UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of colonic contents in patients with chronic constipation using MRI
Title of the study (Brief title)	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	Yumi Inoh
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
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	Yumi Inoh
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024539