UMIN-CTR Clinical Trial

Basic information
Public title	Perioperative risk factors for postoperative hoarseness
Acronym	Perioperative risk factors for postoperative hoarseness
Scientific Title	Perioperative risk factors for postoperative hoarseness
Scientific Title:Acronym	Perioperative risk factors for postoperative hoarseness
Region	Japan

Condition
Condition	Perioperative hoarseness
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate how perioperative risk factors influence perioperative hoarseness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative hoarseness
Key secondary outcomes	Postoperative sore throat

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
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Interventions/Control_2
Interventions/Control_3
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent general anesthesia in Osaka City University Hospital from 2009 to 2015
Key exclusion criteria	Patients who were intubated before surgery,who underwent tracheostomy after surgery,or who underwent esophagectomy
Target sample size	22000

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,Osaka545-8585 Japan
TEL	06-6645-2186
Email	anesth@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sayaka Tsujimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Anesthesiology
Zip code
Address	1-5-7,Asahimachi,Abeno-ku,Osaka545-8585 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
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IRB Contact (For public release)
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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	2016 Year 01 Month 31 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
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Results Delayed
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Baseline Characteristics
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Adverse events
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Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date	2016 Year 01 Month 31 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 perioperative hoarseness and to perioperative sore throat from perioperative records of patients who underwent general anesthesia.We also collect informations about age,sex,operative time,drugs,airway method,operation method and position,which may exert influence over perioperative hoarseness.Thereafter,multiple logistic regression analysis are performed using them.

Management information
Registered date	2016 Year 01 Month 29 Day
Last modified on	2016 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023997

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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