UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057533 |
|---|---|
| Receipt number | R000065732 |
| Scientific Title | Observational study about relationship between atmospheric pressure and length of time for colon cleansing in colonoscopy |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2026/04/09 18:51:06 |
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Basic information
Public title
Observational study about relationship between atmospheric pressure and length of time for colon cleansing in colonoscopy
Acronym
Relationship between atmospheric pressure and lengthy of time for colon cleansing in colonoscopy
Scientific Title
Observational study about relationship between atmospheric pressure and length of time for colon cleansing in colonoscopy
Scientific Title:Acronym
Relationship between atmospheric pressure and lengthy of time for colon cleansing in colonoscopy
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the relationship between atmospheric pressure and lengthy of time for colon cleansing in colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time until stool becomes clear or yellow lquid
Key secondary outcomes
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjective who takes colonoscopy for occasional screening
Key exclusion criteria
Detection of some disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hozumi |
Organization
Self Defense Force Sendai Hospital
Division name
Internal Medicine
Zip code
983-0041
Address
1-1 Minaminomedate Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-231-1111
sd37667hozu1334@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hozumi |
Organization
Self Defense Force Sendai Hospital
Division name
Internal Medicine
Zip code
983-0041
Address
1-1 Minaminomedate Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-231-1111
Homepage URL
sd37667hozu1334@yahoo.co.jp
Sponsor or person
Institute
Self Defense Force Sendai Hospital
Institute
Department
Personal name
Hideaki Hozumi
Funding Source
Organization
Self Defense Force Sendai 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
Self Defense Force Sendai Hospital
Address
1-1 Minaminomedate Miyagino-ku, Sendai, Miyagi, Japan
Tel
022-231-1111
sd37667hozu1334@yahoo.co.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
| 2025 | Year | 04 | Month | 07 | 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
377
Results
Significant correlations were observed when pressure difference was stratified by direction: negative correlations in the increasing-pressure group and positive correlations in the decreasing-pressure group. Greater absolute pressure differences were associated with shorter preparation times. Participants exposed to high diurnal fluctuation exhibited approximately 20-minute shorter preparation times than those exposed to low fluctuation.
Results date posted
| 2026 | Year | 04 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 30 | Day |
Other
Other related information
Observe atmospheric pressure and length of time for colon cleansing in colonoscopy, then analyse their relationchip
Management information
Registered date
| 2025 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065732
