UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021129 |
|---|---|
| Receipt number | R000024259 |
| Scientific Title | A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleeding |
| Date of disclosure of the study information | 2016/02/21 |
| Last modified on | 2019/09/24 21:48:34 |
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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
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
rniikura@triton.ocn.ne.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024259
