BACKGROUND: There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. METHODS: Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. RESULTS: Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p < 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment effect 25.9 (95% CI, 20.3-31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7-12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3-4.3) pre- and postoperatively, respectively (all p < 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores. CONCLUSION: In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle andsaline spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.
RCT Entities:
BACKGROUND: There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. METHODS:Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. RESULTS: Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p < 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment effect 25.9 (95% CI, 20.3-31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7-12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3-4.3) pre- and postoperatively, respectively (all p < 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores. CONCLUSION: In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle and saline spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.