Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Intra-operative blood loss - 1
研究概览
简要总结
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.
详细描述
The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated.
During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.
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)
盲法说明
Clinicians grading blood loss and surgical field disability on the recorded video footage will be blinded to patient identity and group status. Data analysis will be done by a blinded assessor.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery
排除标准
- •Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.
研究组 & 干预措施
Pre-operative oral steroids
Patients will be given a course of oral prednisone (30mg daily) for 5 days.
干预措施: Prednisone (Drug)
结局指标
主要结局
Intra-operative blood loss - 1
时间窗: Intra-operative
Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])
Intra-operative blood loss - 2
时间窗: Intra-operative
Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])
Surgical field visibility
时间窗: Intra-operative
Blinded assessor's grading of surgical field visualization
次要结局
- Patient intolerance of steroids(Pre-operative)