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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017545
Receipt No. R000020334
Scientific Title Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study
Date of disclosure of the study information 2015/05/13
Last modified on 2018/05/15

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Basic information
Public title Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study
Acronym Efficacy and safety of cold polypectomy
Scientific Title Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study
Scientific Title:Acronym Efficacy and safety of cold polypectomy
Region
Japan

Condition
Condition Colorectal adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety, tolerability of patients, and recurrence rate after resection by cold polypectomy, compared to conventional electrocautery method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of delayed bleeding
Key secondary outcomes The incidence of immediate bleeding and perforation, procedure time, tolerability of patients, endoscopical en bloc resection rate, recurrence rate, rate of advanced neoplasia, and cost of procedure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Conventional polypectomy
Interventions/Control_2 Cold polypectomy
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 (1) Endoscopically diagnosed as colorectal adenoma 6mm<= and <10mm
(2) 20 y.o. <=
(3) Written informed consent
Key exclusion criteria (1) Patients with serious heart disease
(2) Patients with diseases that cause the bleeding tendency.
(3) Patients who have serious complications
(4) Pregnant
(5) 20 y.o.>
(6) Pedunculated lesion
(7) Others
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ito
Organization Asahikawa-Kosei General Hospital
Division name Department of gastroenterology
Zip code
Address 1-24-111,Asahikawa,Hokkaido
TEL 0166-33-7171
Email dr-ito@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Ito
Organization Asahikawa-Kosei General Hospital
Division name Department of gastroenterology
Zip code
Address 1-24-111,Asahikawa,Hokkaido
TEL 0166-33-7171
Homepage URL
Email dr-ito@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa-Kosei General 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 旭川厚生病院

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially 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
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 13 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020334

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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