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

Condition(s) targeted: Nasal Polyps

Intervention: Prednisone (Drug); Placebo comparator (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Official(s) and/or principal investigator(s):
Ian Witterick, MD FRCSC, Principal Investigator, Affiliation: University of Toronto Department of Otolaryngology-Head and Neck Surgery
Randy M Leung, BSc MD, Study Director, Affiliation: University of Toronto Department of Otolaryngology-Head and Neck Surgery

Overall contact:
Ian Witterick, MD FRCSC, Phone: 416-586-4800, Ext: 8313, Email: iwitterick@mtsinai.on.ca

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Time spent suctioning/wiping scope (absolute and relative to total surgery time), total surgery time (from video)

Surgeon surveys

Intraoperative blood loss

Secondary outcome: Quality of life (SNOT20, SF36)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Ian Witterick, MD FRCSC, Phone: 416-586-4800, Ext: 8313, Email: iwitterick@mtsinai.on.ca

Mount Sinai Hospital, University of Toronto, Toronto, Ontario M5G 1X5, Canada; Recruiting

St. Joseph's Health Centre, Toronto, Ontario M6R 1B5, Canada; Recruiting

Related publications:

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.

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. Epub 2006 May 19.

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.

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.

Starting date: November 2007
Ending date: December 2009
Last updated: July 28, 2009