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 |
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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
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
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
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
