ChiCTR2300075776 版本V1.1 版本创建时间2024/02/16 16:41:14 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：

ChiCTR2300075776 

最近更新日期：

Date of Last Refreshed on：

2023-09-15 08:48:38 

注册时间：

Date of Registration：

2023-09-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

腹腔镜疝修补术腹膜前间隙中二氧化碳与血清肿形成的关系：一项前瞻性随机对照研究

Public title：

Relationship between carbon dioxide in preperitoneal space and seroma formation in laparoscopic hernia repair: A prospective randomized controlled study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

腹腔镜疝修补术腹膜前间隙中二氧化碳与血清肿形成的关系：一项前瞻性随机对照研究

Scientific title：

Relationship between carbon dioxide in preperitoneal space and seroma formation in laparoscopic hernia repair: A prospective randomized controlled study.

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：

胡继霖 

研究负责人：

胡继霖 

Applicant：

Hu Jilin 

Study leader：

Hu Jilin 

申请注册联系人电话：

Applicant telephone：

+86 131 7628 9332

研究负责人电话：

Study leader's telephone：

+86 131 7628 9332

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：

1063201818@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1063201818@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：

青岛大学附属医院西海岸院区胃肠外科

研究负责人通讯地址：

青岛大学附属医院西海岸院区胃肠外科

Applicant address：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, China,

Study leader's address：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, 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：

青岛大学附属医院西海岸院区胃肠外科

Applicant's institution：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, China,

研究负责人所在单位：

青岛大学附属医院西海岸院区胃肠外科

Affiliation of the Leader：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, China,

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

[临研]伦审QYFYEC2023-05

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：

青岛大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Affiliated Hospital of Qingdao University

伦理委员会批准日期：

Date of approved by ethic committee：

2022-08-23 00:00:00

伦理委员会联系人：

朱婕

Contact Name of the ethic committee：

Zhu Jie

伦理委员会联系地址：

青岛大学附属医院市南院区行政楼四楼会议室

Contact Address of the ethic committee：

Conference room, 4th Floor, Administrative Building, South Hospital of Qingdao University

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 532 8291 1869

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：

青岛大学附属医院西海岸院区胃肠外科

Primary sponsor：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, China,

研究实施负责（组长）单位地址：

青岛大学附属医院西海岸院区胃肠外科

Primary sponsor's address：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, 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)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

青岛大学附属医院

具体地址：

青岛市黄岛区五台山路1677号

Institution
hospital：

Affiliated Hospital of Qingdao University

Address：

No. 1677, Wutaishan Road, Huangdao District, Qingdao

经费或物资来源：

青岛大学附属医院西海岸院区胃肠外科

Source(s) of funding：

Department of Gastroenterology Surgery, Affiliated Hospital of Qingdao University, Qingdao, China,

Target disease：

Indirect inguinal hernia, seroma

Target disease code：

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：

探讨腹腔镜经腹腹膜前腹股沟斜疝修补术（TAPP）中腹膜前间隙CO2与血清肿形成的关系。  

Objectives of Study：

To explore the relationship between CO2 in preperitoneal space and seroma formation in Laparoscopic Trans-Abdominal PrePeritoneal (TAPP).

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：（1）年龄≥18 岁男性患者；（2）原发性腹股沟斜疝；（3）同意纳入本研究并签署知情同意书。

Inclusion criteria

Inclusion criteria: (1) male patients aged ≥18 years; (2) Primary oblique inguinal hernia; (3) Agree to be included in this study and sign the informed consent.

排除标准：

排除标准：（1）复发疝、嵌顿疝、绞窄疝；（2）失访；（3）合并严重系统性疾病；（4）出现术中血管脏器损伤；（5）中转开放手术；（6）3个月内参与过其他临床试验。该研究经我院伦理委员会批准实施。

Exclusion criteria：

Exclusion criteria: (1) recurrent hernia, incarcerated hernia, strangulated hernia; (2) loss of follow-up; (3) Combined with serious systemic diseases; (4) Intraoperative vascular and organ injury; (5) Transfer to open surgery; (6) Participating in other clinical trials within 3 months. This study was approved by the Ethics Committee of our hospital.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-01-01 00:00:00 至 To 2023-06-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

52

Group：

Experimental group

Sample size：

干预措施：

采用全身麻醉，置入气腹针建立人工气腹后，于脐下置入 10 mm 观察 Trocar，探查腹腔内情况，直视下于脐水平双侧腹直肌外缘置入5 mm 操作 Trocar，自脐内侧韧带起弧形切开腹膜至髂前上棘水平，分离Bogros间隙和Retzius间隙，分离疝囊后行精索腹壁化，使用聚丙烯3D补片覆盖肌耻骨孔，并以医用胶固定补片后，3/0 倒刺线连续缝合关闭腹膜，将吸引器经腹膜缺损（倒刺线缝合时两针之间的腹膜漏洞）置入腹膜前间隙，吸净残留CO2，观察到壁腹膜紧贴补片，腹膜前间隙消失时证明操作成功，退出 Trocar 缝合切口。

