UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043111
Receipt number R000049212
Scientific Title The characteristics of right-sided colonic diverticulitis.
Date of disclosure of the study information 2021/01/25
Last modified on 2021/01/24 10:59:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The characteristics of right-sided colonic diverticulitis.

Acronym

The characteristics of right-sided colonic diverticulitis.

Scientific Title

The characteristics of right-sided colonic diverticulitis.

Scientific Title:Acronym

The characteristics of right-sided colonic diverticulitis.

Region

Japan


Condition

Condition

Patients admitted to our department with a diagnosis of colonic diverticulitis

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A retrospective comparison of the characteristics, treatment methods, and recurrence rates of right-sided colonic diverticulitis and left-sided colonic diverticulitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Characteristics and treatment of right and left-sided colonic diverticulitis, respectively, and evaluation of recurrence

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

10 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients admitted to our hospital with a diagnosis of colonic diverticulitis in the period from April 2013 to April 2020 in the Department of Surgery.

Key exclusion criteria

If the patient is enrolled in another clinical trial that conflicts with this study.
Other patients who are deemed inappropriate by the treating physician.

Target sample size

137


Research contact person

Name of lead principal investigator

1st name Ippei
Middle name
Last name Yamana

Organization

Hakujyuji hospital

Division name

surgery

Zip code

819-8511

Address

3-2-1, ishimaru, nishiku, Fukuoka city

TEL

0928912511

Email

3949noex@jcom.home.ne.jp


Public contact

Name of contact person

1st name Ippei
Middle name
Last name Yamana

Organization

Hakujyuji hospital

Division name

surgery

Zip code

819-8511

Address

3-2-1, Ishimaru, nishiku, Fukuoka city

TEL

0928912511

Homepage URL


Email

3949noex@jcom.home.ne.jp


Sponsor or person

Institute

hakujyuji hospital
surgery

Institute

Department

Personal name



Funding Source

Organization

nothing

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

Hakujyuji hospital

Address

3-2-1, Ishimaru, nishiku, Fukuoka city

Tel

0928912511

Email

3949noex@jcom.home.ne.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

2021 Year 01 Month 25 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

137

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

Main results already published

Date of protocol fixation

2020 Year 10 Month 29 Day

Date of IRB

2020 Year 10 Month 29 Day

Anticipated trial start date

2020 Year 10 Month 30 Day

Last follow-up date

2021 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Gender, age, BMI, smoking history, alcohol consumption history, history, presence of regular oral Nsaids, presence of regular oral steroids, history of diverticulitis, history of abdominal surgery, ASA-PS, duration of illness, presence of surgery, clinical symptoms (vomiting, diarrhea)
Physical findings (recoil pain, muscular defenses), operative procedure, hospital stay, postoperative hospital stay, temperature, WBC level, CRP level, CT imaging endpoints (intra-abdominal free gas image, mesenteric air, abscess size, modified Hinchey classification)


Management information

Registered date

2021 Year 01 Month 24 Day

Last modified on

2021 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name