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

NCT00440219 | Completed Phase 3 DMC

• 1 other identifier: 07-0001-A
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasal Polyps

Keywords

Nasal polyps; Steroids; Prednisone; Nasal polypectomy; Blood loss, surgical

Outcome Measures

Primary Outcomes (3)

• 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.

  Intraoperative

• 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.

  Immediate Postoperative period

• 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.

  4 weeks, 3 months, 6 months

Secondary Outcomes (1)

• Quality of life survey (SNOT22)

  2 weeks, 4 weeks, 3 months, 6 months post-op

Study Arms (2)

Prednisone group

EXPERIMENTAL

Prednisone 50 mg daily for 10 days immediately pre-op

Drug: Oral Prednisone

Placebo group

PLACEBO COMPARATOR

Placebo pill for 10 days immediately pre-operative

Drug: Placebo comparator

Interventions

Oral Prednisone DRUG

Prednisone 50 mg once daily for 10 days pre-op

Also known as: steroids, corticosteroids

Prednisone group

Placebo comparator DRUG

Placebo pill identical to Prednisone 10 days once daily pre-op

Also known as: sugar pill

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with severe obstructing nasal polyps scheduled for surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (2)

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Related Publications (5)

• 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.

  PMID: 8094111 BACKGROUND

• 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.

  PMID: 16815148 BACKGROUND

• 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.

  PMID: 10779190 BACKGROUND

• 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.

  PMID: 16900802 BACKGROUND

• 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.

  PMID: 17989575 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps; Blood Loss, Surgical

Interventions

Prednisone; Steroids; Adrenal Cortex Hormones; Sugars

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Carbohydrates

Study Officials

• Ian Witterick, MD FRCSC

  University of Toronto Department of Otolaryngology-Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

• Randy M Leung, BSc MD

  University of Toronto Department of Otolaryngology-Head and Neck Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist Head-Neck Surgeon

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

CA (2)