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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015377
Receipt No. R000017898
Scientific Title Assessment of colonic contents in patients with chronic constipation using MRI
Date of disclosure of the study information 2014/10/15
Last modified on 2015/12/20

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Basic information
Public title Assessment of colonic contents in patients with chronic constipation using MRI
Acronym Assessment of colonic contents in patients with chronic constipation using MRI
Scientific Title Assessment of colonic contents in patients with chronic constipation using MRI
Scientific Title:Acronym Assessment of colonic contents in patients with chronic constipation 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 connect to appropriate therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean luminal diameter, and distribution, calculated from each image of MRI.
Score of interview sheet.
Colonic transit time calculated from radiopaque particles.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who are diagnosed chronic constipation from their symptom, X-ray, and CT scan.
2)Written informed consent was obtained.
Key exclusion criteria 1) Patients with organic digestive tract disease.
2) Patients with current or past history of malignant disease.
3) Patients with current other digestive diseases.
4) Subjects with contraindications to MRI.
5) Patients judged inappropriate for the trial by investigators.
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
Email 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
Email iyumi@yokohama-cu.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-aid for Scienfitic Resarch from Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama Rabores' Hospital, Kanagawa
Odawara Municipal Hospital, Kanagawa
Itabashi Medical Association Hospital, Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜労災病院(神奈川)Yokohama Raborers’ Hospital, Kanagawa
小田原市立病院(神奈川) Odawara Municipal Hospital, Kanagawa

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially 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 Terminated
Date of protocol fixation
2014 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information To assess the correlation between colonic contents and other indicators in patients of chronic constipation, we will evaluate the usefulness of MRI as a diagnostic method, and connect to appropriate therapy.

Management information
Registered date
2014 Year 10 Month 08 Day
Last modified on
2015 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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