UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Title of the study (Brief title)	Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Region	Japan

Condition
Condition	Chronic Intestinal Pseudoobstruction
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Chronic intestinal pseudoobstruction is the syndrome that without intestinal obstructions. CIP is the rare syndrome, and there is no study about prevalence rate of CIP. We study epidemiology and QOL investigation of CIP in Japan.
Basic objectives2	Others
Basic objectives -Others	Chronic intestinal pseudoobstruction is the syndrome that without intestinal obstructions. CIP is the rare syndrome, and there is no study about prevalence rate of CIP. We study epidemiology and QOL investigation of CIP in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-questionnaire about subject of chronic intestinal psudoobstruction. Self-questionnaire for digestive symptoms.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a. Obtaining informed consent b. Patient of 15 years or more c. Patient diagnosed chronic intestinal pseudoobstruction.
Key exclusion criteria	a. Not obtaining informed consent b. Patient before 15 years
Target sample size	300

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Email

Public contact
Name of contact person	Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Homepage URL
Email	inamorim@med.yokohama-cu.ac.jp

Sponsor
Institute	Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare labor science research expense subsidy
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 31 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	before the observation examination

Management information
Registered date	2010 Year 08 Month 12 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004850