A prospective randomised single‐blinded clinical trial comparing the efficacy and tolerability of the nasal douching products Sterimar™ and Sinus Rinse™ following functional endoscopic sinus surgery

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Abstract
Objectives: To compare the efficacy and tolerability of two commonly used nasal douching products, low‐volume high‐pressure Sterimar™ and high‐volume low‐pressure Sinus Rinse™ following functional endoscopic sinus surgery.Design: Prospective randomised single‐blinded study.Setting: Tertiary referral centre.Participants: Thirty‐one patients, undergoing functional endoscopic sinus surgery for chronic rhinosinusitis with and without polyps, were recruited for the study. The patients acted as their own comparators self‐administering each douche three times daily into one randomly allocated nostril for a period of 12 weeks following the surgery.Main outcome measures: The primary outcome measure was a blinded objective endoscopic assessment of each operated side using a modified Lund‐Kennedy endoscopic assessment tool undertaken at 2, 4 and 12 weeks postoperatively. As secondary outcome measures, the patients were asked to express a preference between the two products based on perceived effectiveness and ease of use.Results: Compared with the preoperative scores, there was a statistically significant improvement in the SNOT‐22 score at all three postoperative time points (P < 0.001). Compared with week 2, there was a statistically significant reduction in the modified Lund‐Kennedy endoscopic scores (P < 0.05) for both Sterimar™ and Sinus Rinse™ at weeks 4 and 12. When comparing Sterimar™ with SinuRinse™, there was a statistically significant lower modified Lund‐Kennedy score at 2 and 4 weeks postoperatively for the side treated with Sinus Rinse™ (P ≤ 0.05), indicating a more favourable outcome. However, this difference was not apparent at 12 weeks postoperatively (P = 0.66). At all time points, patients perceived Sinus Rinse™ to be more effective than Sterimar™ (P < 0.0001), but there was no significant difference in the patients' preference for either product (P > 0.05).Conclusion: High‐volume low‐pressure saline irrigation is recommended as an efficacious, easy to use and well‐tolerated adjunct to endoscopic sinonasal toilet in the early postoperative period following functional endoscopic sinus surgery.

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