Postoperative Oral Antibiotics and Sinonasal Outcomes following Endoscopic Transsphenoidal Surgery for Pituitary Tumors (POET) Study: A Multicenter, Prospective, Randomized, Double-Blinded, Placebo-Controlled Study

Introduction: Postoperative prophylactic antibiotics are used commonly in pituitary surgery, but evidence supporting their use is lacking. We conducted a multicenter, double-blinded, randomized, placebo-controlled trial to evaluate whether receipt of postoperative oral antibiotics resulted in superior sinonasal quality of life (QOL) compared with placebo among patients who underwent endoscopic endonasal transsphenoidal pituitary surgery.

Methods: Patients were randomized to receive either oral placebo or cefdinir (trimethoprim-sulfamethoxazole in patients intolerant to cefdinir) for 7 days after surgery and followed-up for 12 weeks. The primary outcome measure was sinonasal QOL at 2 weeks on the Anterior Skull Base Nasal Inventory-12. Supplementary end points included sinonasal QOL reported on the Sinonasal Outcome Test-22 and objective endoscopy scores to assess nasal healing according to the Lund-Kennedy method.

Results: Four hundred and sixty-one patients were screened, 131 were randomized, and 113 (placebo arm: 55; antibiotic arm: 58) were analyzed. There was no clinically meaningful or statistically significant difference in sinonasal QOL at any measured time point (p > 0.24) using either QOL instrument. There was no significant difference in nasal cavity endoscopy scores at 1 to 2 weeks after surgery (p = 0.25) or at 3 to 4 weeks after surgery (p = 0.08).

Conclusions: Postoperative prophylactic oral antibiotics did not result in superior sinonasal QOL when compared with placebo among patients who underwent standard endoscopic transsphenoidal surgery. This result has implications for antibiotic stewardship.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
12 February 2021