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Recruitment status Terminated
Unique ID issued by UMIN UMIN000014136
Receipt No. R000016457
Scientific Title Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Date of disclosure of the study information 2014/06/01
Last modified on 2017/06/03

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Basic information
Public title Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Acronym Assessment of colon motility using cine-MRI
Scientific Title Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Scientific Title:Acronym Assessment of colon motility using cine-MRI
Region
Japan

Condition
Condition megacolon and slow tlansit constipation (STC)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand the pathophysiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mean luminal diameter, contraction ratio, and contraction cycle, calculated from each image of cine-MRI.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are diagnosed megacolon or STC from their symptom, X-rays, 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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
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 nakajima-tky@umin.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 045-787-2864
Homepage URL
Email iyumi@yokohama-cu.ac.jp

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
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
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 小田原市立病院(神奈川)Odawara Municipal Hospital, Kanagawa
板橋区医師会病院(東京都)Itabashi Medical Association Hospital, Tokyo
岩手医科大学(岩手県) Iwate Medical University, Iwate

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 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
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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To understand the pathophisiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.

Management information
Registered date
2014 Year 06 Month 01 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016457


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