None listed
Conditions
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.
Interventions
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.
Sponsors
Dr. Andrew James Wood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient undergoing Bilateral Comprehensive Endoscopic Sinus Surgery for the treatment of chronic rhinosinusitis as defined by the European Position Statement, 2012.
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
Outcome results
None listed