UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038696
Receipt number R000044110
Scientific Title A single-center retrospective study regarding the exacerbation factor for recurrent colonic diverticular bleeding after endoscopic hemostasis
Date of disclosure of the study information 2019/11/27
Last modified on 2023/02/27 18:06:17

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Basic information

Public title

A single-center retrospective study regarding the exacerbation factor for recurrent colonic diverticular bleeding after endoscopic hemostasis

Acronym

A single-center retrospective study regarding the exacerbation factor for recurrent colonic diverticular bleeding after endoscopic hemostasis

Scientific Title

A single-center retrospective study regarding the exacerbation factor for recurrent colonic diverticular bleeding after endoscopic hemostasis

Scientific Title:Acronym

A single-center retrospective study regarding the exacerbation factor for recurrent colonic diverticular bleeding after endoscopic hemostasis

Region

Japan


Condition

Condition

colonic diverticular bleeding

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify exacerbation factors for rebleeding after colonoscopy and reduce the post-hemostasis rebleeding rate.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The exacerbation factors for rebleeding within 30 days after colonoscopy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with hemorrhage of the lower digestive tract requiring admission, those who underwent contrast-enhanced CT at the Emergency Outpatient Unit or during admission, followed by detailed examination for gastrointestinal hemorrhage, and those aged more than 20 years on admission.

Key exclusion criteria

patients with hematemesis, black vomit, or tarry stool, those who underwent upper gastrointestinal endoscopy and were diagnosed with hemorrhage of the upper digestive tract, and those who underwent IVR or abdominal surgery during admission.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Toshiro
Middle name
Last name Kamoshida

Organization

Hitachi General Hospital

Division name

Department of Gastroenterology

Zip code

317-0077

Address

2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture

TEL

0294231111

Email

toshiro.kamoshida.fu@hitachi.com


Public contact

Name of contact person

1st name Toshiro
Middle name
Last name Kamoshida

Organization

Hitachi General Hospital

Division name

Department of Gastroenterology

Zip code

317-0077

Address

2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture

TEL

0294231111

Homepage URL


Email

toshiro.kamoshida.fu@hitachi.com


Sponsor or person

Institute

Hitachi General Hospital

Institute

Department

Personal name



Funding Source

Organization

Hitachi General Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hitachi General Hospital

Address

2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture

Tel

0294231111

Email

toshiro.kamoshida.fu@hitachi.com


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

2019 Year 11 Month 27 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

150

Results


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

Completed

Date of protocol fixation

2019 Year 11 Month 20 Day

Date of IRB

2019 Year 11 Month 22 Day

Anticipated trial start date

2019 Year 11 Month 20 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(1) Approval by the Ethics Review Board
The principal investigator will submit the protocol of this study to the Ethics Review Board of this institution for inspection, and obtain approval on the study execution from the director of this institution.
(2) Study type/design
A single-center, retrospective, comparative study.
(3) Study period
One year.
(4) Storage of samples from human bodies and information to be used for research
The information obtained in this study will be centrally stored on a security-assured personal computer.
The data will be anonymized, and used for this study alone. As a rule, the principal investigator of this institution must store the data on a password-locked personal computer and paper materials in a key-locked locker in this institution.
As a rule, the data input to a personal computer should be stored for 5 years or 3 years after the publication of an article (the longer period should be chosen).


Management information

Registered date

2019 Year 11 Month 27 Day

Last modified on

2023 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name