UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007193 |
|---|---|
| Receipt number | R000008470 |
| Scientific Title | oxidative stress in peri-operative period |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2019/08/09 19:11:17 |
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Basic information
Public title
oxidative stress in peri-operative period
Acronym
oxidative stress in peri-operative period
Scientific Title
oxidative stress in peri-operative period
Scientific Title:Acronym
oxidative stress in peri-operative period
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate whether oxidative stress in the peri-operative period predict the surgical stress and postoperative recovery course. Then, a randomized controlled trial is conducted to analyze effect of anesthetic method and technique on the peri-operatve oxidative stress and postoperative recovery course.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative course
postoperative complication
peri-operative oxidative stress
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
General anesthesia with volatile anesthetics
Interventions/Control_2
General anesthesia with intravenous anesthetics
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 esophageal cancer who were performed esophagectomy at Osaka City University Medical School
Key exclusion criteria
Patients who were performed other surgery with esophagectomy
Patients with severe complication
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tsuchiya |
Organization
Osaka City University Medical school
Division name
Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-2186
oxymasa@ea.mbn.or.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Tsuchiya |
Organization
Osaka City University Medical school
Division name
Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-2186
Homepage URL
oxymasa@ea.mbn.or.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Medical school
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Medical school
Address
1-5-7 Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-2121
webmaster@med.osaka-cu.ac.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
大阪市立大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008470
