Not provided
Not provided
Not provided
Not provided
Inability to recruit subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canine fossa trephine group (CFT) | Experimental |
| |
| Non Canine fossa trephine group (NonCFT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canine fossa trephine technique | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standard validated symptom scores |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian J Witterick, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt Sinai Hospital | Toronto | Ontario | M5G 1H4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15933514 | Background | 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. | |
| 18388769 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard Endoscopic Sinus Surgery | Procedure | 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. |
|
|
Measured in minutes |
| At the time of surgery |
| Endoscopy scores |
| Measured at 2,6, 12 months |
| 7715384 | Background | 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. |
| 17621816 | Background | 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. |
| 8140385 | Background | Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available. |
| D010254 |
| Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |