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A Postoperative Study on HVSI vs LVSI Treatment of Chronic Rhinosinusitis

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02636959
First received: December 2, 2015
Last updated: May 18, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Rhinosinusitis Other: saline irrigation Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change of preoperative from postoperative CT endoscopic photo scans used to evaluate different saline irrigation treatment volumes in patients with chronic rhinosinusitis. [ Time Frame: 30 min at enrollment and 20 minutes at 1-month postoperative follow-up ]
    The value of either the HVSI or the LVSI to improve recovery and treatment of CRS postoperatively will be assessed.

  • Change of preoperative from postoperative sinus surgery regarding quality of life based on SNOT-22 questionnaire. [ Time Frame: 15 min at enrollment and 10 minutes at 1-month postoperative follow-up ]
    A standard questionnaire, SNOT-22, will document improvements regarding quality of life.

  • Change of preoperative from postoperative sinus surgery regarding quality of life based on the Nasal and Sinus Symptoms Score questionnaire. [ Time Frame: 15 min at enrollment and 10 minutes at 1-month postoperative follow-up ]
    A standard questionnaire, Nasal and Sinus Symptoms Score, will document improvements regarding quality of life.


Estimated Enrollment: 20
Study Start Date: December 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: high volume saline irrigation (HVSI)
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
HVSI (NeilMed® Sinus Rinse™) versus LVSI (Salinex®) in the early post-operative management in patients with chronic rhinosinusitis. Both are a saline rinse spray.
Active Comparator: low volume saline irrigation (LVSI)
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
HVSI (NeilMed® Sinus Rinse™) versus LVSI (Salinex®) in the early post-operative management in patients with chronic rhinosinusitis. Both are a saline rinse spray.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of unilateral or bilateral CRS
  • Documented failed medical treatment of CRS
  • 18 to 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02636959

Contacts
Contact: Javier Ospina, MD 604-715-8276 jospinadiaz@gmail.com
Contact: Elizabeth Hui, PhD 604-875-4111 ext 22935 elizabeth.hui@ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital/Otolaryngology Clinic Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Arif Janjua, MD    604-875-8296    dr.janjua.office@gmail.com   
Contact: Javier Ospina, MD    604-715-8276    jospinadiaz@gmail.com   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Arif Janjua, MD Vancouver Coastal Health
  More Information

Publications:
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.
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.

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02636959     History of Changes
Other Study ID Numbers: H15-02550
Study First Received: December 2, 2015
Last Updated: May 18, 2016

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 19, 2017