<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680705</url>
  </required_header>
  <id_info>
    <org_study_id>SIESS-2012</org_study_id>
    <nct_id>NCT01680705</nct_id>
  </id_info>
  <brief_title>Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery</brief_title>
  <official_title>Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Luke Rudmik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine what the ideal frequency of high-volume sinonasal&#xD;
      saline irrigation in the early postoperative period following ESS for medically refractory&#xD;
      CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline&#xD;
      irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations&#xD;
      for the first week is ideal with no difference between frequencies after 1 week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Rhinosinusitis (CRS) is a common inflammatory condition of the upper respiratory&#xD;
      tract lasting more than 8 to 12 weeks. Major symptoms include facial congestion/fullness,&#xD;
      facial pain/pressure, nasal obstruction/blockage, purulent nasal drainage, and reduction or&#xD;
      loss of smell. The diagnosis must include two major symptoms and either endoscopic evidence&#xD;
      of polyps, edema or mucopurulent discharge from the middle meatus and/or CT changes in the&#xD;
      mucosa of sinuses or ostiomeatal complexes.&#xD;
&#xD;
      CRS has an estimated prevalence of 5% in the Canadian population, and up to 16% in some adult&#xD;
      populations in the United States. Sinusitis is associated with a major societal health care&#xD;
      burden, costing billions of dollars a year in North America. The medical treatment of CRS&#xD;
      includes topical saline and corticosteroid sprays, systemic steroids and antimicrobials.&#xD;
      Specifically, sinonasal saline irrigation is a safe, nonpharmacologic treatment, and an&#xD;
      important and efficacious component in the management of CRS. Sinonasal saline irrigation can&#xD;
      vary by concentration (e.g. hypertonic, isotonic, hypotonic), pressure (e.g. passive or&#xD;
      active), and volume (e.g. high and low).&#xD;
&#xD;
      A recent evidence-based review by Rudmik et al. recommended sinonasal saline irrigation in&#xD;
      the early postoperative period following endoscopic sinus surgery. Although 'daily' sinonasal&#xD;
      saline irrigations are recommended, the ideal frequency is unknown since there have been no&#xD;
      studies evaluating this topic.&#xD;
&#xD;
      This is a prospective, randomized, single blind study evaluating the subjective and objective&#xD;
      outcomes of different sinonasal saline irrigation frequencies in patients who receive ESS for&#xD;
      medically refractory CRS. Both disease-specific quality of life (QoL) and endoscopy scores&#xD;
      will be measured at 1 week, 3 weeks, and 2 months postoperatively. The expected total number&#xD;
      of patients to be enrolled in this study is approximately 75 (25 per arm), with a planned&#xD;
      completion time of two years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Pre and post operative (1, 3 and 8 weeks post operatively)</time_frame>
    <description>The SNOT-22 and the nasal and sinus symptoms score will be complete by the patient to assess quality of life. They will be completed preoperatively and 1 week, 3 weeks and 2 months postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Endoscopic Score</measure>
    <time_frame>Pre and Post-Operative (1, 3 and 8 weeks post operatively)</time_frame>
    <description>Two endoscopic scales (the Lund-Kennedy and the POSE) will be used to assess the endoscopic appearance pre and post operatively. They will be completed preoperatively and 1 week, 3 weeks and 2 months postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Rhinosinusitis</condition>
  <arm_group>
    <arm_group_label>Frequency: Once Daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will use high volume saline irrigation once daily post operatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency: Twice Daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will use high volume saline irrigation twice daily post operatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frequency: Three Times Daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will use high volume saline irrigation three times daily post operatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Volume Saline Irrigation</intervention_name>
    <description>High volume saline irrigation (240 ml)</description>
    <arm_group_label>Frequency: Once Daily</arm_group_label>
    <arm_group_label>Frequency: Three Times Daily</arm_group_label>
    <arm_group_label>Frequency: Twice Daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with a diagnosis of CRS as per guidelines (&gt; 18 years old)&#xD;
&#xD;
          -  Documented failed medical treatment of CRS&#xD;
&#xD;
          -  Planned ESS for the treatment of CRS&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Cystic Fibrosis&#xD;
&#xD;
          -  Diagnosed immotile cilia syndrome&#xD;
&#xD;
          -  Diagnosed immunodeficiency syndrome&#xD;
&#xD;
          -  Diagnosed fungal sinusitis&#xD;
&#xD;
          -  Sinonasal tumours or obstructive lesions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luke Rudmik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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>
    <PMID>21658337</PMID>
  </reference>
  <reference>
    <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>
    <PMID>12838019</PMID>
  </reference>
  <reference>
    <citation>Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.</citation>
    <PMID>15174752</PMID>
  </reference>
  <reference>
    <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>
    <PMID>10069873</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10992549</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10892694</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12540331</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21490181</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16620328</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18075447</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17903570</PMID>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Luke Rudmik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic Rhinosinusitis</keyword>
  <keyword>Endoscopic Sinus Surgery</keyword>
  <keyword>Sinonasal saline irrigation</keyword>
  <keyword>Frequency</keyword>
  <keyword>Postoperative</keyword>
  <keyword>High Volume</keyword>
  <keyword>Randomized Control Trial</keyword>
  <keyword>Single Blinded</keyword>
  <keyword>Prospective Study</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Endoscopic Sinus Score</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680705
org study id: SIESS-2012
nct id: NCT01680705
lead sponsor: 
has dmc: No
The aim of this study is to determine what the ideal frequency of high-volume sinonasal
      saline irrigation in the early postoperative period following ESS for medically refractory
      CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline
      irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations
      for the first week is ideal with no difference between frequencies after 1 week.
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 ostiomeatal complexes.

