UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029256 |
|---|---|
| Receipt number | 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 | 2023/10/08 22:30:57 |
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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
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
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 15 | Day |
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
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033441
