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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002852
Receipt No. R000001419
Scientific Title Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery
Date of disclosure of the study information 2009/12/09
Last modified on 2011/03/07

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Basic information
Public title Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery
Acronym RCT of antimicrobial prophylaxis in hepatocellular carcinoma surgery
Scientific Title Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery
Scientific Title:Acronym RCT of antimicrobial prophylaxis in hepatocellular carcinoma surgery
Region
Japan

Condition
Condition Patients undergoing elective hepatocellular carcinoma surgery
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In the U.S.,the National Surgical Infection Prevention Project recommends that prophylactic antibiotics not be extended beyond 24 hours of the end of the operation. On the other hands, most Japanese surgeons use antimicrobial prophylaxis until 3 days of postoperativelly. The optimal duration of antimicrobial prophylaxis has been controversial. The Japan Society for Surgical infection is now conducting a randomized trial to investigate the optimal duration of antimicrobial prophylaxis in hepatocellular carcinoma surgery. This study compared the efficacy of U.S. recommended administration and Japanese common administration for the prevention of surgical site infection in patients undergoing elective rectal cancer surgery. The aim of this study is to establish evidence unique in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is to show that a 24 hours antibiotic administarion of the end of the operation was not inferior to the 3 days antibiotic administration of the postoperative period .
Key secondary outcomes The secondary outcome is to investigate the incidence of remote infection in each group.

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Flomoxef Sodium is administered afetr the induction of anesthesia, and the patients recieved an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered agin twice daily for 3 concecutive days after the operation
Interventions/Control_2 Flomoxef Sodium is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered at 6 hour and 18hour at end of the oparation.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Hepatocellular carcinoma patients undergoing liver resection
Liver damage A
ECOG Performance Status Scale:0-2
Written informed consent.
Key exclusion criteria Laparoscopic surgery
Thoracotomy
Digestive organ or vessel reconstruction
Other organ resection.
Those with cardiac dysfunction, renal dysfunction,
Those who received insulin or steroid therapy.
Those who were allergic to cefem or penicillin, pregnant, received antibiotic treatment in the past 2 weeks, had an infection at the time of surgery.
A woman who is pregnant, lactating, or may become pregnant.
ASA score >3.
Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size 460

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Sumiyama
Organization Japan Society for Surgical Infection
Division name The Chief director
Zip code
Address 2-17-6, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan
TEL 03-3481-7316
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masato Kusunoki
Organization Japan Society for Surgical Infection
Division name Chairman of randomized clinical trial committee
Zip code
Address 2-174, Edobashi, Tsu, Mie, 514-8507, Japan
TEL 059-231-5305
Homepage URL
Email

Sponsor
Institute Randomized clinical trial committee, Japan Society for Surgical Infection
Institute
Department

Funding Source
Organization Japan Society for Surgical Infection
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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 09 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 Completed
Date of protocol fixation
2008 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2010 Year 04 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 12 Month 07 Day
Last modified on
2011 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001419

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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