Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients

The group of patients from which the study tem will recruit consists of patients referred to
the University of Florida tertiary referral rhinology practice of Dr. Jeb Justice and Dr.
William Collins. Patients with CRS defined by symptom, endoscopic, and radiographic criteria
who are candidates for surgical intervention will be identified by the above-mentioned
investigators. As part of their initial pre operative work up they will be asked to fill out
SNOT-22 and RSDI surveys. As part of their surgery intraoperative cultures will be obtained
from the surgically opened sinus cavities. The above radiologic, endoscopic procedures,
cultures and QOL/symptoms surveys are typical in the workup of patients who present with
rhinologic related problems. None of the above tests will be undertaken for the sole purpose
of this study.

If the patient meets criteria, he/she will be approached by one of the investigators about
participating in the research study. Information regarding the study, including the informed
consent form, will be extensively discussed. If the patient agrees to take part in this
study, the consent form will be provided for review and will then be signed. This consent
form will be kept in a secure locked location with access given only to study staff
identified in the Institutional Review Board (IRB) protocol. It will be explained to the
patients that there is no obligation for them to participate in the study and that they can
drop out of the study at any time without repercussions regarding their care.

If a patient elects to be a part of the study they will be randomized into one of three
treatment arms. This process will be done by placing an equal number of note cards in
envelopes. The note cards will contain either a "1", "2", or "3" to represent the different
treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the
otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn
and it is documented which treatment arm the patient will be treated under.

All patients will begin with normal saline irrigations immediately following surgery as per
our department's standard of care. At their first one week post op appointment they will then
begin treatment per the treatment arm. The first treatment arm will consist of patients that
are given only saline nasal irrigations to be performed twice daily. The second arm will be
given a prescription for nasal saline + budesonide to be performed twice daily. The final arm
will be given a prescription for nasal saline + budesonide + a culture directed topical
antibiotic. These treatments are commonly used in our practice and will be obtained through
the compounding pharmacies that are already in use by our practice.

Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up
appointments. At each of these appointments they will undergo nasal endoscopy and debridement
as is standard following endoscopic sinus surgery. They will also be asked to fill out
SNOT-22 and RSDI surveys to monitor their progression.

The RSDI contains 30 questions designed to measure the patient's disease-specific status in
the physical, emotional, and functional domains. The questions present the patient with
symptoms and ask if there experience the symptoms never, almost never, sometimes, almost
always, and always. These are scored as 0-4, with never getting a score of 0 and always
getting a score of 4 for a total score range of 0-120.

The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5
where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it
possibly can be. The Snot-22 has a cumulative score of 0-110.

Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This
system grades the endoscopic findings within the paranasal sinuses for the presence of:
polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored
separately and then combined for the total score. Polyps are scored as absent (0), present in
middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0),
thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately
as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal
cavity a total score from 0-20 is found.

Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy
findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.

Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard
practice. During treatment patients will be treated as per standard which could include the
use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition
warrants.

Inclusion Criteria:

- Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and
radiographic criteria who are undergoing endoscopic sinus surgery

Exclusion Criteria:

- Age <18

- endoscopic sinus surgery for reason other than CRS