UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030712 |
|---|---|
| Receipt number | R000035063 |
| Scientific Title | Clinical importance of polypectomy during insertion phase at left side colon: a multi-center randomized controlled study |
| Date of disclosure of the study information | 2018/01/10 |
| Last modified on | 2019/12/20 08:58:52 |
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Basic information
Public title
Clinical importance of polypectomy during insertion phase at left side colon: a multi-center randomized controlled study
Acronym
Clinical importance of polypectomy during insertion phase
Scientific Title
Clinical importance of polypectomy during insertion phase at left side colon: a multi-center randomized controlled study
Scientific Title:Acronym
Clinical importance of polypectomy during insertion phase
Region
| Japan |
Condition
Condition
Colon polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To show that 1) polypectomy during insertion phase increases the total number of polypectomies 2) polypectomy during insertion phase does not have negative effect on the quality of colonoscopy examination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total examination time
Key secondary outcomes
number of treated polyps
number of missed polyps
number of hiding polyps
insertion time
cecal incubation rate
withdrawal time
size of polyps
location of polyps
complication
type of colonoscopes used
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Polypectomy during insertion phase
Interventions/Control_2
Polypectomy during withdrawal phase
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients aged more than 40 who takes colonoscopy
Key exclusion criteria
1. when no polyps < 10mm in size at left side colon during insertion phase of colonoscopy were found.
2. patients with history of colonic surgery
3. Poor bowel preparation
4. Inflammatory bowel disease
5. Coagulation disorder, pregnant, lactating, infection, mental disorder, HOT, COPD
6. when polyps >10mm in size are found during the colonoscopy
7. when 5 or more polyps are detected in each colonoscopy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Teramoto |
Organization
Sano Hospital
Division name
Gastrointestinal center
Zip code
655-0031
Address
Hyogo Prefecture, Kobe, Tarumi-ku, Shimizugaoka 2-5-1
TEL
078-785-1000
akira_teramoto@hotmail.com
Public contact
Name of contact person
| 1st name | Sachiyo |
| Middle name | |
| Last name | Komai |
Organization
Sano Hospital
Division name
RCT Center
Zip code
655-0031
Address
Hyogo Prefecture, Kobe, Tarumi-ku, Shimizugaoka 2-5-1
TEL
078-785-1000
Homepage URL
akira_teramoto@hotmail.com
Sponsor or person
Institute
Sano Hospital
Institute
Department
Personal name
Funding Source
Organization
Sano Hospital
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
Sano Hospital Institutional Review Board
Address
Hyogo Prefecture, Kobe, Tarumi-ku, Shimizugaoka 2-5-1
Tel
078-785-1000
yonedarieko@gmail.com
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 | 01 | Month | 10 | 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
1451
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
| 2017 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035063
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/07/09 | PRESECT Study プロトコールVer1.1.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/07/09 | 症例登録シート.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
