UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to evaluate the efficacy of a technique to prevent inguinal hernia after laparoscopic radical retropubic prostatectomy.
Title of the study (Brief title)	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	Akira Miyajima
Organization	Keio University School of Medicine
Division name	Department of Urology
Address	35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	akiram@a8.keio.jp

Public contact
Name of contact person	Tatsuaki Daimon
Organization	Keio University School of Medicine
Division name	Department of Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017555