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

January 8, 2014 updated by: IWitterick
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1H4
        • Mt Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canine fossa trephine group (CFT)
Procedure: Canine fossa trephine technique
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.
Other Names:
  • Canine fossa puncture
Active Comparator: Non Canine fossa trephine group (NonCFT)
Procedure: Standard Endoscopic Sinus Surgery
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.
Other Names:
  • Functional Endoscopic Sinus Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard validated symptom scores
Time Frame: 6 months
  1. Chronic sinusitis survey
  2. SNOT (Sinonasal Outcome Test)22
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Time Frame: Measured during surgery
Measured by using a surgeon survey
Measured during surgery
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Time Frame: At the time of surgery
Measured in minutes
At the time of surgery
Endoscopy scores
Time Frame: Measured at 2,6, 12 months
  1. Grade 0: Normal mucosa with no evidence of disease
  2. Grade 1: Edematous mucosa and/or eosinophilic mucus
  3. Grade 2: Polypoidal mucosa and/or eosinophilic mucus
  4. Grade 3: Polyps and fungal debris
Measured at 2,6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWitterick

Investigators

  • Principal Investigator: Ian J Witterick, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0211-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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