Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
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
St. Joseph's Hospital and Medical Center, Phoenix
116 participants
Jul 1, 2017
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria17
- 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
Interventions
PO 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 \[Omnicef®\] 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03014687