中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300076071
最近更新日期： Date of Last Refreshed on：	2024-04-02 21:51:17
注册时间： Date of Registration：	2023-09-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	吊线法单孔腹腔镜胆囊切除术对比传统腹腔镜胆囊切除术的单中心、前瞻性、随机、对照临床研究
Public title：	A single-center, prospective, randomized, controlled clinical study of single-port laparoscopic cholecystectomy by line suspension versus traditional laparoscopic cholecystectomy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	吊线法单孔腹腔镜胆囊切除术对比传统腹腔镜胆囊切除术的单中心、前瞻性、随机、对照临床研究
Scientific title：	A single-center, prospective, randomized, controlled clinical study of single-port laparoscopic cholecystectomy by line suspension versus traditional laparoscopic cholecystectomy
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：	赵英安	研究负责人：	赵英安
Applicant：	Yingan Zhao	Study leader：	Yingan Zhao
申请注册联系人电话： Applicant telephone：	+86 138 5745 8092	研究负责人电话： Study leader's telephone：	+86 138 5745 8092
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：	326681578@qq.com	研究负责人电子邮件： Study leader's E-mail：	326681578@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：	浙江省宁波市海曙区柳汀街59号宁波大学附属第一医院16楼肝胆胰疝外科	研究负责人通讯地址：	浙江省宁波市海曙区柳汀街59号宁波大学附属第一医院16楼肝胆胰疝外科
Applicant address：	Department of Hepatobiliary and Pancreatic Hernia, 16th Floor, First Affiliated Hospital of Ningbo University, 59 Liuting Street, Haishu District, Ningbo, Zhejiang	Study leader's address：	Department of Hepatobiliary and Pancreatic Hernia, 16th Floor, First Affiliated Hospital of Ningbo University, 59 Liuting Street, Haishu District, Ningbo, Zhejiang
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：	宁波大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Ningbo University
研究负责人所在单位：	宁波大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Ningbo University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	宁波大学附属第一医院伦审2023研第034号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	宁波大学附属第一医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the First Affiliated Hospital of Ningbo University
伦理委员会批准日期： Date of approved by ethic committee：	2023-09-14 00:00:00
伦理委员会联系人：	陈少莹
Contact Name of the ethic committee：	Shaoying Chen
伦理委员会联系地址：	宁波市海曙区柳汀街59号
Contact Address of the ethic committee：	59 Liuting Street, Haishu District, Ningbo
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 574 8708 5233	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：

宁波大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Ningbo University

研究实施负责（组长）单位地址：

浙江省宁波市海曙区柳汀街59号宁波大学附属第一医院16楼肝胆胰疝外科

Primary sponsor's address：

Department of Hepatobiliary and Pancreatic Hernia, 16th Floor, First Affiliated Hospital of Ningbo University, 59 Liuting Street, Haishu District, Ningbo, Zhejiang

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)：	宁波市
Country：	China	Province：	Zhejiang	City：	Ningbo
单位(医院)：	宁波大学附属第一医院	具体地址：	浙江省宁波市海曙区柳汀街59号宁波大学附属第一医院16楼肝胆胰疝外科
Institution hospital：	The First Affiliated Hospital of Ningbo University	Address：	Department of Hepatobiliary and Pancreatic Hernia, 16th Floor, First Affiliated Hospital of Ningbo University, 59 Liuting Street, Haishu District, Ningbo, Zhejiang

经费或物资来源：

宁波大学附属第一医院

Source(s) of funding：

The First Affiliated Hospital of Ningbo University

研究疾病：

胆囊结石

Target disease：

Gallstones

研究疾病代码：

DC11.1

Target disease code：

DC11.1

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

治疗新技术临床试验

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

1.主要目的：比较吊线法单孔腹腔镜胆囊切除手术与传统 3 孔法腹腔镜胆囊切除手术手术时间 2.次要目的：比较吊线法单孔腹腔镜胆囊切除手术与传统 3 孔法腹腔镜胆囊切除手术术中出血量、术后并发症、术后排气时间、切口疼痛程度、切口满意度。

