UMIN-CTR Clinical Trial

Basic information
Public title	A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleeding
Acronym	Early colonoscopy trial
Scientific Title	A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleeding
Scientific Title:Acronym	Early colonoscopy trial
Region	Japan

Condition
Condition	Acute lower gastrointestinal bleeding
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate stigmata recent of hemorrhage rate of early versus elective colonoscopy in outpatient with acute lower gastrointestinal bleeding.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Stigmata recent of hemorrhage rate in lower gastrointestinal tract
Key secondary outcomes	Success rate of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, 30 day rebleeding rates, length of stay, 30 day thrombosis events, 30 day mortality, preparation related adverse events (nausea, vomitting, abdominal pain, volume overload, aspiration pnumonia, hemorrhagic shock, exacerbation bleeding, and ileus), and colonoscopy related adverse events (hemorrhagic shock, and perforation).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Early colonoscopy: performing prepared colonoscopy within 24 h on arrival.
Interventions/Control_2	Elective colonoscopy: performing prepared colonoscopy between 24 and 96 h on arrival.
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	Inclusion criteria 1.Adults aged>=20 years presenting moderate to severe hematochezia or melena within 24 h on arrival, defined as (i) more than 3 bloody bowel movements within 8 h; (ii) hemorrhagic shock; or (iii) requiring transfusion. 2.All patients were able to provide informed consent.
Key exclusion criteria	Exclusion criteria 1.Patients with hematemesis, black vomiting, or melena. 2.Upper gastrointestinal bleeding patients who diagnosed by nasogastric tube or upper endoscopy. 3.Patients who had impossible consumed the oral bowel preparation solution. 4.Patients who received computed tomography. 5.Patients who diagnosed peptic ulcer diseases within 10 days. 6.Ulcerative colitis, or Crohn diseases patients. 7.Patients who received abdominal surgery. 8.Patients who received polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the colon within 10 days. 9.Patients with suspected perforation, or peritonitis. 10.Patients with suspected intestinal obstruction. 11.Patients with hemorrhagic shock refractory to infusion or blood transfusion. 12.Patients who received total colectomy. 13.Patients with suspected disseminated intravascular coagulation. 14.Patients with end stage malignant disease. 15.Patients with severe cardiac failure. 16.Patients with active thrombosis. 17.Patients with severe respiratory failure. 18.Pregnant patients.
Target sample size	162

Research contact person
Name of lead principal investigator	1st name Atsuo Middle name Last name Yamada
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Zip code	1138655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	yamada-a@umin.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Niikua
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Zip code	1138655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	rniikura@triton.ocn.ne.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo, Clinical Research Review Board
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-5800-8743
Email	crctky-office@umin.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT 03098173
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院　 国立国際医療研究センター病院 石川県立中央病院 聖路加国際病院　 国立国際医療研究センター国府台病院 小樽掖済会病院　 市立豊中病院 国立病院機構函館病院 斗南病院 福井県立病院 弘前大学医学部附属病院 愛知県がんセンター 長崎みなとメディカルセンター市民病院 周東総合病院 地域医療機能推進機構大阪病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 21 Day

Related information
URL releasing protocol	http://www.todai-shoukakan.com/cont4/29.html
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	Completed
Date of protocol fixation	2016 Year 01 Month 29 Day
Date of IRB	2016 Year 01 Month 21 Day
Anticipated trial start date	2016 Year 07 Month 13 Day
Last follow-up date	2018 Year 06 Month 26 Day
Date of closure to data entry	2018 Year 06 Month 26 Day
Date trial data considered complete	2018 Year 08 Month 24 Day
Date analysis concluded	2018 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 21 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024259