UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000870 |
|---|---|
| Receipt number | R000001047 |
| Scientific Title | The analysis of systemic use of antibiotic effect for colorectal surgery |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2007/10/30 15:42:56 |
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Basic information
Public title
The analysis of systemic use of antibiotic effect for colorectal surgery
Acronym
The analysis of systemic use of antibiotic effect for colorectal surgery
Scientific Title
The analysis of systemic use of antibiotic effect for colorectal surgery
Scientific Title:Acronym
The analysis of systemic use of antibiotic effect for colorectal surgery
Region
| Japan |
Condition
Condition
colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To consider the effect of the systemic use of antibiotics for colorectal surgery
Basic objectives2
Others
Basic objectives -Others
Postoperative surgical site and remote infection rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Postoperative surgical site and remote infection rate
Key secondary outcomes
Postoperative hospital day
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
systemic use of antibiotics
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The case of colorectal resection
Key exclusion criteria
The case of total colectomy, perforation,emergency,16 to 79 years age,severe pre-operative complication,pre-operative infection and long term administration of steroid
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Sato |
Organization
Nihon University School of Medicine
Division name
Digestive Surgery
Zip code
Address
30-1 oyaguchi kamimachi Itabashi-ku Tokyo
TEL
03-3972-8111(2471)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Sato |
Organization
Nihon University surugadai hospital
Division name
surgical section
Zip code
Address
1-8-13 Kandasurugadai Chiyoda-ku Tokyo
TEL
03-3293-1711(422)
Homepage URL
takesato@med.nihon-u.ac.jp
Sponsor or person
Institute
Digestive Surgery Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Digestive Surgery Nihon University School of Medicine
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
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2002 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 30 | Day |
Last modified on
| 2007 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001047
