ChiCTR2100043334 版本V1.0 版本创建时间2021/05/30 22:55:26 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：

 ChiCTR2100043334 

最近更新日期：

Date of Last Refreshed on：

 2021-02-11 02:19:14 

注册时间：

Date of Registration：

 2021-02-10 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

RANDOMISED CONTROL TRIAL: PROGRIP MESH VS CONVENTIONAL POLYPROPYLENE MESH, FOR LICHTENSTEIN INGUINAL HERNIOPLASTY

Public title：

RANDOMISED CONTROL TRIAL: PROGRIP MESH VS CONVENTIONAL POLYPROPYLENE MESH, FOR LICHTENSTEIN INGUINAL HERNIOPLASTY

注册题目简写：

English Acronym：

研究课题的正式科学名称：

RANDOMISED CONTROL TRIAL: PROGRIP MESH VS CONVENTIONAL POLYPROPYLENE MESH, FOR LICHTENSTEIN INGUINAL HERNIOPLASTY

Scientific title：

RANDOMISED CONTROL TRIAL: PROGRIP MESH VS CONVENTIONAL POLYPROPYLENE MESH, FOR LICHTENSTEIN INGUINAL HERNIOPLASTY

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：

Syed Saad Mujtahedi 

研究负责人：

Beni Sader 

Applicant：

Syed Saad Mujtahedi 

Study leader：

Beni Sader 

申请注册联系人电话：

Applicant telephone：

 +1 313-725-1983

研究负责人电话：

Study leader's
telephone：

+91 96 86039189

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：

 saadsyed1995@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 sader.bani@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：

101 E Center Street, 412, Rochester, MN, USA

研究负责人通讯地址：

Kasturba Medical College, Light house hill road, Mangalore, 575001, Karnataka, India

Applicant address：

101 E Center Street, 412, Rochester, MN, USA

Study leader's address：

Kasturba Medical College, Light house hill road, Mangalore, 575001, Karnataka, India

申请注册联系人邮政编码：

Applicant postcode：

 55904

研究负责人邮政编码：

Study leader's postcode：

 575001

申请人所在单位：

美国明尼苏达州

Applicant's institution：

co-author

研究负责人所在单位：

印度班加罗尔Kasturba Medical College

Affiliation of the Leader：

Kasturba Medical College

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：

 KMC MLR 12-15/297

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：

Institutional Ethics Committee Kasturba Medical College, Mangalore Manipal University

Name of the ethic committee：

Institutional Ethics Committee Kasturba Medical College, Mangalore Manipal University

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-12-16 00:00:00

伦理委员会联系人：

Dr. Shalini Shenoy

Contact Name of the ethic committee：

Dr. Shalini Shenoy

伦理委员会联系地址：

Office of Medical Education Unit, Light house hill road, Mangalore, 575001, Karnataka, India

Contact Address of the ethic committee：

Office of Medical Education Unit, Light house hill road, Mangalore, 575001, Karnataka, India

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：

研究实施负责（组长）单位：

Beni Sader

Primary sponsor：

Beni Sader

研究实施负责（组长）单位地址：

Kasturba Medical College, Light house hill road, Mangalore, 575001, Karnataka, India

Primary sponsor's address：

Kasturba Medical College, Light house hill road, Mangalore, 575001, Karnataka, India

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Self-funded

Source(s) of funding：

Self-funded

研究疾病：

Inguinal Hernia  

Target disease：

Inguinal Hernia

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

This randomized control trial evaluated whether the Progrip Mesh has an advantage over the Conventional Polypropylene Mesh for open Lichtensteins inguinal hernioplasty in regards to postoperative pain.  

Objectives of Study：

This randomized control trial evaluated whether the Progrip Mesh has an advantage over the Conventional Polypropylene Mesh for open Lichtensteins inguinal hernioplasty in regards to postoperative pain.

