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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032118
Receipt No. R000036641
Scientific Title Randomized comparison of surveillance after colonoscopic removal of adenomatous polyps: Endocuff-assisted colonoscopy versus the standard colonoscopy
Date of disclosure of the study information 2018/04/05
Last modified on 2018/04/05

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Basic information
Public title Randomized comparison of surveillance after colonoscopic removal of adenomatous polyps: Endocuff-assisted colonoscopy versus the standard colonoscopy
Acronym Randomized comparison of surveillance after colonoscopic removal of adenomatous polyps: Endocuff-assisted colonoscopy versus the standard colonoscopy
Scientific Title Randomized comparison of surveillance after colonoscopic removal of adenomatous polyps: Endocuff-assisted colonoscopy versus the standard colonoscopy
Scientific Title:Acronym Randomized comparison of surveillance after colonoscopic removal of adenomatous polyps: Endocuff-assisted colonoscopy versus the standard colonoscopy
Region
Japan

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

Objectives
Narrative objectives1 To compare the performance of Endocuff-assisted colonoscopy(EAC) and standard colonoscopy (SC) as surveillance colonoscopy techniques after complete adenoma removal during EAC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the detection of advanced adenoma
Key secondary outcomes the detection of any adenoma or polyp

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endocuff-assisted colonoscopy
Interventions/Control_2 Standard colonoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent total EAC and removal of all adenomas and undergo follow-up colonoscopy at 3 years
Key exclusion criteria previous bowel resection, inflammatory bowel disease and polyposis syndromes.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Wada
Organization Wada Clinic
Division name Endoscopic department
Zip code
Address 1-4-21, Oda, Wakayama
TEL 073-473-5252
Email w-yoshi@mtj.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Wada
Organization Wada Clinic
Division name Endoscopic department
Zip code
Address 1-4-21, Oda, Wakayama
TEL 073-473-5252
Homepage URL
Email w-yoshi@mtj.biglobe.ne.jp

Sponsor
Institute Wada Clinic
Institute
Department

Funding Source
Organization Wada Clinic
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 05 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
2018 Year 04 Month 05 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036641

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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