Saline Irrigation After Surgery in Patients With Chronic Sinusitis (HVSI)
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.
Device: NeilMed sinus rinse
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The HVSI STUDY: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial|
- Sinonasal Outcomes Scale (SNOT-22) [ Time Frame: One month post-operatively ] [ Designated as safety issue: No ]Subjective scale, completed by patient. Validated scale for chronic sinusitis.
- Lund MacKay score [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]Objective scale, validated, completed by investigator. Preoperative CT scan is scored based on degree of sinus opacification (0-24).
- Nasal and Sinus Symptom Score (NSS) - Subjective scale [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: No ]A subjective scale, filled out by the patient, specific to symptoms of sinusitis.
- Perioperative Sinus Endoscopy scale (POSE) [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: No ]Objective scale, completed by treating physician, to assess sinonasal contents endoscopically. Validated scale.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: High volume saline irrigation
Patients in this group will receive high volume saline irrigation (NeilMed sinus rinse)
Device: NeilMed sinus rinse
High volume saline irrigation
Placebo Comparator: Placebo
Patients in this group will receive low volume saline irrigation (Salinex)
Low volume saline irrigation
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|Contact: Kristian I Macdonald, MD FRCSCemail@example.com|
|Contact: Ian J Witterick, MD MSc FRCSCfirstname.lastname@example.org|
|University of Calgary Otolaryngology - Head & Neck Surgery||Not yet recruiting|
|Calgary, Alberta, Canada, T5J 3E4|
|Contact: Luke Rudmik, MD FRCSC 4032708060 email@example.com|
|Sub-Investigator: Brad Mechor, MD FRCSC|
|Western University Dept. of Otolaryngology - Head & Neck Surgery||Not yet recruiting|
|London, Ontario, Canada, N6A 3K7|
|Contact: Brian Rotenberg, MD FRCSC 5196466320 firstname.lastname@example.org|
|Ottawa University Otolaryngology - Head & Neck Surgery||Not yet recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Shaun Kilty, MD FRCSC 6137292312 email@example.com|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|Contact: Kristian I Macdonald, MD FRCSC 4166240614 firstname.lastname@example.org|
|Principal Investigator:||Ian J Witterick, MD MSc FRCSC||Samuel R Lunenfeld Institute|