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

NCT02900794 | Withdrawn

• 1 other identifier: L16-117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Total Chronic Sinusitis Survey (CSS) Score

  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.

  2 weeks, 8 weeks, 24 weeks

Secondary Outcomes (4)

• Rhinosinusitis Disability Index (RSDI) Score

  2 weeks, 8 weeks, 24 weeks

• 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

• Days Missed At Work/School

  8 weeks, 24 weeks

• Number of Sinus Infections

  24 Weeks

Study Arms (2)

Contrast Arm (Microdebridement)

OTHER

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.

Procedure: Microdebridement

Treatment Arm (Gold Laser)

OTHER

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.

Device: Gold Laser

Interventions

Gold Laser DEVICE

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.

Treatment Arm (Gold Laser)

Microdebridement PROCEDURE

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.

Contrast Arm (Microdebridement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Males and females aged 18 or greater
• 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
• 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
• Radiographic evidence of sinus inflammation during chronic bacterial rhinosinusitis indicating sinus disease at the ostiomeatal complex.
• Willing and able to read and sign informed consent form and remain compliant with the protocol and study procedures
• Able to read and understand English
• Patients whom are planning to have functional endoscopic sinus surgery.

You may not qualify if:

• \. Diagnosis of Acute Rhinosinusitis or recurrent acute rhinosinusitis
• per guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS)
• \. Polyps in nasal cavity or the middle meatus
• \. Prior sinus surgery, not including rhinoplasty or septoplasty
• \. Physician determined need for ethmoidectomy, polypectomy, septoplasty
• \. Patients with known immunodeficiency, ciliary dysfunction, uncontrolled diabetes (defined as most recent HgA1C \> 5.7), and/or autoimmune disease
• \. Any clinically significant illness that may interfere with the evaluation of the study
• \. Patients who were involved in other clinical studies 6 months prior to the study initiation
• \. Patients unable to adhere to follow-up schedule or protocol requirements

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (19)

• Gerlinger I, Lujber L, Jarai T, Pytel J. KTP-532 laser-assisted endoscopic nasal sinus surgery. Clin Otolaryngol Allied Sci. 2003 Apr;28(2):67-71. doi: 10.1046/j.1365-2273.2003.00660.x.

  PMID: 12680820 BACKGROUND

• Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.

  PMID: 24819891 BACKGROUND

• Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. doi: 10.1016/s0194-5998(03)01397-4. No abstract available.

  PMID: 12958561 BACKGROUND

• McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.

  PMID: 7807660 BACKGROUND

• Snow V, Mottur-Pilson C, Hickner JM; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine; Centers for Disease Control; Infectious Diseases Society of America. Principles of appropriate antibiotic use for acute sinusitis in adults. Ann Intern Med. 2001 Mar 20;134(6):495-7. doi: 10.7326/0003-4819-134-6-200103200-00016. No abstract available.

  PMID: 11255527 BACKGROUND

• Bhattacharyya N. Chronic rhinosinusitis: is the nose really involved? Am J Rhinol. 2001 May-Jun;15(3):169-73. doi: 10.2500/105065801779954184.

  PMID: 11453503 BACKGROUND

• Poetker DM, Litvack JR, Mace JC, Smith TL. Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):329-33. doi: 10.2500/ajr.2008.22.3177.

  PMID: 18588769 BACKGROUND

• Metson R. Holmium:YAG laser endoscopic sinus surgery: a randomized, controlled study. Laryngoscope. 1996 Jan;106(1 Pt 2 Suppl 77):1-18. doi: 10.1097/00005537-199601001-00001.

  PMID: 8538352 BACKGROUND

• Lee JC, Lai WS, Ju DT, Chu YH, Yang JM. Diode laser assisted minimal invasive sphenoidotomy for endoscopic transphenoidal pituitary surgery: our technique and results. Lasers Surg Med. 2015 Mar;47(3):239-42. doi: 10.1002/lsm.22340.

  PMID: 25810080 BACKGROUND

• Chester AC, Sindwani R. Symptom outcomes in endoscopic sinus surgery: a systematic review of measurement methods. Laryngoscope. 2007 Dec;117(12):2239-43. doi: 10.1097/MLG.0b013e318149224d.

  PMID: 18322425 BACKGROUND

• Alobid I, Bernal-Sprekelsen M, Mullol J. Chronic rhinosinusitis and nasal polyps: the role of generic and specific questionnaires on assessing its impact on patient's quality of life. Allergy. 2008 Oct;63(10):1267-79. doi: 10.1111/j.1398-9995.2008.01828.x.

  PMID: 18782106 BACKGROUND

• Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001 Jan-Feb;15(1):15-20. doi: 10.2500/105065801781329428.

  PMID: 11258649 BACKGROUND

• Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1175-9. doi: 10.1001/archotol.1997.01900110025004.

  PMID: 9366696 BACKGROUND

• Soler ZM, Hyer JM, Karnezis TT, Schlosser RJ. The Olfactory Cleft Endoscopy Scale correlates with olfactory metrics in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):293-8. doi: 10.1002/alr.21655. Epub 2015 Dec 31.

  PMID: 26718315 BACKGROUND

• Rudmik L, Hopkins C, Peters A, Smith TL, Schlosser RJ, Soler ZM. Patient-reported outcome measures for adult chronic rhinosinusitis: A systematic review and quality assessment. J Allergy Clin Immunol. 2015 Dec;136(6):1532-1540.e2. doi: 10.1016/j.jaci.2015.10.012.

  PMID: 26654198 BACKGROUND

• Gliklich RE, Hilinski JM. Longitudinal sensitivity of generic and specific health measures in chronic sinusitis. Qual Life Res. 1995 Feb;4(1):27-32. doi: 10.1007/BF00434380.

  PMID: 7711687 BACKGROUND

• Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 1995 Apr;105(4 Pt 1):387-90. doi: 10.1288/00005537-199504000-00010.

  PMID: 7715384 BACKGROUND

• Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz J. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013 Jan;3(1):4-9. doi: 10.1002/alr.21065. Epub 2012 Jun 26.

  PMID: 22736422 BACKGROUND

• Metson RB, Gliklich RE. Clinical outcomes in patients with chronic sinusitis. Laryngoscope. 2000 Mar;110(3 Pt 3):24-8. doi: 10.1097/00005537-200003002-00007.

  PMID: 10718411 BACKGROUND

Related Links

• Sinus Surgery \[Internet\]. Pensacola: Medical Energy Inc.; c2015 \[cited 2016 March 24\]
• Winters R, Knight Worley N. Gold Laser Resection of the Concha Bullosa: Description of a New Technique. Otolaryngology. 2012; 2:2.
• Lethbridge-Cejku M, Rose D, Vickerie J. Summary health statistics for US adults: National Health Interview Survey, 2004. Vital Health Stat. 2006;10:19-22.
• Stavem K, Rossberg E, Larsson P. Reliability, validity and responsiveness of a Norwegian Version of the Chronic Sinusitis Survey. BMC Ear, Nose and Throat Disorders. 2006; 6:9.
• 1\. Ware, JE. The SF-36 Health Survey Manual and Interpretation Guide. Nimrod Press, Boston 1993; pp 10-14

MeSH Terms

Conditions

Sinusitis

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Joehassin Cordero, MD

  TTUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 14, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

US (1)