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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000870
Receipt No. 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

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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)
Email

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
Email takesato@med.nihon-u.ac.jp

Sponsor
Institute Digestive Surgery Nihon University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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