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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034603
Receipt No. R000039449
Official scientific title of the study A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy
Date of disclosure of the study information 2018/11/10
Last modified on 2018/10/23

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Basic information
Official scientific title of the study A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy
Title of the study (Brief title) A randomized trial of endoscopic detection for colonic diverticular bleeding
Region
Japan

Condition
Condition colonic diverticular bleeding
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is difficult to detect te site of colonic diverticular bleeding by short hood-assisted colonoscopy. This study was to compare long hood-assisted colonoscopy with short hood-assisted colonoscopy for detection of colonic diverticular bleeding.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the detection rate of colonic diverticular bleeding
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 long hood-assisted colonoscopy
Interventions/Control_2 short hood-assisted 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
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with colonic diverticular bleeding suspected
Key exclusion criteria ileus, colonic stenosis, fistula, active inflammatory bowel disease, colonic diverticulitis
Target sample size 80

Research contact person
Name of lead principal investigator Hiroyuki Imaeda
Organization Saitama Medical University Hospital
Division name Department of Gastroenterology
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Email imaedahi@saitama-med.ac.jp

Public contact
Name of contact person Hiroyuki Imaeda
Organization Saitama Medical University Hospital
Division name Department of Gastroenterology
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Homepage URL
Email imaedahi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Funding Source
Organization Saitama Medical University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokai University Hachioji Hospital
Name of secondary funder(s)

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 11 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 22 Day
Anticipated trial start date
2018 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2018 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039449

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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