UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049352 |
|---|---|
| Receipt number | R000056140 |
| Scientific Title | Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas |
| Date of disclosure of the study information | 2022/10/30 |
| Last modified on | 2022/10/28 06:01:35 |
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Basic information
Public title
Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Acronym
Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Scientific Title
Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Scientific Title:Acronym
Examination of the effectiveness of introducing preoperative DVD viewing to patients with additional stomas
Region
| Japan |
Condition
Condition
colon disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Introduce a DVD about the stoma to patients and their families before stoma enlargement, and conduct an interview survey after watching the DVD before discharge from the hospital. Aimed at finding help
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in accepted body image for stoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
after admission
Interventions/Control_2
before discharge
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stoma expansion patient
Key exclusion criteria
Patients with additional stomas in emergency surgery
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | miho |
| Middle name | |
| Last name | Kawasaki |
Organization
Yamagata University Hospital
Division name
Yamagata University Hospital 9F East Ward
Zip code
999-9585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
023-633-1122
yu-ikekenkyu@jm.kj.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | mariko |
| Middle name | |
| Last name | takeda |
Organization
Yamagata University Hospital
Division name
Yamagata University Hospital 9F East Ward
Zip code
99990-9585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
023-633-1122
Homepage URL
marikoope@gmail.com
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University Hospital
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
Yamagata University School of Medicine Ethics Review Committee
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel
023-628-5047
mailto:yu-ikekenkyu@jm.kj.yamagata-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
| 2022 | Year | 10 | Month | 30 | 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
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056140
