(s) of funding：

NO FUNDING WAS RECEIVED FOR THIS STUDY

研究疾病：

end stage renal diseases (ESRD)  

Target disease：

end stage renal diseases (ESRD)

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：

队列研究 

Study design：

Cohort study 

研究目的：

1. Determination and comparison of patient survival after EBKT surgery based on the type of arterial anastomosis 2. Determining and comparing the survival of patients after EBKT surgery based on the type of ureteral anastomosis 3. Determination and comparison of graft survival after EBKT surgery based on the type of arterial anastomosis 4. Determination and comparison of graft survival after EBKT surgery based on the type of ureteral anastomosis 5. Determining and comparing the rate of vascular complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 6. Determining and comparing the rate of vascular complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 7. Determination and comparison of lymphocele complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 8. Determining and comparing the rate of lymphocele complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 9. Determining and comparing the rate of urinary leakage complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 10. Determining and comparing the rate of urinary leakage complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 11. Determining and comparing the trend of GFR changes in transplant recipients after EBKT surgery based on the type of arterial anastomosis  

Objectives of Study：

1. Determination and comparison of patient survival after EBKT surgery based on the type of arterial anastomosis 2. Determining and comparing the survival of patients after EBKT surgery based on the type of ureteral anastomosis 3. Determination and comparison of graft survival after EBKT surgery based on the type of arterial anastomosis 4. Determination and comparison of graft survival after EBKT surgery based on the type of ureteral anastomosis 5. Determining and comparing the rate of vascular complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 6. Determining and comparing the rate of vascular complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 7. Determination and comparison of lymphocele complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 8. Determining and comparing the rate of lymphocele complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 9. Determining and comparing the rate of urinary leakage complications in transplant recipients after EBKT surgery based on the type of arterial anastomosis 10. Determining and comparing the rate of urinary leakage complications in transplant recipients after EBKT surgery based on the type of ureteral anastomosis. 11. Determining and comparing the trend of GFR changes in transplant recipients after EBKT surgery based on the type of arterial anastomosis

药物成份或治疗方案详述：

In this retrospective study, adult transplant recipients undergoing EBKT kidney transplantation are examined. All patients are selected from Labafinejad, Shahid Modares, Milad, Shariati and transplant center of Mashhad University of Medical Sciences in the period from 2005 to 2022. The basic information of the patients will be extracted from the patients' files using a standardized checklist. This information includes demographic information (age and gender) for transplant donors and recipients, laboratory findings (creatinine and GFR) for transplant donors, anthropometric findings (height, weight, BMI) for transplant donors and recipients and possible comorbidities in the recipients. Then, by carefully examining the surgical report, the type of arterial anastomosis and the type of ureteral connection in the recipients are determined and recorded, and the patients are classified accordingly. Patient survival, graft survival, vascular complications, lymphocele complications, and urinary leakage are compared among the above groups. Also, the speed and amount of GFR increase among the groups are investigated and compared.  

Description for medicine or protocol of treatment in detail：

In this retrospective study, adult transplant recipients undergoing EBKT kidney transplantation are examined. All patients are selected from Labafinejad, Shahid Modares, Milad, Shariati and transplant center of Mashhad University of Medical Sciences in the period from 2005 to 2022. The basic information of the patients will be extracted from the patients' files using a standardized checklist. This information includes demographic information (age and gender) for transplant donors and recipients, laboratory findings (creatinine and GFR) for transplant donors, anthropometric findings (height, weight, BMI) for transplant donors and recipients and possible comorbidities in the recipients. Then, by carefully examining the surgical report, the type of arterial anastomosis and the type of ureteral connection in the recipients are determined and recorded, and the patients are classified accordingly. Patient survival, graft survival, vascular complications, lymphocele complications, and urinary leakage are compared among the above groups. Also, the speed and amount of GFR increase among the groups are investigated and compared.  

纳入标准：

Inclusion criteria

排除标准：

Patients with advanced kidney failure who have undergone kidney transplant surgery from a deceased adult donor or those who declined to provide informed consent for utilization of their health record data .

Exclusion criteria：

Patients with advanced kidney failure who have undergone kidney transplant surgery from a deceased adult donor or those who declined to provide informed consent for utilization of their health record data .

研究实施时间：

Study execute time：

从 From 2022-07-07 00:00:00至 To 2023-01-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-08-17 00:00:00 至 To 2022-10-12 00:00:00

干预措施：

Interventions：

组别：

En-bloc kidney transplantation

样本量：

 99

Group：

En-bloc kidney transplantation

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iran

省(直辖市)：

 Tehran 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Labafinejad hospital 

单位级别：

 Tertiary 

Institution
hospital：

Labafinejad hospital

Level of the institution：

Tertiary

国家：

 Iran

省(直辖市)：

 Tehran 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Shahid Modaress hospital 

单位级别：

 Tertiary 

Institution
hospital：

Shahid Modaress hospital

Level of the institution：

Tertiary

国家：

 Iran

省(直辖市)：

 Tehran 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Milad hospital 

单位级别：

 Tertiary 

Institution
hospital：

Milad hospital

Level of the institution：

Tertiary

国家：

 Iran

省(直辖市)：

 Tehran 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Shariati hospital 

单位级别：

 Tertiary 

Institution
hospital：

Shariati hospital

Level of the institution：

Tertiary

国家：

 Iran

省(直辖市)：

 Mashhad 

市(区县)：

  

Country：

Iran

Province：

Mashhad

City：

单位(医院)：

 Transplant center of Mashhad University of Medical Sciences 

单位级别：

 Tertiary 

Institution
hospital：

Transplant center of Mashhad University of Medical Sciences

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Overall survival

指标类型：

主要指标

Outcome：

Overall survival

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Graft survival

指标类型：

主要指标

Outcome：

Graft survival

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Postoperative complications

指标类型：

副作用指标

Outcome：

Postoperative complications

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

GFR estimation

指标类型：

次要指标

Outcome：

GFR estimation

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：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 15 岁 years
最大 Max age 66 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）：

None

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

None

Blinding：

None

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

否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）：

Not applicable

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

Not applicable

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：

Not applicable

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

Not applicable

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：

  2023-08-29 09:24:14
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