The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
Primary Purpose
Nasal Polyps
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Oral Prednisone
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Polyps focused on measuring Nasal polyps, Steroids, Prednisone, Nasal polypectomy, Blood loss, surgical
Eligibility 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
Sites / Locations
- Mount Sinai Hospital, University of Toronto
- St. Joseph's Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prednisone group
Placebo group
Arm Description
Prednisone 50 mg daily for 10 days immediately pre-op
Placebo pill for 10 days immediately pre-operative
Outcomes
Primary Outcome Measures
Intraoperative blood loss. Wormald Surgical Field Grading Scale
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
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
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)
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.
Full Information
NCT ID
NCT00440219
First Posted
February 22, 2007
Last Updated
January 8, 2014
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00440219
Brief Title
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
Official Title
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps
Keywords
Nasal polyps, Steroids, Prednisone, Nasal polypectomy, Blood loss, surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone group
Arm Type
Experimental
Arm Description
Prednisone 50 mg daily for 10 days immediately pre-op
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo pill for 10 days immediately pre-operative
Intervention Type
Drug
Intervention Name(s)
Oral Prednisone
Other Intervention Name(s)
steroids, corticosteroids
Intervention Description
Prednisone 50 mg once daily for 10 days pre-op
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo pill identical to Prednisone 10 days once daily pre-op
Primary Outcome Measure Information:
Title
Intraoperative blood loss. Wormald Surgical Field Grading Scale
Description
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.
Time Frame
Intraoperative
Title
Visibility and easy of surgery
Description
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.
Time Frame
Immediate Postoperative period
Title
Endoscopic assessment
Description
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.
Time Frame
4 weeks, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Quality of life survey (SNOT22)
Description
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.
Time Frame
2 weeks, 4 weeks, 3 months, 6 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Witterick, MD FRCSC
Organizational Affiliation
University of Toronto Department of Otolaryngology-Head and Neck Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Randy M Leung, BSc MD
Organizational Affiliation
University of Toronto Department of Otolaryngology-Head and Neck Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai Hospital, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
8094111
Citation
O'Driscoll BR, Kalra S, Wilson M, Pickering CA, Carroll KB, Woodcock AA. Double-blind trial of steroid tapering in acute asthma. Lancet. 1993 Feb 6;341(8841):324-7. doi: 10.1016/0140-6736(93)90134-3.
Results Reference
background
PubMed Identifier
16815148
Citation
Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.
Results Reference
background
PubMed Identifier
10779190
Citation
Johansson L, Akerlund A, Holmberg K, Melen I, Stierna P, Bende M. Evaluation of methods for endoscopic staging of nasal polyposis. Acta Otolaryngol. 2000 Jan;120(1):72-6. doi: 10.1080/000164800760370873.
Results Reference
background
PubMed Identifier
16900802
Citation
Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702.
Results Reference
background
PubMed Identifier
17989575
Citation
Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.
Results Reference
background
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The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
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