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The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440219
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : January 10, 2014
Information provided by (Responsible Party):
IWitterick, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Nasal Polyps Drug: Oral Prednisone Drug: Placebo comparator Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
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
Other Names:
  • steroids
  • corticosteroids

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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00440219

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Canada, Ontario
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, Canada, M5G 1X5
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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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
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Responsible Party: IWitterick, Otolaryngologist Head-Neck Surgeon, Samuel Lunenfeld Research Institute, Mount Sinai Hospital Identifier: NCT00440219    
Other Study ID Numbers: 07-0001-A
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by IWitterick, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Nasal polyps
Nasal polypectomy
Blood loss, surgical
Additional relevant MeSH terms:
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Nasal Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents