UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021274 |
|---|---|
| Receipt number | R000024539 |
| Scientific Title | Assessment of colonic contents in patients with chronic constipation using MRI |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/03/30 10:05:24 |
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Basic information
Public title
Assessment of colonic contents in patients with chronic constipation using MRI
Acronym
Assessment of colonic contents using MRI
Scientific Title
Assessment of colonic contents in patients with chronic constipation using MRI
Scientific Title:Acronym
Assessment of colonic contents using MRI
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the correlation between pathophysiology and colonic contents in patients of chronic constipation, we will evaluate the usefulness of MRI as a diagnostic method, and a connect to appropriate therapy.
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the colonic contents and the symptoms: correlation between the homology of colonic contents of ascending colon and sigmoid colon, and GSRS score or Bristol scale.
Key secondary outcomes
1) Correlation between the colonic contents and the environmental factor: correlation between the homology of colonic contents of ascending colon and sigmoid colon, and the medication or last meal or last defecation.
2) Correlation between the luminal diameter of colon and the symptoms: correlation between the maximal diameter of ascending and sigmoid colon, and GSRS score or Bristol scale.
3) Correlation between the luminal diameter of colon and the environmental factor: correlation between the maximal diameter of ascending and sigmoid colon , and the medication or last meal or last defecation.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have constipation as chief complaint.
2) Without mechanical obstruction such as colon cancer.
3) Patients who are between 20 and 80 years old with ability for agreement.
4) Written informed consent was obtained after sufficient explanation.
Key exclusion criteria
1) Patients with organic digestive tract disease before 1 year.
2) Subjects with contraindications to MRI.(such as detained internal metal, or claustrophobia.)
3) Patients with past history of gastrointestinal excision. (without appendectomy)
4) Patients judged inappropriate for the trial by investigators such as severe heart failure, hepatic failure, renal failure, and terminal cancer.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Inoh |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2640
iyumi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Inoh |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2640
Homepage URL
iyumi@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
SHIN-YURIGAOKA General Hospital.
Yokohama Rosai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学病院 Yokohama City University Hospital, Kanagawa
横浜労災病院 Yokohama Rosai Hospital, Kanagawa
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 30 | Day |
Other
Other related information
This study is prospective cross-sectional study in multicenter about symptom and fecal property of chronic constipation using MRI which image the colonic contents.
From March 1st 2016 to 29st February 29 2021, we intend the patients who satisfy the key inclusion criteria and have agreement with document, in our hospital or the collaborate hospital
We evaluate correlation between the colonic contents and the symptoms: correlation between the homology of colonic contents of ascending colon and sigmoid colon, and GSRS score or Bristol scale.
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024539
