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Coblation in Endoscopic Sinus Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Brian Rotenberg, Western University, Canada.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Brian Rotenberg, Western University, Canada Identifier:
First received: February 12, 2013
Last updated: February 14, 2013
Last verified: February 2013
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
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

Resource links provided by NLM:

Further study details as provided by Brian Rotenberg, Western University, Canada:

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

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01793987

Contact: Brian Rotenberg, MD MPH FRCSC 5196466320

Canada, Ontario
St. Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Western University, Canada
  More Information

Responsible Party: Brian Rotenberg, Assistant Professor, Western University, Canada Identifier: NCT01793987     History of Changes
Other Study ID Numbers: BWR001
Study First Received: February 12, 2013
Last Updated: February 14, 2013

Keywords provided by Brian Rotenberg, Western University, Canada:
blood loss between two groups

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 21, 2017