Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000505101
Ethics application status
Approved
Date submitted
11/03/2019
Date registered
28/03/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
28/03/2019
Date results information initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Antibiotics in sinus surgery
Scientific title
A pilot study of post-operative antibiotics in patients undergoing Endoscopic Sinus Surgery in the treatment of Chronic Rhinosinusitis and their effect on sino-nasal outcomes
Secondary ID [1] 297686 0
None
Universal Trial Number (UTN)
U1111-1229-8735
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 311968 0
Condition category
Condition code
Surgery 310542 310542 0 0
Other surgery
Respiratory 310651 310651 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Doxycycline 100mg tablets by mouth twice daily for 4 weeks, commencing on the morning after surgery. Patients will be asked to return any unused tablets to monitor adherence.
Intervention code [1] 313918 0
Treatment: Drugs
Comparator / control treatment
Microcellulose placebo tablet by mouth twice daily for 4 weeks starting on the morning after surgery
Control group
Placebo

Outcomes
Primary outcome [1] 319405 0
Proportional change in 22-item Sino Nasal Outcome Tool (SNOT-22) compared with pre-operative SNOT-22 score
Timepoint [1] 319405 0
3 months after surgery
Secondary outcome [1] 368033 0
Modified Lund Mckay Postoperative Endoscopy Score (MLMES) Reference: Snidvongs et al. Rhinology. 2013
Timepoint [1] 368033 0
3 months after surgery
Secondary outcome [2] 368034 0
Proportional change in 22-item Sino Nasal Outcome Tool (SNOT-22) compared with pre-operative SNOT-22 score
Timepoint [2] 368034 0
12 months after surgery
Secondary outcome [3] 368035 0
Change in sinus mucus microbial ecology assessing the resident microflora of sinus tissue and sinus mucus using PCR to amplify microbial DNA
Timepoint [3] 368035 0
2 weeks after surgery
Secondary outcome [4] 368036 0
Change in sinus mucus microbial ecology assessing the resident microflora of sinus tissue and sinus mucus using PCR to amplify microbial DNA
Timepoint [4] 368036 0
3 months after surgery
Secondary outcome [5] 368037 0
Patient reported adverse events including but not limited to rash, diarrhoea, vomiting, abdominal pain
Timepoint [5] 368037 0
Entire time course over which study drug and placebo are administered

Eligibility
Key inclusion criteria
Patient undergoing Bilateral Comprehensive Endoscopic Sinus Surgery for the treatment of chronic rhinosinusitis as defined by the European Position Statement, 2012.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior sinus surgery
Predisposing condition (e.g. Aspirin exacerbated respiratory disease, Granulomatosis with Polyangitis, Cystic fibrosis)
Antibiotic usage in the 12 weeks prior to recruitment

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is intended as a pilot study with a view to future power analysis and a larger, definitive study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
21/11/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
1/10/2020
Date of last data collection
Anticipated
31/12/2020
Actual
23/12/2020
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 21339 0
New Zealand
State/province [1] 21339 0
Waikato

Funding & Sponsors
Funding source category [1] 302212 0
Charities/Societies/Foundations
Name [1] 302212 0
Waikato Medical Research Foundation
Country [1] 302212 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Andrew James Wood
Address
Department of Surgery
Waikato Clinical School
Waikato Hospital
Pembroke Street
Hamilton 3204
Country
New Zealand
Secondary sponsor category [1] 302061 0
None
Name [1] 302061 0
Address [1] 302061 0
Country [1] 302061 0
Other collaborator category [1] 280600 0
Individual
Name [1] 280600 0
Dr. Charles Lee
Address [1] 280600 0
University of Waikato
Te Whare Wananga o Waikato
Gate 1, Knighton Road
Hamilton 3240

Private Bag 3105
Hamilton 3240
New Zealand
Country [1] 280600 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302891 0
HDEC
Ethics committee address [1] 302891 0
Email: hdecs@moh.govt.nz

Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 302891 0
New Zealand
Date submitted for ethics approval [1] 302891 0
29/03/2019
Approval date [1] 302891 0
01/10/2019
Ethics approval number [1] 302891 0
19/NTA/64/AM01

Summary
Brief summary
Chronic rhinosinusitis (CRS) produces an enormous health burden being common, morbid and expensive. It is characterised by chronic (i.e. more than 12 weeks of) sinus and nasal inflammation causing nasal obstruction and discharge as well as facial pain / pressure and smell disruption with consequent implications for both sleep and daytime productivity. A large European study reported a prevalence of CRS of 10.9%

The pathophysiology of CRS is a matter of significant debate and ongoing research. The Principle Investigator has previously completed a Doctoral Thesis on this topic titled “Characterising host microbe interactions in chronic rhinosinusitis”. Despite ongoing study, the role of bacteria in the disease process remains poorly understood. Observations such as that the presence of Staphylococcus aureus in the sinuses at the time of surgery is associated with worse outcomes have continued to promote hypotheses regarding pathophysiology that incorporate bacteria.

In patients with CRS, medical treatment with saline lavage and topical and systemic corticosteroids is typically recommended. In those individuals who do not respond well to these treatments, Endoscopic Sinus Surgery (ESS) is commonly offered. ESS is now one of the most commonly performed elective surgical procedures in the Western world.

The evidence to support the use of antibiotics both in the treatment of CRS and after ESS for CRS remains limited. A 2018 review of evidence-based peri-operative antibiotic use in Ear Nose and Throat Surgery documented a paucity of data in this area but concluded that "current evidence does not support the routine use of prophylactic antibiotics for endoscopic sinus surgery." The overwhelming majority of Ear Nose and Throat Surgeons when surveyed however reported that they routinely prescribe antibiotics after ESS.

Antibiotic resistance has been described by the World Health Organisation (WHO) as “one of the biggest threats to global health” and is accelerated by misuse of antibiotics. Data to rationalise or discourage the use of antibiotics are therefore urgently required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91754 0
Dr Andrew James Wood
Address 91754 0
Department of Surgery
Waikato Clinical School
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 91754 0
New Zealand
Phone 91754 0
+64 7 8398750
Fax 91754 0
Email 91754 0
andrew.wood@auckland.ac.nz
Contact person for public queries
Name 91755 0
Dr Andrew James Wood
Address 91755 0
Department of Surgery
Waikato Clinical School
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 91755 0
New Zealand
Phone 91755 0
+64 7 8398750
Fax 91755 0
Email 91755 0
andrew.wood@auckland.ac.nz
Contact person for scientific queries
Name 91756 0
Dr Andrew James Wood
Address 91756 0
Department of Surgery
Waikato Clinical School
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 91756 0
New Zealand
Phone 91756 0
+64 7 8398750
Fax 91756 0
Email 91756 0
andrew.wood@auckland.ac.nz

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 demographics, pre-operative clinical parameters, outcome measures and adverse events
When will data be available (start and end dates)?
After completion of the study the intention is to publish the data in the International Scientific literature and present our findings at International Scientific meetings
Available to whom?
Anyone that accesses the published manuscript
Available for what types of analyses?
Any
How or where can data be obtained?
Publication in Scientific literature


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.