NCT00440219

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 .

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	Oral Prednisone	Prednisone 50 mg once daily for 10 days pre-op
DRUG	Placebo comparator	Placebo pill identical to Prednisone 10 days once daily pre-op

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2007-02-26
• Last updated: 2014-01-10

Locations

2 sites across 1 country: Canada