UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB	2018 Year 04 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 05 Day
Last follow-up date	2018 Year 04 Month 05 Day
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	2020 Year 10 Month 06 Day

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