Oral Antibiotics for Sinus Health After Pituitary Surgery
This study is looking at whether taking oral antibiotics after surgery for a pituitary adenoma (a non-cancerous growth on the pituitary gland) helps improve sinus and nasal symptoms. You would either receive oral antibiotics (cefdinir or trimethoprim/sulfamethoxazole) for 7 days, or a placebo (an inactive substance). All participants will also use saline nasal spray and sinus rinses after surgery. Researchers want to see if antibiotics reduce infections like sinusitis and help the nasal passages heal. This study is for adults aged 18 to 84 who are having endoscopic surgery for a pituitary tumor. Success will be measured by changes in your quality of life related to your nose and sinuses, using specific questionnaires. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 116 participants. Participants will be randomly assigned to receive either oral antibiotics or a placebo.
- What's involved
- Participants will take oral medication for 7 days and use saline spray for 7 days, followed by sinus rinses for 23 days. You will complete questionnaires at multiple time points up to 12 weeks post-surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks after surgery to assess changes in their quality of life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
At a glance
Conditions
NCT03014687
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Barrow Brain and Spine
Phoenix, Arizonastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andrew Little, MD · STUDY_CHAIR · Barrow Brain and Spine
- James Evans, MD · STUDY_CHAIR · Thomas Jefferson University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
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)1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
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.