UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003435 |
|---|---|
| Receipt number | R000004159 |
| Scientific Title | Influence of bifidobacterium on surgical site infection and enterobacterial flora in colorectal cancer surgery |
| Date of disclosure of the study information | 2010/04/02 |
| Last modified on | 2012/08/09 12:28:44 |
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Basic information
Public title
Influence of bifidobacterium on surgical site infection and enterobacterial flora in colorectal cancer surgery
Acronym
Influence of bifidobacterium on surgical site infection and enterobacterial flora in colorectal cancer surgery
Scientific Title
Influence of bifidobacterium on surgical site infection and enterobacterial flora in colorectal cancer surgery
Scientific Title:Acronym
Influence of bifidobacterium on surgical site infection and enterobacterial flora in colorectal cancer surgery
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of oral antibiotoic and bifidobacterium on surgical site infection and enterobacterial flora as preoperative preparation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
surgical site infection
changes of enterobacterial flora
Key secondary outcomes
incidence of Clostridium difficile colitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
polyethylene glycol-electrolyte sodium
(2 L)
Interventions/Control_2
polyethylene glycol-electrolyte sodium
(2 L)
oral antibiothics ()Kanamycin, metronidazol)
Interventions/Control_3
polyethylene glycol-electrolyte sodium
(2 L)
oral Bifidobacterium
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
patients who underwent elective colorecal cancer surgery
Key exclusion criteria
emergency surgery
patients with acute inflammation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sotaro Sadahiro |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
Address
143 Shimokasuya Isehara, Kanagawa, 259-1193, Japan
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sotaro Sadahiro |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
Address
143 Shimokasuya Isehara, Kanagawa, 259-1193, Japan
TEL
0463-93-1121
Homepage URL
sadahiro@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University, Department of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2010 | Year | 04 | Month | 02 | 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
| 2007 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2012 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004159
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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