Coblation in Endoscopic Sinus Surgery

Not Applicable

• Conditions: Blood Loss
• Interventions: Device: Coblation polypectomy

• Registration Number: NCT01793987
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-14
• Last Update Submitted: 2013-02-14
• Study First Posted: 2013-02-18
• Last Update Posted: 2013-02-18
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coblation polypectomy	Coblation polypectomy	-

Primary Outcome Measures

Name	Time	Method
Blood loss	intra-operative

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada