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Lap Sleeve Gastrectomy with Cruroplasty (C-LSG) Versus Lap Sleeve Gastrectomy Alone in Symptomatic GERD Associated with Morbid Obesity. A Randomised Controlled Trial.
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注册号：

Registration number：

 ChiCTR2100051780 

最近更新日期：

Date of Last Refreshed on：

 2021-10-03 

注册时间：

Date of Registration：

2021-10-03 

注册号状态：

补注册  

Registration Status：

Retrospective registration  

注册题目：

LOO GUO HOU: please submit the latter of ethics approval Lap Sleeve Gastrectomy with Cruroplasty (C-LSG) Versus Lap Sleeve Gastrectomy Alone in Symptomatic GERD Associated with Morbid Obesity. A Randomised Controlled Trial. 

Public title：

Lap Sleeve Gastrectomy with Cruroplasty (C-LSG) Versus Lap Sleeve Gastrectomy Alone in Symptomatic GERD Associated with Morbid Obesity. A Randomised Controlled Trial. 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Lap Sleeve Gastrectomy with Cruroplasty (C-LSG) Versus Lap Sleeve Gastrectomy Alone in Symptomatic GERD Associated with Morbid Obesity. A Randomised Controlled Trial. 

Scientific title：

Lap Sleeve Gastrectomy with Cruroplasty (C-LSG) Versus Lap Sleeve Gastrectomy Alone in Symptomatic GERD Associated with Morbid Obesity. A Randomised Controlled 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：

LOO GUO HOU 

研究负责人：

Mohd Firdaus Che Ani 

Applicant：

LOO GUO HOU 

Study leader：

Mohd Firdaus Che Ani  

申请注册联系人电话：

Applicant telephone：

+60 01 02393995 

研究负责人电话：

Study leader's telephone：

+60 0193653798 

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：

looguohou@gmail.com 

研究负责人电子邮件：

Study leader's E-mail：

firdaus.cheani@gmail.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, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, 56000, WP Kuala Lumpur, Malaysia 

研究负责人通讯地址：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia 

Applicant address：

Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, 56000, WP Kuala Lumpur, Malaysia 

Study leader's address：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia 

申请注册联系人邮政编码：

Applicant postcode：

56000 

研究负责人邮政编码：

Study leader's postcode：

47000 

申请人所在单位：

马来西亚Universiti Kebangsaan Malaysia Medical Centre 

Applicant's institution：

Universiti Kebangsaan Malaysia Medical Centre 

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：

FF-2015-324 

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：

Universiti Kebangsaan Malaysia Research Ethics Committee 

Name of the ethic committee：

Universiti Kebangsaan Malaysia Research Ethics Committee 

伦理委员会批准日期：

Date of approved by ethic committee：

2015-01-20 

伦理委员会联系人：

Fatimah Binti Mat Zin 

Contact Name of the ethic committee：

Fatimah Binti Mat Zin 

伦理委员会联系地址：

Research Ethics Committee, National University of Malaysia Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lump 

Contact Address of the ethic committee：

Research Ethics Committee, National University of Malaysia Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lump 

伦理委员会联系人电话：

Contact phone of the ethic committee：

+60 3-9145 5046 

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fatimahz@ppukm.ukm.edu.my 

研究实施负责（组长）单位：

Mohd Firdaus Che Ani  

Primary sponsor：

Mohd Firdaus Che Ani  

研究实施负责（组长）单位地址：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia 

Primary sponsor's address：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

马来西亚

省(直辖市)：

Selangor

市(区县)：

Sungai Buloh

Country：

Malaysia

Province：

Selangor

City：

Sungai Buloh

单位(医院)：

Universiti Teknologi MARA

具体地址：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia

Institution
hospital：

Universiti Teknologi MARA

Address：

Department of Surgery, Faculty of Medicine Universiti Teknologi MARA, Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia

经费或物资来源：

NONE 

Source(s) of funding：

NONE 

研究疾病：

MORBID OBESITY WITH GERD 

Target disease：

MORBID OBESITY WITH GERD 

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：

III期临床试验 

Study phase：

3 

研究目的：

to test whether LSG with crura reinforcement can be used as an intervention for GERD post LSG 

Objectives of Study：

to test whether LSG with crura reinforcement can be used as an intervention for GERD post LSG 

药物成份或治疗方案详述：

a single-centre Randomised Control Trial (RCT). All obese patients indicated for surgical intervention were selected between February 2015 until September 2017 for pre-operative work-up. Patients with BMI more than 27.5 kg/m2 with co-morbidities, and all patients with BMI more than 32.5 kg/m2 were selected for this study (13). Patients with severe symptomatic GERD and patients with grade IV Hiatus Hernia (HH) were excluded. Sample size calculation was based on incidence rate of GERD at 83%, with power of study set at 80%. Potential dropout was considered at 10%. The calculated sample size was 36 patients per arm.  

Description for medicine or protocol of treatment in detail：

a single-centre Randomised Control Trial (RCT). All obese patients indicated for surgical intervention were selected between February 2015 until September 2017 for pre-operative work-up. Patients with BMI more than 27.5 kg/m2 with co-morbidities, and all patients with BMI more than 32.5 kg/m2 were selected for this study (13). Patients with severe symptomatic GERD and patients with grade IV Hiatus Hernia (HH) were excluded. Sample size calculation was based on incidence rate of GERD at 83%, with power of study set at 80%. Potential dropout was considered at 10%. The calculated sample size was 36 patients per arm.  

研究设计：

随机平行对照 

Study design：

Parallel 

纳入标准：

Patients with BMI more than 27.5 kg/m2 with co-morbidities, and all patients with BMI more than 32.5 kg/m2 were selected for this study (13). 

Inclusion criteria

Patients with BMI more than 27.5 kg/m2 with co-morbidities, and all patients with BMI more than 32.5 kg/m2 were selected for this study (13). 

排除标准：

Patients with severe symptomatic GERD and patients with grade IV Hiatus Hernia (HH) were excluded. 

Exclusion criteria：

Patients with severe symptomatic GERD and patients with grade IV Hiatus Hernia (HH) were excluded. 

研究实施时间：

Study execute time：

从From2015-02-01至To 2020-09-30 

征募观察对象时间：

Recruiting time：

从From2015-09-01至To 2017-09-30 

干预措施：

Interventions：

组别：

2

样本量：

 100

Group：

2

Sample size：

干预措施：

LAP SLEEVE GASTRECTOMY WITH OR WITHOUT CRUROPLASTY

干预措施代码：

Intervention：

LAP SLEEVE GASTRECTOMY WITH OR WITHOUT CRUROPLASTY

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 马来西亚 

省(直辖市)：

 WP KUALA LUMPUR 

市(区县)：

 BDR TUN RAZAK 

Country：

 MALAYSIA 

Province：

 WP KUALA LUMPUR 

City：

 BDR TUN RAZAK 

单位(医院)：

 UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE 

单位级别：

 三级医院 

Institution
hospital：

 UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE  

Level of the institution：

 Tertiary hospital 

测量指标：

Outcomes：

指标中文名：

SYMPTOMS OF GERD

指标类型：

主要指标 

Outcome：

SYMPTOMS OF GERD

Type：

Primary indicator 

测量时间点：

3 years

测量方法：

HR-QoL GERD score

Measure time point of outcome：

3YEARS

Measure method：

HR-QoL GERD score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

NOT APPLICABLE

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：

结束

Completed

年龄范围：

Participant age：

最小 Min age 20 岁 years
最大 Max age 71 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）：

block randomisation

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

block randomisation

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing

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）：

Not stated

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

Not stated

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：

In a secured encrypted hard disk drive

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

In a secured encrypted hard disk drive

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

 2021-10-03
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