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Trial registered on ANZCTR


Registration number
ACTRN12620000660987p
Ethics application status
Not yet submitted
Date submitted
13/05/2020
Date registered
9/06/2020
Date last updated
9/06/2020
Date data sharing statement initially provided
9/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of acute tonsillectomy in patients with recurrent episodes of acute tonsillitis
Scientific title
A pilot study to determine feasibility of acute coblation tonsillectomy for patients with recurrent acute tonsillitis
Secondary ID [1] 301253 0
Nil known
Universal Trial Number (UTN)
U1111-1251-8907
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
recurrent acute tonsillitis 317430 0
Condition category
Condition code
Oral and Gastrointestinal 315524 315524 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 315673 315673 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coblation tonsillectomy will be performed by a single senior ENT surgeon with more than 20years of operating experience at a metropolitan hospital in Sydney, Australia. The recruitment and selection of suitable adult patients to undergo this procedure will be made on a case by case basis, taking into account personalised clinical history and examination findings. A number of factors will be considered, including frequency and severity of episodes of recurrent tonsillitis and the presence of co-morbidities. Tonsillectomy is an operation which can only be performed once on a patient, since the tonsil is removed during in the course of the operation. Tonsillotomy is not being performed.

Coblation tonsillectomy is a newer technique which involves dissecting the tonsil from the tonsil bed using a localised plasma field created on a "tonsil wand". A radiofrequency current is produced by a generator and this passes through a field of saline at the tip of the tonsil wand, breaking the molecular bonds to create ions which thereby generate the plasma field for tissue dissection. The plasma field is kept localised at the head of the tonsil wand by the continuous supply and suction of the saline stream. This differs from the traditional techniques used in tonsillectomy, such as "cold steel" tonsillectomy and "diathermy" tonsillectomy. In cold steel tonsillectomy, instruments used include scissors and dissecting forceps, and haemostasis may be achieved with the use of ties, while diathermy tonsillectomy involves the use of electrocautery energy to dissect through the peritonsillar plane.

Intra-operative time for coblation tonsillectomy is variable depending on the difficulty of the individual case, but typically would take approximately half an hour or up to one hour. This does not include time for anaesthesia induction and recovery.
Intervention code [1] 317556 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323766 0
Primary post-operative haemorrhage as identified on clinical history and examination
Timepoint [1] 323766 0
24 hours post-operatively
Primary outcome [2] 323767 0
Post-operative analgesia requirements - measured by dosage and frequency of simple and opioid analgesia administration on medication charts
Timepoint [2] 323767 0
24 hours post-operatively
Primary outcome [3] 323768 0
Length of hospital stay assessed on review of hospital medical records
Timepoint [3] 323768 0
Variable, but usually in the first 1-3 days post-operatively
Secondary outcome [1] 382836 0
Return to tolerance of oral diet assessed on review of hospital medical records (documentation that patient was tolerating diet)
Timepoint [1] 382836 0
24 hours post-operatively
Secondary outcome [2] 382837 0
Re-admission to hospital assessed on review of hospital medical records (documented evidence of re-admission)
Timepoint [2] 382837 0
30 days post-operatively
Secondary outcome [3] 382838 0
Post-operative infection in tonsil bed assessed on review of hospital medical records (documentation regarding prolonged admission or re-admission with an infection arising from the tonsil bed). A tonsil bed infection is a clinical diagnosis made on the grounds of signs of infection (pain, redness, fever, temperature, systemic inflammatory response) with the source of infection appearing to be the tonsil bed in which the operation has been performed. This is often supported by blood tests which may indicate a raised white cell count or C-reactive protein, although this is not always the case.
Timepoint [3] 382838 0
3 weeks post-operatively
Secondary outcome [4] 382839 0
Operating time assessed on review of hospital medical records (times for operation commencement and cessation are documented in theatre notes).
Timepoint [4] 382839 0
Intra-operative period
Secondary outcome [5] 382843 0
Secondary post-operative haemorrhage as identified on clinical history and examination
Timepoint [5] 382843 0
Within 3 weeks post-operatively

