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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007193
Receipt No. 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

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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
Email 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
Email oxymasa@ea.mbn.or.jp

Sponsor
Institute Department of Anesthesiology, Osaka City University Medical school
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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