Today is 2019-12-13

The accuracy and safety of radiofrequency thermocoagulation theraphy of semilunar ganglion assisted by cooperative robot in the treatment of trigeminal neuralgia: a prospective randomized controlled trial
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注册号:

Registration number:

ChiCTR1900023773 

最近更新日期:

Date of Last Refreshed on:

2019-06-11 

注册时间:

Date of Registration:

2019-06-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

协作机器人辅助半月神经节射频热凝术治疗三叉神经痛精准性与安全性分析:一项前瞻性随机对照研究 

Public title:

The accuracy and safety of radiofrequency thermocoagulation theraphy of semilunar ganglion assisted by cooperative robot in the treatment of trigeminal neuralgia: a prospective randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

协作机器人辅助半月神经节射频热凝术治疗三叉神经痛精准性与安全性分析:一项前瞻性随机对照研究 

Scientific title:

The accuracy and safety of radiofrequency thermocoagulation theraphy of semilunar ganglion assisted by cooperative robot in the treatment of trigeminal neuralgia: a prospective randomized controlled trial 

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:

王然 

研究负责人:

陆丽娟 

Applicant:

Ran Wang 

Study leader:

Lijuan Lu 

申请注册联系人电话:

Applicant telephone:

+86 13912043223 

研究负责人电话:

Study leader's telephone:

+86 18606190038 

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:

842335319@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

932200932@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:

江苏省南京市中山路321号 

研究负责人通讯地址:

江苏省南京市中山路321号 

Applicant address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210008 

研究负责人邮政编码:

Study leader's postcode:

210008 

申请人所在单位:

南京大学医学院附属鼓楼医院 

Applicant's institution:

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School  

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:

沙莉莉 

Contact Name of the ethic committee:

Sha lili 

伦理委员会联系地址:

江苏省南京市鼓楼区中山路321号鼓楼医院  

Contact Address of the ethic committee:

321 Zhongshan Road, Gulou District, Nanjing, Jiangsu, 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:

南京大学医学院附属鼓楼医院 

Primary sponsor:

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School  

研究实施负责(组长)单位地址:

江苏省南京市中山路321号 

Primary sponsor's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京大学医学院附属鼓楼医院

具体地址:

江苏省南京市中山路321号

Institution
hospital:

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School

Address:

321 Zhongshan Road, Nanjing, Jiangsu, China

经费或物资来源:

Nil 

Source(s) of funding:

Nil 

研究疾病:

三叉神经痛 

Target disease:

trigeminal neuralgia  

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:

其它 

Study phase:

N/A 

研究目的:

评价协作机器人辅助半月神经节射频热凝术治疗原发性三叉神经痛的精准性与安全性。 

Objectives of Study:

To evaluate the accuracy and safety of radiofrequency thermocoagulation therapy of semilunar ganglion assisted by cooperative robot in the treatment of primary trigeminal neuralgia. 

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、原发性三叉神经痛患者;2、药物保守治疗无效或副作用不能耐受,BNI III-V级;3、年龄>18岁; 4、愿意接受经卵圆孔半月神经节射频热凝术,签署知情同意书。 

Inclusion criteria

1. Patients who is diagnosed with primary trigeminal neuralgia; 2. Drug conservative treatment ineffective or side effects intolerable, BNI III-V grade; 3. Older than 18 years old; 4. Willing to accept radiofrequency thermocoagulation of semilunar ganglion through foramen ovale and sign informed consent. 

排除标准:

1、未控制的严重高血压、心脏病等疾病,不能耐受手术;2、凝血功能障碍;3、穿刺部位感染;4、精神障碍,不能配合手术;5、牙齿缺失或其他因素导致颊部皮肤明显凹陷;6、疼痛部位包含三叉神经V1支。 

Exclusion criteria:

1. Uncontrolled severe hypertension, heart disease, etc., unable to tolerate surgery; 2. Coagulation disorders; 3. puncture site infection; 4. Patients with mental handicap; 5. Loss of teeth or other factors leading to obvious depression of buccal skin; 6. The pain site contains the V1 branch of the trigeminal nerve. 

研究实施时间:

Study execute time:

From2019-08-01To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

24

Group:

Experimental group

Sample size:

干预措施:

协作机器人辅助经卵圆孔半月神经节射频热凝术

干预措施代码:

Intervention:

radiofrequency thermocoagulation therapy of semilunar ganglion through foramen ovale assisted by cooperative robot

Intervention code:

组别:

对照组

样本量:

24

Group:

Control group

Sample size:

干预措施:

无导航经卵圆孔半月神经节射频热凝术

干预措施代码:

Intervention:

radiofrequency thermocoagulation therapy of semilunar ganglion without navigation through foramen ovale

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

一次穿刺成功率

指标类型:

主要指标 

Outcome:

one-time success rate of puncture

Type:

Primary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

during the operation

Measure method:

指标中文名:

穿刺次数

指标类型:

次要指标 

Outcome:

times of puncture

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

during the operation

Measure method:

指标中文名:

穿刺时间

指标类型:

次要指标 

Outcome:

time of puncture

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

during the operation

Measure method:

指标中文名:

手术时间

指标类型:

次要指标 

Outcome:

time of operation

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

during the operation

Measure method:

指标中文名:

麻木、肌力减退等不良反应

指标类型:

副作用指标 

Outcome:

complications include the numbness and decreased myodynamia

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛强度评分

指标类型:

附加指标 

Outcome:

numeric rating scales

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

巴罗神经研究所评分

指标类型:

附加指标 

Outcome:

Barrow Neurological Institute

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

整体感知疗效评分

指标类型:

附加指标 

Outcome:

Global perceived effect scale

Type:

Additional 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age >18 years
最大 Max age 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):

研究负责人通过Excel软件随机分组法产生随机序列

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

Study leader generates random sequence through Excel software random grouping method.

盲法:

未说明

Blinding:

Not stated

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:

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6月

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

june 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:

CRF表

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

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-06-11
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