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
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
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
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
