UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041742 |
|---|---|
| Receipt number | R000047485 |
| Scientific Title | Studies of post-operative patients's stress biomarkers using sitting pressure reduction device : fuwatto |
| Date of disclosure of the study information | 2020/09/10 |
| Last modified on | 2021/03/24 16:59:07 |
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Basic information
Public title
Studies of post-operative patients's stress biomarkers
using sitting pressure reduction device : fuwatto
Acronym
Studies of post-operative patients's stress biomarkers
using sitting pressure reduction device : fuwatto
Scientific Title
Studies of post-operative patients's stress biomarkers
using sitting pressure reduction device : fuwatto
Scientific Title:Acronym
Studies of post-operative patients's stress biomarkers
using sitting pressure reduction device : fuwatto
Region
| Japan |
Condition
Condition
Urological diseases in general
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate the reduction
effect of postoperative patients's stress using sitting stress reduction device fuwatto.
A questionnaire is used for subjective evaluation, and stress biomarkers are analyzed in saliva, blood, and urine samples as objective evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before the surgery, 1 day after the surgery, 1 week after the surgery, fill out the questionnaire at the time of discharge and collect samples of saliva, blood and urine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing a seat pressure relief device "Fuwat" after surgery for 1 week to 10 days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing Robotic-assisted radical prostatectomy:male.
Patients undergoing Pelvic Organ Prolapse and stress
incontinence surgery :female
Patients under urethral catheterization
Key exclusion criteria
Patients who do not wish to participate in this study.
Patients who the attending physician has determined to be unable to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Noguchi |
Organization
Saga University Faculty of Medicine
Division name
Department of Urology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2344
nogman@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Kawasaki |
Organization
Saga University Faculty of Medicine
Division name
Department of Urology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2344
Homepage URL
kawasakm@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Saga University Faculty of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, Saga university hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3357
kenkyu-shinsei@ml.cc.saga-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
| 2020 | Year | 09 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047485
