ChiCTR2100047386 版本V1.0 版本创建时间2022/02/07 11:47:13 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：

 ChiCTR2100047386 

最近更新日期：

Date of Last Refreshed on：

 2021-06-13 08:01:37 

注册时间：

Date of Registration：

 2021-06-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Outcomes of OAGB/MGB as Conversional Surgery after Failed Sleeve Gastrectomy

Public title：

Outcomes of OAGB/MGB as Conversional Surgery after Failed Sleeve Gastrectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mid-term Outcomes of OAGB/MGB as Conversional Surgery after Failed Sleeve Gastrectomy; A Tertiary Center Experience

Scientific title：

Mid-term Outcomes of OAGB/MGB as Conversional Surgery after Failed Sleeve Gastrectomy; A Tertiary Center Experience

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：

Mohammad Kermansaravi 

研究负责人：

Mohammad Kermansaravi 

Applicant：

Mohammad Kermansaravi 

Study leader：

Mohammad Kermansaravi 

申请注册联系人电话：

Applicant telephone：

 +98 91 28874084

研究负责人电话：

Study leader's
telephone：

+98 91 28874084

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：

 kermansaravi.m@iums.ac.ir

研究负责人电子邮件：

Study leader's E-mail：

 kermansaravi.m@iums.ac.ir

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：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran

研究负责人通讯地址：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran

Applicant address：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

Study leader's address：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

申请注册联系人邮政编码：

Applicant postcode：

 1449614535

研究负责人邮政编码：

Study leader's postcode：

 1449614535

申请人所在单位：

伊朗德黑兰Rasoole Akram Hospital

Applicant's institution：

Minimally Invasive Surgery Research Center, Division of Minimally Invasive and Bariatric Surgery, Department of Surgery, Rasoole Akram Hospital, Iran University of Medical Sciences, Tehran, Iran

研究负责人所在单位：

伊朗德黑兰Rasoole Akram Hospital

Affiliation of the Leader：

Minimally Invasive Surgery Research Center, Division of Minimally Invasive and Bariatric Surgery, Department of Surgery, Rasoole Akram Hospital, Iran University of Medical Sciences, Tehran, Iran

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：

 IR.IUMS.REC.1399.801

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：

Iran University of Medical Sciences (Ethics Committee in Biomedical Research)

Name of the ethic committee：

Iran University of Medical Sciences (Ethics Committee in Biomedical Research)

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-11-11 00:00:00

伦理委员会联系人：

Iran University of Medical Sciences (Ethics Committee in Biomedical Research)

Contact Name of the ethic committee：

Iran University of Medical Sciences (Ethics Committee in Biomedical Research)

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：

 ethics@behdasht.gov.ir

研究实施负责（组长）单位：

Iran University of Medical Sciences

Primary sponsor：

Iran University of Medical Sciences

研究实施负责（组长）单位地址：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

Primary sponsor's address：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊朗

省(直辖市)：

德黑兰

市(区县)：

Country：

Iran

Province：

Tehran

City：

Tehran

单位(医院)：

Hazrat e Rasool Hospital

具体地址：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

Institution
hospital：

Hazrat e Rasool Hospital

Address：

Hazrat e Rasool Hospital, Shahid Mansouri Ave, Niyayesh StSattarkhan St, Setayesh Street, No 98, Tehran, Iran.

经费或物资来源：

Vice Chancellor for Research & Technology, Iran university of medical sciences

Source(s) of funding：

Vice Chancellor for Research & Technology, Iran university of medical sciences

研究疾病：

morbid obesity  

Target disease：

morbid obesity

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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

General objectives: 1. Determining weight changes and comorbidities after OAGB/MGB Sub-objectives: 1. Determining the amount of BMI changes after OAGB/MGB 2. Determining the extent of EWL changes after OAGB/MGB 3. Determining the changes in diabetes after OAGB/MGB 4. Determination of changes in blood pressure after OAGB/MGB in patients with hypertension Determining the changes of obstructive sleep apnea after OAGB/MGB in patients with obstructive sleep apnea Determination of GERD changes after OAGB/MGB in patients with GERD 7. Determination of dyslipidemia changes after OAGB/MGB patients with dyslipidemia 8. Determining the indications for conversion 9. Determination of surgical complications following OAGB/MGB 10. Determining patients' demographic information  

