Clinical trial NCT01455948: Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
Official title: Canadian Health Economics, Health Outcome, and Effectiveness Comparison of Treatment of the Frontal Sinus Ostium and Recess and Other Sinuses With Functional Endoscopic Sinus Surgery (FESS) or Balloon Sinuplasty in Patients With Chronic Sinusitis (CRS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Rhinosinusitis
Keywords: sinusitis
chronic
Functional endoscopic sinus surgery
balloon sinuplasty
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2011-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement
* Documented failed medical treatment of CRS
* Eighteen (18) to sixty-five (65) years of age
* Employed in full time position or equivalent
* Planned FESS for treatment of CRS
* Must have an American Society of Anesthesiologists physical status of P3 classification or less
* Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities
* Able to read and understand English

Exclusion Criteria:

* Previous sinonasal surgery
* Pregnant
* Cystic Fibrosis
* Diagnosed immotile cilia syndrome
* Samter's Triad
* Diagnosed immunodeficiency syndrome
* Diagnosed fungal sinusitis
* Concurrent septoplasty or turbinate surgery
* Diagnosed recurrent acute sinusitis
* Current smoker
* Presence of grade 2 or greater nasal polyps
* Sinonasal tumors or obstructive lesions
* History of substance or alcohol abuse within the past 12 months
* Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements
* Participation in a research study 30 days prior to surgery

Primary outcomes:
measure: The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
timeFrame: 6 months
Secondary outcomes:
measure: Health outcome of patients in the two treatment groups.
timeFrame: 6 months
measure: Effectiveness of the two treatment groups in relieving symptomology of CRS.
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada
name: Ian Witterick, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: