UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015084
Receipt No. R000017555
Scientific Title A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after laparoscopic radical retropubic prostatectomy.
Date of disclosure of the study information 2014/09/08
Last modified on 2018/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after laparoscopic radical retropubic prostatectomy.
Acronym A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after LRP
Scientific Title A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after laparoscopic radical retropubic prostatectomy.
Scientific Title:Acronym A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after LRP
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after LRP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidence rates of postoperative inguinal hernia
Key secondary outcomes operation time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 hernia prevention
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male
Key inclusion criteria prostate cancer patients performed LRP
Key exclusion criteria past history of inguinal hernia
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Miyajima
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email akiram@a8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuaki Daimon
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email tatsuaki_daimon@hotmail.com

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 08 Day
Last modified on
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017555

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.