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Contrast analysis of the perioperative inflammation stress index of the surgical trauma of laparoscopic versus open Splenectomy for the patients of splenomegaly and hypersplenism secondary to liver cirrhosis
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注册号:

Registration number:

ChiCTR-TNRC-10001028 

最近更新日期:

Date of Last Refreshed on:

2015-06-23 

注册时间:

Date of Registration:

2010-09-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

对比分析腹腔镜脾切除术与开腹脾切除术治疗肝硬化脾大脾亢患者围术期手术创伤炎症应激指标 

Public title:

Contrast analysis of the perioperative inflammation stress index of the surgical trauma of laparoscopic versus open Splenectomy for the patients of splenomegaly and hypersplenism secondary to liver cirrhosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

对比分析腹腔镜脾切除术与开腹脾切除术治疗肝硬化脾大脾亢患者围术期手术创伤炎症应激指标 

Scientific title:

Contrast analysis of the perioperative inflammation stress index of the surgical trauma of laparoscopic versus open Splenectomy for the patients of splenomegaly and hypersplenism secondary to liver cirrhosis 

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:

彭兵 

研究负责人:

彭兵 

Applicant:

Bing Peng 

Study leader:

Bing Peng 

申请注册联系人电话:

Applicant telephone:

+86 18980601481 

研究负责人电话:

Study leader's telephone:

+86 18980601481 

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:

pengbing84@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

pengbing84@hotmail.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:

四川大学华西医院肝胆胰外科 

研究负责人通讯地址:

四川大学华西医院肝胆胰外科 

Applicant address:

Department of Hepatopancreatobiliary Surgery, West China Hospital, Sichuan University 

Study leader's address:

Department of Hepatopancreatobiliary Surgery, West China Hospital, Sichuan University 

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:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China 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:

2010年审(38)号2010.8.12 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院临床试验伦理专委会 

Name of the ethic committee:

Ethics Committee of West China Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-08-18 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院肝胆胰外科 

Primary sponsor:

Department of Hepatopancreatobiliary Surgery, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川大学华西医院肝胆胰外科 

Primary sponsor's address:

Department of Hepatopancreatobiliary Surgery, West China Hospital, Sichuan University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

无 

Source(s) of funding:

NA 

研究疾病:

肝硬化脾大脾亢 

Target disease:

Splenomegaly and hypersplenism secondary to liver cirrhosis 

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:

对比分析腹腔镜下行脾切除术与开腹手术治疗肝硬化脾大脾亢患者的围术期手术创伤炎症应激指标 

Objectives of Study:

Contrast analysis of the perioperative inflammation stress index of the surgical trauma of laparoscopic versus open Splenectomy for the patients of splenomegaly and hypersplenism secondary to liver cirrhosis 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

我院本科室行腹腔镜脾切除术的肝硬化脾大脾亢患者80例 及开腹行脾切除术的肝硬化脾大脾亢患者80例 

Inclusion criteria

There are 80 cases of splenomegaly and hypersplenism secondary to liver cirrhosis treated by laparoscopic splenectomy in our department of west china of hospital and another 80 cases treated by open splenectomy 

排除标准:

1.不愿意参加试验的患者2.合并其他脾脏相关疾病者 

Exclusion criteria:

1. Ones who would not like to attend the trial; 2. Ones who accompanied by other spleen-relative disease. 

研究实施时间:

Study execute time:

From2010-07-01To 2013-07-31 

干预措施:

Interventions:

组别:

Group A

样本量:

80

Group:

Group A

Sample size:

干预措施:

行腹腔镜下脾切除术,对于纳入的研究对象经胃镜证实有中-重度食管下段或胃底静脉曲张,既往有上消化道出血史,肝功能属于ChildA级或B级,需附加贲门食管胃底周围血管离断术。分别于术前第1天,术后第3天、术后第7天检查肝硬化脾大伴脾亢患者血液中的炎症指标

干预措施代码:

Intervention:

The experimentation group underwent the laparoscopic splenectomy . And for the objects that confirmed as mild-severe the inferior esophageal and gastric fundus varication by the gastroscope, or with the history of upper gastrointestinal hemorrhage, and whose liver cirrhosis stage is Child-Pugh A or B, an additional azygoportal disconnection is needed. Then check the inflammation index in the blood of the patients of splenomegaly and hypersplenism secondary to liver cirrhosis.

Intervention code:

组别:

Group B

样本量:

80

Group:

Group B

Sample size:

干预措施:

行开腹脾切除术,对于纳入的研究对象经胃镜证实有中-重度食管下段或胃底静脉曲张,既往有上消化道出血史,肝功能属于ChildA级或B级,需附加贲门食管胃底周围血管离断术。分别于术前第1天,术后第3天、术后第7天检查肝硬化脾大伴脾亢患者血液中的炎症指标

干预措施代码:

Intervention:

The group underwent the open splenectomy. And for the objects that confirmed as mild-severe the inferior esophageal and gastric fundus varication by the gastroscope, or with the history of upper gastrointestinal hemorrhage, and whose liver cirrhosis stage is Child-Pugh A or B, an additional azygoportal disconnection is needed. Then check the inflammation index in the blood of the patients of splenomegaly and hypersplenism secondary to liver cirrhosis.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

IgM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

IL-8

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

C3

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

IgA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

cortisol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

CD4+

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

norepinephrine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

CD8+

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

CD4+/CD8+

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

IL-6

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

C4

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

NK

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

IgG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

epinephrine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

CD3+

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

CR

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 0 years
最大 Max age 0 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):

NA

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

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

四川大学华西医院肝胆胰外科

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

Department of hepatopancreatobiliary surgery, west china hospital

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:

四川大学华西医院肝胆胰外科

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

Department of hepatopancreatobiliary surgery, west china hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-09-20
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