The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
Overview
- Phase
- Phase 3
- Intervention
- Oral Prednisone
- Conditions
- Nasal Polyps
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Endoscopic assessment
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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 .
Investigators
IWitterick
Otolaryngologist Head-Neck Surgeon
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria
Inclusion Criteria
- •All patients with severe obstructing nasal polyps scheduled for surgery.
Exclusion Criteria
- •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
Arms & Interventions
Prednisone group
Prednisone 50 mg daily for 10 days immediately pre-op
Intervention: Oral Prednisone
Placebo group
Placebo pill for 10 days immediately pre-operative
Intervention: Placebo comparator
Outcomes
Primary Outcomes
Endoscopic assessment
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Quality of life survey (SNOT22)(2 weeks, 4 weeks, 3 months, 6 months post-op)