UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022220 |
|---|---|
| Receipt number | R000024713 |
| Scientific Title | JPICS '15:Japanese Post-operative infectious complication surveillance in 2015 |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2018/11/08 18:02:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
JPICS '15:Japanese Post-operative infectious complication surveillance in 2015
Acronym
JPICS '15
Scientific Title
JPICS '15:Japanese Post-operative infectious complication surveillance in 2015
Scientific Title:Acronym
JPICS '15
Region
| Japan |
Condition
Condition
perioperative infection
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform the surveillance of the perioperative infection including the remote infection that was not carried out conventionally, and surgeon oneself devises an operation procedures and preoperative care. And surgeon keeps operative quality and the security, and decreases the postoperative infection. And surgeon prevents the isolation of resistant bacteria.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The payment of medical expenses, a permitted medical act and nation feelings are greatly different from the United States for Japanese medical care. Therefore the medical quality and security cannot be compared simply between United States and Japanese. The tolerance of Japanese cure level is wide, because the Japanese GPC system attaches great importance to maintaining medical quality and security. As for the perioperative infection, the surveillance was carried out only for surgical site infection, but the remote infection, for example respiratory infection, catheter infection, urinary tract infection and antimicrobials-related enteritis, is extremely important on the prognosis of the operation patient, the appearance prevention of resistant bacteria, and one of medical expenses. This surveillance is intended that we maintain Japanese expensive infection measures and that we achieve a higher aim.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The case of perioperative infection after digestive surgeries
Key exclusion criteria
The digestive operative case not to be equal to criteria for selection
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kusachi |
Organization
Toho University Ohashi Medical Center
Division name
Department of Surgery
Zip code
Address
2-17-6, Ohashi, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
kusachi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Niitsuma, Shinya Kusachi |
Organization
Toho University Ohashi Medical Center
Division name
Department of Surgery
Zip code
Address
2-17-6, Ohashi, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
toru.niitsuma@gmail.com
Sponsor or person
Institute
Japan Society for Surgical Infection
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This survey of postoperative infections including SSIs and RIs in patients undergoing digestive surgery and postoperative infections including SSIs and RIs were significantly less frequent in patients undergoing endoscopic surgery and that AMR bacterial infection and colonization were relatively rare.
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 30 | Day |
Other
Other related information
details unknown
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
