Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000200482
Ethics application status
Approved
Date submitted
30/03/2007
Date registered
12/04/2007
Date last updated
12/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized control study of post-operative pain in plasmaknife versus monopolar tonsillectomy
Scientific title
Randomized control study of Plasmaknife Tonsillectomy versus Monopolar Electrocautery Tonsillectomy in effect on post-operative pain in adult patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain after tonsillectomy. 1724 0
Condition category
Condition code
Oral and Gastrointestinal 1815 1815 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
tonsillectomy performed with Plasmaknife is the study procedure, tonsillectomy performed with monopolar diathermy is the control procedure. It takes an average of 30 minutes to perform tonsillectomy.
Intervention code [1] 1681 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 2538 0
Post-operative pain
Timepoint [1] 2538 0
Measured on visual analogue scale daily on the first 14 days in the diaries kept by participants. The diaries are also used to record the nature and dose of analgesic used on each of the first 14 days
Secondary outcome [1] 4387 0
Analgesia use
Timepoint [1] 4387 0
On each of the first 14 days
Secondary outcome [2] 4388 0
Return to normal diet and usual activities following surgery
Timepoint [2] 4388 0
Participant to be contacted after 4 weeks and queried
Secondary outcome [3] 4389 0
Any difference in adverse reactions
Timepoint [3] 4389 0
Participant to be queried on routine post-operative review after 2 weeks.

Eligibility
Key inclusion criteria
Having tonsillectomy for recurrent or chronic tonsillitis.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of malignancy or quinsy, bleeding or coagulation problems, significant medical problems, having implants precluding the use of monopolar diathermy, having inadequate use of English to fill in patient diary.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
patients satisfying the inclusion and exclusion criteria would be approached by the doctors at pre-admission clinic and given printed and verbal information. They would then be enrolled if they agree to participate. Treatment allocation occurs just prior to surgery with the allocated treatment plan contained in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the subjects are blind
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1968 0
Commercial sector/Industry
Name [1] 1968 0
Gyrus
Country [1] 1968 0
Primary sponsor type
Individual
Name
Mr Neil Vallance, ENT (Ear, Nose & Throat) Surgeon
Address
Country
Secondary sponsor category [1] 1779 0
Individual
Name [1] 1779 0
Miss Elizabeth Sigston, ENT (Ear, Nose & Throat) Surgeon
Address [1] 1779 0
Country [1] 1779 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3663 0
Southern Health Ethics Committee
Ethics committee address [1] 3663 0
Ethics committee country [1] 3663 0
Australia
Date submitted for ethics approval [1] 3663 0
Approval date [1] 3663 0
Ethics approval number [1] 3663 0
06056B

Summary
Brief summary
to study if tonsillectomy using the plasmaknife results in any difference in pain and recovery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27784 0
Address 27784 0
Country 27784 0
Phone 27784 0
Fax 27784 0
Email 27784 0
Contact person for public queries
Name 10870 0
Mr Neil Vallance
Address 10870 0
Otolaryngology Southern Health
10 Davey St
Frankston VIC 3199
Country 10870 0
Australia
Phone 10870 0
+61 3 97831433
Fax 10870 0
Email 10870 0
[email protected]
Contact person for scientific queries
Name 1798 0
Mr Neil Vallance
Address 1798 0
Otolaryngology Southern Health
10 Davey St
Frankston VIC 3199
Country 1798 0
Australia
Phone 1798 0
+61 3 97831433
Fax 1798 0
Email 1798 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.