The use of the oral antibiotic, roxithromycin, prior to endoscopic surgery of the paranasal sinuses, to improve the surgical field and outcomes

In patients with chronic rhinosinusitis, does the use of a five day course of preoperative roxithromycin, improve the surgical field and post-operative outcomes.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000485932

Enrollment

Registered

2011-05-10

Start date

2011-06-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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

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

Outcome results