UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053987 |
|---|---|
| Receipt number | R000061629 |
| Scientific Title | Research on the usefulness of preoperative guidance using stoma models and videos for patients scheduled for stoma |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/03/27 18:52:18 |
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Basic information
Public title
Research on the usefulness of preoperative guidance using stoma models and videos for patients scheduled for stoma
Acronym
Research on the usefulness of preoperative guidance using stoma models and videos for patients scheduled for stoma
Scientific Title
Research on the usefulness of preoperative guidance using stoma models and videos for patients scheduled for stoma
Scientific Title:Acronym
Research on the usefulness of preoperative guidance using stoma models and videos for patients scheduled for stoma
Region
| Japan |
Condition
Condition
Patients scheduled for stoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients scheduled to have a stoma, providing guidance through video viewing during preoperative outpatient visits and self-care training of stoma techniques using a stoma model at home by the patient himself/herself will help smooth the acquisition of stoma techniques. The purpose is to make it clear that it is useful. By achieving the above objectives, it is expected that unnecessary hospitalization periods will be shortened and medical costs will be made more efficient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary evaluation item was the score on the stoma technique acquisition status evaluation sheet at the time of postoperative pouch exchange.
Key secondary outcomes
Scores on the stoma skill acquisition status evaluation sheet for the intervention group at admission, length of hospitalization, period from first outpatient visit to surgery, and self-care practice time at home.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The intervention group will receive a colostomy self-care instruction intervention using a video at the preoperative outpatient clinic, will be provided with a stoma model and a stoma face plate, and will be asked to perform self-training at home during the waiting period for surgery.
Interventions/Control_2
In the non-intervention group, no preoperative intervention was performed, and the acquisition status of stoma techniques was scored using an evaluation table for objectively evaluating the acquisition status of stoma techniques.
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
Patients scheduled for elective surgery to have a stoma by March 31, 2025 (including all benign and malignant diseases)
Temporary and permanent colostomy (including ileal stoma and colonic stoma)
Patients who are 18 years of age or older at the time of obtaining consent
Patients who have received sufficient explanation to participate in this study, and who have given their voluntary written consent based on sufficient understanding.
Patients who can watch DVD at home
Key exclusion criteria
Patients with a past history of dementia
Patients who are unable to use their hands due to underlying disease
Patients who cannot obtain consent using the informed consent form
Other patients whose doctor has determined that they are ineligible for enrollment in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Maeda |
| Middle name | |
| Last name | Akihiko |
Organization
Nagasaki University Hospital
Division name
8th floor east ward
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7200
aa84031008@ms.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Maeda |
| Middle name | |
| Last name | Akihiko |
Organization
Nagasaki University Hospital
Division name
8th floor east ward
Zip code
851-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7316
Homepage URL
aa84031008@ms.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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 | 03 | 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
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061629
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
