The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Standard validated symptom scores
研究概览
简要总结
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Standard validated symptom scores
时间窗: 6 months
1. Chronic sinusitis survey 2. SNOT (Sinonasal Outcome Test)22
次要结局
- Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)(Measured during surgery)
- Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups(At the time of surgery)
- Endoscopy scores(Measured at 2,6, 12 months)
研究者
IWitterick
Otolaryngologist Head-Neck Surgeon
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
