UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037301 |
|---|---|
| Receipt number | R000042528 |
| Scientific Title | Assessment of the incidence of surgical site infections after surgery for colorectal cancer with preoperative oral antibiotics. |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2019/07/08 00:49:00 |
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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
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
natsumesoh16@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042528
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
