Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000925246p
Ethics application status
Submitted, not yet approved
Date submitted
22/05/2018
Date registered
31/05/2018
Date last updated
31/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes following full versus selective functional endoscopic sinus surgery
Scientific title
Efficacy of full endoscopic sinus surgery compared to mini endoscopic sinus surgery
Secondary ID [1] 294963 0
None
Universal Trial Number (UTN)
U1111-1214-4588
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 307960 0
Condition category
Condition code
Surgery 306995 306995 0 0
Surgical techniques
Respiratory 307067 307067 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic rhinosinusitis undergo sinus surgery to improve ventilation and drainage of paranasal sinuses (frontal, ethmoid, sphenoid, maxillary sinuses). Limited evidence exists to compare a conservative approach (i.e. operating on select sinuses) or a non-conservative approach (i.e. operating on all paranasal sinuses).

This study compares the two methods - full functional endoscopic sinus surgery (FESS) versus selective (mini) sinus surgery in patients with Chronic rhinosinusitis. Patients will be randomised to receive either full FESS or mini FESS. Outcomes including symptoms scores and revision rates will be studied and compared.

Patients will be recruited from one expert surgeons rooms/clinics who will consent and perform the operation.

Normal sinus surgery takes approximately 60 minutes to 2 hours. Patients will be fasted 6 hours before the operation as it routine. After their operation they are usually discharged from hospital the same day.

They will be followed up in the rooms of the primary surgeon for at least 1 year.
Intervention code [1] 301289 0
Treatment: Surgery
Comparator / control treatment
Full functional endoscopic sinus surgery
Control group
Active

Outcomes
Primary outcome [1] 305983 0
Number of patients needing revision sinus surgery based on clinical examination on follow up
Timepoint [1] 305983 0
1 year post operation
Secondary outcome [1] 347207 0
Symptom improvement based on a standardised symptoms scoring system (SNOT-22) utilised within the specialty. This is a patient questionnaire which has 22 questions patients fill out. This takes into account patient satisfaction. This is a composite outcome.
Timepoint [1] 347207 0
3 months post operation

Eligibility
Key inclusion criteria
Patients over 18 undergoing endoscopic sinus surgery for their condition.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who have had previous sinus surgery will be excluded
Those who are unable to consent

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on 20% improvement, sample size is calculated at approximately 50 patients. This is determined using statistical software (G-Power). Data is expected to be non-parametric.
For parametric data Student T test to compare means across two groups and ANOVA across three or more groups. For non parametric dataMann Whitney U test if non parametric or Kruskal-Wallis for comparisons across three or more groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
1/10/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10958 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 10959 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 10960 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 22744 0
2065 - St Leonards
Recruitment postcode(s) [2] 22745 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 22746 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 299552 0
Hospital
Name [1] 299552 0
Macquarie University Hospital
Country [1] 299552 0
Australia
Funding source category [2] 299627 0
Hospital
Name [2] 299627 0
North Shore Private Hospital
Country [2] 299627 0
Australia
Funding source category [3] 299628 0
Hospital
Name [3] 299628 0
Sydney Adventist Hospital
Country [3] 299628 0
Australia
Primary sponsor type
Individual
Name
Yuresh Naidoo
Address
Dr. Yuresh Naidoo ENT practice
25-29 Hunter Street, Hornsby NSW 2077
Country
Australia
Secondary sponsor category [1] 298911 0
None
Name [1] 298911 0
Address [1] 298911 0
Country [1] 298911 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300447 0
North Shore Private Ethics Committee
Ethics committee address [1] 300447 0
North Shore Private Hospital
Westbourne Street
St Leonards NSW 2065
Ethics committee country [1] 300447 0
Australia
Date submitted for ethics approval [1] 300447 0
23/05/2018
Approval date [1] 300447 0
Ethics approval number [1] 300447 0
Ethics committee name [2] 300448 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [2] 300448 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
3 Technology Pl, Macquarie University NSW 2109
Ethics committee country [2] 300448 0
Australia
Date submitted for ethics approval [2] 300448 0
13/06/2018
Approval date [2] 300448 0
Ethics approval number [2] 300448 0
Ethics committee name [3] 300449 0
Adventist Health Care Human Research Ethics Committee
Ethics committee address [3] 300449 0
Adventist Health Care Limited
Adventist Health Care Human Research Ethics Committee
185 Fox Valley Road
Wahroonga NSW 2076
Ethics committee country [3] 300449 0
Date submitted for ethics approval [3] 300449 0
30/05/2018
Approval date [3] 300449 0
Ethics approval number [3] 300449 0

Summary
Brief summary
Currently functional endoscopic sinus surgery is a treatment offered to patients with chronic sinus disease. This involved opening channels in the sinuses to allow better ventilation and drainage. This can be achieved by either opening channels between all sinuses or only a select few. There is limited evidence to suggest if once is superior to the other and current standard of practice varies between specialists. There is limited evidence to suggest that opening all channels is better than opening a select few. A randomised controlled trial offers the same standard of care to patients with sinus disease but compare outcomes in two techniques - opening all channels versus opening a select few. This study will compare outcomes between the two methods by measuring patient satisfaction, evaluation with imaging and specialised endoscopy and rates of revision surgery.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 83698 0
A/Prof Yuresh Naidoo
Address 83698 0
Yuresh Naidoo ENT Practice
25-29 Hunter Street,
Hornsby NSW 2077
Country 83698 0
Australia
Phone 83698 0
+612 9477 3717
Fax 83698 0
Email 83698 0
[email protected]
Contact person for public queries
Name 83699 0
Sejad Ahmadzada
Address 83699 0
Yuresh Naidoo ENT Practice
25-29 Hunter Street,
Hornsby NSW 2077
Country 83699 0
Australia
Phone 83699 0
+61401046548
Fax 83699 0
Email 83699 0
[email protected]
Contact person for scientific queries
Name 83700 0
Sejad Ahmadzada
Address 83700 0
Yuresh Naidoo ENT Practice
25-29 Hunter Street,
Hornsby NSW 2077
Country 83700 0
Australia
Phone 83700 0
+61401046548
Fax 83700 0
Email 83700 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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