Coblation in Endoscopic Sinus Surgery

Western University, Canada

Status: Unknown

Conditions: Blood Loss

Treatments: Device: Coblation polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01793987

BWR001

Details and patient eligibility

About

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

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

control: shaver

No Intervention group

Coblation polypectomy

Experimental group

Treatment:

Device: Coblation polypectomy