UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054032 |
|---|---|
| Receipt number | R000061105 |
| Scientific Title | Role of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection; prospective randomised study. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/17 21:24:08 |
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Basic information
Public title
Role of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection; prospective randomised study.
Acronym
Role of pelvic drain placement vs no pelvic drain placement after RARP with ePLND; prospective randomised study.
Scientific Title
Role of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection; prospective randomised study.
Scientific Title:Acronym
Role of pelvic drain placement vs no pelvic drain placement after RARP with ePLND; prospective randomised study.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the role of pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection. In the patients performed robot-assisted radical prostatectomy with extended pelvic lymph node dissection, we randomly allocate the patients to drain placement group and no drain placement group. We aim to prove that no drain placement group is not inferior to drain placement group in prevention from organ space surgical site infection.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are the incident rates of organ space surgical site infection more than Clavien-Dindo Grade 3 within 30 days after surgery.
Key secondary outcomes
1: Any complications excluded organ space surgical site infection within 90 days after surgery. We assess complications rates and level based on Clavien-Dindo classification.
2: Cosmesis of surgical wound at the postoperative 2, 7 and 30 days. Patients assess cosmesis (0: very ugly to 10: very beautiful) on the basis of a visual analogue scale.
3: Patient's satisfaction at the postoperative 2, 7 and 30 days. Patients assess satisfaction (0: not satisfied to 10: very satisfied) on the basis of a visual analogue scale.
4: Pain at the postoperative 2, 7 and 30 days. Patients assess pain (0: not painful to 10: very painful) on the basis of a visual analogue scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
No drain placement group: The patients is not placed intracorporeal drain tube after surgery.
Interventions/Control_2
Drain placement group: The patients is placed 15 Fr drain tube at pelvic floor from incision used during RARP. Principal investigator or sub-investigator decide to remove drain tube based on drainage volume and characteristics the next day or later.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1: Patients who are pathologically diagnosed with prostate cancer.
2: Patients who are performed robot-assisted radical prostatectomy with extended pelvic lymph node dissection.
3: Patients who are 20 years of age or older at the time consent is obtained
4: Patients who can obtain written consent for participation in this study from the individual
Key exclusion criteria
Patients deemed inappropriate by the person in principal investigator or sub-investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Hinata |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Urology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture 734-8551, Japan
TEL
082-257-5242
hinata@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Hatayama |
Organization
Hiroshima University Hospital
Division name
Urology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture 734-8551, Japan
TEL
082-257-5242
Homepage URL
htomoya1211@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061105
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| Research case data specifications | |
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| Registered date | File name |
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