Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05095961
Study type Interventional
Source Loma Linda University
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date March 2023
Completion date August 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04970966 - Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings N/A
Recruiting NCT03965767 - Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial Phase 3
Completed NCT01319305 - BREATHE Long-Term Follow-Up Study N/A