A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Trial ID: NCT03014687

Interventional - Phase 4 - Recruiting

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.

Conditions

• Antibiotics
• Pituitary Adenoma

Interventions

• Placebo
• Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• 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
• Any subject who is unwilling or unable to sign informed consent for the study
• Pregnancy
• Incarcerated patients
• Cushing's disease
• Rathke's Cleft cyst or pituitary cyst
• History of chronic sinusitis
• Anticipated use of nasal splints
• Anticipated use of nasal septal flap
• Active sinusitis
• Nasal polyps
• Previous sinus surgery
• Concurrent antibiotics for another indication (i.e., urinary tract infection)
• Immunodeficiency

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix, Thomas Jefferson University, The Cleveland Clinic

Source: ClinicalTrials.gov

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