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

Rhinosinusitis Clinical Trial

— CFT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01615536
• Other study ID #: 09-0211-A
• Status: Withdrawn
• Phase: N/A
• First received: June 5, 2012
• Last updated: January 8, 2014
• Start date: December 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Mt Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
IWitterick

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 1995 Apr;105(4 Pt 1):387-90. — View 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. — View Citation

Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard validated symptom scores	Chronic sinusitis survey; SNOT (Sinonasal Outcome Test)22	6 months	No
Secondary	Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)	Measured by using a surgeon survey	Measured during surgery	No
Secondary	Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups	Measured in minutes	At the time of surgery	No
Secondary	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	Measured at 2,6, 12 months	No