UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trials evaluating the necessity of antimicrobial prophylaxis in colorectal endoscopic submucosal dissection
Title of the study (Brief title)	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	Shinwa Tanaka
Organization	Kobe University
Division name	Gastroenterology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-6305
Email	tanakas@med.kobe-u.ac.jp

Public contact
Name of contact person	Hiroya Sakaguchi
Organization	Kobe University
Division name	Gastroenterology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-6305
Homepage URL
Email	skgch@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032023