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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IWitterick, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00440219
First received: February 22, 2007
Last updated: January 8, 2014
Last verified: January 2014
  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: Oral Prednisone
Drug: Placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Intraoperative blood loss. Wormald Surgical Field Grading Scale [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Quality of life survey (SNOT22) [ Time Frame: 2 weeks, 4 weeks, 3 months, 6 months post-op ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 34
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 .

  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
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, see Learn About Clinical Studies.

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

Locations
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
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:
Responsible Party: IWitterick, Otolaryngologist Head-Neck Surgeon, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00440219     History of Changes
Other Study ID Numbers: 07-0001-A
Study First Received: February 22, 2007
Last Updated: January 8, 2014
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

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014