UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061290 |
|---|---|
| Receipt number | R000070111 |
| Scientific Title | Prospective observational study on clinical characteristics and prognosis of subcutaneous emphysema after robot-assisted laparoscopic radical prostatectomy |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/04/17 13:44:38 |
* 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
Prospective observational study on subcutaneous emphysema after robot-assisted radical prostatectomy
Acronym
RARP-SE Study
Scientific Title
Prospective observational study on clinical characteristics and prognosis of subcutaneous emphysema after robot-assisted laparoscopic radical prostatectomy
Scientific Title:Acronym
RARP-SE Study
Region
| Japan |
Condition
Condition
Prostate cancer (Subcutaneous emphysema after robot-assisted laparoscopic radical prostatectomy)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To characterize clinical features of subcutaneous emphysema after RARP and explore associated factors
Basic objectives2
Others
Basic objectives -Others
Quantitative evaluation of subcutaneous emphysema volume using low-dose CT on POD1, correlation with X-ray qualitative assessment, and exploration of association with postoperative pain
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Volume of subcutaneous emphysema (mL) measured by low-dose CT on postoperative day 1 (POD1)
Key secondary outcomes
Maximum thickness of subcutaneous emphysema (mm), Factors determining subcutaneous emphysema volume, Difference in subcutaneous emphysema volume by robot type, Correlation between X-ray qualitative assessment and CT quantitative assessment, Association between subcutaneous emphysema volume and postoperative pain (NRS), Cervical/mediastinal extension and association with complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male
Key inclusion criteria
Prostate cancer patients scheduled for RARP at Kobe University Hospital or International Clinical Cancer Research Center, Kobe University Hospital; Age 20 years or older; Written informed consent obtained
Key exclusion criteria
Patients with pre-existing subcutaneous emphysema; Patients judged ineligible by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyake |
Organization
Kobe University Hospital
Division name
Department of Urology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017
TEL
078-382-6155
urokobe@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kyono |
Organization
Kobe University Hospital
Division name
Department of Urology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017
TEL
078-382-6155
Homepage URL
urokobe@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
International Clinical Cancer Research Center, Kobe University Hospital (ICCRC)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
Tel
0783826669
ctrcpj-kenkyukanrijimu@med.kobe-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
神戸大学医学部附属病院（兵庫県）、神戸大学医学部附属病院 国際がん医療・研究センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. Prostate cancer patients scheduled for RARP are enrolled. Quantitative assessment of subcutaneous emphysema (volume and maximum thickness) by low-dose CT on POD1, qualitative assessment by chest-abdominal X-ray on POD0, and clinical data including postoperative pain (NRS) and SpO2 are collected. No intervention is performed.
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070111
