今天是:2019-06-17 星期一

三种手术方式治疗单侧甲状腺癌临床效果的前瞻性随机对照研究
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注册号:

Registration number:

ChiCTR1900020669 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

三种手术方式治疗单侧甲状腺癌临床效果的前瞻性随机对照研究 

Public title:

A randomized controlled trial for three thyroid surgery methods in the treatment of unilateral thyroid cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

三种手术方式治疗单侧甲状腺癌临床效果的前瞻性随机对照研究 

Scientific title:

A randomized controlled trial for three thyroid surgery methods in the treatment of unilateral thyroid cancer 

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:

侯建忠 

研究负责人:

伍波 

Applicant:

Hou Jianzhong 

Study leader:

Wu Bo 

申请注册联系人电话:

Applicant telephone:

+86 15316081776 

研究负责人电话:

Study leader's telephone:

+86 18930172932 

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:

jzHou705@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wubo_2932@163.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:

上海市宜山路600号 

研究负责人通讯地址:

上海市宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海交通大学附属第六人民医院 

Applicant's institution:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

上海交通大学附属第六人民医院 

Primary sponsor:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市宜山路600号 

Primary sponsor's address:

Department of General Surgery Shanghai Jiao Tong University Affiliated Sixth People’s Hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属第六人民医院

具体地址:

上海市宜山路600号

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Shanghai

经费或物资来源:

自费 

Source(s) of funding:

Self-pay 

研究疾病:

甲状腺癌 

Target disease:

thyroid cancer 

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:

I期临床试验 

Study phase:

研究目的:

观察经口腔前庭入路、Miccoli以及传统开放入路三种处理单侧甲状腺癌的临床结局,以获得单侧分化型甲状腺癌处理的最佳策略,提高病人的术后满意度,降低术后并发症,为外科医生的手术决策提供强有力的依据。 

Objectives of Study:

To observe the clinical outcomes of unilateral thyroid cancer treated by oral vestibular approach, Miccoli and traditional open approach to obtain the best strategy for unilaterally differentiated thyroid cancer, and improve postoperative satisfaction and reduce postoperative complications. The disease provides a strong basis for surgeons' surgical decisions. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1.年龄18-60岁的单侧分化型甲状腺癌患者; 2.肿块最大直径<3 cm; 3.病人已同意签署知情同意书。 

Inclusion criteria

1. Patients with unilaterally differentiated thyroid cancer aged 18-60 years; 2. The maximum diameter of the mass is <3 cm; 3. The patient has agreed to sign the informed consent form. 

排除标准:

1.未分化甲状腺癌; 2.双侧甲状腺手术; 3.单侧甲状腺良性肿瘤患者; 4.继发性甲亢; 5.术前麻醉评分高于ASA III; 6.对本试验中使用的药物存在过敏、禁忌; 7.存在严重的凝血功能障碍、神经系统疾病或传染性疾病; 8.严重心、肝、肾及血液系统疾病; 9.颈部手术史; 

Exclusion criteria:

1. Undifferentiated thyroid cancer; 2. bilateral thyroid surgery; 3. Patients with unilateral thyroid benign tumors; 4. Secondary hyperthyroidism; 5. Preoperative anesthesia score is higher than ASA III; 6. Allergies and contraindications to the drugs used in this test; 7. With severe coagulopathy, nervous system diseases or infectious diseases; 8. With serious heart, liver, kidney and blood system diseases; 9. With history of surgery in the neck. 

研究实施时间:

Study execute time:

From2019-02-01To 2020-01-31 

干预措施:

Interventions:

组别:

经口腔前庭入路组

样本量:

40

Group:

Oral vestibular approach group

Sample size:

干预措施:

经口腔前庭入路单侧甲状腺癌手术治疗

干预措施代码:

Intervention:

Surgical treatment of unilateral thyroid cancer via oral vestibular approach

Intervention code:

组别:

Miccoli组

样本量:

40

Group:

Miccoli group

Sample size:

干预措施:

Miccoli单侧甲状腺癌手术治疗

干预措施代码:

Intervention:

Miccoli unilateral thyroid cancer surgery

Intervention code:

组别:

传统开放入路组

样本量:

40

Group:

Traditional open access group

Sample size:

干预措施:

传统开放入路单侧甲状腺癌手术治疗

干预措施代码:

Intervention:

Traditional open approach unilateral thyroid cancer surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属第六人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后疼痛评分

指标类型:

主要指标 

Outcome:

Postoperative pain 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:

术后美容评分

指标类型:

主要指标 

Outcome:

Postoperative cosmetic 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:

术后炎症指标

指标类型:

主要指标 

Outcome:

Postoperative inflammation index

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:

次要指标 

Outcome:

operation time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中失血量

指标类型:

次要指标 

Outcome:

Intraoperative blood loss

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后首日引流量

指标类型:

次要指标 

Outcome:

First day after delivery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

清扫淋巴结数及阳性淋巴结数(以术后病理为准)

指标类型:

次要指标 

Outcome:

Number of lymph nodes and positive lymph nodes (based on postoperative pathology)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

误切甲状旁腺个数(以术后病理为准)

指标类型:

次要指标 

Outcome:

Miscuts of parathyroid glands (based on postoperative pathology)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

The number of days in hospital

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口感染

指标类型:

次要指标 

Outcome:

Incision infection

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后出血

指标类型:

次要指标 

Outcome:

Postoperative bleeding

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

是否复发

指标类型:

次要指标 

Outcome:

Whether to relapse

Type:

Secondary 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:

组织:

Sample Name:

No

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 80 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):

由病例纳入者利用计算机软件SPSS生成的随机表而进行,按1:1:1将患者随机分配入经口腔前庭入路组、Miccoli组以及传统开放入路。参与手术的人员及患者在术前均不知晓研究分组情况。

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

Case inclusions were performed using a random table generated by computer software SPSS, and patients were randomly assigned to the oral vestibular approach group, the Miccoli group, and the traditional open approach at 1:1:1. The patients and patients involved in the operation were not aware of the study g

盲法:

未说明

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):

数据上传到中国临床试验注册中心

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

Data uploaded to the China Clinical Trial Registry

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:

研究结果用 Epidata 软件录入,实行双份核对

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

The results were entered using Epidata software and double-checked

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-12
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