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Coblation in Endoscopic Sinus Surgery

Primary Purpose

Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coblation polypectomy
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring blood loss between two groups

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control: shaver

Coblation polypectomy

Arm Description

Outcomes

Primary Outcome Measures

Blood loss

Secondary Outcome Measures

Full Information

First Posted
February 12, 2013
Last Updated
February 14, 2013
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01793987
Brief Title
Coblation in Endoscopic Sinus Surgery
Official Title
The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
blood loss between two groups

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control: shaver
Arm Type
No Intervention
Arm Title
Coblation polypectomy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Coblation polypectomy
Primary Outcome Measure Information:
Title
Blood loss
Time Frame
intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Rotenberg, MD MPH FRCSC
Phone
5196466320
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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Coblation in Endoscopic Sinus Surgery

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