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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008904
Receipt No. R000010444
Scientific Title Correlation between intraoperative hypothermia and perioperative morbidity in patients with esophageal cancer
Date of disclosure of the study information 2012/09/13
Last modified on 2015/03/12

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Basic information
Public title Correlation between intraoperative hypothermia and perioperative morbidity in patients with esophageal cancer
Acronym Correlation between intraoperative hypothermia and perioperative morbidity in patients with esophageal cancer
Scientific Title Correlation between intraoperative hypothermia and perioperative morbidity in patients with esophageal cancer
Scientific Title:Acronym Correlation between intraoperative hypothermia and perioperative morbidity in patients with esophageal cancer
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the correlation between intraoperative body temperature and postoperative morbidity after esophageal cancer surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative morbidity
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent esophageal cancer surgery in Osaka City University Hospital.
Key exclusion criteria Not applicable
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Email anesth@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Homepage URL
Email anesth@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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
Email

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
2012 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S105307701400086X
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
2012 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We collect data related to intraoperative body temperature and to postoperative adverse events from perioperative records of patients who underwent esophageal cancer surgery. And we also collect informations about height, body weight, age, sex, operative time, operation method, blood loss, anesthetic method, ASA risk and chemo-radiation therapy, which may exert influence over postoperative morbidity. Thereafter, multivariate analyses are performed to investigate whether intraoperative hypothermia is the independent risk factor of postoperative morbidity.

Management information
Registered date
2012 Year 09 Month 12 Day
Last modified on
2015 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010444

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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