An interventional study of Canine fossa trephine technique and Standard Endoscopic Sinus Surgery in Disorder of Maxillary Sinus, Aspirin-sensitive Asthma With Nasal Polyps and Rhinosinusitis, sponsored by IWitterick. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-01-10.
Sponsored by IWitterick · Not applicable, Interventional, and Treatment
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.
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.
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Exclusion Criteria:
Procedure: Canine fossa trephine technique
Procedure: Standard Endoscopic Sinus Surgery
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.
Also known as: Canine fossa puncture
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.
Also known as: Functional Endoscopic Sinus Surgery
Standard validated symptom scores
1. Chronic sinusitis survey 2. SNOT (Sinonasal Outcome Test)22
Time frame: 6 months
Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Measured by using a surgeon survey
Time frame: Measured during surgery
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Measured in minutes
Time frame: At the time of surgery
Endoscopy scores
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
Time frame: Measured at 2,6, 12 months
This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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