UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008993
Receipt No. R000010547
Scientific Title Randomized Controlled Trial for the prevention method of inguinal hernia after Robotic assisted laparoscopic radical prostatectomy
Date of disclosure of the study information 2012/09/27
Last modified on 2019/07/23 (Ver. 8)

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Basic information
Public title Randomized Controlled Trial for the prevention method of inguinal hernia after Robotic assisted laparoscopic radical prostatectomy
Acronym Prevention method of inguinal hernia after robotic prostatectomy
Scientific Title Randomized Controlled Trial for the prevention method of inguinal hernia after Robotic assisted laparoscopic radical prostatectomy
Scientific Title:Acronym Prevention method of inguinal hernia after robotic prostatectomy
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the prevention method of inguinal hernia after robotic assisted laparoscopic radical prostatectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effectiveness of the prevention method of inguinal hernia during robotic assisted laparoscopic radical prostatectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The side of performing prevention method of inguinal hernia during robotic assisted laparoscopic radical prostatectomy
Interventions/Control_2 The side of not performing prevention method of inguinal hernia during robotic assisted laparoscopic radical prostatectomy
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
40 years-old <=
Age-upper limit
76 years-old >=
Gender Male
Key inclusion criteria patients scheduled for robotic assisted laparoscopic radical prostatectomy and approving participation in this trial
Key exclusion criteria patients with inguinal hernia or patients who have the history of inguinal hernia repair
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Kadono
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code 920-8640
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2393
Email yskadono@yahoo.co.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Kadono
Organization Kanazawa University Graduate School of Medical Science
Division name Cancer Therapy and Urology
Zip code 920-8640
Address 13-1 Takaramachi Kanazawa
TEL 076-265-2393
Homepage URL
Email yskadono@yahoo.co.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takara-machi, Kanazawa, Ishikawa
Tel 0762652090
Email crc.irb-knz@esct.jp

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 金沢大学附属病院（石川県）

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 27 Day

Related information
URL releasing protocol 10.1089/end.2018.0898
Publication of results Published

Result
URL related to results and publications 10.1089/end.2018.0898
Number of participants that the trial has enrolled 148
Results 
The preventive procedure for IH used in this study reduced the incidence of inguinal hernia after RARP, but the difference was not significant.
Results date posted
2019 Year 07 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Inclusion criterion in the study was patients with localized prostate cancer scheduled to undergo robot-assisted radical prostatectomy at the Kanazawa University Hospital.Patients with a history of inguinal hernia repair or clinical IH on preoperative physical examination were excluded.
Participant flow 
Robot-assisted radical prostatectomy with or without inguinal hernia prevention for localized prostate cancer are provided after written informed consent is provided.
Adverse events 
Adverse events arising from the procedure were not observed
Outcome measures 
The primary endpoint was defined as the rate of incidence of inguinal hernia after robot-assisted radical prostatectomy with or without the preventive procedure. Secondary endpoints were adverse events due to the preventive procedure.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 09 Month 27 Day
Date of IRB
2012 Year 08 Month 03 Day
Anticipated trial start date
2012 Year 09 Month 27 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 09 Month 27 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010547