ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1120-4762

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic rhinosinusitis

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Inflammatory and Immune System

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]

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]

surgical field as graded by the Boezaart scale

Timepoint [1]

Perioperative

Secondary outcome [1]

SNOT 22 scores

Timepoint [1]

2 week pre-operative, immediately prior to surgery, 2 week and 3 month post surgery

Secondary outcome [2]

post-operative synechiae assessed subjectively by the examining ENT surgeon

Timepoint [2]

2 weeks post-operative

Secondary outcome [3]

nasal microbiological swab results

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Small Grants Research Fund, Royal Victorian Eye and Ear Hospital

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Victorian Eye and Ear Hospital

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Stephen O'Leary

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Royal Victorian Eye and Ear Hospital

Ethics committee address [1]

32 Gisborne Street
East Melbourne
Melbourne
Victoria
3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2011

Approval date [1]

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Contact person for public queries

Name

Philip Michael

Address

Royal Victorian Eye and Ear Hospital 32 Gisborne Street East Melbourne Melbourne Victoria 3002

Country

Australia

Phone

+61 3 9929 8666

philip.michael@eyeandear.org.au

Contact person for scientific queries

Name

Philip Michael

Address

Royal Victorian Eye and Ear Hospital 32 Gisborne Street East Melbourne Melbourne Victoria 3002

Country

Australia

Phone

+61 3 9929 8666

philip.michael@eyeandear.org.au

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.

Trial Review

Documents added manually

Documents added automatically