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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035456
Receipt No. R000040298
Scientific Title Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Date of disclosure of the study information 2019/01/06
Last modified on 2019/01/05

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Basic information
Public title Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Acronym Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Scientific Title Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Scientific Title:Acronym Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Region
Japan

Condition
Condition colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effectiveness of lesions resected by cold snare polypectomy and pasted on paper.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evalution of pathological horizontal margin of specimens resected with cold snare polypectomy
Key secondary outcomes Size of specimens
location of the lesion
operater

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 specimens resected by cold snare polypectomy and pasted on a paper
Interventions/Control_2 specimens resected by cold snare polypectomy without paste
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients had adenoma resected by cold snare polypectomy
Key exclusion criteria Adenoma resected piecemeal
Pathological diagnosis is not adenoma
After colon surgery.
Target sample size 240

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tetuya Yosizaki
Organization Saiseikai nakatsu Hospital
Division name Gastroenterology
Zip code
Address Osaka Prefecture Osaka-shi Kita Ward Shibata 2 - chome No. 10 39
TEL 06-6372-0333
Email yoshizak@med.kobe-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takuya Ikeda
Organization Saiseikai nakatsu Hospital
Division name Inspection Technology Div
Zip code
Address Osaka Prefecture Osaka-shi Kita Ward Shibata 2 - chome No. 10 39
TEL 06-6372-0333
Homepage URL
Email tikeda-nakatsu@umin.ac.jp

Sponsor
Institute Saiseikai nakatsu Hospital
Institute
Department

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
Address
Tel
Email

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
2019 Year 01 Month 06 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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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