ChiCTR2000038528 版本V1.3 版本创建时间2020/11/29 20:28:42 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000038528 

最近更新日期：

Date of Last Refreshed on：

 2020-11-29 20:25:19 

注册时间：

Date of Registration：

 2020-09-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

请于伦理委员会批准后才开始征募参试者，并与我们联系上传伦理批件 超声引导泡沫硬化疗法联合大隐静脉高位结扎术治疗严重下肢静脉曲张的前瞻性病例对照研究

Public title：

A prospective case-control study of ultrasourd-guided foam sclerotherapy combined with high ligation of the great saphenous vein in the treatment of severe varicose veins in lower extremities

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声引导泡沫硬化疗法联合大隐静脉高位结扎术治疗严重下肢静脉曲张的前瞻性病例对照研究

Scientific title：

A prospective case-control study of ultrasourd-guided foam sclerotherapy combined with high ligation of the great saphenous vein in the treatment of severe varicose veins in lower extremities

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：

张海鹰 

研究负责人：

张海鹰 

Applicant：

Haiying Zhang 

Study leader：

Haiying Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 15871701138

研究负责人电话：

Study leader's
telephone：

+86 15871701138

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：

 haiyingzhangz@126.com

研究负责人电子邮件：

Study leader's E-mail：

 haiyingzhangz@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 中国人民解放军联勤保障部队第九二八医院

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：

海南省海口市龙昆南路口100号第九二八医院

研究负责人通讯地址：

海南省海口市龙昆南路口100号第九二八医院

Applicant address：

100 South Longkun Road, Haikou, Hai'nan, China

Study leader's address：

100 South Longkun Road, Haikou, Hai'nan, China

申请注册联系人邮政编码：

Applicant postcode：

 570100

研究负责人邮政编码：

Study leader's postcode：

 570100

申请人所在单位：

中国人民解放军联勤保障部队第九二八医院

Applicant's institution：

The 98th Hospital of PLA

研究负责人所在单位：

中国人民解放军联勤保障部队第九二八医院

Affiliation of the Leader：

The 98th Hospital of PLA

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 00:00:00

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：

中国人民解放军联勤保障部队第九二八医院

Primary sponsor：

The 98th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force

研究实施负责（组长）单位地址：

海南省海口市龙昆南路口100号第九二八医院

Primary sponsor's address：

100 South Longkun Road, Haikou, Hai'nan, 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)：

海南省

市(区县)：

海口市

Country：

China

Province：

Hai'nan

City：

单位(医院)：

中国人民解放军联勤保障部队第九二八医院

具体地址：

海南省海口市龙昆南路口100号第九二八医院

Institution
hospital：

The 98th Hospital of PLA

Address：

100 South Longkun Road, Haikou

经费或物资来源：

NO

Source(s) of funding：

NO

研究疾病：

静脉曲张  

Target disease：

varicosity

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

超声引导下泡沫硬化疗法在下肢静脉曲张中的应用日益重要。顺应血液流变学规律、到达终末毛细血管，精确并彻底的手术方式是目前临床诊疗的迫切需求。 随着现代生活节奏的加快，下肢静脉曲张的发病率逐年升高，重度静脉曲张患者若无妥善处理可严重影响生活质量。手术是下肢静脉曲张的标准治疗方法，更好地提高患者生活质量是当前形势下亟待解决的问题。 下肢静脉曲张治疗方法日渐完善，包括传统手术方式和微创手术方式。传统手术方式常用的为大隐静脉高位结扎+分段剥脱术以及大隐静脉高位结扎+点式抽剥术。近年来逐渐发展起来的微创手术有：静脉腔内射频消融术、透光旋切术、电凝术、泡沫硬化剂治疗等。这些手术方式的各有优劣，仍需改进。 大隐静脉高位结扎+分段剥脱术：出血量较多、手术切口多、创伤大，易形成下肢深静脉血栓、静脉炎、隐神经损伤，手术时间长、切口恢复慢。 大隐静脉高位结扎+点式抽剥术：较传统分段剥脱术创伤较小、术后恢复较快，但仍有下肢深静脉血栓形成、神经损伤、静脉炎等风险。 静脉腔内射频消融术：皮下损伤大，术后皮肤感觉异常等并发症的发生率较高。 电凝术：此方法需确定电凝器充分接触静脉壁，否则会使大隐静脉闭合不完全，导致术后就复发。 泡沫硬化剂治疗：操作简单，治疗范围可控性更高。但可能发生硬结色素、炎症反应、皮肤坏死等不良反应。 本项目的研究设想及意义： 根据既往大量针对多种治疗下肢静脉曲张手术方式的研究，以及临床经验的启示，我们欲探究超声引导下泡沫硬化疗法联合大隐静脉高位结扎术治疗下肢静脉曲张的疗效与安全性。联合疗法一方面可以增加疾病的治愈率、降低并发症发生率、改善手术疗效，另一方面可以弥补传统手术操作复杂、伤口过多、愈合缓慢的缺陷。 本研究的意义在于通过进行临床随机对照试验，前瞻性观察超声引导下泡沫硬化疗法联合大隐静脉高位结扎术与传统手术治疗重度下肢静脉曲张患者后的并发症发生率、血液流变学指标、静脉曲张严重程度评分、患者满意度评分变化。由此，进一步评估联合疗法的疗效与安全性，并为临床诊疗提供指导意义。  

