UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029256
Receipt No. R000033441
Scientific Title Randomised comparative study on the usefulness of barium impaction therapy for colonic diverticular hemorrhage
Date of disclosure of the study information 2017/09/23
Last modified on 2017/09/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomised comparative study on the usefulness of barium impaction therapy for colonic diverticular hemorrhage
Acronym Barium impaction therapy for colonic diverticular hemorrhage
Scientific Title Randomised comparative study on the usefulness of barium impaction therapy for colonic diverticular hemorrhage
Scientific Title:Acronym Barium impaction therapy for colonic diverticular hemorrhage
Region
Japan

Condition
Condition Colonic diverticular hemorrhage
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Barium impaction therapy is used for hemostasis of colonic diverticular bleeding. In this study, we evaluate the usefulness of barium impaction therapy for prevention of recurrent colonic diverticular hemorrhage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Rebleeding rate of colonic diverticular bleeding
Key secondary outcomes Barium residual ratio 1 month later

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Barium impaction therapy
Interventions/Control_2 Without barium impaction therapy
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients with colonic divetticular hemorrhage who achieved spontaneous hemostasis and interventional hemostasis in hospital days.
Key exclusion criteria 1. Patients without indication of barium enema like perforating colonic diverticula or with abscess.
2. Patients with obstruction in the coloretum.
3. Patients with severe cardiac or pulmonary dysfunction

4. Patients with indication of surgery
5. Patients inappropriate for this study by other reasons judged by investigators
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine, Department of Gastroenterology
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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 23 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
Ongoing
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 04 Month 30 Day
Date analysis concluded
2022 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 23 Day
Last modified on
2017 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.