UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027982 |
|---|---|
| Receipt number | R000032023 |
| Scientific Title | Randomized controlled trials evaluating the necessity of antimicrobial prophylaxis in colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/06/29 15:48:43 |
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Basic information
Public title
Randomized controlled trials evaluating the necessity of antimicrobial prophylaxis in colorectal endoscopic submucosal dissection
Acronym
Necessity of antibiotics to colonic ESD
Scientific Title
Randomized controlled trials evaluating the necessity of antimicrobial prophylaxis in colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Necessity of antibiotics to colonic ESD
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the necessity of antibiotic in colorectal endoscopic submucosal dissection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative fever
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
No administration of antibiotics during the perioperative period
Interventions/Control_2
Intravenous administration of cefotiam(2.0g per day)for three days
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
Colorectal tumor meeting Japanese
guidelines for colorectal cancer
Key exclusion criteria
1)Patients taking oral steroids or immunosuppressants
2)Patients with an immunosuppressive disease(blood diseases, HIV etc.)
3)Patients with an allergy to Cefotiam
4)Patients deemed inapprorriate
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka |
Organization
Kobe University
Division name
Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-6305
tanakas@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Sakaguchi |
Organization
Kobe University
Division name
Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-6305
Homepage URL
skgch@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | 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
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032023
