今天是:2019-06-20 星期四

内镜下经椎间孔入路与层间入路椎间盘切除术治疗L5/S1椎间盘突出的对比:一项随机对照试验研究方案
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注册号:

Registration number:

ChiCTR1900022549 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

内镜下经椎间孔入路与层间入路椎间盘切除术治疗L5/S1椎间盘突出的对比:一项随机对照试验研究方案 

Public title:

Percutaneous endoscopic transforaminal discectomy versus interlaminar discectomy for L5/S1 disc herniation: a randomised controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经皮内镜下手术入路与椎间盘突出 

Scientific title:

percutaneous endoscopic lumbar discectomy for lumbar disc herniation 

研究课题代号(代码):

Study subject ID:

省自然科学基金(Grant No. LY17H060009)和温州医科大学附属第二医院、育英儿童医院临床研究基金(Grant No. SAHoWMU-CR2017-08-106) 

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:

倪文飞 

研究负责人:

倪文飞 

Applicant:

Wenfei Ni 

Study leader:

Wenfei Ni 

申请注册联系人电话:

Applicant telephone:

+86 18367816115 

研究负责人电话:

Study leader's telephone:

+86 18367816115 

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:

wenfeini@yeah.net 

研究负责人电子邮件:

Study leader's E-mail:

wenfeini@yeah.net 

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:

浙江省温州市鹿城区学院西路109号 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路109号 

Applicant address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, China 

Study leader's address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Wenzhou 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:

浙江省温州医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Wenzhou Medical University  

研究实施负责(组长)单位地址:

浙江省温州市鹿城区学院西路109号 

Primary sponsor's address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, 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):

浙江省

市(区县):

温州市

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

浙江省温州医科大学附属第二医院

具体地址:

浙江省温州市鹿城区学院西路109号

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University

Address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, China

经费或物资来源:

省自然科学基金(Grant No. LY17H060009)和温州医科大学附属第二医院、育英儿童医院临床研究基金(Grant No. SAHoWMU-CR2017-08-106) 

Source(s) of funding:

This work is supported by Natural Science Foundation of Zhejiang Province (Grant No. LY17H060009) and Clinical Research Foundation of the Second Affiliated Hospital and Yuying Children’s Hospital of W 

研究疾病:

腰椎间盘突出 

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:

探讨不同入路的经皮内镜治疗L5/S1椎间盘突出的疗效,并为治疗L5/S1椎间盘突出患者提供建议。 

Objectives of Study:

This randomised controlled trial (RCT) was designed to compare the efficacy and safety of PETD with PEID for L5/S1 LDH. The results will provide more reliable evidence and recommendations for the treatment of patients with L5/S1 LDH. 

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.≥18岁的成年患者 2.明显的临床症状,并伴有背部和/或腿部疼痛 3.符合临床症状和体征的中央、中央旁或脱垂L5/S1椎间盘突出 4.保守治疗失败超过12周 

Inclusion criteria

1. Aged ≥18 years; 2. Obvious symptoms accompanied by back and/or leg pain; 3. Central, paracentral, or prolapsed L5/S1 disc herniation consistent with clinical symptoms and signs; 4. Failure of conservative treatment for more than 12 weeks. 

排除标准:

1. 椎间盘炎或结核,复发性椎间盘突出,多节段椎间盘突出,腰椎不稳,如腰椎滑脱,广泛的腰椎管狭窄,和极外侧椎间盘突出 2. 曾在同一腰椎段做过手术 3. 活动性感染或有手术部位的先前感染 4. 计划在收录后两年内向国外移民 5. 患疾病或长期服用某种药物对脊柱稳定环境产生影响,如代谢性骨病,脊柱结核,全身糖皮质激素或免疫抑制剂治疗中等 6. 目前使用抗凝血剂(或华法林)或术后肝素治疗超过6个月 

Exclusion criteria:

1. Intervertebral disc inflammation or tuberculosis, recurrent disc herniation, multiple segments of disc herniation, lumbar instability, such as lumbar spondylolisthesis, widely lumbar stenosis, and far lateral lumbar disc herniation; 2. They had a history of operation on the same lumbar vertebral segment; 4. Active infection or previous infection at the surgical site; 5. Plan to emigration within 2 years after enrollment; 6. Current use of anticoagulants (e.g. warfarin) or postoperative use of heparin for more than 6 months. 

研究实施时间:

Study execute time:

From2019-12-31To 2023-12-31 

干预措施:

Interventions:

组别:

侧入

样本量:

70

Group:

PETD

Sample size:

干预措施:

椎间孔入路

干预措施代码:

Intervention:

using PETD

Intervention code:

组别:

后入

样本量:

70

Group:

PEID

Sample size:

干预措施:

板间入路

干预措施代码:

Intervention:

using PEID

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

温州市 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

浙江省温州医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operative time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中放射时间

指标类型:

主要指标 

Outcome:

intraoperative fluoroscopy time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

主要指标 

Outcome:

complication

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失血量

指标类型:

主要指标 

Outcome:

intraoperative blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后卧床时间

指标类型:

主要指标 

Outcome:

postoperative bed rest time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

hospitalization time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS评分

指标类型:

次要指标 

Outcome:

VAS scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ODI评分

指标类型:

次要指标 

Outcome:

ODI scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

JOA评分

指标类型:

次要指标 

Outcome:

JOA scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良的MacNab评分

指标类型:

次要指标 

Outcome:

modified MacNab scores

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:

nothing

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:

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):

本研究团队中一名不参与治疗及康复的骨科医师,采用随机信封的方式随机将病人分组。

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

An orthopedic surgeon in the study team who was not involved in the treatment and rehabilitation randomly divided the patients into groups using random envelopes.

盲法:

双盲

Blinding:

A randomised controlled trial with blinding of patients and the statistician, but not the clinicians and researchers, will be conducted.

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

论文发表见刊后,可邮箱传递

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

Paper published in the journal, can be delivered by mail

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:

数据采用Excel数据保存,SPSS 19.0 进行数据统计

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

The data were saved by Excel and analyzed by SPSS19.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-16
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