UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the incidence of surgical site infections after surgery for colorectal cancer with preoperative oral antibiotics.
Acronym	Assessment of the incidence of surgical site infections after surgery for colorectal cancer with preoperative oral antibiotics.
Scientific Title	Assessment of the incidence of surgical site infections after surgery for colorectal cancer with preoperative oral antibiotics.
Scientific Title:Acronym	Assessment of the incidence of surgical site infections after surgery for colorectal cancer with preoperative oral antibiotics.
Region	Japan

Condition
Condition	Patients with surgery forcolorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of preoperative oral antibiotics for surgical site infection in patients with surgery for colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of surgical site infection at 30th days after surgery
Key secondary outcomes	Safety of the preoperative oral antibiotics and, Incidence of postoperative suture failure, incidence of postoperative ileus, incidence of urinary tract infection

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	oral 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with colorectal cancer, who will perform laparoscopic surgery.
Key exclusion criteria	Patients with allergy for Ciprofloxacin and Metronidazole. Patients who have difficulty with oral administration due to intestinal obstruction.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Soichiro Middle name Last name Natsume
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Colorectal surgery
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyoku, Tokyo
TEL	03-3823-2101
Email	natsumesoh16@cick.jp

Public contact
Name of contact person	1st name Soichiro Middle name Last name Natsume
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Colorectal surgery
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyoku, Tokyo
TEL	03-3823-2101
Homepage URL
Email	natsumesoh16@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address	3-18-22, Honkomagome, Bunkyoku, Tokyo
Tel	03-3823-2101
Email	rinri@cick.jp

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	がん・感染症センター　都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 15 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	2019 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 08 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042528