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神经外科加速康复(ERAS)流程制定及效果评估的临床研究
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注册号:

Registration number:

ChiCTR-INR-16009662 

最近更新日期:

Date of Last Refreshed on:

2016-10-27 

注册时间:

Date of Registration:

2016-10-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

神经外科加速康复(ERAS)流程制定及效果评估的临床研究 

Public title:

Clinical study on the development and efficacy evaluation of Enhanced Recovery After Surgery (ERAS) in Neurosurgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

神经外科加速康复(ERAS)流程制定及效果评估的临床研究 

Scientific title:

Clinical study on the development and efficacy evaluation of Enhanced Recovery After Surgery (ERAS) in Neurosurgery 

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:

王元 

研究负责人:

贺世明 

Applicant:

Yuan Wang 

Study leader:

Shiming He 

申请注册联系人电话:

Applicant telephone:

+86 18602910802 

研究负责人电话:

Study leader's telephone:

+86 15991387006 

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:

bladerunnerwang@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

guodong.gao55@gmail.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:

陕西省西安市灞桥区新寺路569号 

研究负责人通讯地址:

陕西省西安市灞桥区新寺路569号 

Applicant address:

569 Xinsi Rd, Baqiao District, Xi'an, Shaanxi, China 

Study leader's address:

569 Xinsi Rd, Baqiao District, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710038 

研究负责人邮政编码:

Study leader's postcode:

710038 

申请人所在单位:

第四军医大学唐都医院 

Applicant's institution:

Tangdu Hospital, The Fourth Military Medical 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:

2016007 

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:

第四军医大学唐都医院伦理委员会 

Name of the ethic committee:

Ethical committee of Tangdu Hospital,Fourth Military Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-10-25 

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:

第四军医大学唐都医院神经外科 

Primary sponsor:

Department of neurosurgery, Tangdu Hospital, Fourth Military Medical University  

研究实施负责(组长)单位地址:

陕西省西安市灞桥区新寺路569号 

Primary sponsor's address:

569 Xinsi Rd, Baqiao District, Xi'an, Shaanxi, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西省

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

唐都医院

具体地址:

灞桥区新寺路569号

Institution
hospital:

Tangdu Hospital

Address:

569 Xinsi Rd, Baqiao District, Xi'an, Shaanxi, China

经费或物资来源:

中国国家卫生和计划生育委员会 

Source(s) of funding:

China national health and Family Planning Commission 

研究疾病:

开颅手术,内镜颅底手术,脊柱手术 

Target disease:

Craniotomy, neuro-endoscopic surgery, spine surgery 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探讨基于ERAS方案下,神经外科择期手术的治疗、康复、护理、医疗管理流程的有效性、安全性及可行性 

Objectives of Study:

The current study aims to evaluate the efficacy and safety of neurosurgical treatment, rehabilitation and medical management strategy under ERAS protocol for Neurosurgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)颅脑肿瘤需进行开颅术或神经内镜经鼻蝶等方式手术入路的患者; (2)性别不限,年龄在18-65岁; (3)择期手术患者; (4)能够与医护人员进行良好沟通交流的患者; (5)知情同意,自愿签署“受试者知情同意书”,具有较好依从性患者。 

Inclusion criteria

(1) Patients with brain tumors who need craniotomy or endoscopic transnasal surgery; patients need spina surgery; (2) Age between 18-65 years; (3) Patients of selective surgery; (4) Patients who are able to communicate well with the medical staff; (5) Patients who understand and sign the Informed Consent,with good compliance in the study. 

