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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031784
Receipt No. R000036234
Scientific Title Survey on chronic constipation practice in Japan
Date of disclosure of the study information 2018/03/20
Last modified on 2019/06/10

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Basic information
Public title Survey on chronic constipation practice in Japan
Acronym Survey on chronic constipation practice
Scientific Title Survey on chronic constipation practice in Japan
Scientific Title:Acronym Survey on chronic constipation practice
Region
Japan

Condition
Condition chronic constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical significance of evaluating the stool form based on Bristol scale
Basic objectives2 Others
Basic objectives -Others Bristol scale
Patient Assessment of Constipation Quality of Life (PAC-QOL)
Constipation Scoring System; CSS
SF-8
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between stool form and Patient Assessment of Constipation Quality of Life (PAC-QOL)
Key secondary outcomes The association between stool form and bowel movement.
The association between stool form and difficulty of defecation
Constipation Scoring System; CSS
SF-8

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
85 years-old >
Gender Male and Female
Key inclusion criteria Outpatients treated with chronic constipation
Key exclusion criteria 1.Patients with organic constipation(rectal intussusception,rectal prolapse and megacolon)
2.Patients with secondary constipation due to metabolic/endocrine disorders neuromuscular disorders and medication(opioids,antipsychotics,anticholinergic etc)
3.Patients with active intra-abdominal and pelvic malignancy
4.Patients with a history of intestinal resection excluding appendicectomy
5.Patients with active intestinal organic disease(inflammatory bowel disease,diverticular disease etc)
6.Patients with pregnant, possibly pregnant, and lactating subjects are excluded
7.Patients who are considered to be unsuitable by the trial investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Yamada
Organization National Hospital Organization Yokohama Medical Center
Division name Gastroenterology
Zip code 245-8575
Address 3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL 0458512621
Email eiji@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yamada
Organization National Hospital Organization Yokohama Medical Center
Division name Gastroenterology
Zip code 245-8575
Address 3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL 0458512621
Homepage URL
Email eiji@yokohama-cu.ac.jp

Sponsor
Institute National Hospital Organization Yokohama Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization Yokohama Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Yokohama Medical Center
Address 3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
Tel 0458512621
Email eiji@yokohama-cu.ac.jp

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
2018 Year 03 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To clarify the clinical significance of evaluating the stool form based on Bristol scale

Management information
Registered date
2018 Year 03 Month 19 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036234

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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