UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043881 |
|---|---|
| Receipt number | R000050097 |
| Scientific Title | The effectiveness of algorithm-based active cleansing protocol for bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2022/02/09 21:38:45 |
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Basic information
Public title
The effectiveness of algorithm-based active cleansing protocol for bowel preparation for colonoscopy
Acronym
The effectiveness of ABAC protocol for bowel preparation for colonoscopy
Scientific Title
The effectiveness of algorithm-based active cleansing protocol for bowel preparation for colonoscopy
Scientific Title:Acronym
The effectiveness of ABAC protocol for bowel preparation for colonoscopy
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will prospectively examine whether the use of a predetermined algorithm-based active cleansing (ABAC) protocol results in faster and safer completion of the bowel preparation compared to conventional method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time spent on bowel preparation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The bowel preparation method by using algorithm-based active cleansing: ABAC protocol
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who undergo colonoscopy for health checkup during the period
Key exclusion criteria
history of surgical colorectal resection, inflammatory bowel disease, familial adenomatous polypsis
Target sample size
325
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
Koganei Tsurukame Clinic
Division name
Endoscopy center
Zip code
184-0004
Address
6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL
042-386-3757
ishibashi@tsurukamekai.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Shinoki |
Organization
Koganei Tsurukame Clinic
Division name
Secretariat of Center for Clinical Research
Zip code
184-0004
Address
6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL
042-386-3757
Homepage URL
shinoki@tsurukamekai.jp
Sponsor or person
Institute
Koganei Tsurukame Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinjuku Tsurukame Clinic
Address
2-11-15-3F, Yoyogi, Shibuya-ku, Tokyo
Tel
03-3299-0077
ando@tsurukamekai.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 | 05 | Month | 01 | 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
362
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
| 2021 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050097
