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Trial registered on ANZCTR


Registration number
ACTRN12611000485932
Ethics application status
Not yet submitted
Date submitted
11/04/2011
Date registered
10/05/2011
Date last updated
10/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of the oral antibiotic, roxithromycin, prior to endoscopic surgery of the paranasal sinuses, to improve the surgical field and outcomes
Scientific title
In patients with chronic rhinosinusitis, does the use of a five day course of preoperative roxithromycin, improve the surgical field and post-operative outcomes.
Secondary ID [1] 259898 0
Nil
Universal Trial Number (UTN)
U1111-1120-4762
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 265499 0
Condition category
Condition code
Other 265651 265651 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Inflammatory and Immune System 265797 265797 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a five day course of 300 mg once daily roxithromycin orally commenced six days prior to surgery for patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery
Intervention code [1] 264392 0
Treatment: Drugs
Comparator / control treatment
a five day course of oral microcellulose placebo once daily commenced six days prior to surgery for patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery
Control group
Placebo

Outcomes
Primary outcome [1] 266508 0
surgical field as graded by the Boezaart scale
Timepoint [1] 266508 0
Perioperative
Secondary outcome [1] 273926 0
SNOT 22 scores
Timepoint [1] 273926 0
2 week pre-operative, immediately prior to surgery, 2 week and 3 month post surgery
Secondary outcome [2] 273927 0
post-operative synechiae assessed subjectively by the examining ENT surgeon
Timepoint [2] 273927 0
2 weeks post-operative
Secondary outcome [3] 273928 0
nasal microbiological swab results
Timepoint [3] 273928 0
2 week pre-operative, during surgery, 2 week post-operative

Eligibility
Key inclusion criteria
1. age above 18
2. able to give written informed consent
3. listed to undergo functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with or without nasal polyposis
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. those who have a history of hypersensitivity to roxithromycin (rulide)
2. those who are having endoscopic procedures for excision of malginant pathology
3. diabetics who are therefore unable to take a course of preoperative prednisilone
4. those whose comordities mitigate against taking peri-operative topical cocaine for decongestion
5. those who have hypersensitivity to co-phenylcaine forte
6. patients who have taken antibiotic therapy in the preceding 4 weeks

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 will be invited to participate when they are seen for listing of their endoscopic sinus surgery. Enrolling will involve written and verbal consent being obtained.
Randomisation will be conducted by the pharmacy department of the Royal Victorian Eye and Ear Hospital and investigators and participants will be blinded to this allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using proprietary computerised randomisation software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264855 0
Hospital
Name [1] 264855 0
Small Grants Research Fund, Royal Victorian Eye and Ear Hospital
Country [1] 264855 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002
Country
Australia
Secondary sponsor category [1] 263954 0
Individual
Name [1] 263954 0
Professor Stephen O'Leary
Address [1] 263954 0
32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002
Country [1] 263954 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266818 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 266818 0
32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002
Ethics committee country [1] 266818 0
Australia
Date submitted for ethics approval [1] 266818 0
27/04/2011
Approval date [1] 266818 0
Ethics approval number [1] 266818 0

Summary
Brief summary
Problem: Chronic rhinosinusitis remains a condition with an associated signficant burden through morbidity and social factors. Its primary management is medical. However, in cases that are recalcitrant to medical therapy, operative intervention has been proven to be beneficial. Surgery is conducted using specialised tools including high definition video equipment and surgical intruments specifically designed for use within the nose and paranasal sinuses. The specialised nature of these tools aids in the the performance of surgical procedures but the ease of operating is also affected by other peri-operative factors including optimising the condition of the lining of the nose (mucosa) and therefore minimising variables such as bleeding that can increase both operative time and complications. The use of pre-operative steroids given orally to the patient prior to an endoscopic sinus surgical procedure has been shown to be favourable. However, while the provision of post-operative antibiotics has been suggested to have beneficial effects, no such evidence has been presented for the use of pre-operative antibitiocs. In particular, there is one group of antibiotics called macrolides that has been found to have anti-inflammatory effects in concert with their usual anti-bacterial actions. These are widely prescribed as a short course prior to endoscopic sinus surgery procedures within our institution but as yet have no formal evidential basis to support their efficacy.


Hypothesis and aims: Consequently, this study will aim to assess whether the use of a short course of the macrolide antibiotic, roxithromycin, is helpful is improving operative conditions as assessed through the degree of bleeding during the procedure. As secondary aims, the study will also evaluate:

1. any change in the flora of the nasal mucosa before and after the prescription of antibiotics
2. changes in patient symptoms as measured by the sinonasal outcome questionnaire (SNOT22)
3. differences in post-surgical outcomes including evidence of scarring
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32424 0
Address 32424 0
Country 32424 0
Phone 32424 0
Fax 32424 0
Email 32424 0
Contact person for public queries
Name 15671 0
Philip Michael
Address 15671 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002
Country 15671 0
Australia
Phone 15671 0
+61 3 9929 8666
Fax 15671 0
Email 15671 0
[email protected]
Contact person for scientific queries
Name 6599 0
Philip Michael
Address 6599 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002
Country 6599 0
Australia
Phone 6599 0
+61 3 9929 8666
Fax 6599 0
Email 6599 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.