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无止血带下全膝关节置换术后切口加压 包扎与非加压包扎的临床效果对比研究
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注册号:

Registration number:

ChiCTR2000034144 

最近更新日期:

Date of Last Refreshed on:

2020-06-26 

注册时间:

Date of Registration:

2020-06-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

无止血带下全膝关节置换术后切口加压 包扎与非加压包扎的临床效果对比研究 

Public title:

Comparative Research on Clinical Result of Pressure Dressing and Non-pressure Dressing of Incision Site after Total Knee Replacement Surgery without Tourniquet 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

无止血带下全膝关节置换术后切口加压 包扎与非加压包扎的临床效果对比研究 

Scientific title:

Comparative Research on Clinical Result of Pressure Dressing and Non-pressure Dressing of Incision Site after Total Knee Replacement Surgery without Tourniquet 

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:

邓立庆 

研究负责人:

邓立庆 

Applicant:

Deng Liqing 

Study leader:

Deng Liqing 

申请注册联系人电话:

Applicant telephone:

+86 18728486525 

研究负责人电话:

Study leader's telephone:

+86 18728486525 

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:

604982346@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

604982346@qq.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:

四川省成都市洗面桥横街20号 

研究负责人通讯地址:

四川省成都市洗面桥横街20号 

Applicant address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China  

Study leader's address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China  

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:

西藏自治区人民政府驻成都办事处医院 

Applicant's institution:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region 

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:

(2019)年科研第58号 

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:

西藏自治区人民政府驻成都办事处医院伦理委员会  

Name of the ethic committee:

Ethics Committee of Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-12 

伦理委员会联系人:

王溯源 

Contact Name of the ethic committee:

Wang suyuan 

伦理委员会联系地址:

四川省成都市洗面桥横街20号 

Contact Address of the ethic committee:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China  

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:

西藏自治区人民政府驻成都办事处医院 

Primary sponsor:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region  

研究实施负责(组长)单位地址:

四川省成都市洗面桥横街20号 

Primary sponsor's address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

西藏自治区人民政府驻成都办事处医院

具体地址:

四川省成都市洗面桥横街20号

Institution
hospital:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region

Address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China

经费或物资来源:

四川省医学会 

Source(s) of funding:

Sichuan medical association  

研究疾病:

膝关节疾病 

Target disease:

Knee joint disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1、对比研究在不使用止血带情况下行全膝关节置换术后切口加压包扎与非加压包扎、放置引流管与不放置引流管的临床效果及对术后早期功能康复的影响。 2、探讨在不使用止血带的情况下结合术中控制性降压,有效的术中止血,同时联合氨甲环酸的静脉、局部使用,切口无需加压包扎及放置引流管。 

Objectives of Study:

1. Comparative study of the clinical effects of pressurized and unpressurized dressing of incision, placement of drainage tube and absence of drainage tube after total knee replacement without the use of tourniquet, and the influence on the early postoperative functional recovery; 2. To explore the effective intraoperative hemostasis in combination with intraoperative controlled hypotension without the use of tourniquet; meanwhile, combined with the intravenous and local use of trantranylic acid, the incision does not need compression dressing and drainage tube placement. 

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 初次单侧全膝关节置换者; ② 术前凝血功能正常; ③ 均在全麻下手术; ④ 所有患者均物理预防+药物预防血栓。 

Inclusion criteria

1. For the first unilateral total knee arthroplasty; 2. Normal coagulation function before surgery; 3. All were operated under general anesthesia; 4. All patients are physical prevention drug prevention thrombosis.  

排除标准:

① 术前存在深静脉血栓者; ②一期双膝置换、翻修、单髁置换者; ③ 抗凝禁忌症者(血友病等); ④ 肝素过敏者; ⑤ 膝关节严重畸形者:内翻>25°、外翻>20°。 ⑥ 精神行为异常、认知障碍者。 

Exclusion criteria:

1. Patients with preoperative deep vein thrombosis; 2. Primary double knee replacement, revision, unicondylar replacement; 3. Anticoagulation contraindications (hemophilia, etc.); 4. People with heparin allergy; 5. severe deformity of the knee joint: valgus > 25 degree, valgus > 20 degree; 6. People with mental and behavioral disorders and cognitive disorders. 

研究实施时间:

Study execute time:

From2020-08-01To 2021-07-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-07-31 

干预措施:

Interventions:

组别:

4

样本量:

160

Group:

Four

Sample size:

干预措施:

-

干预措施代码:

Intervention:

-

Intervention code:

组别:

Group 1

样本量:

40

Group:

Group 1

Sample size:

干预措施:

切口加压包扎引流

干预措施代码:

Intervention:

Pressure dressing of incision drainage

Intervention code:

组别:

Group 2

样本量:

40

Group:

Group 2

Sample size:

干预措施:

加压包扎非引流

干预措施代码:

Intervention:

Pressure dressing incision not drainage

Intervention code:

组别:

Group 3

样本量:

40

Group:

Group 3

Sample size:

干预措施:

非加压包扎引流

干预措施代码:

Intervention:

Not pressure dressing incision drainage

Intervention code:

组别:

Group 4

样本量:

40

Group:

Group 4

Sample size:

干预措施:

非加压包扎非引流

干预措施代码:

Intervention:

Not pressure dressing incision not drainage

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

西藏自治区人民政府驻成都办事处医院 

单位级别:

三甲医院 

Institution
hospital:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

NumericalPainRating Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿胀程度

指标类型:

主要指标 

Outcome:

joint swell degree

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节活动度

指标类型:

主要指标 

Outcome:

Range of motion of knee joint

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢深静脉血栓的发生率

指标类型:

主要指标 

Outcome:

ncidence of deep venous thrombosis in lower extremity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

围手术期总失血量

指标类型:

主要指标 

Outcome:

Total perioperative blood loss

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:

膝关节

组织:

Sample Name:

knee-joint

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 years
最大 Max age 100 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):

由手术医生通过随机抽签的办法决定

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

It will be decided by the surgeon through a random lottery

盲法:

Not stated

Blinding:

Not stated

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):

2021年12月

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

December 2021

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:

病例记录表

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

casebook

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-06-26
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