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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone group | Experimental | Prednisone 50 mg daily for 10 days immediately pre-op |
|
| Placebo group | Placebo Comparator | Placebo pill for 10 days immediately pre-operative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Prednisone | Drug | Prednisone 50 mg once daily for 10 days pre-op |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Witterick, MD FRCSC | University of Toronto Department of Otolaryngology-Head and Neck Surgery | Principal Investigator |
| Randy M Leung, BSc MD | University of Toronto Department of Otolaryngology-Head and Neck Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital, University of Toronto | Toronto | Ontario | M5G 1X5 | Canada | ||
| St. Joseph's Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8094111 | Background | O'Driscoll BR, Kalra S, Wilson M, Pickering CA, Carroll KB, Woodcock AA. Double-blind trial of steroid tapering in acute asthma. Lancet. 1993 Feb 6;341(8841):324-7. doi: 10.1016/0140-6736(93)90134-3. | |
| 16815148 | Background | Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D013256 | Steroids |
| D000305 | Adrenal Cortex Hormones |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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| Placebo comparator | Drug | Placebo pill identical to Prednisone 10 days once daily pre-op |
|
|
| Toronto |
| Ontario |
| M6R 1B5 |
| Canada |
| 10779190 | Background | Johansson L, Akerlund A, Holmberg K, Melen I, Stierna P, Bende M. Evaluation of methods for endoscopic staging of nasal polyposis. Acta Otolaryngol. 2000 Jan;120(1):72-6. doi: 10.1080/000164800760370873. |
| 16900802 | Background | Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702. |
| 17989575 | Background | Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D007431 | Intraoperative Complications |
| D011083 |
| Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002241 | Carbohydrates |