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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
  Purpose

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.


Condition Intervention
Rhinosinusitis
Other: High Volume Saline Irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Frequency: Once Daily
Patients will use high volume saline irrigation once daily post operatively.
Other: High Volume Saline Irrigation
High volume saline irrigation (240 ml)
Active Comparator: Frequency: Twice Daily
Patients will use high volume saline irrigation twice daily post operatively.
Other: High Volume Saline Irrigation
High volume saline irrigation (240 ml)
Active Comparator: Frequency: Three Times Daily
Patients will use high volume saline irrigation three times daily post operatively.
Other: High Volume Saline Irrigation
High volume saline irrigation (240 ml)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01680705

Contacts
Contact: Luke Rudmik, MD lukerudmik@gmail.com
Contact: Kristine Smith, MD 587-228-3391 kasmi@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Luke Rudmik, MD       lukerudmik@gmail.com   
Contact: Kristine Smith, MD    587-228-3391    kasmi@ucalgary.ca   
Sponsors and Collaborators
Dr. Luke Rudmik
Investigators
Principal Investigator: Luke Rudmik, MD University of Calgary
  More Information

Publications:

Responsible Party: Dr. Luke Rudmik, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01680705     History of Changes
Other Study ID Numbers: SIESS-2012
Study First Received: August 30, 2012
Last Updated: September 11, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Chronic Rhinosinusitis
Endoscopic Sinus Surgery
Sinonasal saline irrigation
Frequency
Postoperative
High Volume
Randomized Control Trial
Single Blinded
Prospective Study
Quality of Life
Endoscopic Sinus Score

ClinicalTrials.gov processed this record on November 25, 2014