Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Luke Rudmik, University of Calgary
ClinicalTrials.gov Identifier:
NCT01680705
First received: August 30, 2012
Last updated: September 11, 2012
Last verified: September 2012

August 30, 2012
September 11, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
Change in Quality of Life [ Time Frame: Pre and post operative (1, 3 and 8 weeks post operatively) ] [ Designated as safety issue: No ]
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.
Quality of Life [ Time Frame: Pre and post operative (1, 3 and 8 weeks post operatively) ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01680705 on ClinicalTrials.gov Archive Site
Change in Endoscopic Score [ Time Frame: Pre and Post-Operative (1, 3 and 8 weeks post operatively) ] [ Designated as safety issue: No ]
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.
Endoscopic Score [ Time Frame: Pre and Post-Operative (1, 3 and 8 weeks post operatively) ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery
Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Rhinosinusitis
Other: High Volume Saline Irrigation
High volume saline irrigation (240 ml)
  • Active Comparator: Frequency: Once Daily
    Patients will use high volume saline irrigation once daily post operatively.
    Intervention: Other: High Volume Saline Irrigation
  • Active Comparator: Frequency: Twice Daily
    Patients will use high volume saline irrigation twice daily post operatively.
    Intervention: Other: High Volume Saline Irrigation
  • Active Comparator: Frequency: Three Times Daily
    Patients will use high volume saline irrigation three times daily post operatively.
    Intervention: Other: High Volume Saline Irrigation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
September 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with a diagnosis of CRS as per guidelines (> 18 years old)
  • Documented failed medical treatment of CRS
  • 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
Both
18 Years and older
No
Contact: Luke Rudmik, MD lukerudmik@gmail.com
Contact: Kristine Smith, MD 587-228-3391 kasmi@ucalgary.ca
Canada
 
NCT01680705
SIESS-2012
No
Dr. Luke Rudmik, University of Calgary
Dr. Luke Rudmik
Not Provided
Principal Investigator: Luke Rudmik, MD University of Calgary
University of Calgary
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP