UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020802 |
|---|---|
| Receipt number | R000023997 |
| Scientific Title | Perioperative risk factors for postoperative hoarseness |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2016/01/29 21:19:40 |
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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
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
| 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
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
anesth@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023997
