UMIN-CTR Clinical Trial

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
Institute	hakujyuji hospital surgery
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049212