2026 Proffered Presentations
S044: A MULTICENTER SINGLE-BLINDED CONTROLLED TRIAL COMPARING NASAL OUTCOMES USING SALINE IRRIGATION AFTER ENDONASAL PITUITARY SURGERY-THE NOSE TRIAL
Anthony M Asher, MD1; Troy D Woodard, MD2; Varun R Kshettry, MD2; James J Evans, MD3; Andrew S Little1; Raj Sindwani2; Griffin D Santarelli1; 1Barrow Neurological Institute; 2Cleveland Clinic Foundation; 3Thomas Jefferson University Hospital
Background: Although nasal saline irrigation is widely used with the intention of alleviating sinonasal symptoms after endoscopic pituitary surgery, no randomized trial has evaluated its efficacy.
Objective: To determine whether daily postoperative nasal irrigation improves patient-reported sinonasal quality of life.
Methods: In this multicenter, single-blind randomized controlled trial, adults undergoing endoscopic pituitary surgery were randomized 1:1 to nasal irrigation or to no irrigation. Exclusion criteria included chronic sinusitis, Cushing’s disease, craniopharyngioma, or planned naso-septal flap. Patients completed SNOT-22 and ASK-12 questionnaires preoperatively and at weeks 1, 2, 4, 8, and 12 postop. Lund–Kennedy nasal cavity scores (LKS) were recorded preoperatively and at weeks 1, 4, and 12 postop. The primary endpoint was the difference in SNOT-22 scores between groups at 4 weeks postop. Target enrollment was 140 total patients, but the study was terminated early due to funding constraints.
Results: Of 56 screened patients, 52 were randomized (n=27 irrigation; n=25 control) and 44 were included in the final analysis (25 vs 19) (Figure 1). Pre-operative patient characteristics were comparable (Table 1). At the primary endpoint, the difference in mean SNOT-22 total scores between groups did not reach statistical significance or minimum clinically important difference (MCID) of 7.5 (-7.3, p=0.068). No significant or supra MCID between-group differences were observed in SNOT-22 or LKS raw or change scores at any timepoint (Tables 2-4). ASK-12 raw and change score mean differences did meet MCID (>0.37) at several timepoints, however the results were not statistically significant.
Conclusions: Although this study did not find a statistically significant difference in sinonasal QOL and nasal cavity scores between patients who used saline irrigation and those who did not, the observed data allow for more refined power calculations for a larger trial. With alpha = 0.05 and power = 0.80, a future trial would require approximately 114 total patients to detect a significant difference in the primary QOL outcome.
Figure 1: CONSORT Flow Diagram
Figure 2: Absolute SNOT-22 Score by Week
