Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery

Our primary aim is to study the perioperative hemodynamic profile of patients on chronic
steroids undergoing colon and rectal surgery. We will do this by measuring heart rate,
temperature and blood pressure in the operating room and during their postoperative
hospitalization. Patients will be identified in their preoperative visit. They will be
randomized to high dose and low dose steroid study groups. The standard dose steroid patients
will receive hydrocortisone 100 mg IV preoperatively and 100 mg IV every 8 hrs with standard
taper. The low dose steroid study group will receive the IV equivalent of their preoperative
steroid dose in the postoperative period. The patients blood pressure, temperature and heart
rate will be monitored in the operating room and the ward postoperatively. Outcomes will be
compared between the two groups. We hypothesize that there will be no statistically
significant difference in blood pressure, temperature or heart rate in the high dose and low
dose groups.

The secondary aim of this study will be monitoring of any differences in surgical outcomes,
including postoperative length of stay, between the two patient groups.

Inclusion Criteria:

- History of ulcerative colitis, inflammatory bowel disease unclassified, indeterminate
colitis, or Crohn's disease;

- Major colorectal surgery, defined as surgery requiring an abdominal incision. Both
open and laparoscopic procedures are eligible. Urgent and elective procedures are
eligible;

- Corticosteroid therapy within 12 months of surgery;

- Able and willing to comply with all protocol procedures for the planned duration of
the study

- Able and willing to understand, sign and date an informed consent document, and
authorize access to protected health information.

Exclusion Criteria:

- Patients with hypotension (systolic < 90 mm Hg or diastolic < 50 mm Hg) in the
preoperative area

- Patients having emergency surgery

- Children < 18 or adults > 75 years of age

- Pregnant patients

- Patients who have suffered prior hemodynamic complications of steroid withdrawal

- Other major physical or major psychiatric illness, including alcohol or substance
addiction, within the last 6 months that in the opinion of the investigator would
affect the patient's ability to complete the trial.

- Any condition or situation that, in the opinion of the investigator, would prevent
proper evaluation of the safety or efficacy of the different steroid doses according
to the study protocol

- Patients on steroids without inflammatory bowel disease