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

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.

Conditions

Antibiotics, Pituitary Adenoma

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Study Overview

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Study Details

Study 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.

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

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

Condition
Antibiotics
Intervention / Treatment

-

Contacts and Locations

Phoenix

Barrow Brain and Spine, Phoenix, Arizona, United States, 85013

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2019-07