Clinical trial NCT01615536: The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
Official title: The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Disorder of Maxillary Sinus
Aspirin-sensitive Asthma With Nasal Polyps
Rhinosinusitis
Keywords: chronic rhinosinusitis
canine fossa trephine
canine fossa puncture
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Standard validated symptom scores
timeFrame: 6 months
Secondary outcomes:
measure: Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
timeFrame: Measured during surgery
measure: Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
timeFrame: At the time of surgery
measure: Endoscopy scores
timeFrame: Measured at 2,6, 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mt Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Ian J Witterick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available.