Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery

Sinusitis is a common medical problem, which significantly decreases patients' quality of
life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion
and drainage, decreased sense of smell, and malaise. In the United States annually, 30
million cases of sinusitis are diagnosed with an occurrence of 1 in 8 adults. The direct
medical costs are estimated at $2.4 billion per year with indirect costs reaching upwards of
$5 billion. Rhinosinusitis is described as the symptomatic inflammation of the paranasal
sinuses and nasal cavity. The term rhinosinusitis is preferred because most sinusitis is
accompanied by inflammation of the contiguous nasal mucosa. Uncomplicated rhinosinusitis is
defined as rhinosinusitis without clinically evident extension of inflammation outside the
paranasal sinuses and nasal cavity at the time of diagnosis (e.g. no neurologic,
ophthalmologic, or soft tissue involvement). Rhinosinusitis may be classified by duration as
acute rhinosinusitis (ARS) (<4 weeks' duration) or as chronic rhinosinusitis (CRS) (>12
weeks), with or without acute exacerbations. This condition can resolve spontaneously, but
often requires antibiotics and/or steroids, which is successful in a majority of patients.
Sinus surgery is therefore indicated in patients whose symptoms persist despite conservative
medical management. A guideline providing evidence-based recommendations for the diagnosis
and management of adult sinusitis was developed and revised by a panel of physicians, nurses,
and healthcare professionals under the support of the American Academy of Otolaryngology -
Head and Neck Surgery.

Surgical therapy for sinusitis attempts to restore the sinus health by directly relieving
sinus obstruction. Small telescopes, called endoscopes, are placed through the nostrils into
the nasal cavity to enhance visualization, illumination, and magnification of the sinuses and
adjacent structures. This "endoscopic sinus surgery" or (ESS) techniques have been developed
to treat four types of sinuses (maxillary, frontal, sphenoid, and ethmoid). The variability
of involvement of the sinuses vary from patient to patient. There are a variety of surgical
instruments available to a surgeon for ESS such as stainless steel tools (shavers,
microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been shown to
improve QOL, decrease medication use and days missed at work for subjects.

The use of lasers has shown to be beneficial in several otolaryngological procedures. The
LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical
use in various head and neck surgical procedures including functional endoscopic sinus
surgery. With the use of the LF-40 Gold Laser, this study is being performed with the
intentions of comparing post-operative outcomes with sinus surgeries performed using a
microdebrider.

The purpose of this study will be to determine if post operative outcomes while utilizing the
gold laser for performing excision of the concha bullosa, maxillary antrostomy, and
submucosal cauterization of the turbinates are significantly improved as compared to use of
microdebrider for sinus surgeries. The investigators aim to determine the treatment outcomes
2 weeks, 2 months, and 6 months postoperatively as compared to use of a microdebrider.

Inclusion Criteria:

- Study will include subjects age 18 or older with chronic rhinosinusitis as described
by the guidelines published in the 2015 Clinical practice guideline (update): adult
sinusitis of the American Academy of Otolaryngology - Head & Neck Surgery (AAO-HNS).

1. Males and females aged 18 or greater

2. Chronic rhinosinusitis as described by the guidelines published in the 2015
Clinical practice guideline (update): adult sinusitis of the American Academy of
Otolaryngology - Head & Neck Surgery (AAO-HNS)

a. >12 weeks of two or more of the following signs i. mucopurulent drainage
(anterior, posterior, or both) ii. nasal obstruction or congestion iii. facial
pain/pressure or fullness, or iv. decreased ability to smell b. AND inflammation
is documented by one or more of the following findings i. Purulent mucus or edema
in the middle meatus or ethmoid region ii. Radiographic imaging showing
inflammation of the paranasal sinuses

3. At least one episode of CRS documented in study investigator's practice with an
endoscopic examination with purulent drainage and edema at the time consistent
with CRS

4. Radiographic evidence of sinus inflammation during chronic bacterial
rhinosinusitis indicating sinus disease at the ostiomeatal complex.

5. Willing and able to read and sign informed consent form and remain compliant with
the protocol and study procedures

6. Able to read and understand English

7. Patients whom are planning to have functional endoscopic sinus surgery.

Exclusion Criteria:

- 1. Diagnosis of Acute Rhinosinusitis or recurrent acute rhinosinusitis

1. per guidelines published in the 2015 Clinical practice guideline (update): adult
sinusitis of the American Academy of Otolaryngology - Head & Neck Surgery
(AAO-HNS)

2. Polyps in nasal cavity or the middle meatus

3. Prior sinus surgery, not including rhinoplasty or septoplasty

4. Physician determined need for ethmoidectomy, polypectomy, septoplasty

5. Patients with known immunodeficiency, ciliary dysfunction, uncontrolled
diabetes (defined as most recent HgA1C > 5.7), and/or autoimmune disease

6. Any clinically significant illness that may interfere with the evaluation of
the study

7. Patients who were involved in other clinical studies 6 months prior to the
study initiation

8. Patients unable to adhere to follow-up schedule or protocol requirements