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Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later
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注册号：

Registration number：

 ChiCTR1900027713 

最近更新日期：

Date of Last Refreshed on：

 2019-11-24 19:56:26 

注册时间：

Date of Registration：

 2019-11-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

Public title：

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

Scientific title：

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

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：

Bahtiyar Muhammedoglu 

研究负责人：

ilhami Taner Kale 

Applicant：

Bahtiyar Muhammedoglu 

Study leader：

ilhami Taner Kale 

申请注册联系人电话：

Applicant telephone：

 +90 541 8455083

研究负责人电话：

Study leader's
telephone：

+90 (344) 300 10 00

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：

 baha197647@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 kale@ksu.edu.tr

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：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv. No: 251 / A 46040 - Oniki?ubat/KAHRAt?rlü?ü, Av?ar Mah. Bat? ?evreyolu Blv. 251/A Onikisubat/KAHRAMANMARA, Turkey

研究负责人通讯地址：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv. No: 251 / A 46040 - Oniki?ubat/KAHRAt?rlü?ü, Av?ar Mah. Bat? ?evreyolu Blv. 251/A Onikisubat/KAHRAMANMARA, Turkey

Applicant address：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv. No: 251 / A 46040 - Oniki?ubat/KAHRAt?rlü?ü, Av?ar Mah. Bat? ?evreyolu Blv. No: 251/A 46040 - Onikisubat/KAHRAMANMARA

Study leader's address：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv. No: 251 / A 46040 - Onikisubat/KAHRAMANMARA

申请注册联系人邮政编码：

Applicant postcode：

 46040

研究负责人邮政编码：

Study leader's postcode：

 46040

申请人所在单位：

土耳其伊玛目大学

Applicant's institution：

Ministry of Health, Turkey

研究负责人所在单位：

土耳其伊玛目大学

Affiliation of the Leader：

Kahramanmaras Sutcu Imam University, Turkey

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：

 148

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：

KAHRAMANMARAS SüTcü iMAM UNIVERSITY Ethics Committees

Name of the ethic committee：

KAHRAMANMARAS SüTcü iMAM UNIVERSITY Ethics Committees

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Nuray ORHAN

Contact Name of the ethic committee：

Nuray ORHAN

伦理委员会联系地址：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv.

Contact Address of the ethic committee：

Kahramanmaras Sutcu Imam University Rectorate, Avsar Mah. West Ring Road Blv.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +90 344 300 34 24

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tipkaek@ksu.edu.tr

研究实施负责（组长）单位：

No financial support in this study

Primary sponsor：

No financial support in this study

研究实施负责（组长）单位地址：

No financial support in this study

Primary sponsor's address：

No financial support in this study

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No financial support in this study

Source(s) of funding：

No financial support in this study

研究疾病：

因胆石症和胆总管结石引起的阻塞性黄疸  

Target disease：

obstructive jaundice due to cholelithiasis and choledocholithiasis

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The present study aimed to assess the feasibility of performing cholecystectomy in the same session or same hospitalization following single-stage ERCP in patients with obstructive jaundice due to cholelithiasis and choledocholithiasis.  

Objectives of Study：

The present study aimed to assess the feasibility of performing cholecystectomy in the same session or same hospitalization following single-stage ERCP in patients with obstructive jaundice due to cholelithiasis and choledocholithiasis.

药物成份或治疗方案详述：

Patients diagnosed with cholelithiasis and choledocholithiasis between October 2017 and May 2019 were prospectively enrolled in the study in a randomized manner.  

Description for medicine or protocol of treatment in detail：

Patients diagnosed with cholelithiasis and choledocholithiasis between October 2017 and May 2019 were prospectively enrolled in the study in a randomized manner.  

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria included age under 16 years, pregnancy, diagnostic ERCP, Perforated gallbladder, suspected or confirmed malignancy and uncompleted ERCP. Patients not meeting the eligibility criteria were excluded. ERCP and LC procedures were performed by the same endoscopic surgeon. The indication for ERCP was thoroughly evaluated for each patient in consultation with a radiologist prior to the procedure.

Exclusion criteria：

Exclusion criteria included age under 16 years, pregnancy, diagnostic ERCP, Perforated gallbladder, suspected or confirmed malignancy and uncompleted ERCP. Patients not meeting the eligibility criteria were excluded. ERCP and LC procedures were performed by the same endoscopic surgeon. The indication for ERCP was thoroughly evaluated for each patient in consultation with a radiologist prior to the procedure.

研究实施时间：

Study execute time：

从 From 2017-10-10 00:00:00至 To 2018-10-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-10-10 00:00:00 至 To 2019-08-05 00:00:00

干预措施：

Interventions：

组别：

A (single-stage ERCP plus Laparoscopic cholecystectomy)

样本量：

 39

Group：

A (single-stage ERCP plus Laparoscopic cholecystectomy)

Sample size：

干预措施：

ERCP+laparoscopic cholecystectomy

干预措施代码：

 Use code 43264 and 47562

Intervention：

ERCP+laparoscopic cholecystectomy

Intervention code：

组别：

B

样本量：

 43

Group：

B

Sample size：

干预措施：

ERCP and same hospitalization period laparoscopic cholecystectomy

干预措施代码：

 Use code 43264 and 47562

Intervention：

ERCP and same hospitalization period laparoscopic cholecystectomy

Intervention code：

组别：

C

样本量：

 37

Group：

C

Sample size：

干预措施：

ERCP and delayed laparoscopic cholecystectomy

干预措施代码：

 Use code 43264 and 47562

Intervention：

ERCP and delayed laparoscopic cholecystectomy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 kahramanmara 

市(区县)：

  

Country：

Turkey

Province：

kahramanmara

City：

单位(医院)：

 Kahramanmaras Sutcu Imam University 

单位级别：

 三级医院 

Institution
hospital：

Kahramanmaras Sutcu Imam University

Level of the institution：

Tertiary Hospital

国家：

 土耳其

省(直辖市)：

 kahramanmaras 

市(区县)：

 kahramanmaras 

Country：

Turkey

Province：

kahramanmaras

City：

kahramanmaras

单位(医院)：

 Kahramanmaras Necip Fazil City Hospital 

单位级别：

 二级医院 

Institution
hospital：

Kahramanmaras Necip Fazil City Hospital

Level of the institution：

Secondary Hospital

测量指标：

Outcomes：

指标中文名：

advantageous in terms of length of hospital stay

指标类型：

主要指标

Outcome：

advantageous in terms of length of hospital stay

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

total cost

指标类型：

主要指标

Outcome：

total cost

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

$, USD

指标中文名：

recurrent acute cholecystitis

指标类型：

主要指标

Outcome：

recurrent acute cholecystitis

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 16 岁 years
最大 Max age 95 岁 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）：

The cases were performed by lot by simple randomization method.

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

The cases were performed by lot by simple randomization method.

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：

No

Blinding：

No

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）：

i don't use web-based public database

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

i don't use web-based public database

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：

With a standard data collection and method, the criteria we determined before the study were collected by entering the manual.

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

With a standard data collection and method, the criteria we determined before the study were collected by entering the manual.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2019-11-24 11:55:57
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