UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038093 |
|---|---|
| Receipt number | R000043419 |
| Scientific Title | Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/03/31 23:18:54 |
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Basic information
Public title
Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Acronym
Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Scientific Title
Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Scientific Title:Acronym
Study for Impact of Individual Feedback on Improvement of Adenoma Detection Rate during Screening Colonoscopy
Region
| Japan |
Condition
Condition
Colonic polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of the methodology of training endoscopists including individual feedback system for improving adenoma detection rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma detection rate
Polyp detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Feedback group
Interventions/Control_2
Control group
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
Patients who underwent screening colonoscopy in the institute from August, 2018 to March, 2019.
Key exclusion criteria
Patients who underwent surgical resection of the colon or rectum, patients who suffered from inflammatory bowel disease or familial adenomatous polyposis excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
Shinjuku Tsurukame Clinic
Division name
Digestive Disease Center
Zip code
151-0053
Address
2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-3299-0077
ishibashi@tsurukamekai.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
Shinjuku Tsurukame Clinic
Division name
Digestive Disease Center
Zip code
151-0053
Address
2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-3299-0077
Homepage URL
ishibashi@tsurukamekai.jp
Sponsor or person
Institute
Shinjuku Tsurukame Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinjuku Tsurukame Clinic
Address
2-11-15-3F Yoyogi, Shibuya-ku, Tokyo, Japan
Tel
03-3299-0077
ishibashi@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
新宿つるかめクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | 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
1728
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
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043419
