UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022225 |
|---|---|
| Receipt number | R000025599 |
| Scientific Title | Necessity of Postoperative Antibiotic Treatment After Emergency Cholecystectomy for Acute Cholecystitis: A Randomized Clinical Trial OSG-02 (Ogaki Surgical Group) |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/11/21 11:48:30 |
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Basic information
Public title
Necessity of Postoperative Antibiotic Treatment After Emergency Cholecystectomy for Acute Cholecystitis: A Randomized Clinical Trial
OSG-02 (Ogaki Surgical Group)
Acronym
Necessity of Postoperative Antibiotic Treatment After Emergency Cholecystectomy
Scientific Title
Necessity of Postoperative Antibiotic Treatment After Emergency Cholecystectomy for Acute Cholecystitis: A Randomized Clinical Trial
OSG-02 (Ogaki Surgical Group)
Scientific Title:Acronym
Necessity of Postoperative Antibiotic Treatment After Emergency Cholecystectomy
Region
| Japan |
Condition
Condition
Acute Cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the Postoperative Antibiotic Treatment After Cholecystectomy for Acute Cholecystitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical Site Infection
Key secondary outcomes
Distant Site Infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antibiotics (CEZ ; Cefazoline 1g)
single
Interventions/Control_2
Antibiotics (CEZ ; Cefazoline 1g)
3 days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Acute cholecystitis
2.Emergency operation
3.Over 18 years old
4.With informed concent
Key exclusion criteria
A.Tokyo guideline grade 3 Acute cholecystitis
B.CBD stone or cholangitis
C.Peritonitis
D.Acute pancreatitis
E.Liver cirrhosis
F.Suspected malignancy
G.American Society of Anesthesiologists (ASA) score 3or4
H.beta-lactam allergy
I.Under the antibiotic treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fukami |
| Middle name | |
| Last name | Yasuyuki |
Organization
Ogaki Municipal Hospital
Division name
Department of Surgery
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
TEL
0584-81-3341
yasuyuki490225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Fukami |
| Middle name | |
| Last name | Yasuyuki |
Organization
Ogaki Municipal Hospital
Division name
Department of Surgery
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
TEL
0584-81-3341
Homepage URL
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Municipal 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
Ogaki Municipal Hospital
Address
4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan
Tel
0584-81-3341
clinical-trial@omh.ogaki.gifu.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
| 2016 | Year | 06 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025599
