The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

Study 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 .

Official Title
-----------------
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

Conditions
-----------------
Nasal Polyps

Intervention / Treatment
-----------------
* Drug: Oral Prednisone
* Drug: Placebo comparator


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone group<br>Prednisone 50 mg daily for 10 days immediately pre-op | Drug: Oral Prednisone<br>* Prednisone 50 mg once daily for 10 days pre-op<br>* Other names: corticosteroids;|
| Placebo Comparator: Placebo group<br>Placebo pill for 10 days immediately pre-operative | Drug: Placebo comparator<br>* Placebo pill identical to Prednisone 10 days once daily pre-op<br>* Other names: sugar pill;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss. Wormald Surgical Field Grading Scale | 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. | Intraoperative | 
| Visibility and easy of surgery | 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. | Immediate Postoperative period | 
| Endoscopic assessment | 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. | 4 weeks, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life survey (SNOT22) | The Sino-nasal Outcome Test - 22 (SNOT-22) will be used as the main instrument to assess patients' disease specific symptoms. The total score from the SNOT-22 at 3 months follow-up will be the main outcome. The profile of symptom scores over the full follow-up period will be a secondary outcome. | 2 weeks, 4 weeks, 3 months, 6 months post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal polyps, Steroids, Prednisone, Nasal polypectomy, Blood loss, surgical