      CRS has an estimated prevalence of 5% in the Canadian population, and up to 16% in some adult
      populations in the United States. Sinusitis is associated with a major societal health care
      burden, costing billions of dollars a year in North America. The medical treatment of CRS
      includes topical saline and corticosteroid sprays, systemic steroids and antimicrobials.
      Specifically, sinonasal saline irrigation is a safe, nonpharmacologic treatment, and an
      important and efficacious component in the management of CRS. Sinonasal saline irrigation can
      vary by concentration (e.g. hypertonic, isotonic, hypotonic), pressure (e.g. passive or
      active), and volume (e.g. high and low).

      A recent evidence-based review by Rudmik et al. recommended sinonasal saline irrigation in
      the early postoperative period following endoscopic sinus surgery. Although 'daily' sinonasal
      saline irrigations are recommended, the ideal frequency is unknown since there have been no
      studies evaluating this topic.

      This is a prospective, randomized, single blind study evaluating the subjective and objective
      outcomes of different sinonasal saline irrigation frequencies in patients who receive ESS for
      medically refractory CRS. Both disease-specific quality of life (QoL) and endoscopy scores
      will be measured at 1 week, 3 weeks, and 2 months postoperatively. The expected total number
      of patients to be enrolled in this study is approximately 75 (25 per arm), with a planned
      completion time of two years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change in Quality of Life
time frame: Pre and post operative (1, 3 and 8 weeks post operatively)
description: The SNOT-22 and the nasal and sinus symptoms score will be complete by the patient to assess quality of life. They will be completed preoperatively and 1 week, 3 weeks and 2 months postoperatively.
measure: Change in Endoscopic Score
time frame: Pre and Post-Operative (1, 3 and 8 weeks post operatively)
description: Two endoscopic scales (the Lund-Kennedy and the POSE) will be used to assess the endoscopic appearance pre and post operatively. They will be completed preoperatively and 1 week, 3 weeks and 2 months postoperatively.
arm group label: Frequency: Once Daily
arm group type: Active Comparator
description: Patients will use high volume saline irrigation once daily post operatively.
arm group label: Frequency: Twice Daily
arm group type: Active Comparator
description: Patients will use high volume saline irrigation twice daily post operatively.
arm group label: Frequency: Three Times Daily
arm group type: Active Comparator
description: Patients will use high volume saline irrigation three times daily post operatively.
intervention type: Other
intervention name: High Volume Saline Irrigation
description: High volume saline irrigation (240 ml)
arm group label: Frequency: Once Daily
arm group label: Frequency: Three Times Daily
arm group label: Frequency: Twice Daily
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luke Rudmik, MD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
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.
PMID: 21658337
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.
PMID: 12838019
citation: Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.
PMID: 15174752
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.
PMID: 10069873
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor-Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Luke Rudmik
investigator title: Principal Investigator