Completed

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

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What is being tested

High Volume Saline Irrigation

+ High Volume Saline Irrigation

+ High Volume Saline Irrigation

Other
Who is being recruted

Infections+6

+ Nose Diseases

+ Otorhinolaryngologic Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorDr. Luke Rudmik
Last updated: December 3, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorDr. Luke Rudmik
Last updated: December 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsNose DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsRhinitisSinusitisRhinosinusitis

Criteria

4 inclusion criteria required to participate
Able to read and understand English

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

6 exclusion criteria prevent from participating
Cystic Fibrosis

Diagnosed fungal sinusitis

Diagnosed immotile cilia syndrome

Diagnosed immunodeficiency syndrome

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients will use high volume saline irrigation once daily post operatively.

Group II

Active Comparator
Patients will use high volume saline irrigation twice daily post operatively.

Group III

Active Comparator
Patients will use high volume saline irrigation three times daily post operatively.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Calgary

Calgary, CanadaOpen University of Calgary in Google Maps
CompletedOne Study Center