Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lund-Kennedy Endoscopy Score (LKES)
研究概览
简要总结
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
- •Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
- •These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.
- •These symptoms must include at least one of the following:
- •nasal obstruction
- •rhinorrhea
- •postnasal drip.
- •Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
- •These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes.
- •The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).
排除标准
- •Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
- •Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
- •Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
研究组 & 干预措施
Steroid
The steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).
干预措施: Prednisone (Drug)
Placebo
The placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Lund-Kennedy Endoscopy Score (LKES)
时间窗: 12 weeks
Objective endoscopic measure of sino-nasal mucosal health
次要结局
- Sino-nasal Outcomes Test (SNOT-22)(12 weeks)
- Boezaart bleeding score(Day of surgery)
- Estimated blood loss(Day of surgery)
- Difficulty of surgery score(Day of surgery)
研究者
Kristin Seiberling, MD
Physician
Loma Linda University