NCT05095961

Pre-operative Steroids in CRSsP

Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.

Detailed description

The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated. During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.

Conditions

• Chronic Sinus Disease
• Chronic Sinusitis, Ethmoidal
• Chronic Sinusitis, Sphenoidal
• Chronic Sinusitis - Maxillary Bilateral
• Chronic Sinusitis - Frontoethmoidal

Interventions

Type	Name	Description
DRUG	Prednisone	5 day course of oral prednisone pre-operatively. 30mg per day.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-08-01
• First posted: 2021-10-27
• Last updated: 2023-08-09

Regulatory

• FDA-regulated drug study