Clinical Trials Logo
  1. Home
  2. Chronic Sinusitis
  3. NCT01564355

Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery

Chronic Sinusitis Clinical Trial

Official title:
The Role of Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Middle Meatal Spacer Following Endoscopic Sinus Surgery: A Randomized, Double-Blind, Placebo Controlled Trial

Clinical Trial Summary

Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It affects about 5 to 10% of Canadians. Patients suffer from congestion in the nose and sinuses, nasal discharge, pressure in the face, and a reduced sense of smell. This affects people's enjoyment of life. Medical management uses sprays or pills to treat these symptoms but for some patients sinus surgery is needed. This type of surgery is called endoscopic sinus surgery (ESS).

There is no single correct approach to take care of patients after sinus surgery. Most experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus swelling and minimize complications related to scarring.

"Steroid-eluting nasal spacers" are devices placed inside the sinus during surgery and slowly release topical steroids into the sinuses better than steroid sprays. These "spacers" have been shown to improve results following sinus surgery. When using these special "spacers", there may no longer be a need for oral steroid pills following surgery. This would help to avoid potential side effects associated with these medications.

The purpose of this study is to find out whether taking oral (systemic) steroid pills following sinus surgery is necessary to improve surgical results, now that steroid-eluting nasal spacers are commonly used during surgery.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01564355
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase N/A
Start date April 2012
Completion date December 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT02266810 - Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus Phase 3
Completed NCT01706484 - Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis Phase 3
Completed NCT01197612 - Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis Phase 3
Completed NCT04163978 - Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) Phase 2
Completed NCT04418622 - Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
Not yet recruiting NCT06070311 - Wound Healing After Endoscopic Sinus Surgery N/A
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Withdrawn NCT01185808 - Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps N/A
Completed NCT01700725 - Gulf War Illness Nasal Irrigation Study Phase 2
Withdrawn NCT00671281 - The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery N/A
Completed NCT00447837 - Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis Phase 2
Recruiting NCT04362501 - Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Phase 2
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Completed NCT02562924 - The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery N/A
Completed NCT01007799 - Vitamin D for Chronic Sinusitis N/A
Completed NCT03358329 - Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) Phase 3
Withdrawn NCT02981017 - Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure N/A
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Recruiting NCT01854619 - Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis N/A
Completed NCT00924404 - Xylitol Versus Saline in Chronic Sinusitis N/A