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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035964
Receipt No. R000040959
Scientific Title Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Date of disclosure of the study information 2019/02/21
Last modified on 2019/03/03

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Basic information
Public title Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Acronym Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Scientific Title Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Scientific Title:Acronym Establishment of autonomic function reflecting surgical invasiveness induced by tonsillectomy
Region
Japan

Condition
Condition Patients underwent bilateral tonsillectomy
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the parameters and methods reflecting surgical invasiveness induced by tonsillectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Parameters of Pupil light reflex (PLR) and Heart rate variability (HRV) at two times before tonsillectomy and POD1, 2 and 2-4 weeks.
Pupil: initial diameter, minimum diameter, latency, max constriction velocity, averaged constriction velocity, constriction ratio, averaged dilation velocity, 4 different stimulus intensity (10,50,121,180)
HRV: LF norm, HF norm, LF/HF
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
10 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients underwent bilateral tonsillectomy
Key exclusion criteria 1) Patients required post surgical hemostasis for severe bleeding
2) Patients with severe central neural disorders and cardiac disorders.
3) Patients whom doctors judge as an inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASAAKI ISHIKAWA
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of otolaryngology and head and neck
Zip code
Address Amagasaki city higashinanbacho 2chome 17-77
TEL 06-6480-7000
Email aimaruko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name MASAAKI ISHIKAWA
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of otolaryngology and head and neck
Zip code
Address Amagasaki city higashinanbacho 2chome 17-77
TEL 06-6480-7000
Homepage URL
Email aimaruko@gmail.com

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Hyogo Prefectural Amagasaki General Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 21 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2019 Year 02 Month 21 Day
Last modified on
2019 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040959

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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