The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy. - Full Text View

Sponsor:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00440219

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: Prednisone Drug: Placebo comparator	Phase III

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:

Drug Information available for: Prednisone

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Prednisone 50 mg daily for 10 days immediately pre-op	Drug: Prednisone Prednisone 50 mg once daily for 10 days pre-op
Placebo Comparator: 2 Placebo pill for 10 days immediately pre-operative	Drug: Placebo comparator Placebo pill identical to Prednisone 10 days once daily pre-op

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

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

Contacts

Contact: Ian Witterick, MD FRCSC

416-586-4800 ext 8313

iwitterick@mtsinai.on.ca

Locations

Canada, Ontario
Mount Sinai Hospital, University of Toronto	Recruiting
Toronto, Ontario, Canada, M5G 1X5
St. Joseph's Health Centre	Recruiting
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:

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.

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.

Responsible Party:	Ian Witterick, Mt. Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00440219 History of Changes
Other Study ID Numbers:	07-0001-A
Study First Received:	February 22, 2007
Last Updated:	May 9, 2011
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 February 09, 2012