Pre-operative Steroids in CRSsP

Chronic Sinus Disease Clinical Trial

Official title:

Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05095961
• Other study ID #: 5210327
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: March 2023
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinus Disease
• Chronic Sinusitis - Frontoethmoidal
• Chronic Sinusitis, Ethmoidal
• Chronic Sinusitis, Sphenoidal
• Ethmoid Sinusitis
• Paranasal Sinus Diseases
• Sinusitis

Intervention

Drug:
• Prednisone
5 day course of oral prednisone pre-operatively. 30mg per day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Surgical field visibility	Blinded assessor's grading of surgical field visualization	Intra-operative
Secondary	Patient intolerance of steroids	Patient report of intolerable adverse effects of pre-operative steroids	Pre-operative