UMIN-CTR Clinical Trial

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