UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005142
Receipt number R000005443
Scientific Title COMPARATIVE STUDY OF SINGLE-DOSE AND THREE-DAY THERAPY FOR LAPAROSCOPIC CHOLECYSTECTOMY
Date of disclosure of the study information 2011/02/25
Last modified on 2014/09/23 22:32:11

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Basic information

Public title

COMPARATIVE STUDY OF SINGLE-DOSE AND THREE-DAY THERAPY FOR LAPAROSCOPIC CHOLECYSTECTOMY

Acronym

COMPARATIVE STUDY OF SINGLE-DOSE AND THREE-DAY THERAPY FOR LAPAROSCOPIC CHOLECYSTECTOMY

Scientific Title

COMPARATIVE STUDY OF SINGLE-DOSE AND THREE-DAY THERAPY FOR LAPAROSCOPIC CHOLECYSTECTOMY

Scientific Title:Acronym

COMPARATIVE STUDY OF SINGLE-DOSE AND THREE-DAY THERAPY FOR LAPAROSCOPIC CHOLECYSTECTOMY

Region

Japan


Condition

Condition

Laparoscopic Cholecystectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Levofloxacin 500mg/day to discuss the effectiveness of postoperative infection with a single dose administered for 3 days

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Incidence of surgical site infection

Key secondary outcomes

Blood and Bile concentrations of LVFX


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

LVFX500mg single dose

Interventions/Control_2

LVFX500mg 3days

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

laparoscopic cholecystectomy
Patients who undersutand the study and agree with written informed consent.

Key exclusion criteria

Patients have been treated with other antibiotics before the start of study drug administration
Patients were treated with quinolone antibacterial agent within one week before the start of study drug administration
Treatment with oral administration in patients with severe infection is not expected to effect
Complications have serious underlying disease, patients have difficulty assessing the safety and efficacy of drug testing
Patients with a history of allergy to quinolone antibacterials
Patients with Severe cardiac dysfunction, liver dysfunction
Patients with severe renal impairment
Patients with a history of epilepsy or other seizure disorder
Pregnant women and lactating women and the women are pregnant may
Patients who are considered unsuitable for the doctor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Ikoma

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery, Department of Surgery

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto

TEL

075-251-5527

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Ikoma

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery, Department of Surgery

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto

TEL

075-251-5527

Homepage URL


Email

ikoma@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine
Division of Digestive Surgery, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine
Division of Digestive Surgery, Department of Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

京都府立医科大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 25 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

2011 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 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

2011 Year 02 Month 25 Day

Last modified on

2014 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005443


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name