UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024097 |
|---|---|
| Receipt number | 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 | 2021/02/15 11:16:37 |
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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
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
cda40950@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027742