Objectives of Study：

1. Main objective: To compare the single-port laparoscopic cholecystectomy surgery by the hanging wire method and the traditional 3-hole laparoscopic cholecystectomy surgery hand Surgical time 2. Secondary objective: To compare the single-port laparoscopic cholecystectomy surgery by hanging wire method with the traditional 3-hole laparoscopic cholecystectomy surgery Moderate bleeding volume, postoperative complications, postoperative exhaust time, incision pain, incision satisfaction.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1. 排除胆囊炎急性发作者； 2. 排除合并胆管结石或胰腺炎者； 3. 排除有上腹部手术史者； 4. 排除术前高度怀疑胆囊恶性病变者； 5. 排除凝血机制异常尚未纠正者； 6. 排除妊娠期或者脯乳期妇女。

Exclusion criteria：

1. Exclusion of acute onset of cholecystitis; 2. Exclude patients with bile duct stones or pancreatitis; 3. Exclude people with a history of upper abdominal surgery; 4. To exclude patients with high suspicion of malignant gallbladder lesions before surgery; 5. Exclude those whose coagulation mechanism abnormalities have not been corrected; 6. Exclude pregnant or lactating women.

研究实施时间：

Study execute time：

从 From 2023-10-07 00:00:00至 To 2024-10-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-10-07 00:00:00 至 To 2024-09-01 00:00:00

干预措施：

Interventions：

组别：	A组	样本量：	60
Group：	group A	Sample size：	60
干预措施：	吊线法单孔腹腔镜胆囊切除术：患者仰卧位，常规气管插管全麻，脐下缘取 15mm 切口，逐层进腹，置入单孔穿刺器并建立气腹（气腹参数：CO2流量 40L/min，腹内压 10-12mmHg）。穿刺器下方孔作为观察孔，上方孔作为操作孔。腹腔镜探查腹腔情况，确认无殊后，持针器置入长直针 7 号线于腹腔，镜下缝合胆囊底浆肌层，腹壁肋缘下出针后牵拉胆囊及肝下缘。长直针 7 号线于腹壁剑突右侧缘进针，缝合胆囊壶腹浆肌层，绕线打结后由右腋前线平脐处出针，通过牵拉缝合线暴露胆囊前后三角。电凝钩及分离钳交替使用游离胆囊管及胆囊动脉，生物夹闭合后离断。沿胆囊床完整分离胆囊，经穿刺孔取出。逐层缝合切口，皮肤采用皮下缝合。	干预措施代码：
Intervention：	Single-port laparoscopic cholecystectomy by hanging wire: the patient is in the supine position, conventional endotracheal intubation is under general anesthesia, a 15mm incision is taken at the inferior umbilical edge, the abdomen is inserted layer by layer, a single-hole puncture device is inserted and a pneumoperitoneum is established (pneumoperitoneum parameters: CO2 flow rate 40L/min, intra-abdominal pressure 10-12mmHg). The lower hole of the trocar serves as an observation hole and the upper hole serves as an operating hole. After laparoscopic exploration of the abdominal cavity and confirming that there is no difference, the needle holder is placed with a long straight needle No. 7 line in the abdominal cavity, and the muscular layer of the benladder is sutured under the microscope, and the needle is pulled out under the rib margin of the abdominal wall and then the lower edge of the liver is pulled. A long straight needle No. 7 is inserted at the right edge of the xiphoid process of the abdominal wall, suturing the ampullary sarrosis muscle layer of the gallbladder, and then the needle is threaded through the flat umbilicus of the anterior axillary line of the right axilla, exposing the anterior and posterior triangle of the gallbladder by pulling the suture. The electrocoagulation hook and separation forceps alternately use the free cystic duct and gallbladder artery, and the bioclamp is disconnected after closure. The gallbladder is completely separated along the gallbladder bed and removed through the puncture hole. The incision is sutured layer by layer, and the skin is sutured subcutaneously.	Intervention code：

组别：	B组	样本量：	60
Group：	group B	Sample size：	60
干预措施：	三孔法腹腔镜胆囊切除术：患者仰卧位，常规气管插管全麻，脐下缘取 10mm 切口，置入穿刺针并建立气腹（气腹参数：CO2流量 40L/min，腹内压 10-12mmHg）。脐下置入10mm 穿刺器，再于剑突下及右锁中线肋缘下分别取 5mm 切口并置入穿刺器。腹腔镜探查腹腔，确认无殊后左手使用无创抓钳牵拉胆囊暴露胆囊三角。右手电凝钩及分离钳交替使用游离胆囊管及胆囊动脉，生物夹闭合后离断。沿胆囊床完整分离胆囊，置入标本袋并将胆囊放入其中。适当扩大观察孔切口，由此取出胆囊。逐个、逐层缝合切口，皮肤采用皮下缝合。准确记录手术时间及术中出血量。	干预措施代码：
Intervention：	Three-hole laparoscopic cholecystectomy: the patient is supine position, conventional endotracheal intubation is anesthetic, a 10mm incision is taken at the inferior umbilical margin, a puncture needle is inserted and a pneumoperitoneum is established (pneumoperitoneum parameters: CO2 flow 40L/min, intra-abdominal pressure 10-12mmHg). A 10mm puncture device is placed under the umbilicus, and a 5mm incision is taken under the xiphoid process and under the costal margin of the right midline of the lock, and the trocar is inserted. Laparoscopic exploration of the abdominal cavity to confirm that there is no difference, the left hand uses noninvasive grasping forceps to stretch the gallbladder to expose the gallbladder triangle. The right-hand electrocoagulation hook and separation forceps alternately use free cystic duct and gallbladder artery, and the bioclamp is closed and dissociated. The gallbladder is completely separated along the gallbladder bed, a specimen bag is placed, and the gallbladder is placed in it. Appropriately enlarge the viewing hole incision, from which the gallbladder is removed. The incisions are sutured one by one, layer by layer, and the skin is sutured subcutaneously. Accurately record the time of surgery and the amount of intraoperative bleeding.	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)：	宁波市
Country：	China	Province：	Zhejiang	City：	Ningbo
单位(医院)：	宁波大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Ningbo University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	手术时间	指标类型：	主要指标
Outcome：	Duration of surgery	Type：	Primary indicator
测量时间点：	手术结束时	测量方法：
Measure time point of outcome：	At the end of the operation	Measure method：

指标中文名：	术中出血量	指标类型：	主要指标
Outcome：	Amount of intraoperative bleeding	Type：	Primary indicator
测量时间点：	手术结束时	测量方法：
Measure time point of outcome：	At the end of the operation	Measure method：

指标中文名：	疼痛评分	指标类型：	次要指标
Outcome：	Pain score	Type：	Secondary indicator
测量时间点：	术后第一天	测量方法：
Measure time point of outcome：	The first day after surgery	Measure method：

指标中文名：	排气时间	指标类型：	次要指标
Outcome：	Fart time	Type：	Secondary indicator
测量时间点：	出院时	测量方法：
Measure time point of outcome：	At discharge	Measure method：

指标中文名：	住院时间	指标类型：	次要指标
Outcome：	Length of hospital stay	Type：	Secondary indicator
测量时间点：	出院时	测量方法：
Measure time point of outcome：	At discharge	Measure method：

指标中文名：	手术并发症	指标类型：	次要指标
Outcome：	Surgical complications	Type：	Secondary indicator
测量时间点：	出院时	测量方法：
Measure time point of outcome：	At discharge	Measure method：

指标中文名：	切口满意度	指标类型：	次要指标
Outcome：	Incision satisfaction	Type：	Secondary indicator
测量时间点：	术后一周	测量方法：
Measure time point of outcome：	One week after surgery	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：	静脉血
Sample Name：	Blood	Tissue：	Venous blood
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	18	岁 years
最大 Max age	80	岁 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）：

采用随机抽签法

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

Using the random drawing method

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：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	不共享原始数据
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Raw data is not shared
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：	病例记录表主要由6个部分组成，第一部分为受试者的基本信息，包括姓名、性别、出生年月、联系方式等等；第二部分受试者的纳入标准；第三部分为受试者的排除标准；第四部分为受试者术中手术时间及出血量；第五部分为术后随访内容，包括术后并发症、术后排气时间、切口疼痛程度、切口满意度。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The case record form is mainly composed of 6 parts, the first part is the basic information of the subject, including name, gender, date of birth, contact information, etc.; Inclusion criteria for the second participant; The third section was the exclusion criteria for participants; The fourth part was the intraoperative operation time and the amount of bleeding of the subjects; The fifth part is the content of postoperative follow-up, including postoperative complications, postoperative exhaust time, incision pain, and incision satisfaction.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2023-09-23 19:40:10