| February 22, 2007 |
| July 28, 2009 |
| November 2007 |
| November 2009 (final data collection date for primary outcome measure) |
- Time spent suctioning/wiping scope (absolute and relative to total surgery time), total surgery time (from video) [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
- Surgeon surveys [ Time Frame: Immediate Postoperative period ] [ Designated as safety issue: No ]
- Intraoperative blood loss [ Time Frame: Immediately postoperative ] [ Designated as safety issue: No ]
|
- Time spent suctioning/wiping scope (absolute and relative to total surgery time), total surgery time (from video)
- Surgeon surveys
- Intraoperative blood loss
|
| Complete list of historical versions of study NCT00440219 on ClinicalTrials.gov Archive Site |
| Quality of life (SNOT20, SF36) [ Time Frame: 2 weeks, 4 weeks, 6 months, 12 months post-op ] [ Designated as safety issue: No ] |
| Quality of life (SNOT20, SF36) |
| |
| The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study |
| The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study |
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 40 patients. 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 and on the day of surgery. Symptom surveys (SNOT20, SF36) will also be administered at these same time points. Video recordings of the surgery will be obtained to evaluate ease of surgery. Blood loss will be determined volumetrically from the suction canister. Surgeons will also complete a survey postoperatively evaluating visibility and difficulty. At 2 weeks, 1 month, 6 months and 1 year, patients will again fill out the SNOT20 and SF36 surveys. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Nasal Polyps |
- Drug: Prednisone
- Drug: Placebo comparator
|
- Experimental: Prednisone 50 mg daily for 10 days immediately pre-op
- Placebo Comparator: Placebo pill for 10 days immediately pre-operative
|
- 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.
- 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. Epub 2006 May 19.
- 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.
- 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.
|
| |
| Recruiting |
| 40 |
| December 2009 |
| November 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00440219 |
| Ian Witterick, Mt. Sinai Hospital |
| 07-0001-A |
| Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
|
| Principal Investigator: |
Ian Witterick, MD FRCSC |
University of Toronto Department of Otolaryngology-Head and Neck Surgery |
|
| Study Director: |
Randy M Leung, BSc MD |
University of Toronto Department of Otolaryngology-Head and Neck Surgery |
|
|
| Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| July 2009 |