Clinical trial NCT05095961: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Sinus Disease
Chronic Sinusitis, Ethmoidal
Chronic Sinusitis, Sphenoidal
Chronic Sinusitis - Maxillary Bilateral
Chronic Sinusitis - Frontoethmoidal
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient's will be randomized to one of two groups: pre-operative oral steroids or no control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intra-operative blood loss - 1
timeFrame: Intra-operative
measure: Intra-operative blood loss - 2
timeFrame: Intra-operative
measure: Surgical field visibility
timeFrame: Intra-operative
Secondary outcomes:
measure: Patient intolerance of steroids
timeFrame: Pre-operative
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Nadia Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Gunel C, Basak HS, Bleier BS. Oral steroids and intraoperative bleeding during endoscopic sinus surgery. B-ENT. 2015;11(2):123-8.
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.