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

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440219
• Other study ID #: 07-0001-A
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2007
• Last updated: January 8, 2014
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Drug:
• Oral Prednisone
Prednisone 50 mg once daily for 10 days pre-op
• Placebo comparator
Placebo pill identical to Prednisone 10 days once daily pre-op

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, University of Toronto	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. Epub 2006 May 19. — View Citation

Johansson L, Akerlund A, Holmberg K, Melén I, Stierna P, Bende M. Evaluation of methods for endoscopic staging of nasal polyposis. Acta Otolaryngol. 2000 Jan;120(1):72-6. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Quality of life survey (SNOT22)	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.	2 weeks, 4 weeks, 3 months, 6 months post-op	No