The Efficacy of Debridement of the Sinus Cavity Following Primary Functional Endoscopic Sinus Surgery (FESS): A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Postoperative Synechiae
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is the gold standard surgical intervention for management of patients with chronic rhinosinusitis (CRS). Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery after FESS. Nasal debridement is a postoperative procedure used in the prevention of synechiae formation. This procedure lacks standardized evidence-based guidelines. The currently existing studies that have been conducted to determine the efficacy of post-operative debridement have shown conflicting results. We hypothesize that there is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
详细描述
Purpose The purpose of this study is to assess the efficacy of post-FESS nasal debridements in the prevention of post-operative synechiae formation.
Hypothesis There is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
Justification To prevent synechiae formation, many studies have been published evaluating the efficacy of post-operative debridement procedures. Many of these studies have shown conflicting results. There were many inconsistent variables between the studies, such as limited follow-up periods, varying extent of surgery, and variability in pre and post-operative treatment.
With a well designed study, we would like to assess if there is a difference in the incidence of formation of middle meatal synechiae between patients who have debridement and patients who don't.
This will further add much needed evidence to the need for this procedure in the post operative period following FESS.
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 (Investigator)
盲法说明
The patient will know if he/she is getting debridement or not. The PI will comment on all the objective outcome measures and will be the blinded assessor (he will not perform the debridements).
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
- •Over the age of 19;
- •Have chronic sinus disease (CRS) and are scheduled to undergo sinus surgery on both sides of your nose for the first time.
排除标准
- •Unable to speak English;
- •Are having surgery for the removal of a nasal tumor;
- •Have a disorder of your immune system in which your body's immune system attacks itself (autoimmune disorder)
- •Diagnosed with cystic fibrosis
- •Have had sinus surgery in the past
- •Are scheduled to have a procedure known as nasal septal reconstruction, without additional sinus surgery
研究组 & 干预措施
Debridement group
Patients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments.
干预措施: Debridement (Procedure)
Non Debridement Group
Patients will not receive debridement at any follow up visit after surgery. They will continue with saline irrigation.
结局指标
主要结局
Change in Postoperative Synechiae
时间窗: Day 30, 60, 90, and 180 follow-up visits.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence).
次要结局
- Sinonasal Outcomes Test - 22 (SNOT-22)(Day 30, 60, 90, and 180 follow-up visits.)
- Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)(Day 30, 60, 90, and 180 follow-up visits.)
- Visual Analog Score (VAS) for pain and discomfort(Day 6, 30, 60, 90, and 180 follow-up visits.)
研究者
Amin Javer
Director, St. Paul's Sinus Centre
St. Paul's Hospital, Canada