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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022225
Receipt No. 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

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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
Email 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
Email yasuyuki490225@yahoo.co.jp

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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