The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study - 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Surgery

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:

Time spent suctioning/wiping scope (absolute and relative to total surgery time), total surgery time (from video) [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Surgeon surveys [ Time Frame: Immediate Postoperative period ] [ Designated as safety issue: No ]
Intraoperative blood loss [ Time Frame: Immediately postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life (SNOT20, SF36) [ Time Frame: 2 weeks, 4 weeks, 6 months, 12 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Prednisone 50 mg daily for 10 days immediately pre-op	Drug: Prednisone Prednisone 50 mg once daily for 10 days pre-op
2: Placebo Comparator 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 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.

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.

Responsible Party:	Mt. Sinai Hospital ( Ian Witterick )
Study ID Numbers:	07-0001-A
Study First Received:	February 22, 2007
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00440219 History of Changes
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:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Prednisone
Otorhinolaryngologic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Polyps
Glucocorticoids
Hormones
Nose Diseases
Pharmacologic Actions
Nasal Polyps
Therapeutic Uses

ClinicalTrials.gov processed this record on November 22, 2009