UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037379 |
|---|---|
| Receipt number | R000042608 |
| Scientific Title | Prospective study on prevention of surgical site infection by supplemental periopreative oxygen in digestive surgery |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2021/08/31 15:33:14 |
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Basic information
Public title
Prospective study on prevention of surgical site infection by supplemental periopreative oxygen in digestive surgery
Acronym
Supplemental perioperative oxygen and surgical site infection
Scientific Title
Prospective study on prevention of surgical site infection by supplemental periopreative oxygen in digestive surgery
Scientific Title:Acronym
Supplemental perioperative oxygen and surgical site infection
Region
| Japan |
Condition
Condition
Gastrointestinal surgery case over 20 years of age under general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of supplemental perioperative oxygen in digestive surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Occurrence of surgical site infection that occurred within 30 days after surgery
Key secondary outcomes
Complications associated with anesthesia and surgery occurred within 30 days after surgery
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
| Maneuver |
Interventions/Control_1
After induction of general anesthesia, the oxygen concentration is set to 80%. After extubation, 5 L of oxygen is administered up to 4 hours after surgery
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
Gastrointestinal surgery case performed under general anesthesia over 20 years old
The function of major organs is maintained
Key exclusion criteria
Day surgery
Sever COPD
Patients attending physician is determined to be inappropriate
Cases consent can not be obtained
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hasegawa |
Organization
Osaka Rosai Hospital
Division name
Department of Surgery
Zip code
591-8025
Address
1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
TEL
072-252-3561
j-hasegawa@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Chikato |
| Middle name | |
| Last name | Koga |
Organization
Osaka Rosai Hospital
Division name
Department of Surgery
Zip code
591-8025
Address
1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
TEL
072-252-3561
Homepage URL
ckoga@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka Rosai Hospital
Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
Tel
072-252-3561
soumukatyou@osakah.johas.go.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
大阪労災病院（大阪府）
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042608
| 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 |
