Not Yet RecruitingPhase 4ACTRN12611000485932

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.


Sponsor

Royal Victorian Eye and Ear Hospital

Enrollment

58 participants

Start Date

Jun 5, 2011

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether taking the antibiotic roxithromycin before endoscopic sinus surgery improves the surgical field and patient outcomes. Chronic sinusitis with or without nasal polyps often involves inflammation that can make surgery more difficult. Participants must be 18-80, scheduled for sinus surgery, and must not have taken antibiotics in the past 4 weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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


Locations(1)

Australia

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ACTRN12611000485932


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