UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044303 |
|---|---|
| Receipt number | R000050559 |
| Scientific Title | A retrospective study on the risk of ischemic colitis in our hospital |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2021/05/24 11:06:50 |
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Basic information
Public title
A retrospective study on the risk of ischemic colitis in our hospital
Acronym
Risk of ischemic colitis
Scientific Title
A retrospective study on the risk of ischemic colitis in our hospital
Scientific Title:Acronym
Risk of ischemic colitis
Region
| Japan |
Condition
Condition
ischemic colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the risk of ischemic colitis
Basic objectives2
Others
Basic objectives -Others
Identify the risk of recurrent ischemic colitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk Factors for Ischemic colitis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who present with sudden onset of bloody stool or abdominal pain, have had blood test and imaging studies (CT or Colonoscopy) performed, and have a diagnosis of ischemic colitis.
Key exclusion criteria
Patients who cannot be ruled out to be affected by other colorectal diseases such as autoimmune enteritis, infectious enteritis.
Due to trauma or mechanical factors (e.g., hernia).
Patients who have undergone abdominal surgery within the past six months.
Patients with severe acute ischemic changes in other organs.
Those with secondary disease.
Pregnant women.
Patients who have refused to give blanket consent.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Takatsu |
Organization
Yokohama City University Hospital
Division name
Endoscopy Center / Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama-shi Kanaga wa-ken, Japan
TEL
045-787-2800
t196038d@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Takatsu |
Organization
Yokohama City University Hospital
Division name
Endoscopy Center / Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama-shi Kanaga wa-ken, Japan
TEL
045-787-2800
Homepage URL
t196038d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
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
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura Kanazawa-ku Yokohama-shi Kanagawa-ken, Ja pan, Kanagawa, Kanagawa
Tel
045-370-7627
rinri@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
| 2021 | Year | 05 | Month | 24 | 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
225
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
| 2020 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We extracted the following data from the patients' medical records: patient characteristics (sex, age, body mass index, drinking history, smoking history, medical history, comorbidities, medications, vital signs), clinical signs and symptoms (abdominal pain, diarrhea, bloody stools, peritoneal irritation symptoms), laboratory findings (contrast CT findings, endoscopic and histological features), method of treatment, length of hospital stay, disease course (time of resolution of abdominal pain, time of resolution of bloody stools, initiation of meals), and the frequency of IC morbidities.
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050559
