To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.
Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma
Adults >18 and <85 years of age
English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable
Anaphylaxis/intolerance to the study drugs
Cirrhosis, hepatitis
Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators
Renal failure on dialysis
Parallel
Placebo
DrugPO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
DrugOral antibiotics (cefdinir \[Omnicef®\] 300 mg PO BID or trimethoprim/sulfamethoxazole \[Bactrim DS™\] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)
Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.
Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)
Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.
Incidence of Acute Bacterial Sinusitis
Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.
Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)
Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.
Sinusitis and antibiotic resistance as evidenced by nasal congestion
Cultures and sensitivities when nasal congestion noted by patient report or physical exam.
Sinusitis and antibiotic resistance as evidenced by purulent discharge
Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.
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St. Joseph's Hospital and Medical Center, Phoenix
Lead sponsor
Thomas Jefferson University
Collaborator
The Cleveland Clinic
Collaborator
