Clinical trial NCT01575223: Saline Irrigation After Surgery in Patients With Chronic Sinusitis
Official title: The HVSI STUDY: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis
Keywords: saline irrigation
chronic rhinosinusitis
endoscopic sinus surgery
high volume saline irrigation
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
Collaborators: name: NeilMed Pharmaceuticals
First posted: 2012-04-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™) offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early post-operative management in patients with chronic rhino sinusitis.

Detailed description: Background: Chronic Rhinosinusitis (CRS) is a common inflammatory condition of the upper respiratory tract lasting more than 8 to 12 weeks. Major symptoms include facial congestion/fullness, facial pain/pressure, nasal obstruction/blockage, purulent nasal drainage, and reduction or loss of smell. The diagnosis must include two major symptoms and either endoscopic evidence of polyps, edema or mucopurulent discharge from the middle meatus and/or CT changes in the mucosa of sinuses or osteomeatal complexes.1

CRS has an estimated prevalence of 5% in the Canadian population2, and up to 16% in some adult populations in the United States.3 Sinusitis is associated with a major societal health care burden, costing billions of dollars a year in North America.4,5 The medical treatment of CRS includes topical saline and corticosteroid sprays, systemic steroids and antimicrobials. Specifically, saline nasal irrigation (SNI) is a safe, nonpharmacologic treatment, and an important and efficacious component in the management of CRS.6,7 SNI can vary by concentration (e.g. hypertonic, isotonic, hypotonic) and device (e.g. bulb syringe, nasal mist, squeeze bottle).

The Mayo Clinic recently reviewed major expert consensus guidelines on the medical treatment of CRS.8 Although they recognized an overall paucity of controlled trials for any medical treatment, and a lack of a consensus or algorithm in the treatment of CRS, there is an overall consensus agreement of the use for SNI in this population. In this review, there was no mention of treatment of CRS in postoperative period, and no recommendation of what type of SNI is best.

Few studies examine various SNI formulations in the postoperative period. These were highlighted by Canadian authors in a recent exhaustive review of SNI in sinusitis.9 Three studies, all greater than 15 years old, include formulations that are not currently in popular use, or even available in North America.10-12 These did show that pressurized jets or sprays of seawater were more effective than nasal drops. More recently, Harvey et al. examined how irrigation is delivered and retained in the sinus, using more common devices.13,14 In a cadaveric model, they compared HVSI to LVSI devices and found a greater delivery (p\<..02) in the former. To date there are no studies comparing HVSI to LVSI, using subjective patient benefit and objective endoscopic measure outcomes, in the postoperative CRS patient.

One study did examine two different SNI devices in the management of CRS.15 The authors recruited 150 subjects with CRS in the primary care setting, and randomized them to two weeks of SNI with a bulb syringe, SNI with a nasal irrigation pot, and a control group of reflexology massage.15 Hypertonic saline was used in both treatment groups. Subjective questionnaires were administered at baseline and at the end of the study period. Both groups significantly improved, with no significant difference between the two SNI devices. Patients equally preferred the two devices.

Popular HVSI and LVSI formulations with patients and physicians are NeilMed® Sinus Rinse™ and Salinex®, respectively. These are two examples of positive pressure treatments,13 which have enjoyed widespread usage in North America preceding sufficient evidence-based medicine demonstrating safety and efficacy. This is likely because topical saline sprays are considered safe; they do not require a prescription, and perhaps most importantly the massive marketing campaign surrounding SNI devices. SNI devices have received significant news coverage and appearances on major television shows, including the Oprah Winfrey Show, the New York Times, and numerous YouTube videos.16 Purpose: The authors hypothesize that there is an advantage of HVSI over LVSI. The mechanical effect of high volume irrigation helps ensure that a larger surface area of sinonasal mucosa is debrided and cleansed.

The aim of this study is to determine if there is a clinical benefit of HVSI over LVSI in the postoperative period in patients with CRS. This information would help otolaryngologists, family physicians, and other health care professionals recommend the best SNI device for their patients with CRS. It would also provide a much-needed prospective and controlled trial in the evidence for SNI in CRS in the post-operative period.

Population/Procedure: This is a multicenter, randomized, single blind, controlled prospective study evaluating the subjective and objective outcomes of HSVI versus LSVI in patients who have ESS for CRS. One month postoperative scores will be compared to preoperative scores. The expected total number of patients to be enrolled in this study is approximately 100, with a planned completion time of one year.

At our institution, ten patients who are offered endoscopic sinus surgery (ESS) for CRS will be approached for study participation.

Eligibility criteria: Inclusion criteria:

* Documented diagnosis of unilateral or bilateral CRS
* Documented failed medical treatment of CRS
* Eighteen (18) to sixty-five (65) years of age
* Planned ESS for the treatment of CRS
* Able to read and understand English

Exclusion criteria:

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

Primary outcomes:
measure: Sinonasal Outcomes Scale (SNOT-22)
timeFrame: One month post-operatively
measure: Lund MacKay score
timeFrame: 1 month postoperatively
measure: Nasal and Sinus Symptom Score (NSS) - Subjective scale
timeFrame: 1 month post-operatively
measure: Perioperative Sinus Endoscopy scale (POSE)
timeFrame: 1 month post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Otolaryngology - Head & Neck Surgery
state: Alberta
city: London
country: Canada
facility: Western University Dept. of Otolaryngology - Head & Neck Surgery
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa University Otolaryngology - Head & Neck Surgery
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Samuel R Lunenfeld Institute
name: Ian J Witterick, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.
citation: 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.
citation: 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.