Objectives of Study：

The application of ultrasound-guided foam sclerotherapy in varicose veins of the lower extremities is increasingly important. Accurate and thorough surgical methods that conform to the laws of hemorheology and reach the terminal capillaries are urgent needs for clinical diagnosis and treatment. With the acceleration of the modern life rhythm, the incidence of varicose veins in the lower extremities is increasing year by year, and patients with severe varicose veins can seriously affect the quality of life if they are not handled properly. Surgery is the standard treatment for varicose veins of the lower extremities, and better improving the quality of life of patients is an urgent problem to be solved under the current situation. The treatment of varicose veins of the lower extremities is gradually improving, including traditional surgical methods and minimally invasive surgical methods. Traditional surgical methods commonly used are high ligation of the great saphenous vein + segmental stripping and high ligation of the great saphenous vein + point stripping. The minimally invasive surgery that has gradually developed in recent years includes: intravenous radiofrequency ablation, translucent atherectomy, electrocoagulation, and foam sclerotherapy. These surgical methods have their own advantages and disadvantages, and still need to be improved. High ligation of the great saphenous vein + segmental stripping: more bleeding, more surgical incisions, large trauma, easy to form deep vein thrombosis, phlebitis, saphenous nerve injury, long operation time, slow incision recovery. Great saphenous vein high ligation + point stripping: Compared with traditional segmental stripping, it has less trauma and faster recovery after surgery, but there are still risks of deep vein thrombosis, nerve damage, and phlebitis in the lower extremities. Intravenous radiofrequency ablation: The subcutaneous injury is large, and the incidence of complications such as postoperative skin paresthesia is high. Electrocoagulation: This method needs to make sure that the coagulator fully contacts the vein wall, otherwise the great saphenous vein will be incompletely closed, leading to recurrence after surgery. Foam sclerosing agent treatment: simple operation, more controllable treatment range. However, adverse reactions such as indurated pigment, inflammation, and skin necrosis may occur. Research assumptions and significance of this project: Based on a large number of previous studies on various surgical methods for the treatment of varicose veins of the lower extremities and the enlightenment of clinical experience, we would like to explore the efficacy and safety of ultrasound-guided foam sclerotherapy combined with high saphenous vein ligation in the treatment of varicose veins of the lower extremities. On the one hand, combination therapy can increase the cure rate of diseases, reduce the incidence of complications, and improve the efficacy of surgery. On the other hand, it can make up for the defects of traditional surgical procedures, excessive wounds, and slow healing. The significance of this study lies in the prospective observation of ultrasound-guided foam sclerotherapy combined with high saphenous vein ligation and traditional surgery in the treatment of patients with severe varicose veins, the incidence of complications, blood rheology, and Varicose vein severity score and patient satisfaction score changes. As a result, further evaluate the efficacy and safety of combination therapy, and provide guidance for clinical diagnosis and treatment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准：年龄在18-85岁；经下肢彩色多普勒超声检查，明确存在浅表静脉曲张，大隐静脉反流并符合下肢静脉曲张的诊断标准；CEAP分级为C4-C6级。

Inclusion criteria

1. Aged 18 to 85 years;
2. Lower extremity color Doppler ultrasonography showed superficial varicose veins and great saphenous vein reflux, which met the diagnostic criteria of lower extremity varicose veins;
3. CEAP c4-C6.

排除标准：

(1)合并下肢深静脉瓣膜反流;
(2)静脉畸形、骨肥大综合征;
(3)既往下肢深静脉血栓形成;
(4)妊娠、恶性肿瘤、严重心、肺、肾疾病;
(5)原发性下肢深静脉瓣膜功能不全;
(6)存在泡沫硬化剂过敏等。

Exclusion criteria：

(1) Combined with deep venous valve reflux of lower extremities;
(2) Venous malformation and hypertrophy syndrome;
(3) Previous deep vein thrombosis of lower extremity;
(4) Pregnancy, malignant tumor, severe heart, lung and kidney diseases;
(5) Primary deep venous valve insufficiency of lower limbs;
(6) the existence of foam sclerosing agent allergy.

研究实施时间：

Study execute time：

从 From 2020-09-22 00:00:00至 To 2021-09-22 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-09-22 00:00:00 至 To 2021-09-22 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 150

Group：

Experimental group

Sample size：

干预措施：

超声介入

干预措施代码：

Intervention：

ultrasound intervenion

Intervention code：

组别：

对照组

样本量：

 150

Group：

control group

Sample size：

干预措施：

无超声介入

干预措施代码：

Intervention：

without ultrasound intervenion

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南省 

市(区县)：

 海口市 

Country：

China

Province：

Hai'nan

City：

单位(医院)：

 中国人民解放军联勤保障部队第九二八医院 

单位级别：

 三级甲等 

Institution
hospital：

The 98th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

手术指标

指标类型：

主要指标

Outcome：

Operation indicator

Type：

Primary 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：

血管

组织：

Sample Name：

blood vessel

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 岁 years
最大 Max age 89 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

按照计算机生成的随机方案

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

According to a computer-generated random scheme

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

实验完成后6个月内，报刊公示

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

Within 6 months after the completion of the experiment, the press and publication

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：

病例登记表

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

Case register

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-09-23 04:40:33