Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial Comparing Gloved Merocel and Silastic Middle Meatal Spacers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.
排除标准
- •Patients with sino-nasal tumors
- •Patients solely undergoing nasal septal reconstruction
- •Patients with previous history of endoscopic sinus surgery
- •Cystic fibrosis or syndromic patients
- •Patients with autoimmune diseases
研究组 & 干预措施
Silastic Spacer
This study arm receives the experimental treatment, a Silastic spacer.
干预措施: Silastic Spacer (Device)
Merocel Spacer
Merocel spacers are actively being used as the standard of care.
干预措施: Merocel Spacer (Device)
结局指标
主要结局
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
时间窗: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers.
次要结局
- Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.(Participants will be followed for the duration of post op standard of care, an expected average of 90 days.)
研究者
Amin Javer
Director, St. Paul's Sinus Centre
St. Paul's Hospital, Canada