今天是:2020-08-03 星期一

常规腹腔镜手术与经自然腔道取标本手术治疗结直肠癌的近期疗效与远期疗效对比研究:一项国际多中心随机前瞻性试验
下载XML文档

注册号:

Registration number:

ChiCTR1900022664 

最近更新日期:

Date of Last Refreshed on:

2019-04-21 

注册时间:

Date of Registration:

2019-04-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

常规腹腔镜手术与经自然腔道取标本手术治疗结直肠癌的近期疗效与远期疗效对比研究:一项国际多中心随机前瞻性试验 

Public title:

The Comparision of Short-term and Long-term Results Between Conventional Laparoscopic Surgery and NOSES in Resection for Colorectal Cancer: An International Multicenter Randomized Prospective Trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

常规腹腔镜手术与经自然腔道取标本手术治疗结直肠癌的近期疗效与远期疗效对比研究:一项国际多中心随机前瞻性试验 

Scientific title:

The Comparision of Short-term and Long-term Results Between Conventional Laparoscopic Surgery and NOSES in Resection for Colorectal Cancer: An International Multicenter Randomized Prospective 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:

马晨曦 

研究负责人:

王锡山 

Applicant:

Chenxi Ma 

Study leader:

Xishan Wang 

申请注册联系人电话:

Applicant telephone:

+86 15201623811 

研究负责人电话:

Study leader's telephone:

+86 13552367779 

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:

glimmerma@icloud.com 

研究负责人电子邮件:

Study leader's E-mail:

wxshan1208@126.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:

北京市朝阳区潘家园南里17号 

研究负责人通讯地址:

北京市朝阳区潘家园南里17号 

Applicant address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

Study leader's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, 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:

中国医学科学院肿瘤医院 

Applicant's institution:

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

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:

中国医学科学院肿瘤医院 

Primary sponsor:

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

研究实施负责(组长)单位地址:

北京市朝阳区潘家园南里17号 

Primary sponsor's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院肿瘤医院

具体地址:

北京市朝阳区潘家园南里17号

Institution
hospital:

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

结直肠癌 

Target disease:

Colorectal 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:

探索性研究/预试验 

Study phase:

研究目的:

1.比较常规腹腔镜切除与NOSES(经自然腔道取标本手术)治疗结直肠癌的安全性和有效性。 2.建立国际多中心NOSES临床数据库。  

Objectives of Study:

1. To compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction (NOSES)versus conventional laparoscopic surgery for colorectal cancer; 2. To establish an international multi-center clinical database of NOSES in colorectal cancer. 

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.病理确诊为腺癌; 2.肿瘤距离齿状线≤15cm; 3.肿瘤术前T分期为T1-T3; 4.患者年龄18-80岁; 5.身体质量指数(Body Mass Index,BMI)≤34kg/m2; 6.ECOG评分≤3。 

Inclusion criteria

1. The pathological diagnosis was adenocarcinoma; 2. The distance from the tumor to the dentate line is less than 15 cm; 3. Tumors' T stage was T1-T3 before operation; 4. The age of the patients ranged from 18 to 80 years; 5. Body Mass Index (BMI) ≤ 34kg/m2; 6. ECOG score ≤ 3.  

排除标准:

1. ASA分级>Ⅲ级; 2. 存在腹腔镜禁忌证(如严重心肺功能不全者); 3. 既往多次行腹腔手术或腹腔广泛粘连者; 4. 5年内有恶性肿瘤病史者; 5. 需急诊手术的患者(如急性肠梗阻); 6. 满足经肛门局切标准的T1期直肠癌患者; 7. 家族性腺瘤性息肉病,林奇综合征相关性直肠癌以及炎症性肠病活动期的患者; 8. 预防性造瘘患者; 9. 接受新辅助治疗患者; 10. 肿瘤侵及临近组织或脏器; 11. 有远处脏器转移。 

Exclusion criteria:

1. ASA Grading > Grade III; 2. Laparoscopic contraindications (such as severe cardiopulmonary insufficiency); 3. Those who had undergone abdominal surgery or had extensive abdominal adhesions in the past; 4. Patients with a history of malignant tumors within 5 years; 5. Patients requiring emergency surgery (such as acute intestinal obstruction); 6. Patients with stage T1 rectal cancer who meet the criteria of transanal local excision; 7. Patients with familial adenomatous polyposis, Lynch syndrome-related rectal cancer and inflammatory bowel disease in active. 8. Patients with Preventive fistula ; 9. Patients with neoadjuvant therapy. 10. Tumors invade adjacent tissues or organs; 11. With distant organ metastasis. 

研究实施时间:

Study execute time:

From2019-10-01To 2023-10-01 

征募观察对象时间:

Recruiting time:

From2019-10-01To 2021-10-01 

干预措施:

Interventions:

组别:

A组

样本量:

150

Group:

Group A

Sample size:

干预措施:

常规腹腔镜手术

干预措施代码:

Intervention:

Conventional Laparoscopic Surgery

Intervention code:

组别:

B组

样本量:

150

Group:

Group B

Sample size:

干预措施:

NOSES手术方式

干预措施代码:

Intervention:

NOSES

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医学科学院肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨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 Harbin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

日本 

省(直辖市):

 

市(区县):

长岗 

Country:

Japan 

Province:

 

City:

Nagaka 

单位(医院):

长岗综合医院 

单位级别:

 

Institution
hospital:

Nagaka Chuo General Hospital  

Level of the institution:

 

国家:

俄罗斯 

省(直辖市):

 

市(区县):

莫斯科 

Country:

Russia 

Province:

 

City:

Moscow 

单位(医院):

莫斯科第一医科大学 

单位级别:

 

Institution
hospital:

Sechenov First Moscow State Medical University  

Level of the institution:

 

国家:

土耳其 

省(直辖市):

 

市(区县):

马拉蒂亚 

Country:

Turkey 

Province:

 

City:

Malatya 

单位(医院):

伊诺努大学 

单位级别:

 

Institution
hospital:

Inonu University  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

术后并发症发生率

指标类型:

主要指标 

Outcome:

Early morbidity rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中转开腹率

指标类型:

次要指标 

Outcome:

Conversion rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹膜感染

指标类型:

次要指标 

Outcome:

Peritoneal bacterial contamination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恢复及疼痛评分

指标类型:

次要指标 

Outcome:

Postoperative recovery and pain score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能和生活质量评估

指标类型:

次要指标 

Outcome:

Functional and quality of life assessments

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无病生存率

指标类型:

次要指标 

Outcome:

disease-free survival rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局部复发率

指标类型:

主要指标 

Outcome:

Local recurrence rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存率

指标类型:

次要指标 

Outcome:

overall survival rate

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:

未涉及标本

组织:

Sample Name:

Not applicable

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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):

本研究采用完全随机方法进行随机化分组,由各中心负责人负责人使用计算机产生的随机数字法产生随机序列,各中心负责人确定病例的入组,同时通知该病例所在医疗组,并严格按照分组确定受试者进入各研究组。

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

We will perform the randomization to assign candidates into 2 groups based on the computer-generated random numbers. When receiving a patient who meets the inclusion criteria, the doctors will assign the newly participant to a group regarding the number on the envelopes.

盲法:

开放

Blinding:

open label

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):

联系人邮件索取

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

the metadata and protocol could be required by email

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

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-21
返回列表