A Phase 2/3 interventional study of Prednisone in Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal and Chronic Sinusitis, Sphenoidal, sponsored by Loma Linda University. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Loma Linda University · Phase 2/3, Interventional, and Treatment
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.
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.
Loma Linda University is the lead sponsor of 305 studies on the registry; 48 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
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Exclusion Criteria:
Patients will be given a course of oral prednisone (30mg daily) for 5 days.
Drug: Prednisone
No pre-operative medication will be prescribed
5 day course of oral prednisone pre-operatively. 30mg per day.
Intra-operative blood loss - 1
Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\])
Time frame: 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 \[less the irrigation used\])
Time frame: Intra-operative
Surgical field visibility
Blinded assessor's grading of surgical field visualization
Time frame: Intra-operative
Patient intolerance of steroids
Patient report of intolerable adverse effects of pre-operative steroids
Time frame: Pre-operative
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisone