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Coblation in Endoscopic Sinus Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Western University, Canada
Sponsor:
Information provided by (Responsible Party):
Brian Rotenberg, Western University, Canada
ClinicalTrials.gov Identifier:
NCT01793987
First received: February 12, 2013
Last updated: February 14, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Western University, Canada:

Primary Outcome Measures:
  • 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
Criteria

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 ClinicalTrials.gov identifier: NCT01793987

Contacts
Contact: Brian Rotenberg, MD MPH FRCSC 5196466320

Locations
Canada, Ontario
St. Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Western University, Canada
  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 November 27, 2014