RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-07-01
Study Completion:2019-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03014687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 84 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma
  2. * Adults \>18 and \<85 years of age
  3. * English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
  4. * Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable
  1. * Anaphylaxis/intolerance to the study drugs
  2. * Cirrhosis, hepatitis
  3. * Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators
  4. * Renal failure on dialysis
  5. * Any subject who is unwilling or unable to sign informed consent for the study
  6. * Pregnancy
  7. * Incarcerated patients
  8. * Cushing's disease
  9. * Rathke's Cleft cyst or pituitary cyst
  10. * History of chronic sinusitis
  11. * Anticipated use of nasal splints
  12. * Anticipated use of nasal septal flap
  13. * Active sinusitis
  14. * Nasal polyps
  15. * Previous sinus surgery
  16. * Concurrent antibiotics for another indication (i.e., urinary tract infection)
  17. * Immunodeficiency

Contacts and Locations

Study Contact

Heidi Jahnke, RN, MSN
CONTACT
602-406-6976
heidi.jahnke@dignityhealth.org

Principal Investigator

Andrew Little, MD
STUDY_CHAIR
Barrow Brain and Spine
James Evans, MD
STUDY_CHAIR
Thomas Jefferson University

Study Locations (Sites)

Barrow Brain and Spine
Phoenix, Arizona, 85013
United States

Collaborators and Investigators

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

  • Andrew Little, MD, STUDY_CHAIR, Barrow Brain and Spine
  • James Evans, MD, STUDY_CHAIR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-01
Study Completion Date2019-07

Study Record Updates

Study Start Date2017-07-01
Study Completion Date2019-07

Terms related to this study

Keywords Provided by Researchers

  • transsphenoidal surgery

Additional Relevant MeSH Terms

  • Antibiotics
  • Pituitary Adenoma