Clinical Trials Directory

Trials / Unknown

UnknownNCT01793987

Coblation in Endoscopic Sinus Surgery

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
22 (estimated)
Sponsor
Western University, Canada · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICECoblation polypectomy

Timeline

Start date
2013-05-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-02-18
Last updated
2013-02-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01793987. Inclusion in this directory is not an endorsement.