Sinusitis Clinical Trial
Official title:
Comparing Post-Operative Outcomes Between Gold Laser and Micro-Debriders for Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
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. 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. 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 in treatment of chronic sinus infections is well documented. The LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing), post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates and compare postoperative outcomes with the use of a microdebrider. These uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.
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.
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