排除标准:

(1)非颅脑肿瘤患者,如重度颅脑损伤导致双侧瞳孔散大,生命体征不平稳者; (2)儿童(患者小于18岁)、清醒开颅手术者; (3)重度脊髓损伤休克患者; (4)其他外伤致术前心脏骤停、合并严重四肢骨折或胸腹部损伤者; (5)手术区域存在感染或炎症者; (6)严重并发症疾病(血液系统、呼吸系统、消化系统等)患者; (7)严重心脏疾病(如冠心病、心肌梗死病史等)患者; (8)肝功能(ALT、AST)>2倍ULN和/或肾功能(Cr)>1.5倍ULN患者; (9)精神病或严重心理疾病患者; (10)女性6个月内有育儿计划、处于妊娠期或哺乳期的患者; (11)研究者认为其他不适合入组的患者。 

Exclusion criteria:

(1) non-brain tumor patients, such as severe craniocerebral injury leading to bilateral mydriasis, vital signs were not stable; (2) children (patients less than 18 years), awake craniotomy; (3) patients with severe spinal cord injury shock; (4) other trauma caused by preoperative cardiac arrest, combined with severe limb fractures or thoracic and abdominal injury; (5) infection or inflammation in the surgical area; (6) serious complications of disease (blood system, respiratory system, digestive system, etc.) patients; (7) patients with severe heart disease (such as coronary heart disease, myocardial infarction, etc.); (8) Patients with ULN and / or renal function (Cr)> 1.5 times ULN with liver function (ALT, AST)> 2 times; (9) patients with mental illness or severe mental illness; (10) Women who have a childcare plan within 6 months of pregnancy or breastfeeding; (11) Other patients who were considered unsuitable for inclusion in the study. 

研究实施时间:

Study execute time:

From2016-10-26To 2017-03-25 

干预措施:

Interventions:

组别:

ERAS组

样本量:

50

Group:

ERAS Group

Sample size:

干预措施:

围手术期给予神经外科ERAS流程

干预措施代码:

Intervention:

Perioperative ERAS protocol for Neurosurgery

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

传统常规神经外科治疗策略

干预措施代码:

Intervention:

Conventional neurosurgery perioperative management

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shaanxi 

City:

Xi'an 

单位(医院):

唐都医院 

单位级别:

三甲 

Institution
hospital:

Tangdu Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

输血量

指标类型:

主要指标 

Outcome:

Blood transfusion volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operational time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

VAS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口并发症

指标类型:

主要指标 

Outcome:

Wound complication

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时间

指标类型:

主要指标 

Outcome:

Length of stay after surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经电生理检测

指标类型:

主要指标 

Outcome:

electroneurophysiological monitoring

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中补液量

指标类型:

主要指标 

Outcome:

intraoperative fluid infusion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

KPS评分

指标类型:

主要指标 

Outcome:

KPS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症发生率

指标类型:

主要指标 

Outcome:

Postoperative complication rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

预防性抗血栓治疗

指标类型:

主要指标 

Outcome:

Preventive antithrombotic therapy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口备皮方式

指标类型:

主要指标 

Outcome:

skin preparation method

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前术后营养

指标类型:

主要指标 

Outcome:

Preoperative fasting water treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失血量

指标类型:

主要指标 

Outcome:

intraoperational blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口缝合方式

指标类型:

主要指标 

Outcome:

Incision suture method

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

引流管放置

指标类型:

主要指标 

Outcome:

Drainage tube placement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

癫痫预防

指标类型:

主要指标 

Outcome:

Prevention of epilepsy treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心呕吐处理

指标类型:

主要指标 

Outcome:

Nausea, vomiting treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

主要指标 

Outcome:

Hospitalization cost

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛处理

指标类型:

主要指标 

Outcome:

Postoperative pain management

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黏膜保护

指标类型:

主要指标 

Outcome:

mucosa protection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养风险筛查评分

指标类型:

主要指标 

Outcome:

NRS2002

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麻醉风险评分

指标类型:

主要指标 

Outcome:

ASA score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恶心呕吐预防

指标类型:

主要指标 

Outcome:

PONV prevention

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后留置尿管时间

指标类型:

主要指标 

Outcome:

Foley's catheter placement time

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:

血液

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

临床研究助理使用电脑产生随机数,信封法

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

The clinical research assistant use the computer to generate the random number. sealed envelopes

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2017-10-26

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

2017-10-26

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:

Excel 2013

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

Excel 2013

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-10-27
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