Saline Irrigation After Surgery in Patients With Chronic Sinusitis
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): NeilMed sinus rinse; Salinex
Intervention type(s): Device; Device
Intervention description(s): High volume saline irrigation; Low volume saline irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: saline irrigation; chronic rhinosinusitis; endoscopic sinus surgery; high volume saline irrigation