|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000013369 |
|
Date of registration:
|
20/03/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections 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 - Efficacy of oral antibiotics prophylaxis in patients with Crohn's disease |
|
Date of first enrolment:
|
2014/04/01 |
|
Target sample size:
|
240 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015539 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase II
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Motoi Uchino |
|
Address:
|
1-1 mukogawacho Nishinomiya Hyogo Japan
Japan |
|
Telephone:
|
0798-45-6371 |
|
Email:
|
uchino2s@hyo-med.ac.jp |
|
Affiliation:
|
Hyogo college of medicine Inflammatory bowel disease |
|
|
Name:
|
Motoi Uchino |
|
Address:
|
1-1 Mukogawacho Nishinomiya Hyogo Japan
Japan |
|
Telephone:
|
0798-45-6371 |
|
Email:
|
uchino2s@hyo-med.ac.jp |
|
Affiliation:
|
Hyogo college of medicine Inflammatory bowel disease |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Emergent surgery. Patients who are not able to orally intake. Patients with drug allergy for kanamycin and 500mg of metronidazole
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn's disease
|
|
Intervention(s)
|
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)
without oral antibiotics
|
|
Primary Outcome(s)
|
|
Incidence of surgical site infection
|
|
Secondary Outcome(s)
|
|
Incidence of infectious enteritis
|
|
Source(s) of Monetary Support
|
|
Hyogo college of medicine
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/03/2017 |
|
URL:
|
|
|
|