UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055605 |
|---|---|
| Receipt number | R000063515 |
| Scientific Title | Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form. |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/07/12 08:28:27 |
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Basic information
Public title
Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form.
Acronym
Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form.
Scientific Title
Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form.
Scientific Title:Acronym
Measurement of internal colonic pressure using a colonoscopy and development of a predictive model of defecation and stool form.
Region
| Japan |
Condition
Condition
Patients who will receive a colonoscopy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a method for measuring intracolonic pressure through a colonoscope.
Basic objectives2
Others
Basic objectives -Others
To reveal the relationship between the subject's defecation, stool form, and intracolonic pressure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak internal pressure values in the cecum, transverse colon, and rectum during carbon dioxide injection through a colonoscope.
Key secondary outcomes
Rate of increased internal colonic pressure by carbon dioxide injection.
Relationship between abdominal discomfort or symptom and internal colonic pressure.
Relationship between defecation frequency and internal colonic pressure.
Relationship between Bristol stool form scale and internal colonic pressure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measuring the internal colonic pressure with carbon dioxide injection through a colonoscope.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who will undergo colonoscopy
2. Age of 20-89 years
3. Written informed consent
Key exclusion criteria
1. History of colorectal surgery
2. Known inflammatory bowel disease
3. Known hereditary or non-hereditary polyposis syndrome
4. Known hereditary non-polyposis colorectal cancer (HNPCC)
5. Known severe diverticular segment which restricts colonoscopy
6. Unable to intake bowel preparation agent
7. Allergy for any drugs used during colonoscopy
8. Known colorectal adenoma, polyp, or cancer before the trial
9. Pregnancy
10. Breast-feeding
11. Lack of informed consent
12. Others
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba, Japan. 272-0827
TEL
047-375-1111
sho-suzuki@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Tonishi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba, Japan. 272-0827
TEL
047-375-1111
Homepage URL
24M3013@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Institutional Review Board of International University of Health and Welfare
Address
4-3, Kozunomori, Narita, Chiba, Japan
Tel
047-620-7708
rinri_md@iuhw.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
国際医療福祉大学市川病院/International University of Health and Welfare Ichikawa Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063515
