Pre-operative Steroids in CRSsP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient's will be randomized to one of two groups: pre-operative oral steroids or no control

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Clinicians grading blood loss and surgical field disability on the recorded video footage will be blinded to patient identity and group status. Data analysis will be done by a blinded assessor.

Study Groups

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Pre-operative oral steroids

Patients will be given a course of oral prednisone (30mg daily) for 5 days.

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

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

Control

No pre-operative medication will be prescribed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prednisone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No