Clinical trial NCT02900794: Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery
Official title: Comparing Post-Operative Outcomes Between Gold Laser and Micro-Debriders for Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sinusitis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Chronic Sinusitis Survey (CSS) Score
timeFrame: 2 weeks, 8 weeks, 24 weeks
Secondary outcomes:
measure: Rhinosinusitis Disability Index (RSDI) Score
timeFrame: 2 weeks, 8 weeks, 24 weeks
measure: Number of Patients Reporting Use of Sinusitis Related Medications Post-Surgically (Medications include: Oral antibiotics, Oral steroids, Topical intranasal steroid sprays, Topical and Nasal Anti-histamines)
timeFrame: 8 weeks, 24 weeks
measure: Days Missed At Work/School
timeFrame: 8 weeks, 24 weeks
measure: Number of Sinus Infections
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: TTUHSC
name: Joehassin Cordero, MD
role: PRINCIPAL_INVESTIGATOR
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