The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Endoscopic assessment
研究概览
简要总结
This study aims to determine if a short course of oral prednisone helps to improve the operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.
详细描述
This study will be conducted as a double blinded randomized control trial and aims to recruit about 34 patients (17 patients per arm). Patients will be randomized to receive either prednisone 50 mg po x10 days or an identical looking placebo x10 days. Photographs of the polyps will be taken prior to the intervention, on the day of surgery and in the follow-up visit. Symptom survey (SNOT22) will also be administered at these same time points. Blood loss will be determined volumetrically from the suction canister and by using the Wormald Surgical field grading scale. Surgeons will also complete a survey postoperatively evaluating visibility, difficulty and ease of surgery. At 2 weeks, 1 month, 3 months and 6 months, patients will again fill out the Sino-nasal Outcome Test - 22 (SNOT-22) and the surgeon will do an endoscopic assessment by using the Peri-Operative Sinus Endoscopy (POSE) scoring system .
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with severe obstructing nasal polyps scheduled for surgery.
排除标准
- •Patient unable to tolerate side effects of prednisone
- •Uncontrolled diabetes mellitus
- •Hypertension
- •Previous congestive heart failure
- •Acute/chronic systemic infection
- •History of hypersensitivity to prednisone
- •History of cataracts or glaucoma
研究组 & 干预措施
Prednisone group
Prednisone 50 mg daily for 10 days immediately pre-op
干预措施: Oral Prednisone (Drug)
Placebo group
Placebo pill for 10 days immediately pre-operative
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Endoscopic assessment
时间窗: 4 weeks, 3 months, 6 months
The Peri-Operative Sinus Endoscopy (POSE) scoring system (total score) will be used to assess the condition of the patients' sinus cavities and the Lindholdt scale will be used to provide objective measures of polyp recurrence size based on the percent obstruction of the nasal cavity and obstruction based on anatomic location.
Intraoperative blood loss. Wormald Surgical Field Grading Scale
时间窗: Intraoperative
This is an 11-point validated scale designed to provide a standardized method of documenting bleeding in endoscopic sinus surgery \[Athanasiadis et al., 2007\]. In addition blood loss during the surgery will be calculated from the suction canisters after accounting for the amount of irrigation used.
Visibility and easy of surgery
时间窗: Immediate Postoperative period
The surgeon will assess visibility and easy of surgery during the surgery and the technical difficulty of the surgery using two visual analogue scale questions.
次要结局
- Quality of life survey (SNOT22)(2 weeks, 4 weeks, 3 months, 6 months post-op)
研究者
IWitterick
Otolaryngologist Head-Neck Surgeon
Samuel Lunenfeld Research Institute, Mount Sinai Hospital