RecruitingPhase 4NCT03014687

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

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Enrollment

116 participants

Start Date

Jul 1, 2017

Study Type

INTERVENTIONAL

Conditions

Pituitary Adenoma Antibiotics

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

Min Age: 18 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a short course of antibiotics by mouth after surgery through the nose (endoscopic transsphenoidal surgery) to remove a pituitary tumor helps prevent sinus and nasal problems afterward. **You may be eligible if...** - You are an adult (18 to 85 years old) scheduled to have endoscopic surgery to remove a pituitary tumor — specifically a non-functioning adenoma, a growth-hormone-producing tumor (acromegaly), or a prolactin-producing tumor (prolactinoma) - You speak English and can understand the questionnaires used in the study - You have no physical, mental, or medical conditions that would make participation unsafe **You may NOT be eligible if...** - You have a severe allergy or reaction to the antibiotics used in the study - You have liver disease such as cirrhosis or hepatitis - You are pregnant - You have taken antibiotics within the past 4 weeks - You have immune system problems or certain other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

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.

DRUGOral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

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.