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Coblation in Endoscopic Sinus Surgery

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ClinicalTrials.gov Identifier: NCT01793987
Recruitment Status : Unknown
Verified February 2013 by Brian Rotenberg, Western University, Canada.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2013
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):
Brian Rotenberg, Western University, Canada

February 12, 2013
February 18, 2013
February 18, 2013
May 2013
May 2014   (Final data collection date for primary outcome measure)
Blood loss [ Time Frame: intra-operative ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Coblation in Endoscopic Sinus Surgery
The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
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
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Blood Loss
Device: Coblation polypectomy
  • No Intervention: control: shaver
  • Experimental: Coblation polypectomy
    Intervention: Device: Coblation polypectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
22
Same as current
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01793987
BWR001
No
Not Provided
Not Provided
Brian Rotenberg, Western University, Canada
Western University, Canada
Not Provided
Not Provided
Western University, Canada
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP