Pre-operative Steroids in CRSsP

Loma Linda University

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

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

Interventions

PrednisoneDRUG

5 day course of oral prednisone pre-operatively. 30mg per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Intra-operative blood loss - 1

Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])

Time frame: Intra-operative

Intra-operative blood loss - 2

Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])

Time frame: Intra-operative

Surgical field visibility

Blinded assessor's grading of surgical field visualization

Time frame: Intra-operative

Secondary Outcomes

Patient intolerance of steroids

Patient report of intolerable adverse effects of pre-operative steroids

Time frame: Pre-operative

Data from ClinicalTrials.gov

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