Coblation in Endoscopic Sinus Surgery

Blood Loss Clinical Trial

Official title:

The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01793987
• Other study ID #: BWR001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2013
• Last updated: February 14, 2013
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2013
• Source: Western University, Canada
• Contact: Brian Rotenberg, MD MPH FRCSC
• Phone: 5196466320
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• Coblation polypectomy

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss		intra-operative	No