search
Back to results

Pre-operative Steroids in CRSsP

Primary Purpose

Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal, Chronic Sinusitis, Sphenoidal

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinus Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pre-operative oral steroids

    Control

    Arm Description

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

    No pre-operative medication will be prescribed

    Outcomes

    Primary Outcome Measures

    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])
    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])
    Surgical field visibility
    Blinded assessor's grading of surgical field visualization

    Secondary Outcome Measures

    Patient intolerance of steroids
    Patient report of intolerable adverse effects of pre-operative steroids

    Full Information

    First Posted
    September 29, 2021
    Last Updated
    August 7, 2023
    Sponsor
    Loma Linda University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05095961
    Brief Title
    Pre-operative Steroids in CRSsP
    Official Title
    Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Loma Linda University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal, Chronic Sinusitis, Sphenoidal, Chronic Sinusitis - Maxillary Bilateral, Chronic Sinusitis - Frontoethmoidal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patient's will be randomized to one of two groups: pre-operative oral steroids or no control
    Masking
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-operative oral steroids
    Arm Type
    Experimental
    Arm Description
    Patients will be given a course of oral prednisone (30mg daily) for 5 days.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No pre-operative medication will be prescribed
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Intervention Description
    5 day course of oral prednisone pre-operatively. 30mg per day.
    Primary Outcome Measure Information:
    Title
    Intra-operative blood loss - 1
    Description
    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
    Title
    Intra-operative blood loss - 2
    Description
    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
    Title
    Surgical field visibility
    Description
    Blinded assessor's grading of surgical field visualization
    Time Frame
    Intra-operative
    Secondary Outcome Measure Information:
    Title
    Patient intolerance of steroids
    Description
    Patient report of intolerable adverse effects of pre-operative steroids
    Time Frame
    Pre-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nadia Chan, MD
    Organizational Affiliation
    Loma Linda University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19930748
    Citation
    Govindaraj S, Adappa ND, Kennedy DW. Endoscopic sinus surgery: evolution and technical innovations. J Laryngol Otol. 2010 Mar;124(3):242-50. doi: 10.1017/S0022215109991368. Epub 2009 Nov 23.
    Results Reference
    background
    PubMed Identifier
    9366694
    Citation
    Linder TE, Simmen D, Stool SE. Revolutionary inventions in the 20th century. The history of endoscopy. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1161-3. doi: 10.1001/archotol.1997.01900110011001.
    Results Reference
    background
    PubMed Identifier
    33478255
    Citation
    Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.
    Results Reference
    background
    PubMed Identifier
    24591266
    Citation
    Wawrzyniak K, Burduk PK, Cywinski JB, Kusza K, Kazmierczak W. Improved quality of surgical field during endoscopic sinus surgery after clonidine premedication--a pilot study. Int Forum Allergy Rhinol. 2014 Jul;4(7):542-7. doi: 10.1002/alr.21308. Epub 2014 Mar 3.
    Results Reference
    background
    PubMed Identifier
    16900802
    Citation
    Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702.
    Results Reference
    background
    PubMed Identifier
    26563012
    Citation
    Gunel C, Basak HS, Bleier BS. Oral steroids and intraoperative bleeding during endoscopic sinus surgery. B-ENT. 2015;11(2):123-8.
    Results Reference
    background
    PubMed Identifier
    27554509
    Citation
    Hwang SH, Seo JH, Joo YH, Kang JM. Does the Preoperative Administration of Steroids Reduce Intraoperative Bleeding during Endoscopic Surgery of Nasal Polyps? Otolaryngol Head Neck Surg. 2016 Dec;155(6):949-955. doi: 10.1177/0194599816663455. Epub 2016 Aug 23.
    Results Reference
    background

    Learn more about this trial

    Pre-operative Steroids in CRSsP

    We'll reach out to this number within 24 hrs