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The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study
This study is currently recruiting participants.
Study NCT00440219   Information provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
First Received: February 22, 2007   Last Updated: July 28, 2009   History of Changes

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Contact: Ian Witterick, MD FRCSC 416-586-4800 ext 8313 iwitterick@mtsinai.on.ca
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP