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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031345
Receipt No. R000035654
Scientific Title Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Date of disclosure of the study information 2018/02/17
Last modified on 2018/02/17

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Basic information
Public title Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Acronym Randomized controlled trial on prophylactic antibiotic administration in totally implantable central venous port
Scientific Title Randomized controlled trial to evaluate the effect of prophylactic antibiotic administration for patients in totally implantable central venous port
Scientific Title:Acronym Randomized controlled trial on prophylactic antibiotic administration in totally implantable central venous port
Region
Japan

Condition
Condition Case of totally implantable central venous port
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the appropriate use of prophylactic antibiotics administration in totally implantable central venous port
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Incidence of surgical site infection within 30 days after totally implantable central venous port
Key secondary outcomes Incidence of totally infectious complications within 30 days after totally implantable central venous port


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of 1g of cefazolin before and after surgery
Interventions/Control_2 Omission of prophylactic antibiotics administration
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 1) Patients with elective totally implantable central venous port
2) No previous chemotherapy or radiation
3) Fulfil all following conditions
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T.Bil < 2.0 g/dl
Cre < 1.5mg/dl
4) written informed consent
Key exclusion criteria 1) Having active infectious disease
2) With uncontrolled diabetes mellitus
3) With myelosuppression due to immunodeficiency or chemotherapy history
4) With short bowel syndrome
5) With allergy to cephalosporin
6) Patient judged inappropriate by the attending physician
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Uchiyama
Organization Osaka Medical College
Division name General and Gastroenterological Surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL 072-683-1221
Email uchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Tanaka
Organization Osaka Medical College
Division name General and Gastroenterological Surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL 072-683-1221
Homepage URL
Email sur148@osaka-med.ac.jp

Sponsor
Institute Osaka medical college, General and Gastroenterological Surgery
Institute
Department

Funding Source
Organization none
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
Email

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 大阪医科大学 一般・消化器外科

Other administrative information
Date of disclosure of the study information
2018 Year 02 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 17 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035654

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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