UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035964 |
|---|---|
| Receipt number | 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 11:35:58 |
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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
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
aimaruko@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040959
