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The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus (CFT)

Primary Purpose

Disorder of Maxillary Sinus, Aspirin-sensitive Asthma With Nasal Polyps, Rhinosinusitis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Canine fossa trephine technique
Standard Endoscopic Sinus Surgery
Sponsored by
IWitterick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Maxillary Sinus focused on measuring chronic rhinosinusitis, canine fossa trephine, canine fossa puncture

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with extensively opacified maxillary sinuses on CT scanning undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
  • Patients with Eosinophilic Mucin Chronic Rhinosinusitis or fungal sinusitis disease undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
  • Patients with Recalcitrant Chronic Rhinosinusitis undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
  • Patients over the age of 18
  • Patients able to give informed consent to participate in the study

Exclusion Criteria:

  • Patients will be excluded if they are unable to undergo surgery due to co morbidities.
  • Patients with previous Caldwell-Luc procedures
  • Patients with pre existing paraesthesia of the upper teeth or gums
  • Patients with destructive lesions of the maxilla
  • Patients with systemic disease affecting the paranasal sinuses (e.g. Wegener's granulomatosis)
  • Patients immune compromised

Sites / Locations

  • Mt Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Canine fossa trephine group (CFT)

Non Canine fossa trephine group (NonCFT)

Arm Description

Outcomes

Primary Outcome Measures

Standard validated symptom scores
Chronic sinusitis survey SNOT (Sinonasal Outcome Test)22

Secondary Outcome Measures

Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Measured by using a surgeon survey
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Measured in minutes
Endoscopy scores
Grade 0: Normal mucosa with no evidence of disease Grade 1: Edematous mucosa and/or eosinophilic mucus Grade 2: Polypoidal mucosa and/or eosinophilic mucus Grade 3: Polyps and fungal debris

Full Information

First Posted
June 5, 2012
Last Updated
January 8, 2014
Sponsor
IWitterick
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1. Study Identification

Unique Protocol Identification Number
NCT01615536
Brief Title
The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
Acronym
CFT
Official Title
The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to recruit subjects
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
IWitterick

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.
Detailed Description
Chronic sinusitis (CRS) with nasal polyps and thick mucin in the sinuses adversely affects results from endoscopic sinus surgery (ESS) because failure to clear the disease leads to ongoing inflammation and symptoms. In particular a subset of CRS patients with thick eosinophilic mucin (EMCRS) develop recurrent symptoms and require further surgeries. ESS techniques for the maxillary sinus requires a WMA in the side wall of the sinus and the use of curved debrider instruments to clear the polyps. Sometimes this doesn't provide access to the inferior/floor and anterior/front aspects of the maxillary sinus due to the fact that the maxillary sinus is on the side of the nasal cavity at an angle. The CFT through the front wall of the sinus was developed years ago as an alternative approach to improve access to these areas. Both techniques are acceptable standard treatments and which one is initially used to address the maxillary sinus currently depends on surgeon preference. The role of CFT has been studied by Sathanatar et al (Laryngoscope 2005) and Lee et al (Laryngoscope 2008) which provided conflicting results. Differences in their study patients and methodology could explain the different outcomes. Hence this study is proposed to clarify the role of CFT in patients with extensive maxillary sinus disease to see whether initial use of CFT is more helpful than WMA in the severely diseased maxillary sinus with polyps and mucin. Findings from this study may improve surgical outcomes for CRS patients in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Maxillary Sinus, Aspirin-sensitive Asthma With Nasal Polyps, Rhinosinusitis
Keywords
chronic rhinosinusitis, canine fossa trephine, canine fossa puncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canine fossa trephine group (CFT)
Arm Type
Experimental
Arm Title
Non Canine fossa trephine group (NonCFT)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Canine fossa trephine technique
Other Intervention Name(s)
Canine fossa puncture
Intervention Description
Patients undergoing standard ESS and a canine fossa trephine technique, which is a 6 mm puncture in the anterior wall of the maxillary sinus, to allow standard sinus debrider blades and instruments to pass into the sinus to clear polyps in the maxillary sinus.
Intervention Type
Procedure
Intervention Name(s)
Standard Endoscopic Sinus Surgery
Other Intervention Name(s)
Functional Endoscopic Sinus Surgery
Intervention Description
Patients undergoing standard ESS without canine fossa trephination with clearance of the maxillary sinus polyps via a wide maxillary antrostomy (WMA) with use of curved debrider surgical blades and instruments.
Primary Outcome Measure Information:
Title
Standard validated symptom scores
Description
Chronic sinusitis survey SNOT (Sinonasal Outcome Test)22
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Description
Measured by using a surgeon survey
Time Frame
Measured during surgery
Title
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Description
Measured in minutes
Time Frame
At the time of surgery
Title
Endoscopy scores
Description
Grade 0: Normal mucosa with no evidence of disease Grade 1: Edematous mucosa and/or eosinophilic mucus Grade 2: Polypoidal mucosa and/or eosinophilic mucus Grade 3: Polyps and fungal debris
Time Frame
Measured at 2,6, 12 months

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: Patients with extensively opacified maxillary sinuses on CT scanning undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis Patients with Eosinophilic Mucin Chronic Rhinosinusitis or fungal sinusitis disease undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis Patients with Recalcitrant Chronic Rhinosinusitis undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis Patients over the age of 18 Patients able to give informed consent to participate in the study Exclusion Criteria: Patients will be excluded if they are unable to undergo surgery due to co morbidities. Patients with previous Caldwell-Luc procedures Patients with pre existing paraesthesia of the upper teeth or gums Patients with destructive lesions of the maxilla Patients with systemic disease affecting the paranasal sinuses (e.g. Wegener's granulomatosis) Patients immune compromised
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian J Witterick, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1H4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15933514
Citation
Sathananthar S, Nagaonkar S, Paleri V, Le T, Robinson S, Wormald PJ. Canine fossa puncture and clearance of the maxillary sinus for the severely diseased maxillary sinus. Laryngoscope. 2005 Jun;115(6):1026-9. doi: 10.1097/01.MLG.0000162651.22019.4A.
Results Reference
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PubMed Identifier
18388769
Citation
Lee JY, Lee SH, Hong HS, Lee JD, Cho SH. Is the canine fossa puncture approach really necessary for the severely diseased maxillary sinus during endoscopic sinus surgery? Laryngoscope. 2008 Jun;118(6):1082-7. doi: 10.1097/MLG.0b013e318169028d.
Results Reference
background
PubMed Identifier
7715384
Citation
Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 1995 Apr;105(4 Pt 1):387-90. doi: 10.1288/00005537-199504000-00010.
Results Reference
background
PubMed Identifier
17621816
Citation
Singhal D, Douglas R, Robinson S, Wormald PJ. The incidence of complications using new landmarks and a modified technique of canine fossa puncture. Am J Rhinol. 2007 May-Jun;21(3):316-9. doi: 10.2500/ajr.2007.21.3022.
Results Reference
background
PubMed Identifier
8140385
Citation
Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available.
Results Reference
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The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus

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