UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022177
Receipt number R000025399
Scientific Title The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Date of disclosure of the study information 2016/05/09
Last modified on 2021/05/06 12:12:08

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Basic information

Public title

The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.

Acronym

The efficacy of the new strategy for the patients with diverticula and hematochezia.

Scientific Title

The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.

Scientific Title:Acronym

The efficacy of the new strategy for the patients with diverticula and hematochezia.

Region

Japan


Condition

Condition

colonic diverticula

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Multicenter prospective study of the efficacy of the treatment strategy for the patients with colonic diverticula and hematochezia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of re-bleeding in the hospital

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

Treatment

Type of intervention

Other

Interventions/Control_1

the group of urgent colonoscopy. If bleeding point is detected, endoscopic hemostasis is performed. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.

Interventions/Control_2

the group of conservative treatment. Without urgent colonoscopy, the patient is treated by intravenous hemostatic agent. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.

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

The patients with colonic diverticula by abdominal enhanced CT or colonoscopy, without extravazation.
The patients with hematochezia.
The patients who agreed to this study.

Key exclusion criteria

The patients with extravasation in abdominal enhanced CT.
The patients who were suspected the other disease, for example ischemic colitis and colorectal cancer

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahide
Middle name
Last name Ebi

Organization

Aichi medical university

Division name

Department of Gastroentelorogy

Zip code

4801195

Address

1-1 yazako-karimata Nagakute-city Aichi prefecture

TEL

0561-62-3311

Email

mebi@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Masahide
Middle name
Last name Ebi

Organization

Aichi medical university

Division name

Department of Gastroentelorogy

Zip code

4801195

Address

1-1 yazako-karimata Nagakute-city Aichi prefecture Japan

TEL

0561-62-3311

Homepage URL


Email

mebi@aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi medical university

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kasugai municipal hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Aichi medical university

Address

1-1 Yazakokarimata, Nagakute

Tel

0561623311

Email

mebi@aichi-med-u.ac.jp


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

2016 Year 05 Month 09 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Number of participants that the trial has enrolled

30

Results

finished

Results date posted

2021 Year 05 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

bloody stool

Participant flow

informed consent

Adverse events

none

Outcome measures

the usefulness of strategy

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2016 Year 05 Month 02 Day

Date of IRB

2016 Year 05 Month 09 Day

Anticipated trial start date

2016 Year 05 Month 09 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 02 Day

Last modified on

2021 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name