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

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 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


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

Value
https://center6.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