Objectives of Study：

General objectives: 1. Determining weight changes and comorbidities after OAGB/MGB Sub-objectives: 1. Determining the amount of BMI changes after OAGB/MGB 2. Determining the extent of EWL changes after OAGB/MGB 3. Determining the changes in diabetes after OAGB/MGB 4. Determination of changes in blood pressure after OAGB/MGB in patients with hypertension Determining the changes of obstructive sleep apnea after OAGB/MGB in patients with obstructive sleep apnea Determination of GERD changes after OAGB/MGB in patients with GERD 7. Determination of dyslipidemia changes after OAGB/MGB patients with dyslipidemia 8. Determining the indications for conversion 9. Determination of surgical complications following OAGB/MGB 10. Determining patients' demographic information

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

patients who had undergone OAGB/MGB following failed sleeve gastrectomy

Inclusion criteria

patients who had undergone OAGB/MGB following failed sleeve gastrectomy

排除标准：

Patients whose indication for surgery is early complications (less than 8 weeks) after surgery, such as a stapler line leak.
Lack of necessary data in the database

Exclusion criteria：

Patients whose indication for surgery is early complications (less than 8 weeks) after surgery, such as a stapler line leak.
Lack of necessary data in the database

研究实施时间：

Study execute time：

从 From 2016-01-01 00:00:00至 To 2020-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-01-02 00:00:00 至 To 2020-08-31 00:00:00

干预措施：

Interventions：

组别：

patients with history of sleeve gastrectomy failure

样本量：

 23

Group：

patients with history of sleeve gastrectomy failure

Sample size：

干预措施：

one anastomosis gastric bypass (OAGB/MGB)

干预措施代码：

Intervention：

one anastomosis gastric bypass (OAGB/MGB)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊朗

省(直辖市)：

 德黑兰 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Hazrat e Rasool Hospital 

单位级别：

 三级医院 

Institution
hospital：

Hazrat e Rasool Hospital

Level of the institution：

Tertiary center

测量指标：

Outcomes：

指标中文名：

weight changes

指标类型：

主要指标

Outcome：

weight changes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

diabetes

指标类型：

次要指标

Outcome：

diabetes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

hypertention

指标类型：

次要指标

Outcome：

hypertention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

dyslipidemia

指标类型：

次要指标

Outcome：

dyslipidemia

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

obstructive sleep apnea

指标类型：

次要指标

Outcome：

obstructive sleep apnea

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

gastroesophageal reflux disease

指标类型：

次要指标

Outcome：

gastroesophageal reflux disease

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：

blood

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

Mucosa

组织：

stomach

Sample Name：

mucosa

Tissue：

stomach

人体标本去向

 使用后保存  

说明

2 months

Fate of sample：

Preservation after use  

Note：

2 months

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 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）：

No

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

not applicable due to being retrospective

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：

N/A

Blinding：

not applicable

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

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：

Based on national obesity surgery database, the data will be collected at the time of SG and OAGB/MGB including age, gender, weight, height, nadir weight, BMI, percent excess weight loss (%EWL): %EWL=[(Initial Weight) – (Post-Op Weight)]/[(Initial Weight) – (Ideal Weight)] [7] and conversion indication. Some obesity-related comorbidities including type-2 Diabetes Mellitus (DM), arterial Hypertension (HTN), dyslipidemia, Obstructive Sleep Apnea (OSA) and GERD. Weight indicators and comorbidity outcomes are evaluated 1, 2, 3 and 5 years after the conversion surgery. The changes in comorbidities are classified in five categories: No change, remission, improvement, new onset and recurrence, which are assessed according to standardized outcomes reporting in metabolic and bariatric surgery.

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

Based on national obesity surgery database, the data will be collected at the time of SG and OAGB/MGB including age, gender, weight, height, nadir weight, BMI, percent excess weight loss (%EWL): %EWL=[(Initial Weight) – (Post-Op Weight)]/[(Initial Weight) – (Ideal Weight)] [7] and conversion indication. Some obesity-related comorbidities including type-2 Diabetes Mellitus (DM), arterial Hypertension (HTN), dyslipidemia, Obstructive Sleep Apnea (OSA) and GERD. Weight indicators and comorbidity outcomes are evaluated 1, 2, 3 and 5 years after the conversion surgery. The changes in comorbidities are classified in five categories: No change, remission, improvement, new onset and recurrence, which are assessed according to standardized outcomes reporting in metabolic and bariatric surgery.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-06-13 08:01:37