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Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Recruiting
18-84 years
All
Phase 4

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Overview

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.

Description

Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas. Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and pituitary gland, the technique causes disruption of sinonasal function and temporarily impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of postoperative morbidity following transsphenoidal surgery. Common sinonasal complications include sinusitis, synechiae formation, nasal obstruction and crusting. The development of postoperative sinusitis is specifically associated with decreased sinonasal function after surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard prophylactic perioperative intravenous antibiotics) with the intention of improving nasal functional outcomes. To date, no studies have examined whether the administration of oral antibiotics following transsphenoidal surgery improves sinonasal healing. This question has been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A meta-analysis of clinical trial data obtained in FESS indicated that current literature does not support the use of oral antibiotics to reduce infection, improve symptoms scores, or improve endoscopic findings. Furthermore, there is the potential for antibiotic-related adverse events including the emergence of bacterial resistance, Clostridium difficile infection, and allergic reactions to the medication. Despite the lack of supporting evidence in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.

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

Study details
    Antibiotics
    Pituitary Adenoma

NCT03014687

St. Joseph's Hospital and Medical Center, Phoenix

14 October 2025

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