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：	ChiCTR2500104800
最近更新日期： Date of Last Refreshed on：	2025-06-24 08:47:02
注册时间： Date of Registration：	2025-06-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	Randomized Control Trial on Effectiveness and Safety of Direct Trocar versus Veress Needle Entry Techniques in Obese Women During Laparoscopic Cholecystectomy
Public title：	Randomized Control Trial on Effectiveness and Safety of Direct Trocar versus Veress Needle Entry Techniques in Obese Women During Laparoscopic Cholecystectomy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Randomized Control Trial on Effectiveness and Safety of Direct Trocar versus Veress Needle Entry Techniques in Obese Women During Laparoscopic Cholecystectomy
Scientific title：	Randomized Control Trial on Effectiveness and Safety of Direct Trocar versus Veress Needle Entry Techniques in Obese Women During 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：	Dr Umer Naeem	研究负责人：	Dr Umer Naeem
Applicant：	Dr Umer Naeem	Study leader：	Dr Umer Naeem
申请注册联系人电话： Applicant telephone：	+92 320 6247953	研究负责人电话： Study leader's telephone：	+92 320 6247953
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：	tifal_bydagh@hotmail.com	研究负责人电子邮件： Study leader's E-mail：	tifal_bydagh@hotmail.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：	Department of Surgery Quetta institute of Medical Sciences	研究负责人通讯地址：	Department of Surgery Quetta institute of Medical Sciences
Applicant address：	Department of Surgery Quetta institute of Medical Sciences	Study leader's address：	Department of Surgery Quetta institute of Medical Sciences
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：	Combined Military Hospital Quetta
Applicant's institution：	Combined Military Hospital Quetta
研究负责人所在单位：	Department of Surgery Quetta institute of Medical Sciences
Affiliation of the Leader：	Department of Surgery Quetta institute of Medical Sciences

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：	CMH QTA-IERB/108/2025 dated 30 May 2025	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：	Combine Military Hospital Quetta Institutinal Ethical Review Board
Name of the ethic committee：	Combine Military Hospital Quetta Institutinal Ethical Review Board
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-30 00:00:00
伦理委员会联系人：	Not stated
Contact Name of the ethic committee：	Not stated
伦理委员会联系地址：	Combine Military Hospital Quetta
Contact Address of the ethic committee：	Combine Military Hospital Quetta
伦理委员会联系人电话： Contact phone of the ethic committee：	+92 81 2827459	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：

Combine Military Hospital Quetta

Primary sponsor：

Combine Military Hospital Quetta

研究实施负责（组长）单位地址：

Chilton Road, Quetta Cantt

Primary sponsor's address：

Chilton Road, Quetta Cantt

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	Pakistan	省(直辖市)：	Balochistan	市(区县)：	Quetta
Country：	Pakistan	Province：	Balochistan	City：	Quetta
单位(医院)：	Combine Military Hospital Quetta	具体地址：	Chilton Road, Quetta Cantt
Institution hospital：	Combine Military Hospital Quetta	Address：	Chilton Road, Quetta Cantt

经费或物资来源：

Source(s) of funding：

Chilton road quetta cantt

研究疾病：

Cholelithiasis

Target disease：

Cholelithiasis

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：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

To compare the outcomes of direct trocar versus Veress needle entry techniques in obese women during laparoscopic cholecystectomy.

Objectives of Study：

To compare the outcomes of direct trocar versus Veress needle entry techniques in obese women during laparoscopic cholecystectomy.

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：

Men, non-obese women, Patients who had previous history of abdominal surgery, ASA status ≥ III, clinically obvious ongoing infection, those having poorly controlled type 2 diabetes mellitus, other comorbid conditions like hypertension and chronic renal failure, concomitant cardiopulmonary severe disease, abnormalities with the clotting/bleeding and the patients who are unfit to undergo general anesthesia.

Exclusion criteria：

Men, non-obese women, Patients who had previous history of abdominal surgery, ASA status ≥ III, clinically obvious ongoing infection, those having poorly controlled type 2 diabetes mellitus, other comorbid conditions like hypertension and chronic renal failure, concomitant cardiopulmonary severe disease, abnormalities with the clotting/bleeding and the patients who are unfit to undergo general anesthesia.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2026-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-07-01 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：	Group A	样本量：	90
Group：	Group A	Sample size：	90
干预措施：	Regarding the method of gaining entry into the peritoneum, in Group-A (n = 90), a small incision will be made just above the umbilicus while the patients lying supine. Using the towel clamps, the skin of the operative field will be uplifted and at a horizontal thirty degrees angle directed towards pelvis of the patient, trocar will be inserted into the abdomen.	干预措施代码：
Intervention：	Regarding the method of gaining entry into the peritoneum, in Group-A (n = 90), a small incision will be made just above the umbilicus while the patients lying supine. Using the towel clamps, the skin of the operative field will be uplifted and at a horizontal thirty degrees angle directed towards pelvis of the patient, trocar will be inserted into the abdomen.	Intervention code：

组别：	Group B	样本量：	90
Group：	Group B	Sample size：	90
干预措施：	In Group-B (n = 90), after infliction of incision, Veress needle will be put through at an angle of forty five degrees while keeping its tip directed towards pelvis. Once the characteristics pops of piercing the fascia and peritoneum, needle aspiration will be performed to ensure entry into the peritoneum and subsequently trocars will be inserted.	干预措施代码：
Intervention：	In Group-B (n = 90), after infliction of incision, Veress needle will be put through at an angle of forty five degrees while keeping its tip directed towards pelvis. Once the characteristics pops of piercing the fascia and peritoneum, needle aspiration will be performed to ensure entry into the peritoneum and subsequently trocars will be inserted.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	Pakistan	省(直辖市)：	Balochistan	市(区县)：	Quetta
Country：	Pakistan	Province：	Balochistan	City：	Quetta
单位(医院)：	Combine Military Hospital Quetta	单位级别：	Tertiary care teaching hospital
Institution hospital：	Combine Military Hospital Quetta	Level of the institution：	Tertiary care teaching hospital

测量指标：

Outcomes：

指标中文名：	frequency of patients in which successful peritoneal entry will be achieved in the first attempt	指标类型：	主要指标
Outcome：	frequency of patients in which successful peritoneal entry will be achieved in the first attempt	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	frequency of achievement of successful peritoneal entry achieved in the subsequent attempt	指标类型：	次要指标
Outcome：	frequency of achievement of successful peritoneal entry achieved in the subsequent attempt	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	time to successfully penetrate peritoneum	指标类型：	次要指标
Outcome：	time to successfully penetrate peritoneum	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	perioperative complications	指标类型：	次要指标
Outcome：	perioperative complications	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	post-operative pain six hours after surgery	指标类型：	次要指标
Outcome：	post-operative pain six hours after surgery	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	immediate post-operative complications	指标类型：	次要指标
Outcome：	immediate post-operative complications	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：	none	组织：
Sample Name：	none	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		岁 years
最大 Max age		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）：

The patients will be divided into two equal groups by using lottery method.

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

The patients will be divided into two equal groups by using lottery 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：	Not stated
Blinding：	Not stated
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）：	no
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	no
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：	no
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	no
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-06-24 08:46:45