UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031783 |
|---|---|
| Receipt number | 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 15:15:04 |
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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
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
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Department of anesthesia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036281
| Research Plan | |
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| 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 |
