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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002187
Receipt No. R000002684
Scientific Title A prospective randomized controlled trial of utility of antibiotic prophylaxis in patients after liver resection
Date of disclosure of the study information 2009/07/13
Last modified on 2010/01/14

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Basic information
Public title A prospective randomized controlled trial of utility of antibiotic prophylaxis in patients after liver resection
Acronym Evaluation of antibiotic prophylaxis after liver resection
Scientific Title A prospective randomized controlled trial of utility of antibiotic prophylaxis in patients after liver resection
Scientific Title:Acronym Evaluation of antibiotic prophylaxis after liver resection
Region
Japan

Condition
Condition hepatocellular carcinoma, metastatic liver tumor, cholangiocarcinoma, liver tumor, biliary cancer, biliary tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the incidence of septic complications with non-prophylactic administration of antibiotics after liver resection in liver tumor and biliary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of septic complications with non-prophylactic administration of antibiotics with those of antibiotic prophylaxis after liver resection.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes septic complications (wound infection, infectious ascites, abdominal abscess, pneumonia, urinary infection, catheter infection)
Key secondary outcomes the incidence of other postoperative complications, mortality,bile leakage, ascites, abdominal hemorrhage.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Administration of prophylactic antibiotic after liver resection
Interventions/Control_2 Non-administration of prophylactic antibiotic after liver resection
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with hepato-biliary disease who were performed hepatectomy at Osaka Medical college Hospital
Key exclusion criteria 1) patients with severe complications which were possible to prolong hospital stay, 2) patients undergone hemodialysis, 3) patients combined resection of other organs, 4) patients who were diagnosed inadequacy for this study by a physician, and 5) patients without an informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitoshi hirokawa
Organization Osaka Medical College
Division name Department of General and Gastroenterological Surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki city Osaka
TEL 072-683-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumitoshi hirokawa
Organization Osaka Medical College
Division name Department of General and Gastroenterological Surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki city Osaka
TEL 072-683-1221
Homepage URL
Email sur122@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 13 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 Enrolling by invitation
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 13 Day
Last modified on
2010 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002684

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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