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 aged 18 to 69 years of any gender, diagnosed with an uncomplicated unilateral inguinal hernia who were considered fit for elective open inguinal hernia repair were eligible to participate in the study. Subjects consenting for the study

Inclusion criteria

Patients aged 18 to 69 years of any gender, diagnosed with an uncomplicated unilateral inguinal hernia who were considered fit for elective open inguinal hernia repair were eligible to participate in the study. Subjects consenting for the study

排除标准：

Exclusion criteria were patients aged <18 years or ≥70 years, requiring emergency procedure, enrolment in another trial, with bilateral inguinal hernia, recurrent, strangulated or incarcerated hernia, BMI >30kg/m2 , concomitant abdominal surgery, long-term analgesic or steroid use, American Society of Anesthesiologists (ASA) physical status classification III or more, Child-Pugh grade C hepatic cirrhosis, any other disease severely compromising health and recovery( immunocompromised, uncontrolled diabetes mellitus), with renal compromise or hypersensitivity to injection Diclofenac.

Exclusion criteria：

Exclusion criteria were patients aged <18 years or ≥70 years, requiring emergency procedure, enrolment in another trial, with bilateral inguinal hernia, recurrent, strangulated or incarcerated hernia, BMI >30kg/m2 , concomitant abdominal surgery, long-term analgesic or steroid use, American Society of Anesthesiologists (ASA) physical status classification III or more, Child-Pugh grade C hepatic cirrhosis, any other disease severely compromising health and recovery( immunocompromised, uncontrolled diabetes mellitus), with renal compromise or hypersensitivity to injection Diclofenac.

研究实施时间：

Study execute time：

从 From 2015-11-01 00:00:00至 To 2017-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-11-01 00:00:00 至 To 2017-07-31 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 33

Group：

Control group

Sample size：

干预措施：

Conventional Polypropylene mesh

干预措施代码：

Intervention：

Conventional Polypropylene mesh

Intervention code：

组别：

Experimental group

样本量：

 32

Group：

Experimental group

Sample size：

干预措施：

Progrip mesh

干预措施代码：

Intervention：

Progrip mesh

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 Karnataka 

市(区县)：

 Mangalore 

Country：

India

Province：

Karnataka

City：

Mangalore

单位(医院)：

 Kasturba Medical College, Mangalore, Manipal Academy of Higher Education. 

单位级别：

 Manipal Academy of Higher Education 

Institution
hospital：

Kasturba Medical College, Mangalore, Manipal Academy of Higher Education.

Level of the institution：

Manipal Academy of Higher Education

测量指标：

Outcomes：

指标中文名：

postoperative pain during the first three months following the operation

指标类型：

主要指标

Outcome：

postoperative pain during the first three months following the operation

Type：

Primary indicator

测量时间点：

one, two, and three months post-operation

测量方法：

Verbal Numerical Rating Scale (VNRS)

Measure time point of outcome：

one, two, and three months post-operation

Measure method：

Verbal Numerical Rating Scale (VNRS)

指标中文名：

foreign body sensation during the first three months following the operation

指标类型：

次要指标

Outcome：

foreign body sensation during the first three months following the operation

Type：

Secondary indicator

测量时间点：

one, two, and three months post-operation

测量方法：

assessed clinically

Measure time point of outcome：

one, two, and three months post-operation

Measure method：

assessed clinically

指标中文名：

number of days taken to return to work

指标类型：

次要指标

Outcome：

number of days taken to return to work

Type：

Secondary indicator

测量时间点：

one, two and three months post-operation

测量方法：

assessed clinically

Measure time point of outcome：

one, two and three months post-operation

Measure method：

assessed clinically

指标中文名：

recurrence of a hernia

指标类型：

次要指标

Outcome：

recurrence of a hernia

Type：

Secondary indicator

测量时间点：

one, two and three months post-operation

测量方法：

assessed clinically

Measure time point of outcome：

one, two and three months post-operation

Measure method：

assessed clinically

采集人体标本：

Collecting sample(s)
from participants：

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 69 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）：

Sequence generation was done using randomization software Research Randomizer (Version 4.0) described as a "pseudo-random number generator." Research Randomizer uses the "Math.random" method within the JavaScript programming language as the core method for generating its random numbers. Following which the participants were alloca

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

Sequence generation was done using randomization software Research Randomizer (Version 4.0) described as a "pseudo-random number generator." Research Randomizer uses the "Math.random" method within the JavaScript programming language as the core method for generating its random numbers. Following which the participants were alloca

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）：

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）：

N/A

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

N/A

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：

N/A

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

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-02-11 02:19:14