Coblation in Endoscopic Sinus Surgery
The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
1 other identifier
interventional
22
1 country
1
Brief Summary
Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms, including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects close to 5% of the Canadian population(2). When medical therapy fails, patients are often referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management. Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed medical management(3). Traditionally, the microdebrider has been the go-to tool for performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than so-called "cold" surgical techniques (i.e. the microdebrider). In a retrospective study by Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of less intraoperative blood loss when the Coblator was used in their surgery, than those patients who underwent surgery with the microdebrider. The investigators plan to further investigate this in a randomized, controlled fashion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 18, 2013
February 1, 2013
1 year
February 12, 2013
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood loss
intra-operative
Study Arms (2)
control: shaver
NO INTERVENTIONCoblation polypectomy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- between 18-70 years old, and
- having a diagnosis of CRS.
You may not qualify if:
- previous Endoscopic Sinus Surgery,
- coagulopathies,
- being pregnant, or
- being prescribed anti-coagulants or anti-platelet agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 18, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 18, 2013
Record last verified: 2013-02