UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034603
Receipt number R000039449
Scientific Title A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy
Date of disclosure of the study information 2018/11/10
Last modified on 2022/10/26 10:30:02

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Basic information

Public title

A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy

Acronym

A randomized trial of endoscopic detection for colonic diverticular bleeding

Scientific Title

A randomized control trial of endoscopic detection for colonic diverticular bleeding in long hood-assisted colonoscopy versus short hood-assisted colonoscopy

Scientific Title:Acronym

A randomized trial of endoscopic detection for colonic diverticular bleeding

Region

Japan


Condition

Condition

colonic diverticular bleeding

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is difficult to detect te site of colonic diverticular bleeding by short hood-assisted colonoscopy. This study was to compare long hood-assisted colonoscopy with short hood-assisted colonoscopy for detection of colonic diverticular bleeding.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the detection rate of colonic diverticular bleeding

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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

long hood-assisted colonoscopy

Interventions/Control_2

short hood-assisted colonoscopy

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with colonic diverticular bleeding suspected

Key exclusion criteria

ileus, colonic stenosis, fistula, active inflammatory bowel disease, colonic diverticulitis

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Imaeda

Organization

Saitama Medical University Hospital

Division name

Department of Gastroenterology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

TEL

049-276-1667

Email

imaedahi@saitama-med.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Imaeda

Organization

Saitama Medical University Hospital

Division name

Department of Gastroenterology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

TEL

049-276-1667

Homepage URL


Email

imaedahi@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokai University Hachioji Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University

Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama

Tel

049-276-1111

Email

hirb@saitama-med.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

2018 Year 11 Month 10 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

80

Results

The rate of stigmata of recent hemorrhage in long-hood group was significantly higher compared to that in short-hood group.

Results date posted

2022 Year 10 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

There is no significant difference in patient characteristics between both groups.

Participant flow

Patients who had colonic diverticular bleeding underwent colonoscopy.

Adverse events

none

Outcome measures

The rate of stigmata of recent hemorrhage

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 10 Month 22 Day

Date of IRB

2018 Year 11 Month 20 Day

Anticipated trial start date

2018 Year 11 Month 20 Day

Last follow-up date

2021 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

2018 Year 10 Month 23 Day

Last modified on

2022 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039449


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name