A Postoperative Study on HVSI vs LVSI Treatment of Chronic Rhinosinusitis

NCT02636959 | Unknown Early Phase 1

• 1 other identifier: H15-02550
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic sinusitis (CRS) is a common inflammatory sinus condition among Canadians. Saline irrigation is an effective therapy used in the management of CRS and is a commonly prescribed treatment in preoperative surgery for people with this condition. Recently, a study performed by a Toronto group in Canada tried to show if there is any significant improvement between using high versus low volume saline irrigation to treat CRS. Despite finding a trend, the number of people with CRS used in this pilot study was not large enough to conclusively declare any difference between the two treatment groups. PURPOSE: The purpose of this study is to determine if there is a clinical benefit of high volume saline nasal irrigation (HVSI) over low volume saline irrigation (LVSI) in the postoperative period in patients with chronic Rhinosinusitis (CRS). This study is part of a multicenter collaborative project initiated by Macdonald et al. (20). A sample size of 176 participants (88 in each condition) is required to achieve data significance. To achieve this, our role is to collect data (plus those of four other Canadian rhinology research centres) from 20 patients and add our findings to theirs to establish an acceptable and significant result. This information would help otolaryngologists, family physicians, and other health care professionals recommend the best post-operative SNI (saline nasal irrigation) device for their patients with CRS.

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (3)

• Change of preoperative from postoperative CT endoscopic photo scans used to evaluate different saline irrigation treatment volumes in patients with chronic rhinosinusitis.

  The value of either the HVSI or the LVSI to improve recovery and treatment of CRS postoperatively will be assessed.

  30 min at enrollment and 20 minutes at 1-month postoperative follow-up

• Change of preoperative from postoperative sinus surgery regarding quality of life based on SNOT-22 questionnaire.

  A standard questionnaire, SNOT-22, will document improvements regarding quality of life.

  15 min at enrollment and 10 minutes at 1-month postoperative follow-up

• Change of preoperative from postoperative sinus surgery regarding quality of life based on the Nasal and Sinus Symptoms Score questionnaire.

  A standard questionnaire, Nasal and Sinus Symptoms Score, will document improvements regarding quality of life.

  15 min at enrollment and 10 minutes at 1-month postoperative follow-up

Study Arms (2)

high volume saline irrigation (HVSI)

ACTIVE COMPARATOR

High volume nasal spray, NeilMed® Sinus Rinse, is a high saline nasal rinse that is a safe, nonpharmacologic treatment. Randomized participants will be asked to use the rinse for one month (twice daily) by following the manufacturer's guidelines and use of the squeeze bottle provided. Preoperative and one month Postoperative sinus surgery, the participants will complete subjective questionnaires and at one-month after surgery, endoscopic sinonasal photos will be taken. These data will be used to assess the quality of postoperative improvements after treatment.

Other: saline irrigation

low volume saline irrigation (LVSI)

ACTIVE COMPARATOR

Low volume nasal spray, Salinex Rinse, is a low saline nasal rinse that is a safe, nonpharmacologic treatment. Randomized participants will be asked to use the rinse for one month (twice daily) by following the manufacturer's guidelines and use of the squeeze bottle provided. Preoperative and one month Postoperative sinus surgery, the participants will complete subjective questionnaires and at one-month after surgery, endoscopic sinonasal photos will be taken. These data will be used to assess the quality of postoperative improvements after treatment.

Other: saline irrigation

Interventions

saline irrigation OTHER

HVSI (NeilMed® Sinus Rinse™) versus LVSI (Salinex®) in the early post-operative management in patients with chronic rhinosinusitis. Both are a saline rinse spray.

high volume saline irrigation (HVSI); low volume saline irrigation (LVSI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of unilateral or bilateral CRS
• Documented failed medical treatment of CRS
• to 65 years of age
• Planned ESS for the treatment of CRS
• Able to read and understand English

You may not qualify if:

• Pregnant
• Cystic Fibrosis
• Diagnosed immotile cilia syndrome
• Diagnosed immunodeficiency syndrome
• Diagnosed fungal sinusitis
• Sinonasal tumours or obstructive lesions

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital/Otolaryngology Clinic

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Publications (20)

• Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.

  PMID: 12838019 BACKGROUND

• Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.

  PMID: 15174752 BACKGROUND

• Ray NF, Baraniuk JN, Thamer M, Rinehart CS, Gergen PJ, Kaliner M, Josephs S, Pung YH. Healthcare expenditures for sinusitis in 1996: contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):408-14. doi: 10.1016/s0091-6749(99)70464-1.

