Pre-operative Steroids in CRSsP

Phase 2

Withdrawn

• Conditions: Chronic Sinusitis, Ethmoidal; Chronic Sinus Disease; Chronic Sinusitis, Sphenoidal; Chronic Sinusitis - Maxillary Bilateral; Chronic Sinusitis - Frontoethmoidal
• Interventions: Drug: Prednisone

• Registration Number: NCT05095961
• Lead Sponsor: Loma Linda University

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-27
• Study Start: 2023-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-03
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery

Exclusion Criteria

• Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-operative oral steroids	Prednisone	Patients will be given a course of oral prednisone (30mg daily) for 5 days.

Primary Outcome Measures

Name	Time	Method
Intra-operative blood loss - 1	Intra-operative	Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])
Intra-operative blood loss - 2	Intra-operative	Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])
Surgical field visibility	Intra-operative	Blinded assessor's grading of surgical field visualization

Secondary Outcome Measures

Name	Time	Method
Patient intolerance of steroids	Pre-operative	Patient report of intolerable adverse effects of pre-operative steroids