UMIN-CTR Clinical Trial

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
Email	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
Email	t196038d@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050559