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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name