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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030712
Receipt No. 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 2019/07/09

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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
Email 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
Email akira_teramoto@hotmail.com

Sponsor
Institute Sano Hospital
Institute
Department

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
Email 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 No longer recruiting
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 07 Month 09 Day


Link to view the page
URL(English) https://upload.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


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