Actively Recruiting

Phase 4
Age: 18Years - 84Years
All Genders
NCT03014687

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

Led by St. Joseph's Hospital and Medical Center, Phoenix · Updated on 2018-08-15

116

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

S

St. Joseph's Hospital and Medical Center, Phoenix

Lead Sponsor

T

Thomas Jefferson University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 84Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma
  • Adults over 18 and under 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
Not Eligible

You will not qualify if you...

  • Anaphylaxis or intolerance to the study drugs
  • Cirrhosis or hepatitis
  • Any solid organ or bone marrow transplant or immunocompromised status
  • Renal failure requiring dialysis
  • Unwilling or unable to sign informed consent
  • Pregnancy
  • Incarcerated patients
  • Diagnosis of Cushing's disease
  • Presence of Rathke's Cleft cyst or pituitary cyst
  • History of chronic sinusitis
  • Anticipated use of nasal splints or nasal septal flap
  • Active sinusitis
  • Nasal polyps
  • Previous sinus surgery
  • Use of antibiotics for another infection
  • Immunodeficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Barrow Brain and Spine

Phoenix, Arizona, United States, 85013

Actively Recruiting

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Research Team

H

Heidi Jahnke, RN, MSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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