UMIN-CTR Clinical Trial

Basic information
Public title	Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Acronym	Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Scientific Title	Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Scientific Title:Acronym	Construction of a scoring system predicting the bleeding part identification with the colonoscopy for colonic diverticular hemorrhage
Region	Japan

Condition
Condition	Diverticular hemorrhage
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Can we establish an efficient and safe emergency endoscopic care system using a scoring system (JD score) created based on past cases at our hospital?
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in bleeding source identification rate by scoring
Key secondary outcomes	Period of admission, volume of blood transfusion, rebleeding rate, harmful events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Emergency endoscopy
Interventions/Control_2	No Emergency endoscopy
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with clinically suspected colonic diverticular hemorrhage after exclusion of other diseases based on clinical course, physical examination, and contrast-enhanced CT findings
Key exclusion criteria	1) Patients under 20 years of age who could not give consent, including a surrogate; 2) Patients who had a bloody episode within 30 days prior to the visit; 3) Patients with suspected bleeding other than diverticular hemorrhage; 4) Patients who deviated from the protocol.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name UEHARA
Organization	saitama medical center jichi medical univ
Division name	Gastroenterology
Zip code	330-8503
Address	1-847 amanuma oomiya saitama
TEL	048-647-2111
Email	t.uehara@jichi.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name UEHARA
Organization	saitama medical center jichi medical univ
Division name	Gastroenterology
Zip code	330-8503
Address	1-847 amanuma oomiya saitama
TEL	048-647-2111
Homepage URL
Email	t.uehara@jichi.ac.jp

Sponsor
Institute	saitama medical center jichi medical univ
Institute
Department

Funding Source
Organization	saitama medical center jichi medical univ
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	saitama medical center jichi medical univ
Address	1-847 amanuma oomiya saitama
Tel	048-647-2111
Email	t.uehara@jichi.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	自治医科大学附属さいたま医療センター　埼玉県

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 16 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	91
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	No longer recruiting
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 05 Month 24 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2024 Year 12 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	2022 Year 09 Month 15 Day
Last modified on	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042594