Clinical trial NCT00440219: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Polyps
Keywords: Nasal polyps
Steroids
Prednisone
Nasal polypectomy
Blood loss, surgical
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2007-02-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: Intraoperative blood loss. Wormald Surgical Field Grading Scale
timeFrame: Intraoperative
measure: Visibility and easy of surgery
timeFrame: Immediate Postoperative period
measure: Endoscopic assessment
timeFrame: 4 weeks, 3 months, 6 months
Secondary outcomes:
measure: Quality of life survey (SNOT22)
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months post-op
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital, University of Toronto
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: University of Toronto Department of Otolaryngology-Head and Neck Surgery
name: Ian Witterick, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto Department of Otolaryngology-Head and Neck Surgery
name: Randy M Leung, BSc MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.