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Withdrawn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
About this trial
This is an interventional treatment trial for Chronic Sinus Disease
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.
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
NCT ID
NCT05095961
First Posted
September 29, 2021
Last Updated
August 7, 2023
Sponsor
Loma Linda University
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Withdrawn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
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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
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Pre-operative Steroids in CRSsP
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