A Randomized, Double-Blind Study of Oral Antibiotics to Improve Nasal Outcomes After Endoscopic Transsphenoidal Surgery for Pituitary Lesions

What this Trial Is About

Researchers are evaluating whether taking oral antibiotics after endoscopic transsphenoidal surgery for pituitary adenoma can improve sinus and nasal symptoms, reduce infection rates such as sinusitis, and help the nasal passages heal. This surgery, which accesses the pituitary gland through the nasal passage, often disrupts nasal function and quality of life, causing issues like sinusitis, nasal obstruction, and crusting. While oral antibiotics are commonly prescribed postoperatively to improve healing, there is limited evidence supporting their benefit in this setting, and potential risks exist, including antibiotic resistance and allergic reactions. Participants will receive standard preoperative intravenous antibiotics during surgery. After surgery, they will be randomly assigned to one of two groups: one group will take a placebo pill twice daily for 7 days along with standard nasal care, and the other will take oral antibiotics (cefdinir or trimethoprim/sulfamethoxazole) twice daily for 7 days plus the same nasal care. Nasal care includes saline sprays and sinus irrigation rinses for up to 30 days post-surgery. Both groups receive a single postoperative intravenous antibiotic dose. During the 12 weeks following surgery, participants will be regularly assessed for changes in sinonasal quality of life using questionnaires (ASK Nasal-12 and SNOT-22), incidence of sinus infections, and nasal healing as observed through endoscopic exams. Researchers will monitor symptoms such as nasal congestion, discharge, pressure, pain, and headache to evaluate antibiotic effects and any resistance patterns. The study is double-blind and randomized to fairly compare outcomes between the antibiotic and placebo groups.

Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions