Today is 2020-01-26

Comparison of the effect of intervertebral foramen decompression on lumbar disc herniation
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注册号:

Registration number:

ChiCTR1900023561 

最近更新日期:

Date of Last Refreshed on:

2019-06-02 

注册时间:

Date of Registration:

2019-06-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

孟强医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 椎间孔镜单双侧减压治疗腰椎间盘突出疗效对比 

Public title:

Comparison of the effect of intervertebral foramen decompression on lumbar disc herniation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

椎间孔镜单双侧减压治疗腰椎间盘突出疗效对比 

Scientific title:

Comparison of the effect of intervertebral foramen decompression on lumbar disc herniation 

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:

孟强 

研究负责人:

吴继彬 

Applicant:

Meng Qiang 

Study leader:

Wu Jibin 

申请注册联系人电话:

Applicant telephone:

+86 15705207076 

研究负责人电话:

Study leader's telephone:

+86 15755386195 

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:

836988673@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

310793926@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:

江苏省徐州市泉山区风化街研究生宿舍 

研究负责人通讯地址:

江苏省徐州市泉山区淮海西路44号 

Applicant address:

Postgraduate Dormitory, Fenghua Street, Quanshan District, Xuzhou, Jiangsu, China 

Study leader's address:

44 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

221002 

研究负责人邮政编码:

Study leader's postcode:

221002 

申请人所在单位:

徐州医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Xuzhou Medical University 

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:

徐州医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市泉山区淮海西路44号 

Primary sponsor's address:

44 Huaihai Road West, Quanshan District, Xuzhou, 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):

江苏省

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州医科大学附属医院

具体地址:

泉山区淮海西路44号

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University

Address:

44 Huaihai Road West, Quanshan District

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

腰椎间盘突出症 

Target disease:

lumbar disc herniation 

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:

探讨采用内镜下椎板间入路腰椎髓核切除术治疗对侧症状腰椎间盘突出症的患者,行单双侧减压的术后效果。 

Objectives of Study:

To investigate the efficacy of unilateral and bilateral decompression in the treatment of contralateral lumbar disc herniation by percutaneous endoscopic interlaminar disectomy. 

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病人存在腰部及下肢疼痛,直腿抬高试验阳性。②各项检查完善,且CT或MRI检查见单一节段腰椎间盘突出,并且症状由此节段引发,但左右相反。③经保守治疗超过3个月症状未见明显缓解甚至加重者。 ④患者要求手术治疗。 

Inclusion criteria

1. the patient had low back and lower extremity pain, and the straight leg elevation test was positive; 2. the examination was perfect, and CT or MRI showed single segment lumbar disc protrusion, and the symptoms were caused by this segment. But the left and right side opposite; 3. after conservative treatment for more than 3 months, the symptoms were not significantly relieved or even aggravated; 4. The patients requested surgical treatment. 

排除标准:

①肿瘤、感染等非退变疾病。②合并有后纵韧带骨化,腰椎滑脱等不宜行微创治疗者。③无法耐受较长时间俯卧位者。 

Exclusion criteria:

1. tumor, infection and other non-degenerative diseases; 2. patients with ossification of posterior longitudinal ligament and lumbar spondylolisthesis should not be treated with minimally invasive treatment; 3. those who could not tolerate prone position for a long time. 

研究实施时间:

Study execute time:

From2019-06-30To 2020-05-01 

干预措施:

Interventions:

组别:

A组

样本量:

20

Group:

Group A

Sample size:

干预措施:

单侧减压

干预措施代码:

Intervention:

Unilateral decompression

Intervention code:

组别:

B组

样本量:

20

Group:

Group B

Sample size:

干预措施:

双侧减压

干预措施代码:

Intervention:

Bilateral decompression

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):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

视觉疼痛模拟评分

指标类型:

主要指标 

Outcome:

visual analogue scale

Type:

Primary indicator 

测量时间点:

患者入院时,术后,术后1,3,6个月

测量方法:

电话或邮件随访

Measure time point of outcome:

At the time of admission, 1, 3, 6 months after surgery

Measure method:

Follow up by phone or email

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No sample

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 17 years
最大 Max age 70 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):

本人采用Matlab生成随机序列

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

I use Matlab to generate random sequences

盲法:

open

Blinding:

open

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):

请填写公共原始数据的日期和方式

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

请填写公共原始数据的日期和方式

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:

请填写数据采集和管理的方式

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

请填写数据采集和管理的方式

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-02
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