UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047390
Receipt number R000053921
Scientific Title Multicenter prospective study of Diverticulitis of the colon
Date of disclosure of the study information 2022/04/05
Last modified on 2022/04/04 17:25:58

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Basic information

Public title

Multicenter prospective study of Diverticulitis of the colon

Acronym

study of Diverticulitis of the colon

Scientific Title

Multicenter prospective study of Diverticulitis of the colon

Scientific Title:Acronym

Multicenter prospective study of Diverticulitis of the colon

Region

Japan


Condition

Condition

colonic diverticulitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Pathological analysis of colonic diverticulitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To clarify the clinical course and prognosis of diverticulitis

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

120 years-old >

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with colonic diverticulitis by imaging examinations

Key exclusion criteria

Patients denied colonic diverticulitis by imaging examinations

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Noriaki
Middle name
Last name manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code

700-8505

Address

2-6-1 Nakasange, Kita-ku, Okayama city, Okayama, Japan

TEL

0862252111

Email

n_manabe@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Noriaki
Middle name
Last name Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code

700-8505

Address

2-6-1 Nakasange, Kita-ku, Okayama city, Okayama, Japan

TEL

0862252111

Homepage URL


Email

n_manabe@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

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

Kawasaki Medical School

Address

2-6-1 Nakasange, Kita-ku, Okayama city, Okayama, Japan

Tel

0862252111

Email

n_manabe@med.kawasaki-m.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

2022 Year 04 Month 05 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


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

Preinitiation

Date of protocol fixation

2022 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2022 Year 08 Month 01 Day

Last follow-up date

2023 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no special instruction


Management information

Registered date

2022 Year 04 Month 04 Day

Last modified on

2022 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053921


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name