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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024097
Receipt No. R000027742
Scientific Title Study on the correction between the anorectal function evaluation and other modality.
Date of disclosure of the study information 2016/09/18
Last modified on 2019/03/22

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Basic information
Public title Study on the correction between the anorectal function evaluation and other modality.
Acronym Study on anorectal function evaluation.
Scientific Title Study on the correction between the anorectal function evaluation and other modality.
Scientific Title:Acronym Study on anorectal function evaluation.
Region
Japan

Condition
Condition Anorectal motor dysfunction and healty adults
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the correlation between anorectal manometry and other modality
Basic objectives2 Others
Basic objectives -Others Study of the clinical features of anorectal manometry cases in Japan
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine the correlation between anorectal manometry and other modality
ex;Rectal motion estimation method by transabdominal ultrasound
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Agree to the examination of patients or healty subjects
Key exclusion criteria Consent can NOT be obtained patients or healty subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Noriaki
Middle name
Last name Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code 701-0192
Address 577 Matsushima, Kurashiki 701-0192, Japan
TEL 086-462-1111
Email cda40950@hkg.odn.ne.jp

Public contact
Name of contact person
1st name Rui
Middle name
Last name Noriaki Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code 701-0192
Address 577 Matsushima, Kurashiki 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email cda40950@hkg.odn.ne.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization None
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 Kawasaki Medical School
Address Kawasaki Medical School, 577 Matsushima, Kurashiki 701-0192, Japan
Tel 0864621111
Email kmsrec@med.kawasaki-m.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
2016 Year 09 Month 18 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
2016 Year 09 Month 18 Day
Date of IRB
2018 Year 03 Month 12 Day
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prior to the start of the study

Management information
Registered date
2016 Year 09 Month 18 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027742

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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