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Coblation in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Brian Rotenberg, Western University, Canada

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

Condition or disease Intervention/treatment Phase
Blood Loss Device: Coblation polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
Study Start Date : May 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
No Intervention: control: shaver
Experimental: Coblation polypectomy Device: Coblation polypectomy

Primary Outcome Measures :
  1. Blood loss [ Time Frame: intra-operative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01793987

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Contact: Brian Rotenberg, MD MPH FRCSC 5196466320

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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Western University, Canada
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Responsible Party: Brian Rotenberg, Assistant Professor, Western University, Canada Identifier: NCT01793987    
Other Study ID Numbers: BWR001
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Keywords provided by Brian Rotenberg, Western University, Canada:
blood loss between two groups
Additional relevant MeSH terms:
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Pathologic Processes