UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034603 |
|---|---|
| Receipt number | R000039449 |
| Scientific Title | A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2024/04/27 14:57:50 |
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Basic information
Public title
A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy
Acronym
A randomized trial of endoscopic detection for colonic diverticular bleeding
Scientific Title
A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy
Scientific Title:Acronym
A randomized trial of endoscopic detection for colonic diverticular bleeding
Region
| Japan |
Condition
Condition
colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is difficult to detect te site of colonic diverticular bleeding by short hood-assisted colonoscopy. This study was to compare long hood-assisted colonoscopy with short hood-assisted colonoscopy for detection of colonic diverticular bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the detection rate of colonic diverticular bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
long hood-assisted colonoscopy
Interventions/Control_2
short hood-assisted colonoscopy
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with colonic diverticular bleeding suspected
Key exclusion criteria
ileus, colonic stenosis, fistula, active inflammatory bowel disease, colonic diverticulitis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
imaedahi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
imaedahi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokai University Hachioji Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1111
hirb@saitama-med.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
| 2018 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
80
Results
The rate of stigmata of recent hemorrhage in long-hood group was significantly higher compared to that in short-hood group.
Results date posted
| 2022 | Year | 10 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There is no significant difference in patient characteristics between both groups.
Participant flow
Patients who had colonic diverticular bleeding underwent colonoscopy.
Adverse events
none
Outcome measures
The rate of stigmata of recent hemorrhage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039449
