UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015460 |
|---|---|
| Receipt number | R000017941 |
| Scientific Title | Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2016/04/17 10:49:13 |
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Basic information
Public title
Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics.
Acronym
Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics.
Scientific Title
Assessment of the incidence of surgical site infections after digestive surgery with preoperative oral antibiotics.
Scientific Title:Acronym
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.
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
| 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
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Tohoku University Hospital
Division name
Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7205
k-wata@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Tohoku University Hospital
Division name
Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7205
Homepage URL
k-wata@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Dep. Surgery, Tohoku University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017941
