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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031783
Receipt No. R000036281
Scientific Title Prospective study on the effects of Japanese preoperative smoking status on postoperative complications
Date of disclosure of the study information 2018/04/01
Last modified on 2019/11/12

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Basic information
Public title Prospective study on the effects of Japanese preoperative smoking status on postoperative complications
Acronym Relationship between preoperative smoking status and postoperative complications
Scientific Title Prospective study on the effects of Japanese preoperative smoking status on postoperative complications
Scientific Title:Acronym Relationship between preoperative smoking status and postoperative complications
Region
Japan

Condition
Condition Patient undergoing scheduled surgery
Classification by specialty
Anesthesiology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of preoperative active smoking and passive smoking on the incidence of postoperative complications
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence or absence of decrease in SpO2 within 48 hours after operation, respiratory complication, wound infection, cerebrovascular event, cardiovascular event, acute renal failure, suture failure, infection, re-intubation, death within 30 days , death within 60 days and death within 1 year and the artificial respiration period
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
1 days-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing scheduled surgery under general anesthesia and spinal anesthesia
Key exclusion criteria Patients in reoperation, patients who could not obtain informed consent to the study
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Murakawa
Organization Fukushima Medical University
Division name Department of anesthesia
Zip code 9601247
Address Hikarigaoka1,Fukushima City,Fukushima Prefecture
TEL 024-547-1342
Email masui@fmu.ac.jp

Public contact
Name of contact person
1st name Asami
Middle name
Last name Takagi
Organization Fukushima Medical University
Division name Department of anesthesia
Zip code 960-1247
Address Hikarigaoka1,Fukushima City,Fukushima Prefecture
TEL 024-547-1342
Homepage URL
Email masui@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Department of anesthesia
Institute
Department

Funding Source
Organization non
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 Fukushima Medical University , Department of anesthesia
Address Hikarigaoka1,Fukushima City,Fukushima Prefecture
Tel 024-547-1825
Email rs@fmu.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 福島県立医科大学附属病院(福島県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 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
2018 Year 03 Month 31 Day
Date of IRB
2018 Year 02 Month 23 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects are from April 1, 2018 to March 31, 2019, patients who obtained informed consent among patients undergoing scheduled surgery under general anesthesia spinal anesthesia. Cohort study

Management information
Registered date
2018 Year 03 Month 18 Day
Last modified on
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036281

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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