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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002853
Receipt No. R000003484
Scientific Title Reduction of post-operative pain by PGA sheet attachment to wound after tonsillectomy
Date of disclosure of the study information 2010/01/01
Last modified on 2013/06/07

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Basic information
Public title Reduction of post-operative pain by PGA sheet attachment to wound after tonsillectomy
Acronym Post-tonsillectomy pain after PGA sheet attachment
Scientific Title Reduction of post-operative pain by PGA sheet attachment to wound after tonsillectomy
Scientific Title:Acronym Post-tonsillectomy pain after PGA sheet attachment
Region
Japan

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

Objectives
Narrative objectives1 Objective of this study is to investigate an effect of PGA sheet attachment to wound on post-tonsillectomy pain
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes post-operative pain evaluated by visual analogue scale(VAS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Side to which PGA sheet will be attached
Interventions/Control_2 How to attach the PGA sheet to the wound: suture or fibrin glue
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men or women who will be undergone tonsillectomy at our hospital
Key exclusion criteria Patients who do not agree with the participation in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Arata Horii
Organization Suita Municipal Hospital
Division name Department of Otolaryngology
Zip code
Address 13-20 2chome katayama-cho Suita-City Osaka
TEL 06-6387-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Suita Municipal Hospital
Division name Otolaryngology
Zip code
Address
TEL 06-6387-3311
Homepage URL
Email

Sponsor
Institute Suita Municipal Hospital
Institute
Department

Funding Source
Organization None
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
2010 Year 01 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 Completed
Date of protocol fixation
2009 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 07 Day
Last modified on
2013 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003484

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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