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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028716
Receipt No. R000032845
Scientific Title Local recurrence after cold forceps polypectomy for diminutive polyps
Date of disclosure of the study information 2017/08/18
Last modified on 2017/08/18

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Basic information
Public title Local recurrence after cold forceps polypectomy for diminutive polyps
Acronym Local recurrence after CFP for diminutive polyps
Scientific Title Local recurrence after cold forceps polypectomy for diminutive polyps
Scientific Title:Acronym Local recurrence after CFP for diminutive polyps
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the local recurrence rate after cold forceps polypectomy for diminutive polyps
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes local recurrence rate after cold forceps polypectomy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 diminutive polyps of <5mm in cecum or rectum resected by cold forceps polypectomy
Key exclusion criteria patients with a history of inflammatory bowel disease
familial adenomatous polyposis
patients who refuse to undergo endoscopic surveillance colonoscopy at 1 year after cold forceps polypectomy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Nagata
Organization Hiroshima City Asa Citizens Hospital
Division name Department of Endoscopy
Zip code
Address 2-1-1 Kabe-minami, Asakita-ku, Hiroshima City, Japan
TEL 082-815-5211
Email s-nagata@asa-hosp.city.hiroshima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenjiro Shigita
Organization Hiroshima City Asa Citizens Hospital
Division name Department of Endoscopy
Zip code
Address 2-1-1 Kabe-minami, Asakita-ku, Hiroshima City, Japan
TEL 082-815-5211
Homepage URL
Email k-shigita@asa-hosp.city.hiroshima.jp

Sponsor
Institute Hiroshima City Asa Citizens Hospital
Institute
Department

Funding Source
Organization Self funding
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
2017 Year 08 Month 18 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
2017 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective study aiming to reveal local recurrence rate of CFP underwent just in cecum or rectum.

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032845

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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