The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
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|ClinicalTrials.gov Identifier: NCT00440219|
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyps||Drug: Oral Prednisone Drug: Placebo comparator||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||June 2013|
Experimental: Prednisone group
Prednisone 50 mg daily for 10 days immediately pre-op
Drug: Oral Prednisone
Prednisone 50 mg once daily for 10 days pre-op
Placebo Comparator: Placebo group
Placebo pill for 10 days immediately pre-operative
Drug: Placebo comparator
Placebo pill identical to Prednisone 10 days once daily pre-op
Other Name: sugar pill
- 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.
- 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.
- Quality of life survey (SNOT22) [ Time Frame: 2 weeks, 4 weeks, 3 months, 6 months post-op ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440219
|Mount Sinai Hospital, University of Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|St. Joseph's Health Centre|
|Toronto, Ontario, Canada, M6R 1B5|
|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|