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

Not Applicable

Withdrawn

• Conditions: Sinusitis
• Interventions: Procedure: Microdebridement; Device: Gold Laser

• Registration Number: NCT02900794
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Study Start: 2016-10
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contrast Arm (Microdebridement)	Microdebridement	Typical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary.
Treatment Arm (Gold Laser)	Gold Laser	Typical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. If the Investigator determines that the sinus is not sufficiently dilated or cannot be accessed, the need for and the type of additional treatment will be at the discretion of the Investigator.

Primary Outcome Measures

Name	Time	Method
Total Chronic Sinusitis Survey (CSS) Score	2 weeks, 8 weeks, 24 weeks	Comparison will be made of change in patient-reported quality of life (QOL) as measured by Total CSS score at 2 weeks, 8 weeks, and 24 weeks postoperatively for subjects randomized to micro-debridement versus gold laser.

Secondary Outcome Measures

Name	Time	Method
Rhinosinusitis Disability Index (RSDI) Score	2 weeks, 8 weeks, 24 weeks	Comparison will be made of change in patient-reported quality of life (QOL) as measured by rhinosinusitis disability index (RSDI) total, physical, functional, and emotional sub-scores at 2 weeks, 8 weeks, and 24 weeks postoperatively for subjects randomized to microdebridement versus gold laser
Days Missed At Work/School	8 weeks, 24 weeks	Comparison will be made of missed days at work/school and unscheduled medical care visits due to sinusitis at 8 weeks and 24 weeks postoperatively for subjects randomized to microdebridement versus gold laser.
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)	8 weeks, 24 weeks	Comparison will be made of medication type (name), dosage, frequency, and route of administration at 8 weeks and 24 weeks postoperatively (days of oral antibiotics, oral steroids, topical intranasal steroid sprays, topical and nasal anti-histamines) for subjects randomized to microdebridement versus gold laser.
Number of Sinus Infections	24 Weeks	Comparison will be made of patient reported pre-post-enrollment sinus infections and patient-reported sinus infection severity for subjects randomized to microdebridement versus gold laser

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States