  PMID: 10069873 BACKGROUND

• Van Cauwenberge P, Watelet JB. Epidemiology of chronic rhinosinusitis. Thorax. 2000 Oct;55 Suppl 2(Suppl 2):S20-1. doi: 10.1136/thorax.55.suppl_2.s20. No abstract available.

  PMID: 10992549 BACKGROUND

• Tomooka LT, Murphy C, Davidson TM. Clinical study and literature review of nasal irrigation. Laryngoscope. 2000 Jul;110(7):1189-93. doi: 10.1097/00005537-200007000-00023.

  PMID: 10892694 BACKGROUND

• Rabago D, Zgierska A, Mundt M, Barrett B, Bobula J, Maberry R. Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial. J Fam Pract. 2002 Dec;51(12):1049-55.

  PMID: 12540331 BACKGROUND

• Meltzer EO, Hamilos DL. Rhinosinusitis diagnosis and management for the clinician: a synopsis of recent consensus guidelines. Mayo Clin Proc. 2011 May;86(5):427-43. doi: 10.4065/mcp.2010.0392. Epub 2011 Apr 13.

  PMID: 21490181 BACKGROUND

• Lavigne F, Alizadehfar R, Balter Met al. Optimizing the usage of saline nasal irrigation (SNI) in the management of common respiratory conditions: from clinical evidence to daily practice. Unpublished, submission in progress 2011.

  BACKGROUND

• Krayenbuhl M, Seppey M. [Efficacy of Rhinomer Force 3 in the postoperative course of endonasal surgery]. Rev Med Suisse Romande. 1995 Mar;115(3):249-52. No abstract available. French.

  PMID: 7777766 BACKGROUND

• Seppey M, Schweri T, Hausler R. Comparative randomised clinical study of tolerability and efficacy of Rhinomer Force 3 versus a reference product in post-operative care of the nasal fossae after endonasal surgery. ORL J Otorhinolaryngol Relat Spec. 1996 Mar-Apr;58(2):87-92. doi: 10.1159/000276805.

  PMID: 8736053 BACKGROUND

• Pigret D, Jankowski R. Management of post-ethmoidectomy crust formation: randomized single-blind clinical trial comparing pressurized seawater versus antiseptic/mucolytic saline. Rhinology. 1996 Mar;34(1):38-40.

  PMID: 8739868 BACKGROUND

• Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.

  PMID: 19932850 BACKGROUND

• Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020.

  PMID: 18585576 BACKGROUND

• Heatley DG, McConnell KE, Kille TL, Leverson GE. Nasal irrigation for the alleviation of sinonasal symptoms. Otolaryngol Head Neck Surg. 2001 Jul;125(1):44-8. doi: 10.1067/mhn.2001.115909.

  PMID: 11458213 BACKGROUND

• Sweeney C. Short, Stout, Has a Handle on Colds. Available at: http://www.nytimes.com/2008/01/03/fashion/03skin.html. Accessed September 5th, 2011. Published Jan. 3rd, 2008.

  BACKGROUND

• Morley AD, Sharp HR. A review of sinonasal outcome scoring systems - which is best? Clin Otolaryngol. 2006 Apr;31(2):103-9. doi: 10.1111/j.1749-4486.2006.01155.x.

  PMID: 16620328 BACKGROUND

• Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.

  PMID: 18075447 BACKGROUND

• Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.

  PMID: 17903570 BACKGROUND

• Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Robert Schellenberg R, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S99-193. English, French.

  PMID: 21658337 BACKGROUND

• Macdonald KI, Wright ED, Sowerby LJ, Rotenberg BW, Chin CJ, Rudmik L, Sommer DD, Nayan S, DesRosiers M, Tewfik MA, Valdes CJ, Massoud E, Thomas D, Kilty SJ, Vescan A, Mechor B, Lavigne F, Fandino M, Javer AR, Witterick IJ. Squeeze bottle versus saline spray after endoscopic sinus surgery for chronic rhinosinusitis: a pilot multicentre trial. Am J Rhinol Allergy. 2015 Jan-Feb;29(1):e13-7. doi: 10.2500/ajra.2015.29.4125.

  PMID: 25590308 RESULT

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Arif Janjua, MD

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Ospina, MD

CONTACT

604-715-8276; jospinadiaz@gmail.com

Elizabeth Hui, PhD

CONTACT

604-875-4111; elizabeth.hui@ubc.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

CA (1)