UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013093 |
|---|---|
| Receipt number | R000015274 |
| Scientific Title | The investigation of the utility of non-intravenous treatment for uncomplicated diverticulitis |
| Date of disclosure of the study information | 2014/02/06 |
| Last modified on | 2025/03/23 10:06:42 |
* 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 investigation of the utility of non-intravenous treatment for uncomplicated diverticulitis
Acronym
The non-intravenous treatment for diverticulitis
Scientific Title
The investigation of the utility of non-intravenous treatment for uncomplicated diverticulitis
Scientific Title:Acronym
The non-intravenous treatment for diverticulitis
Region
| Japan |
Condition
Condition
uncomplicated diverticulitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of non-intravenous treatment for uncomplicated diverticulitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the duration of treatment, hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The non-intravenous treatment group: oral antibiotics and elemental diet
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient we obtain the informed consent.
The patient who is more than 20 years old male and female.
The patient diagnosed as uncomplicated diverticulitis with abdominal CT.
The patient indicated to not surgical intervention but conservative treatment.
Key exclusion criteria
The patient incapable of complaining abdominal symptom because of dementia and any other reasons.
The patient who has the history of abdominal operation including gastrectomy, colectomy and etc.
The patient indicated to surgical intervention.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Miwa |
Organization
Toshiba General Hospital
Division name
Department of Gastroenterology
Zip code
Address
6-3-22 Higashiohi Shinagawa-ku Tokyo Japan
TEL
03-3764-0511
jun.miwa@toshiba.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiro Yamazaki |
Organization
Toshiba General Hospital
Division name
Department of General Medicine
Zip code
Address
6-3-22 Higashiohi Shinagawa-ku Tokyo Japan
TEL
03-3764-0511
Homepage URL
tadahiro.yamazaki@toshiba.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Toshiba General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Toshiba General Hospital
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
Address
Tel
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
| 2014 | Year | 02 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015274
