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

This study has been withdrawn prior to enrollment.
(Inability to recruit subjects)
Sponsor:
Information provided by (Responsible Party):
IWitterick, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01615536
First received: June 5, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.


Condition Intervention
Disorder of Maxillary Sinus
Aspirin-sensitive Asthma With Nasal Polyps
Rhinosinusitis
Procedure: Canine fossa trephine technique
Procedure: Standard Endoscopic Sinus Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Standard validated symptom scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    1. Chronic sinusitis survey
    2. SNOT (Sinonasal Outcome Test)22


Secondary Outcome Measures:
  • Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus) [ Time Frame: Measured during surgery ] [ Designated as safety issue: No ]
    Measured by using a surgeon survey

  • Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
    Measured in minutes

  • Endoscopy scores [ Time Frame: Measured at 2,6, 12 months ] [ Designated as safety issue: No ]
    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


Enrollment: 0
Study Start Date: December 2010
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Functional Endoscopic Sinus Surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615536

Locations
Canada, Ontario
Mt Sinai Hospital
Toronto, Ontario, Canada, M5G 1H4
Sponsors and Collaborators
IWitterick
Investigators
Principal Investigator: Ian J Witterick, MD Mount Sinai Hospital, New York
  More Information

Publications:
Responsible Party: IWitterick, Otolaryngologist Head-Neck Surgeon, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01615536     History of Changes
Other Study ID Numbers: 09-0211-A
Study First Received: June 5, 2012
Last Updated: January 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
chronic rhinosinusitis
canine fossa trephine
canine fossa puncture

Additional relevant MeSH terms:
Nasal Polyps
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 22, 2014