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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043776
Receipt No. 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 2021/03/29

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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
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
2 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
Email manabu.komori@marianna-u.ac.jp

Public contact
Name of contact person
1st name Taro
Middle name
Last name Inagaki
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
Email t2inagaki@marianna-u.ac.jp

Sponsor
Institute St. Marianna University, school of medicine.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2023 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
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049971

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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