干预措施代码：

Intervention：

After the artificial pneumoperitoneum was established with pneumoperitoneum needle under general anesthesia, Trocar was placed 10 mm under the umbilicus to observe and explore the intraperitoneal situation. Trocar was placed 5 mm at the outer edge of both rectus abdominis muscles at the umbilical level under direct vision, and the peritoneum was incised in an arc from the umbilical medial ligament to the anterior superior spine of iliac. The Bogros space and Retzius space were separated, and the abdominal wall of the semen cord was performed after the hernia capsule was separated. The musculopubic foramina was covered with 3D mesh of polypropylene, and the mesh was fixed with medical glue. The peritoneum was closed by continuous suture with 3/0 barb wire, and the aspirator was placed into the preperitoneal space through the peritoneal defect (peritoneal hole between the two needles during barb suture), and residual CO2 was absorbed. When the parietal peritoneal patch was observed and the preperitoneal space disappeared, the operation was proved successful and the Trocar suture incision was withdrawn.

Intervention code：

组别：

对照组

样本量：

49

Group：

Control group

Sample size：

干预措施：

采用全身麻醉，置入气腹针建立人工气腹后，于脐下置入 10 mm 观察 Trocar，探查腹腔内情况，直视下于脐水平双侧腹直肌外缘置入5 mm 操作 Trocar，自脐内侧韧带起弧形切开腹膜至髂前上棘水平，分离Bogros间隙和Retzius间隙，分离疝囊后行精索腹壁化，使用聚丙烯3D补片覆盖肌耻骨孔，并以医用胶 固定补片后，3/0 倒刺线连续缝合关闭腹膜，退出Trocar缝合切口。

干预措施代码：

Intervention：

After the artificial pneumoperitoneum was established with pneumoperitoneum needle under general anesthesia, Trocar was placed 10 mm under the umbilicus to observe and explore the intraperitoneal situation. Trocar was placed 5 mm at the outer edge of both rectus abdominis muscles at the umbilical level under direct vision, and the peritoneum was incised in an arc from the umbilical medial ligament to the anterior superior spine of iliac. The Bogros space and Retzius space were separated, the hernia capsule was separated, the abdominal wall of the semen cord was performed, and the musculopubic foramina was covered with 3D mesh of polypropylene, and the mesh was fixed with medical glue. After that, the peritonea was closed by continuous suture with 3/0 barb line, and the Trocar suture incision was exited.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China 

Province：

shandong 

City：

 

单位(医院)：

青岛大学附属医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Hospital of Qingdao University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血清肿发生率和体积

指标类型：

主要指标

Outcome：

Incidence and volume of seroma

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后疼痛程度

指标类型：

次要指标

Outcome：

Degree of postoperative pain

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

感染

指标类型：

次要指标

Outcome：

infect

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Operation time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中出血量

指标类型：

次要指标

Outcome：

Intraoperative blood loss

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疝复发

指标类型：

次要指标

Outcome：

Recurrent hernia

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：

未采集人体标本

组织：

Sample Name：

No human specimens were collected

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

研究者胡继霖采用随机数字表将101例患者随机分入试验组和对照组，试验组51例，对照组49例。

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

Researcher Hu Jilin used a random number table to randomly divide 101 patients into the experimental group and the control group, with 51 patients in the experimental group and 49 patients in the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本试验采用双盲，参与试验的患者对分组不知情，外科医师及超声科医师对分组也不知情

Blinding：

This experiment is double-blind. The patients who participated in the experiment were unaware of the grouping, and neither were the surgeons and sonographers.

是否共享原始数据：

IPD sharing

Yes

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）：

临床试验公共管理平台ResMan (http://www.medresman.org.cn/login.aspx)

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

Clinical trials of public management platform ResMan (http://www.medresman.org.cn/login.aspx)

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：

1、数据采集：使用青岛大学附属医院HIS系统进行数据采集，并使用Microsoft Excel记录数据 2、电子采集和管理系统使用临床试验公共管理平台ResMan

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

1. Data collection: HIS system of the Affiliated Hospital of Qingdao University was used for data collection, and Microsoft Excel was used to record data; 2. ResMan, a public clinical trial management platform, was used for electronic collection and management system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-09-15 08:47:44