UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008993 |
|---|---|
| Receipt number | 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 11:29:45 |
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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
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
yskadono@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010547
