UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007768 |
|---|---|
| Receipt number | R000009151 |
| Scientific Title | Analysis about decreasing of duration of postoperative antimicrobial therapy for acute cholecystitis |
| Date of disclosure of the study information | 2012/04/17 |
| Last modified on | 2012/04/16 14:02:27 |
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Basic information
Public title
Analysis about decreasing of duration of postoperative antimicrobial therapy for acute cholecystitis
Acronym
Decreasing of duration of postoperative antimicrobial therapy for acute cholecystitis
Scientific Title
Analysis about decreasing of duration of postoperative antimicrobial therapy for acute cholecystitis
Scientific Title:Acronym
Decreasing of duration of postoperative antimicrobial therapy for acute cholecystitis
Region
| Japan |
Condition
Condition
acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is decrease of postoperative antimicrobial therapy for acute cholecystitis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative complication
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
age less than 65 years, body temperature less than 37.5, CRP less than 10.0, without severe local inflammation including gangrenous cholecystitis, pericholecystic abscess, etc.
Key exclusion criteria
1. taking anti-coaglants
2. severe co-morbidity
3. intraoperative massive bile leak
4. conversion to open surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Asai |
Organization
Toho university, Ohashi medical center
Division name
Surgery
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Asai |
Organization
Toho university, Ohashi medical center
Division name
Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2012 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
comparison about duration of antimicrobial therapy between 0 POD and until 24 hours after inflammation away
Management information
Registered date
| 2012 | Year | 04 | Month | 16 | Day |
Last modified on
| 2012 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009151
