UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043776 |
|---|---|
| Receipt number | R000049971 |
| Scientific Title | evaluation for the result of conventional tonsillectomy and tonsillectomy with micro-debridder. |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2023/04/25 17:06:52 |
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Basic information
Public title
evaluation for the result of conventional tonsillectomy and tonsillectomy with micro-debridder.
Acronym
evaluation for conventional tonsillectomy and with micro-debridder.
Scientific Title
evaluation for the result of conventional tonsillectomy and tonsillectomy with micro-debridder.
Scientific Title:Acronym
evaluation for the result of conventional tonsillectomy and tonsillectomy with micro-debridder.
Region
| Japan |
Condition
Condition
chronic tonsillitis
sleeping apnea syndrome
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conventional tonsillectomy is widely operated for chronic tonsillitis. Therefor the pain and bleeding after operation are sometime occurred as complications. For this problems, we evaluate for the result of conventional tonsillectomy and with micro-debridder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain scale
dose of pain killer
amount of meals per day
presence of the bleeding after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
conventional tonsillectomy
Interventions/Control_2
tonsillectomy with micro-debridder
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
| 5 | years-old | <= |
Age-upper limit
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
chronic tonsillitis
sleeping apnea syndrome
Key exclusion criteria
IgA nephropathy
Periodic Fever with Aphtous Pharingitis and Adenitis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Komori |
Organization
St. Marianna University, school of medicine.
Division name
otolaryngology
Zip code
216-8511
Address
2-16-1, sugao, miyamaeku, kawasaki
TEL
0449778111
manabu.komori@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Komori |
Organization
St. Marianna University, school of medicine.
Division name
otolaryngology
Zip code
216-8511
Address
2-16-1, sugao, miyamaeku, kawasaki
TEL
0449778111
Homepage URL
manabu.komori@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University, school of medicine.
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University, 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
St. Marianna University, IRB
Address
2-16-1, sugao, miyamaeku
Tel
04449778111
t2inagaki@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049971
