Coblation in Endoscopic Sinus Surgery
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Purpose
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
| Condition | Intervention |
|---|---|
|
Blood Loss |
Device: Coblation polypectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial |
- Blood loss [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 22 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: control: shaver | |
| Experimental: Coblation polypectomy | Device: Coblation polypectomy |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- between 18-70 years old, and
- having a diagnosis of CRS.
Exclusion Criteria:
- previous Endoscopic Sinus Surgery,
- coagulopathies,
- being pregnant, or
- being prescribed anti-coagulants or anti-platelet agents
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Brian Rotenberg, Assistant Professor, Western University, Canada |
| ClinicalTrials.gov Identifier: | NCT01793987 History of Changes |
| Other Study ID Numbers: | BWR001 |
| Study First Received: | February 12, 2013 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Western University, Canada:
|
blood loss between two groups |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013