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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001684
Receipt No. R000002012
Scientific Title A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Date of disclosure of the study information 2009/02/02
Last modified on 2010/11/24

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Basic information
Public title A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Acronym RCT of DBE vs. SBE for difficult colonoscope insertion
Scientific Title A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Scientific Title:Acronym RCT of DBE vs. SBE for difficult colonoscope insertion
Region
Japan

Condition
Condition Colon disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate efficacy and safety on balloon enteroscopy using double balloon enteroscopy or single balloon enteroscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total colonoscopy rate
Examination time
Manual compression rate
Changing position rate
X-ray exposure time
Diagnostic yield
Key secondary outcomes Patient's pain on examination,
Operability of endoscopy
Complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Double balloon enteroscopy
Interventions/Control_2 Single balloon enteroscopy
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 Patients who had incomplete colonoscopy with a conventional colonoscope
Key exclusion criteria Patients with known fulminant colitis or colorectal malignancy
Incomplete colonoscopy because of fixed stenosis or poor bowel preparation
Severe hepatic dysfunction or severe renal dysfunction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Yamaji
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Yamaji
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku,Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email yamaji-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2009 Year 02 Month 02 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 Completed
Date of protocol fixation
2008 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 02 Day
Last modified on
2010 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002012

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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