UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013369
Receipt number R000015539
Scientific Title Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease
Date of disclosure of the study information 2014/03/20
Last modified on 2017/06/26 14:52:26

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Basic information

Public title

Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease

Acronym

Efficacy of oral antibiotics prophylaxis in patients with Crohn's disease

Scientific Title

Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease

Scientific Title:Acronym

Efficacy of oral antibiotics prophylaxis in patients with Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is evaluation of the efficacy and safety for chemical cleansing by oral antibiotics which can help to reduce the incidence of surgical site infections.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of surgical site infection

Key secondary outcomes

Incidence of infectious enteritis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Oral antibiotics will be administrated on the day before surgery (500mg of kanamycin and 500mg of metronidazole at 14:00, 15:00, and 21:00)

Interventions/Control_2

without oral antibiotics

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

surgical patients with crohn's disease

Key exclusion criteria

Emergent surgery.
Patients who are not able to orally intake.
Patients with drug allergy for kanamycin and 500mg of metronidazole

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motoi Uchino

Organization

Hyogo college of medicine

Division name

Inflammatory bowel disease

Zip code


Address

1-1 Mukogawacho Nishinomiya Hyogo Japan

TEL

0798-45-6371

Email

uchino2s@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motoi Uchino

Organization

Hyogo college of medicine

Division name

Inflammatory bowel disease

Zip code


Address

1-1 mukogawacho Nishinomiya Hyogo Japan

TEL

0798-45-6371

Homepage URL


Email

uchino2s@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo college of medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo college 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

2014 Year 03 Month 20 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

Oral antibiotic prophylaxis has decreasing effect for the surgical site infection, It prevent especially in incisional surgical site infection

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

2014 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 04 Month 29 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 07 Day

Last modified on

2017 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name