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FDA Warns About Lenalidomide, Duloxetine Hydrochloride

Pharmacy Focus

The U.S. Food and Drug Administration has issued warnings about the cancer drug lenalidomide and the antidepressant duloxetine hydrochloride.

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Surgery Grand Rounds

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Grand Rounds

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Educational Schedule - November 2014 (PDF)

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Colorectal Surgery Trials Challenge Dogma

By Karen Zaghiyan, MD, and Phillip Fleshner, MD

No one can argue about the importance of the three pillars of surgical practice: clinical, education and research. The Cedars-Sinai Division of Colorectal Surgery remains busy in the operating room while continuing to have its own fellowship program and to play an integral role in the educational program of the General Surgery Residency.

On the research front, our group has been working hard to look at our perioperative clinical decision-making more skeptically and to evaluate our decisions with randomized, controlled trials that challenge dogma regarding the preoperative and postoperative management of patients undergoing colorectal surgery.

One of these pivotal studies, published in Annals of Surgery, examined the long-held dogma that stress-dose steroids were mandatory in steroid-treated patients undergoing major colorectal surgery. We embarked on a controlled trial to compare the safety of perioperative low-dose steroid against high-dose steroids in steroid-treated patients with inflammatory bowel disease undergoing major colorectal surgery.

Our data clearly demonstrated the safety of a low-dose perioperative corticosteroid regimen that did not increase the risk of hemodynamic instability. All patients taking steroids, or recently exposed to steroids, and undergoing major colorectal surgery should be managed with perioperative low-dose steroids.

A second study, also published in Annals of Surgery, challenged the practice of not feeding patients after elective colorectal surgery. Dietary management of the patient after intestinal surgery has been dictated by unsubstantiated surgical dogma. Traditionally, patients receive nothing by mouth until resolution of the postoperative ileus for fear that early postoperative feeding could lead to serious complications such as anastomotic breakdown, aspiration and wound separation.

This traditional view has been challenged extensively in recent literature showing that early clear-liquid feeding is safe and not associated with increased postoperative morbidity. What remained to be known is whether early intake of a solid diet confers the same benefits and is as safe as clear liquids for elective colorectal patients.

Our randomized, controlled trial of patient tolerance of either a clear-fluid or low-residue diet started on postoperative day 1 (POD 1) after elective colorectal surgery showed a statistically significant reduction in length of stay and better patient tolerance with early low-residue diet compared to early clear fluid. No detrimental effects of early low-residue diet were demonstrated with regard to postoperative morbidity, in particular reoperation for abdominal complications. These data suggest that surgeons should strongly consider adopting an early solid diet from POD 1 as part of standard practice for patients undergoing elective colorectal surgery.

On another front, our group has embarked on a randomized prospective study to evaluate the optimal timing of chemical venous prophylaxis after major colorectal surgery. The current chest and Surgical Care Improvement Project guidelines are vague, recommending that chemical venous prophylaxis start within 24 hours of major colorectal surgery. Thus, many surgeons wait until after surgery to begin prophylaxis due to concern for bleeding with preoperative prophylaxis.

On the other hand, postoperative prophylaxis leaves patients vulnerable for venous thromboembolism (VTE) during surgery, when the risk may be the highest. In our study, patients are randomized to preoperative prophylaxis (heparin 5,000 units subcutaneous given in the preoperative holding area) or postoperative prophylaxis (heparin 5,000 units subcutaneous started in the 24-hour postoperative period). All patients undergo a lower extremity venous duplex in the preoperative holding area before surgery, followed by a duplex immediately after surgery and on POD2.

Our study is ongoing, but the results of our planned interim analysis were presented this year at the American College of Surgeons. We found a statistically higher incidence of VTE occurring in the 48-hour postoperative period in patients managed with postoperative chemical prophylaxis (7 percent) compared with no VTE in patients randomized to preoperative prophylaxis.

Interestingly, there were fewer bleeding complications in patients managed with preoperative chemical prophylaxis. We also found a 3 percent incidence of preoperative deep vein thrombosis in patients walking in for elective colorectal surgery. These results may have serious implications both for our patients' well-being and with respect to hospital reimbursement in an era where hospitals may be penalized for perioperative VTE complications.

Thus, preoperative screening lower extremity venous duplex may prove to be worthwhile in patients scheduled for major colorectal surgery. While the study is ongoing, the results so far are striking, with potentially practice-changing findings.


"Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery," Cedars-Sinai Institutional Review Board no. Pro00022170

"Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients," Cedars-Sinai Institutional Review Board no. Pro00029966