Coblation in Endoscopic Sinus Surgery

NCT ID: NCT01793987

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

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

Conditions

Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control: shaver

Group Type: NO_INTERVENTION

No interventions assigned to this group

Coblation polypectomy

Group Type: EXPERIMENTAL

Coblation polypectomy

Intervention Type: DEVICE

Interventions

Coblation polypectomy

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Brian Rotenberg

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

Central Contacts

Brian Rotenberg, MD MPH FRCSC

Role: CONTACT

5196466320

Other Identifiers

BWR001

Identifier Type: -

Identifier Source: org_study_id