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加速康复外科理念应用于择期剖宫产手术的效价分析
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注册号:

Registration number:

ChiCTR1900025456 

最近更新日期:

Date of Last Refreshed on:

2019-08-26 

注册时间:

Date of Registration:

2019-08-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

加速康复外科理念应用于择期剖宫产手术的效价分析 

Public title:

Effectiveness analysis of the application of enhanced recovery after surgery to cesarean section 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

加速康复外科理念应用于择期剖宫产手术的效价分析 

Scientific title:

Effectiveness analysis of the application of enhanced recovery after surgery to cesarean section 

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:

周少丽 

研究负责人:

周少丽 

Applicant:

Shaoli Zhou 

Study leader:

Shaoli Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13610272308 

研究负责人电话:

Study leader's telephone:

+86 13610272308 

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:

13610272308@139.com 

研究负责人电子邮件:

Study leader's E-mail:

13610272308@139.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:

广东省广州市天河路600号中山大学附属第三医院麻醉科 

研究负责人通讯地址:

广东省广州市天河路600号中山大学附属第三医院麻醉科 

Applicant address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China 

Study leader's address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510630 

研究负责人邮政编码:

Study leader's postcode:

510630 

申请人所在单位:

中山大学附属第三医院 

Applicant's institution:

The Third Affiliated Hospital of Sun Yat-sen 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:

201902-338-01 

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:

中山大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the third affiliated hospital of Sun Yat-sen university 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

黄桂珍 

Contact Name of the ethic committee:

Guizhen Huang 

伦理委员会联系地址:

广东省广州市天河路600号中山大学附属第三医院 

Contact Address of the ethic committee:

The Third Affiliated Hospital of Sun Yat-sen university, 600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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:

中山大学附属第三医院 

Primary sponsor:

The Third Affiliated Hospital of Sun Yat-sen university 

研究实施负责(组长)单位地址:

广东省广州市天河路600号中山大学附属第三医院麻醉科 

Primary sponsor's address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第三医院

具体地址:

广东省广州市天河路600号中山大学附属第三医院麻醉科

Institution
hospital:

The Third Affiliated Hospital of Sun Yat-sen university

Address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised funds 

研究疾病:

剖宫产 

Target disease:

cesarean section 

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究通过前瞻性研究分析行择期剖宫产手术的患者,应用加速康复外科理念是否在产后抑郁发生率、术后住院时间、住院花费、疼痛管理、术后并发症、患者满意度等方面产生明显优势。 

Objectives of Study:

In this study, a prospective study was conducted to analyze the patients who underwent elective cesarean section surgery, and whether the application of accelerated rehabilitation surgery concept had significant advantages in the incidence of postpartum depression, postoperative hospitalization time, hospitalization cost, pain management, postoperative complications, patient satisfaction and other aspects. 

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:

2019年5月-2019年10月,年龄25岁-45岁,ASAⅠ-Ⅱ级,行择期剖宫产的200名产妇。 

Inclusion criteria

In May 2019 - in October 2019, aged 25 to 45 years old, ASA I / II, 200 women underwent elective cesarean section 

排除标准:

术前合并有精神异常等产后抑郁危险因素的产妇严重妊娠期高血压疾病、子痫、子痫前期,严重妊娠期甲状腺疾病产妇;胎盘植入、前置胎盘患者;合并严重心律不齐、心肺功能障碍、严重糖尿病等产妇,胃肠排空障碍的产妇;术前一般情况极差、不能配合围术期ERAS策略者;一个月内行其他器官系统重大手术者;同时参加其他临床研究者;拒绝参与本项研究的产妇。 

Exclusion criteria:

Pregnant women with severe gestational hypertension, eclampsia, preeclampsia, and severe thyroid disease during pregnancy who had mental disorders and other risk factors for postpartum depression before operation;Placental implantation, placenta previa; Parturients with severe arrhythmia, cardiopulmonary dysfunction, severe diabetes mellitus, gastrointestinal emptying disorder; The preoperative general situation is extremely poor and cannot match the perioperative ERAS strategy; Major operation on other organs within one month; Join other clinical investigators; Women who refused to participate in the study. 

研究实施时间:

Study execute time:

From2019-10-01To 2020-03-31 

征募观察对象时间:

Recruiting time:

From2019-10-01To 2020-03-31 

干预措施:

Interventions:

组别:

ERAS组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

术前宣教; 预防性缩宫素的使用; 预防术后恶心呕吐; 预防术中低体温; 避免体液超载; 术后镇痛; 促进胃肠功能恢复; 术后早期下床活动

干预措施代码:

Intervention:

Preoperative education; Prophylactic use of oxytocin; Prevent postoperative nausea and vomiting; Prevention of intraoperative hypothermia; Avoid fluid overload; postoperative analgesia; Promote gastrointestinal function recovery; early activity

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital of Sun Yat-sen university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

是否呕吐

指标类型:

主要指标 

Outcome:

emesis

Type:

Primary indicator 

测量时间点:

术后2小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

pain

Type:

Primary indicator 

测量时间点:

术后2小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活动情况

指标类型:

主要指标 

Outcome:

progress of activity

Type:

Primary indicator 

测量时间点:

术后2小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

pain

Type:

Primary indicator 

测量时间点:

术后24小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

pain

Type:

Primary indicator 

测量时间点:

术后48小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SAS抑郁评分

指标类型:

主要指标 

Outcome:

SAS depression score

Type:

Primary indicator 

测量时间点:

术后第2天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

爱丁堡抑郁评分

指标类型:

主要指标 

Outcome:

Edinburgh depression score

Type:

Primary indicator 

测量时间点:

术后第2天

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 45 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

产妇入院明确诊断后,由产科医生通过随机数字表对其进行分组,随机分为ERAS组(100例)及常规治疗组组(对照组)(100例)。由于ERAS策略与传统方式的明显差异,产妇及外科医生、麻醉医生、手术室及病房护士无法做到盲法。术后随访、数据录入及分析由专人负责,且在不知道具体分组的情况下进行记录和分析。

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

ERAS group (100 cases) and the conventional treatment group (100 cases) were randomly divided into ERAS group (100 cases) and control group (100 cases).Because ERAS 'strategy is so different from the traditional one, the women and surgeons, anesthesiologists, operating room and ward nurses cannot be blinded.Postope

盲法:

产妇入院明确诊断后,由产科医生通过随机数字表对其进行分组,随机分为ERAS组(100例)及常规治疗组组(对照组)(100例)。由于ERAS策略与传统方式的明显差异,产妇及外科医生、麻醉医生、手术室及病房护士无法做到盲法。术后随访、数据录入及分析由专人负责,且在不知道具体分组的情况下进行记录和分析。

Blinding:

ERAS group (100 cases) and the conventional treatment group (100 cases) were randomly divided into ERAS group (100 cases) and control group (100 cases).Because ERAS 'strategy is so different from the traditional one, the women and surgeons, anesthesiologists, operating room and ward nurses cannot be blinded.Postoperative follow-up, data entry and analysis were performed by special personnel without knowing the specific group.

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):

https://www.zssy.com.cn

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

https://www.zssy.com.cn

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(Case Record Form, CRF)

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-26
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