Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440219
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2007-02-22
Brief Title:
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None