Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2013
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.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Salib R J, Talpallikar S, Uppal S, Nair S B
Аннотация
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.
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.