UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002853
Receipt number 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 13:03:36

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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 or person

Institute

Suita Municipal Hospital

Institute

Department

Personal name



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

Value
https://center6.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