Eligibility
Key inclusion criteria
Patients over the age of 16 years with acute tonsillitis, with or without peri-tonsillar abscess, requiring admission to hospital. Symptoms and signs evidencing an episode of acute tonsillitis include fever >38.0 degrees Celsius, tonsillar erythema and/or exudate, sore throat, cervical lymphadenopathy, with or without a culture positive for Group A b-haemolytic Streptococcus. Patient's should additionally warrant tonsillectomy based on their history of clinically significant episodes of sore throat diagnosed as recurrent acute tonsillitis as per the Paradise Criteria (3 episodes per year for previous 3 consecutive years, 5 episodes per year for previous 2 consecutive years, or 7 episodes in the previous year).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 16 years, patients unable to provide consent, only a single documented episode of acute tonsillitis or where the history of recurrent acute tonsillitis cannot be established, pregnancy, suspected tonsillar malignancy, and if obstructive sleep apnoea is the main indication for tonsillectomy. Patients with bleeding disorders or haematological malignancies, or other significant co-morbidities (patients with American Society of Anaesthesiologists Score 3-4) will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a single centre, non-randomised clinical trial which will prospectively recruit a cohort of patients who present to our institution via the Emergency Department with acute tonsillitis. The trial will operate for a period of 12 months or until the total number of patients is recruited, whichever comes first.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study which is aiming to recruit 20 patients to demonstrate the safety and efficacy of coblation tonsillectomy in the setting of acute tonsillitis. Simple descriptive data will be presented on rates of post-operative haemorrhage, analgesia requirements, infection, re-admission to hospital, operative time and length of hospital stay. For example, the mean, range, and simple patient characteristics will be described.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16644 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 30240 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 305700 0
Self funded/Unfunded
Name [1] 305700 0
N/A
Country [1] 305700 0
Primary sponsor type
Individual
Name
A/Prof Alan Cheng
Address
Department of Surgery, Canterbury Hospital
575 Canterbury Rd, Campsie NSW 2194
Country
Australia
Secondary sponsor category [1] 306117 0
None
Name [1] 306117 0
N/A
Address [1] 306117 0
N/A
Country [1] 306117 0
Other collaborator category [1] 281306 0
Individual
Name [1] 281306 0
Dr Shibalik Misra
Address [1] 281306 0
Department of Surgery, Canterbury Hospital
575 Canterbury Rd, Campsie NSW 2194
Country [1] 281306 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305978 0
Royal Prince Alfred Hospital, Research Ethics and Governance Office
Ethics committee address [1] 305978 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 305978 0
Australia
Date submitted for ethics approval [1] 305978 0
25/06/2020
Approval date [1] 305978 0
Ethics approval number [1] 305978 0

Summary
Brief summary
This is a single site, prospective clinical trial aiming to determine if immediate tonsillectomy in patients presenting with acute tonsillitis is a safe and acceptable alternative to delayed elective tonsillectomy for patients with recurrent acute tonsillitis. Currently patients undergo elective tonsillectomy for recurrent tonsillitis but may wait for approximately 12 months on the public hospital waiting list for their procedure, during which time they may suffer further debilitating episodes of tonsillitis. Suitable patients who present to the hospital with acute tonsillitis will receive routine medical management but will proceed to coblation-assisted tonsillectomy under general anaesthesia, a newer surgical technique using a "tonsil wand" with a localised plasma field at the tip for tissue dissection.

This approach represents a shift in current treatment paradigms much the same as in other infective surgical pathologies such as acute cholecystitis and appendicitis. We hypothesise that coblation tonsillectomy in the acute setting will be a safe alternative to delayed tonsillectomy, providing the impetus for further larger studies to corroborate these findings.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 102286 0
A/Prof Alan Cheng
Address 102286 0
Department of Surgery, Canterbury Hospital
575 Canterbury Rd, Campsie NSW 2194
Country 102286 0
Australia
Phone 102286 0
+61 0418667719
Fax 102286 0
Email 102286 0
[email protected]
Contact person for public queries
Name 102287 0
A/Prof Alan Cheng
Address 102287 0
Department of Surgery, Canterbury Hospital
575 Canterbury Rd, Campsie NSW 2194
Country 102287 0
Australia
Phone 102287 0
+61 0418667719
Fax 102287 0
Email 102287 0
[email protected]
Contact person for scientific queries
Name 102288 0
A/Prof Alan Cheng
Address 102288 0
Department of Surgery, Canterbury Hospital
575 Canterbury Rd, Campsie NSW 2194
Country 102288 0
Australia
Phone 102288 0
+61 0418667719
Fax 102288 0
Email 102288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data can be shared at the request of appropriately qualified investigators. Our data is de-identified with the use of a Master Code Sheet containing recruited patients, with corresponding de-identified data stored in a separate spreadsheet. Summarised end-points derived from the data will be made available through publications arising from the present study.
When will data be available (start and end dates)?
Data will be made available at the time of publication, which remains to be determined based on progress of the study. There will be no time limit on the availability of the data, and there is no intention to destroy the data at the present time.
Available to whom?
De-identified individual participant data can be shared at the request of appropriately qualified investigators with an interest in performing further research on the topic.
Available for what types of analyses?
There would be no restrictions on the type of analyses to be performed.
How or where can data be obtained?
De-identified data can be obtained by liaising with the principle investigator for this study (A/Prof Alan Cheng), who will be contactable through details provided in publications arising from this work.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7917Study protocol    379807-(Uploaded-11-05-2020-17-08-50)-Study-related document.docx
7918Informed consent form    379807-(Uploaded-11-05-2020-16-11-20)-Study-related document.doc



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.