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The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study

This study is not yet open for participant recruitment.
Verified by Samuel Lunenfeld Research Institute, Mount Sinai Hospital, March 2007

Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00440219
  Purpose

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.


Condition Intervention Phase
Nasal Polyps
Drug: Prednisone
Phase II

ChemIDplus related topics:   Prednisone    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Time spent suctioning/wiping scope (absolute and relative to total surgery time), total surgery time (from video)
  • Surgeon surveys
  • Intraoperative blood loss

Secondary Outcome Measures:
  • Quality of life (SNOT20, SF36)

Estimated Enrollment:   40
Study Start Date:   March 2007
Estimated Study Completion Date:   September 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440219

Contacts
Contact: Ian Witterick, MD FRCSC     416-586-4800 ext 8313     iwitterick@mtsinai.on.ca    

Locations
Canada, Ontario
Mount Sinai Hospital, University of Toronto     Not yet recruiting
      Toronto, Ontario, Canada, M5G 1X5
St. Joseph's Health Centre     Not yet recruiting
      Toronto, Ontario, Canada, M6R 1B5

Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators
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    
  More Information

Publications:

Study ID Numbers:   07-0001-A
First Received:   February 22, 2007
Last Updated:   March 6, 2007
ClinicalTrials.gov Identifier:   NCT00440219
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Nasal polyps  
Steroids  
Prednisone  
Nasal polypectomy  
Blood loss, surgical  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Nasal Polyps
Prednisone
Otorhinolaryngologic Diseases
Salicylsalicylic acid
Sodium Salicylate
Blood Loss, Surgical
Polyps
Hemorrhage

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on August 29, 2008




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