Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Antibiotics, Pituitary Adenoma
In brief
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.
Key facts
- Study ID
- NCT03014687
- Run by
- St. Joseph's Hospital and Medical Center, Phoenix
- People needed
- 116
- Starts
- 2017-07-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2018-08-15
Who can join
Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Barrow Brain and Spine — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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