Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000537853
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
6/05/2021
Date last updated
1/03/2023
Date data sharing statement initially provided
6/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Coblation vs Bizact Tonsillectomy on Post-Operative Pain: a randomised control trial
Scientific title
Coblation vs Bizact Tonsillectomy for post-operative pain in adults : a randomised control trial
Secondary ID [1] 303612 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tonsillectomy 321000 0
Condition category
Condition code
Surgery 318807 318807 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. Participants will be blinded and randomised to either the Coblation or Bizact tonsillectomy method. These procedures will be performed by highly experienced ENT surgeons. Analgesia will be standardised (Post-surgical analgesia protocol – Tapentadol, Celebrex with oxycodone after tapentadol runs out. Difflam for breakthrough).

Both Coblation and Bizact tonsillectomy involve pulling the tonsil away from the pharyngeal wall with forceps. The relevant instrument is then used to separate the tonsil capsule from the pharyngeal constrictor muscles. Both instruments provide simultaneous dissection and haemostasis but can sometimes fail to control bleeding 100%, hence the need for “touch-up” bipolar diathermy in some cases. Normal length of procedure would be estimated to be 5-20 minutes in total.

The Evac 70 Coblation wand and Bizact ligasure device are disposable devices, hence needing to be recorded in the operation record and can be checked for adherence to the claimed technique.
Intervention code [1] 319913 0
Treatment: Surgery
Comparator / control treatment
Coblation tonsillectomy using the Evac 70 Coblation wand
Control group
Active

Outcomes
Primary outcome [1] 326753 0
Pain after tonsillectomy: measured by visual analogue scores
Timepoint [1] 326753 0
once daily for 14 days post surgery
Secondary outcome [1] 392581 0
Bleeding during surgery: measured by volume of blood in suction bottles and weight of swabs
Timepoint [1] 392581 0
Within the surgical procedure
Secondary outcome [2] 392582 0
Bleeding after surgery: measured using Flinders modification of the Stammberger grade for Secondary Post Tonsillectomy Haemorrhage
Timepoint [2] 392582 0
For period of the 14 days post surgery assessed by the surgeon at the two week follow up appointment
Secondary outcome [3] 392583 0
Duration of surgery: minutes. Recorded by medical staff during the procedure and stored securely with other patient research information.
Timepoint [3] 392583 0
During the surgical procedure
Secondary outcome [4] 392584 0
Days to normal activity: defined as tolerating normal diet, physical activities and return to work/study where appropriate. Assessed through a study specific questionnaire.
Timepoint [4] 392584 0
Until which time participants can return to normal activity

Eligibility
Key inclusion criteria
Over 18 years of age, able to consent, clinical indications for tonsillectomy as recurrent tonsillitis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of bleeding disorders, history of general anaesthetic risk, previous peri-tonsillar abscess, tonsillectomy performed due to suspicion of malignancy, contraindications to post-surgical analgesia protocol.

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)
Sealed Opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of normality will be performed then Chi-squared for parametric and Mann-Witney for non-parametric data. P<0.05 will be regarded as significant. Sample size calculations were determined to require 56 to be suffiency powered to show a differnence in pain scores of 1.5. 70 will be recruited to account for drop out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308032 0
Self funded/Unfunded
Name [1] 308032 0
Professor Simon Carney
Country [1] 308032 0
Australia
Primary sponsor type
Individual
Name
Professor Simon Carney
Address
Suite 200 Southern ENT, Flinders Private Hospital, 1 Flinders Dr, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 308767 0
None
Name [1] 308767 0
Address [1] 308767 0
Country [1] 308767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308025 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 308025 0
Flinders Medical Centre, Level 6, Ward 6C, Room 6A219, Flinders Dr, Bedford Park SA 5042
Ethics committee country [1] 308025 0
Australia
Date submitted for ethics approval [1] 308025 0
09/03/2021
Approval date [1] 308025 0
03/06/2021
Ethics approval number [1] 308025 0
2021/HRE00092

Summary
Brief summary
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. This trial will randomise patients to one of these two methods and study post-operative pain outcomes by visual analogue pain scores and days to normal activity. Bleeding during and after surgery, and the duration of surgery, will also be measured.
We hypothesize that coblation tonsillectomy will result in reduced post-operative pain, reduced primary and secondary bleeding during and after surgery, a shorter duration of surgery and faster return to normal activity when compared to the Bizact method.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109262 0
Prof Simon Carney
Address 109262 0
Suite 200 Southern ENT, Flinders Private Hospital, 1 Flinders Dr, Bedford Park SA 5042
Country 109262 0
Australia
Phone 109262 0
+61 8 8277 0288
Fax 109262 0
Email 109262 0
simoncarney@me.com
Contact person for public queries
Name 109263 0
Prof Simon Carney
Address 109263 0
Suite 200 Southern ENT, Flinders Private Hospital, 1 Flinders Dr, Bedford Park SA 5042
Country 109263 0
Australia
Phone 109263 0
+61 8 8277 0288
Fax 109263 0
Email 109263 0
simoncarney@me.com
Contact person for scientific queries
Name 109264 0
Prof Simon Carney
Address 109264 0
Suite 200 Southern ENT, Flinders Private Hospital, 1 Flinders Dr, Bedford Park SA 5042
Country 109264 0
Australia
Phone 109264 0
+61 8 8277 0288
Fax 109264 0
Email 109264 0
simoncarney@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.