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

IWitterick

Status

Withdrawn

Conditions

Rhinosinusitis

Aspirin-sensitive Asthma With Nasal Polyps

Disorder of Maxillary Sinus

Treatments

Procedure: Canine fossa trephine technique

Procedure: Standard Endoscopic Sinus Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01615536

09-0211-A

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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