UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics.
Title of the study (Brief title)	Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics.
Region	Japan

Condition
Condition	Patients with lower digestive surgery (Inflammatory bowel disease, Colorectal 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 lower digestive surgery
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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with IBD or colorectal cancer, who will perform digestive surgery. No allergy for Ciprofloxacin and Metronidazole.
Key exclusion criteria	Patients with allergy for Ciprofloxacin or Metronidazole.
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuhiro Watanabe
Organization	Tohoku University Hospital
Division name	Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	+81-22-717-7205
Email	k-wata@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Kazuhiro Watanabe
Organization	Tohoku University Hospital
Division name	Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	+81-22-717-7205
Homepage URL
Email	k-wata@surg1.med.tohoku.ac.jp

Sponsor
Institute	Dep. Surgery, Tohoku University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	kouhi
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 12 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 10 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	2014 Year 10 Month 17 Day
Last modified on	2016 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017941