UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002187 |
|---|---|
| Receipt number | 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 19:20:56 |
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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
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
sur122@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002684
