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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007165
Receipt No. R000008444
Scientific Title Randomized controlled trial for preventive efficacy of postpolypectomy bleeding using clipping
Date of disclosure of the study information 2012/01/30
Last modified on 2018/08/31

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Basic information
Public title Randomized controlled trial for preventive efficacy of postpolypectomy bleeding using clipping
Acronym Clip study
Scientific Title Randomized controlled trial for preventive efficacy of postpolypectomy bleeding using clipping
Scientific Title:Acronym Clip study
Region
Japan

Condition
Condition Colon polyp
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluatte preventive efficacy of postpolypectomy bleeding using clipping
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of hemorrhage after polypectomy in the clipping group and the non-clipping group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 clipping group postpolepectomy
Interventions/Control_2 non-clipping group postpolypectomy
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 Polypectomy patients with polyp of smaller than 2cm in diameter polyps
Key exclusion criteria 1)Patients with bleeding endency(bleeding time>5 minites,platelet<50000)
2)Patients with severe complications(liver cirrhosis,Renal failure)
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mototsugu Kato
Organization Hokkaido Univercity hospital
Division name Division of endoscopy
Zip code
Address kita14jo nishi5cho-me,kita-ku,sSapporo city,Hokkaido,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido univercity hospital
Division name Division of Endoscopy
Zip code
Address
TEL
Homepage URL
Email kirennjai@yahoo.co.jp

Sponsor
Institute Division of endoscopy,Hokkaido univercity hospital
Institute
Department

Funding Source
Organization nothing
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
2012 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 30 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008444

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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