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A Prospective, Randomized, Noninferiority Trial of Steroid Dosing After Major Colorectal Surgery

Zaghiyan, Karen MD*; Melmed, Gil Y. MD; Berel, Dror MS; Ovsepyan, Gayane BS*; Murrell, Zuri MD*; Fleshner, Phillip MD*

doi: 10.1097/SLA.0b013e318297adca
Randomized Controlled Trials

Objective: To evaluate the safety of perioperative low-dose steroids (LDS) versus high-dose steroids (HDS) in steroid-treated patients with inflammatory bowel disease (IBD) undergoing major colorectal surgery.

Background: Corticosteroid-treated patients undergoing major colorectal surgery are commonly prescribed HDS to prevent perioperative adrenal insufficiency and cardiovascular collapse. There is little evidence to support this practice.

Methods: We performed a single-blinded noninferiority trial to compare perioperative hemodynamic instability in 92 steroid-treated IBD patients undergoing major colorectal surgery. Patients were randomly assigned to receive perioperative high-dose corticosteroids (HDS; hydrocortisone, 100 mg, intravenously 3 times daily, followed by taper) or low-dose corticosteroids (LDS; intravenous hydrocortisone equivalent to presurgical oral dosing, followed by taper). The primary outcome was the absence of postural hypotension on postoperative day 1, defined as a decrease in systolic blood pressure by 20 mm Hg after sitting from a supine position.

Results: The primary outcome, absence of postural hypotension on postoperative day 1, occurred in 95% of those randomized to receive high doses of corticosteroids compared with 96% of those who received low doses (noninferiority 95% confidence interval = −0.08 to 0.09; P = 0.007).

Conclusions: In IBD patients undergoing abdominal surgery, the incidence of postural hypotension or adrenal insufficiency is similar among those receiving high doses or low doses of corticosteroids in the perioperative period. To reduce complications associated with unnecessarily high doses of steroids, steroid-treated IBD patients undergoing major colorectal surgery should be treated with low doses of steroids in the perioperative period. (Clinicaltrials.gov ID# NCT01559675)

In this prospective study of steroid-treated patients with inflammatory bowel disease (IBD) undergoing major colorectal surgery, perioperative low-dose steroids (LDS) were found to be noninferior to high-dose steroids (HDS) with respect to our primary endpoint, postural hypotension on postoperative day 1. Steroid-treated patients with IBD should be treated with perioperative LDS instead of HDS.

Divisions of *Colorectal Surgery and

Gastroenterology; and

Department of Biostatistics and Bioinformatics, Cedars Sinai Medical Center, Los Angeles, CA.

Reprints: Phillip Fleshner, MD, Division of Colorectal Surgery, Cedars Sinai Medical Center, 8737 Beverly Blvd, Suite 101, Los Angeles, CA 90048. E-mail: Pfleshner@aol.com.

Disclosure: The authors declare no conflicts of interest.

© 2014 by Lippincott Williams & Wilkins.