UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063540 |
|---|---|
| Receipt number | R000072681 |
| Scientific Title | Understanding Ostomy Appliance Wear Time and Exploring Factors Influencing Wear Time Decision-Making Among People Living with a Stoma |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 08:03:36 |
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Basic information
Public title
Understanding Ostomy Appliance Wear Time and Exploring Factors Influencing Wear Time Decision-Making Among People Living with a Stoma
Acronym
Understanding Ostomy Appliance Wear Time and Exploring Factors Influencing Wear Time Decision-Making Among People Living with a Stoma
Scientific Title
Understanding Ostomy Appliance Wear Time and Exploring Factors Influencing Wear Time Decision-Making Among People Living with a Stoma
Scientific Title:Acronym
Understanding Ostomy Appliance Wear Time and Exploring Factors Influencing Wear Time Decision-Making Among People Living with a Stoma
Region
| Japan |
Condition
Condition
People living with a stoma
Classification by specialty
| Gastrointestinal surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to understand the current status of ostomy appliance wear time among people living with a stoma, to identify who determines the frequency of appliance changes, to explore the factors that influence this decision-making process, and to elucidate preferences regarding appliance change frequency (i.e., wear time).
Basic objectives2
Others
Basic objectives -Others
Cross-sectional survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ostomy appliance wear time
Key secondary outcomes
Factors influFencing wear-time decision-making
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals with a permanent or temporary stoma
2. Aged 18 years or older
3. Individualas who provided informed consent to participate in this survey
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Stefan |
| Middle name | Linde |
| Last name | Jakobsen |
Organization
Coloplast K.K.
Division name
Counrtry Manager
Zip code
102-0074
Address
11F, 2-1-30 Kudan Minami, Chiyoda-ku, Tokyo
TEL
03-3514-4141
consumercarejp@coloplast.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Nakamura |
Organization
Coloplast K.K.
Division name
Marketing and Market Access
Zip code
102-0074
Address
11F, 2-1-30 Kudan Minami, Chiyoda-ku, Tokyo
TEL
080-4771-1037
Homepage URL
jpnna@coloplast.com
Sponsor or person
Institute
Coloplast K.K.
Institute
Department
Personal name
Funding Source
Organization
Coloplast K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10 Hamamatsucho
Tel
03-5408-1559
rinri@s-palace-clinic.com
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
| 2026 | Year | 11 | Month | 06 | 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 | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational cross-sectional study using an anonymous web-based survey
Management information
Registered date
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072681
