Pre-operative Steroids in CRSsP

NCT05095961 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 5210327
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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 \[less the irrigation used\])

  Intra-operative

• Surgical field visibility

  Blinded assessor's grading of surgical field visualization

  Intra-operative

Secondary Outcomes (1)

• Patient intolerance of steroids

  Pre-operative

Study Arms (2)

Pre-operative oral steroids

EXPERIMENTAL

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

Drug: Prednisone

Control

NO INTERVENTION

No pre-operative medication will be prescribed

Interventions

Prednisone DRUG

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

Pre-operative oral steroids

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Related Publications (7)

• 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.

  PMID: 19930748 BACKGROUND

• 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.

  PMID: 9366694 BACKGROUND

• 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.

  PMID: 33478255 BACKGROUND

• 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.

  PMID: 24591266 BACKGROUND

• 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.

  PMID: 16900802 BACKGROUND

• Gunel C, Basak HS, Bleier BS. Oral steroids and intraoperative bleeding during endoscopic sinus surgery. B-ENT. 2015;11(2):123-8.

  PMID: 26563012 BACKGROUND

• 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.

  PMID: 27554509 BACKGROUND

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nadia Chan, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 27, 2021
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share