Prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis: a randomized, double‐blind, placebo‐controlled noninferiority clinical trial

Abstract

Background Surgeons commonly prescribe prophylactic antibiotics after endoscopic sinus surgery (ESS), yet minimal data exist to support this practice. In this study we aimed to assess the impact of post‐ESS antibiotics on infection, quality of life (QOL), and endoscopic scores. Methods This was a randomized, double‐blind, placebo‐controlled, noninferiority trial comparing amoxicillin‐clavulanate vs placebo after ESS (NCT01919411, ClinicalTrials.gov). Adults (N = 77) with chronic rhinosinusitis (CRS) refractory to appropriate medical therapy who underwent ESS were randomized to antibiotics (N = 37) or placebo (N = 40) and followed clinically (mean ± standard deviation: 1.3 ± 0.3 and 8.8 ± 3.9 weeks postoperatively). At baseline and follow‐up, QOL was measured with 22‐item Sino‐Nasal Outcome Test questionnaires and Lund‐Kennedy endoscopic scores were evaluated. Outcomes were analyzed with repeated‐measures analysis of variance and analysis of covariance and z tests for proportions. Results Placebo was noninferior to antibiotic prophylaxis with regard to postoperative SNOT‐22 scores (β = 0.18, 2‐tailed p < 0.05). There were no significant differences between the antibiotic and placebo groups in LK score trajectories over time (p = 0.63) or in postoperative infection rates (2.6% vs 2.4%, respectively; p = 0.96). The rate of diarrhea was significantly higher in the antibiotic group (24.3% vs 2.5%; relative risk = 10.8; p = 0.02). Conclusion Although statistically underpowered, the results suggest placebo was noninferior to prophylactic antibiotics after ESS for CRS regarding postoperative sinonasal‐specific QOL. There were no significant differences in postoperative endoscopic scores or rates of infection, but the rate of diarrhea was significantly higher in the antibiotic group. These findings add to the growing evidence that routine use of prophylactic postoperative antibiotics does not improve outcomes post‐ESS and significantly increases the rate of diarrhea.

Postoperative antibiotic use in patients with unilateral purulent chronic rhinosinusitis

“…Antibiotics are commonly prescribed in the postoperative period following ESS to prevent bacterial infection and to optimize wound healing. However, there is increasing evidence that antibiotics may not improve patient outcomes 4,6,7 . We chose to evaluate patients undergoing unilateral ESS with active infection at the time of surgery as even less is known about appropriate postoperative antibiotic use in these patients compared to the broader ESS population.…”

“…However, an optimal postoperative regimen remains unknown and is currently a topic of controversy. Antibiotics are commonly prescribed in the postoperative period to minimize infection and improve healing, but recently their efficacy has been challenged in several studies 4‐7 . In 2020, Lehmann et al published a randomized, double‐blind, placebo‐controlled noninferiority clinical trial evaluating postoperative prophylactic antibiotics in patients undergoing ESS for CRS.…”

Postoperative antibiotics: preparing for the leap of faith

“…The findings from this double‐blind, randomized, controlled trial indicate that placebo is no worse than a postoperative antibiotic (amoxicillin‐clavulanate) with respect to patient‐reported scores on the 22‐item Sino‐Nasal Outcome Test, nasal endoscopy findings, and postoperative infection rates 1 . It is curious to note, as the authors highlight in their Discussion, that several major national and international medical bodies have already declared prophylactic antibiotics to be unnecessary after ESS.…”

“…In their study, Lehmann et al directly confront the longstanding practice of prophylactic antibiotic use after endoscopic sinus surgery (ESS) 1 . This is a topic of perennial importance as the drive toward thoughtful antibiotic stewardship continues across the medical field.…”

Challenging our assumptions: oral corticosteroids and chronic rhinosinusitis without nasal polyposis

“…Although it is easy to become dispassionate toward this repetitive call for better clinical studies, it is invigorating to see studies being performed that heed the call. For example, a recent double-blind randomized clinical trial from Lehmann et al 12 showed that prophylactic administration of oral amoxicillin/clavulanate after ESS was not more effective than placebo in preventing postoperative infections, and was in fact associated with a higher incidence of adverse effects. Studies that are designed to critically assess long-held tenets of treatment are not undertaken lightly.…”