UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050099 |
|---|---|
| Receipt number | R000057074 |
| Scientific Title | Exploratory study of the association between bowel urgency and transperineal ultrasonography/endoscopy in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/01/22 01:21:32 |
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Basic information
Public title
Exploratory study of the association between bowel urgency and transperineal ultrasonography/endoscopy in patients with ulcerative colitis.
Acronym
Bowel urgency and transperineal ultrasound in ulcerative colitis
Scientific Title
Exploratory study of the association between bowel urgency and transperineal ultrasonography/endoscopy in patients with ulcerative colitis.
Scientific Title:Acronym
Bowel urgency and transperineal ultrasound in ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the correlation between bowel urgency and transperineal ultrasonography/endoscopy in patients with ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The intent of the study is to explore the association between bowel urgency and transperineal ultrasonography/endoscopy in ulcerative colitis.
Key secondary outcomes
1. Serologic marker
2. Feacal biomarker
3. Endoscopic activity
4. Clinical severity index
5. Prognosis
6. Histological activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
transperineal ultrasonography
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients fulfilling all of the following criteria were subjected to the survey.
1. Diagnosed UC patients who underwent colonoscopy according to well-known ciriteria.
2. Patients who understood the purpose of experiment and signed a consent form
Key exclusion criteria
1. The patient with history of total colectomy.
2. When the principal investigator considered not suitable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kanade |
| Middle name | |
| Last name | Serizawa |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
03-3444-6161
seri@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanade |
| Middle name | |
| Last name | Serizawa |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
03-3444-6161
Homepage URL
seri@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
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
Kitasato University Kitasato Institute Hospital
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
0334446161
seri@kitasato-u.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
| 2023 | Year | 01 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057074
