UMIN-CTR Clinical Trial

Basic information
Public title	Natural history of Lower Gastrointestinal Bleeding of unknown origin
Acronym	Natural history of Lower Gastrointestinal Bleeding of unknown origin
Scientific Title	Natural history of hematochezia of unknown origin: Real-world analysis with long-term follow-up
Scientific Title:Acronym	Natural history of hematochezia of unknown origin: Real-world analysis with long-term follow-up
Region	Japan

Condition
Condition	hematochezia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	constructing proper management of hematochezia cases in which the bleeding source was not identified
Basic objectives2	Others
Basic objectives -Others	Case control study
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rebleeding rate in hematochezia patients with an unidentified bleeding source
Key secondary outcomes	The period until rebleeding, total number of rebleeding episodes, the source of bleeding and the identification rate in rebleeding, the bleeding-related death rate, and rebleeding risk factors

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted to Dokkyo Medical University Hospital with the chief complaint of hematochezia
Key exclusion criteria	Exclusion criteria 1. those in whom hematochezia was not observed after the hospital visit 2. those who received endoscopic treatment within 1 month before the visit 3. those for whom observation up to the terminal ileum could not be done using colonoscopy 4. those for whom the cause of hematochezia was identified during the first colonoscopy 5. those who had no follow-up visit after hospital discharge (follow-up period 0 day) 6. those who had a past history of hematochezia
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Irisawa
Organization	Dokkyo Medical University Hospital
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL	0282-87-2147
Email	irisawa@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Takanao Middle name Last name Tanaka
Organization	Dokkyo Medical University Hosipital
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL	0282-87-2147
Homepage URL
Email	tana1986@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	None
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	Dokkyo Medical University Hospital
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel	0282-87-2147
Email	tana1986@dokkyomed.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 11 Month 06 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	159
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	2019 Year 02 Month 26 Day
Date of IRB	2019 Year 03 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 05 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other

Other related information

Study design:Case control study Subject patients: Patients admitted to Dokkyo Medical University Hospital during April 1, 2009-March 31, 2015 with the chief complaint of hematochezia Factors investigated: Age, sex, blood types, number of rebleeding episodes, colonoscopic findings (presence or absence of diverticula, tumor lesions, vascular lesions and anal diseases), hemoglobin on admission, platelet count on admission, use history of antithrombotic medicines during the observation period, use history of NSAIDs during the observation period, use history of prednisolone during the observation period, comorbidity (cardiovascular disease, liver disease, renal disease, cerebrovascular disease, diabetes, and hyperlipidemia), and death during the observation period

Management information
Registered date	2021 Year 11 Month 02 Day
Last modified on	2021 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052450