Dr Andrew Wood
Chronic rhinosinusitis (CRS) produces an enormous health burden being common, morbid and expensive. Endoscopic Sinus Surgery (ESS) is one of the most commonly performed surgical procedures in the Western world with demonstrated efficacy in the management of CRS. One of the aims of the surgery is to generate widely patent sinus drainage pathways, free from an obstructing scar. However, bleeding after ESS is common and unpleasant for patients and can necessitate re-presentation to hospital, incurring disruption for patients and cost to the Health Sector. The notion of a nasal dressing to assist with healing and prevention of bleeding has been attractive for some time. In reality however many materials have been trialed unsatisfactorily as these can potentially worsen scar formation and post-operative outcomes as well as having additional risks.
In this pilot study, we propose the use of topical Tranexamic acid (TXA) in the immediate post-operative period. TXA is a readily available, cheap and safe medication. It has been shown to be effective in various surgical fields in reducing bleeding when administered in intravenous, oral or topical form. In ESS, it has been shown to reduce blood loss and improve surgical visualization. However, there has only been one randomised study in the literature looking at the use of topical TXA during ESS and this study included no post-operative outcomes.
In our study, patients will be randomised to receive either topical TXA or topical normal saline (placebo). The primary outcome measure will be comparing the relative reduction in the SNOT-22 score (calculated from the pre-operative and 3-month scores) in the TXA and placebo groups. Secondary outcome measures will include any re-presentations to the GP or Hospital owing to post-operative bleeding, SNOT-22 score at 2 weeks follow up and the Modified Lund Mackay Endoscopic Score (MLMES), an objective measure of the endoscopic appearance of the sinuses at 2 weeks and 3 months follow-up.
We hypothesise that post-operative use of topical TXA after ESS for the treatment of CRS results in improved long-term outcomes with regards patient-reported symptoms.
The primary utility of this pilot study is to facilitate a subsequent, larger study, with appropriate power calculations, to assess the use of topical TXA immediately after ESS.
Ultimately this has the capacity to improve the peri-operative care of one of the most commonly performed elective surgical procedures in the Western world.