Surgery News - February 2008 - (Page 14)

GENERAL SURGERY SURGERY NEWS • F E B R U A RY 2 0 0 8 Infliximab Cuts Colectomy Rate in Ulcerative Colitis pared two dosages of infliximab (either 5 mg/kg or 10 mg/kg) with placebo in two different protocols that treated patients for P H I L A D E L P H I A — Patients with mod- as long as 54 weeks. The primary finding erate to severe ulcerative colitis treated was that patients treated with either with infliximab had their colectomy rate dosage were more likely than placebo pacut by more than a third during the first tients to have a clinical response after 8, 30, year of treatment, compared with control and 54 weeks of treatment (N. Engl. J. patients, according to a review of more Med. 2005;353:2462-76). This led to Food than 600 patients enrolled in two studies. and Drug Administration approval of inThe results will likely be important for fliximab (Remicade) for treating moderphysicians who must decide whether a pa- ately to severely active UC. Data on the incidence of colectomy tient with advanced ulcerative colitis (UC) should start treatment with a biologic during the first year of treatment with indrug that blocks tumor necrosis factor–α fliximab were not collected for all patients in these studies. This information was (TNF-α). “These data add more fuel to the debate available from trial records for about half about medical therapy versus surgery” for of the patients; more information was patients with advanced UC, said Dr. Brian collected retrospectively. About 14% of G. Feagan at the annual meeting of the patients in the study were excluded due to American College of Gastroenterology. lack of data on their colectomy status, “Which is more desirable: chronic im- leaving 630 patients in the new analysis. The incidence of colectomies was 9.5% munosuppression [with a biologic drug] or colectomy? You can’t say that one size fits among all patients treated with infliximab during 54 weeks of treatment, compared all patients.” The new analysis used data collected in with a 14.8% rate in the placebo group, a the Active Ulcerative Colitis Trials 1 and 2 5.3% absolute cut in the rate of surgery (ACT 1 and ACT 2), which together com- that was statistically significant and a 43% relative reduction, said Dr. Feagan, professor of medIncidence of Colectomies in Patients icine in the gastroenterology service, University of With Moderate to Severe Ulcerative Colitis Western Ontario, London. Further analysis showed 14.8% that several patients who received only 30 weeks of placebo treatment by the study protocol were 9.5% crossed to infliximab during an extension phase. The incidence of either colectomy or the start of infliximab treatment was cut in half in the inflixInfliximab Placebo imab-treated patients, compared with the control Note: Based on data for 630 patients treated for 54 weeks. group. Source: Dr. Feagan Infliximab treatment also BY MITCHEL L. ZOLER Else vier Global Medical Ne ws was linked to significant reductions in hospitalizations for UC, and in surgical and endoscopic procedures of all kinds. The adverse event profile for infliximab was similar to what was reported in 2005 for the ACT 1 and 2 studies, with no additional cases of tuberculosis, demyelinating disease, or hematologic events, Dr. Feagan said. Physicians and patients will need to decide whether the risks and complications of colectomy are high or low compared with biologic therapy, and whether quality of life is better with colectomy or bio- logic therapy, said Dr. Miguel D. Regueiro, codirector of the Inflammatory Bowel Disease Center at the University of Pittsburgh. The ACT 1 and 2 studies were sponsored by Centocor Inc., which markets infliximab in the United States, and by Schering-Plough, which markets the drug in all other countries. Dr. Feagan receives research support from, and is a consultants to and speaker for Centocor. Dr. Regueiro receives research support from and is a consultant to Centocor. ■ Ileonanal Pouch Outcome Pleases Most Patients B Y M I C H E L E G. S U L L I VA N Else vier Global Medical Ne ws N E W O R L E A N S — Although longterm functional outcomes after ileoanal pouch surgery may decline, most patients report a higher quality of life than they had before their surgery, Dr. Feza H. Remzi said at the annual clinical congress of the American College of Surgeons. Dr. Remzi, an ACS Fellow with the Cleveland Clinic Foundation, reported the results of a long-term follow-up study of 3,080 patients who underwent ileoanal pouch formation at the clinic from 1983 to 2006. The patients’ mean age at surgery was 38 years. Most (87%) had a final diagnosis of ulcerative or indeterminate colitis. A total of 43% of patients underwent surgery because of failed medical therapy or steroid dependence. Some of the other indications were prior colectomy (33%), dysplasia, cancer, or cancer prevention (11%), and familial polyposis (4%). STUDENT MANUAL, 7TH EDITION The ATLS® Program was developed to teach doctors one safe, reliable method for assessing and initially managing the trauma patient. The course teaches an organized approach for evaluation and management of seriously injured patients and offers a foundation of common knowledge for all members of the trauma team. The emphasis is on the critical “ﬁrst hour” of care, focusing on initial assessment, lifesaving intervention, reevaluation, stabilization, and, when needed, transfer to a trauma center. This publication, in its 7th edition, was written for use in ATLS Student Courses and is updated approximately every four years. Price: $80 each ATLS FOR DOCTORS NOW AVAILABLE : To obtain an ATLS for Doctors Student Manual, visit the American College of Surgeons online publication catalog at: https://web2.facs.org/timssnet464/acspub/frontpage.cfm?product_class=trauma The most commonly performed surgical technique was a stapled anastomosis (78%). A J-pouch design was used in 82% of patients, and 17% had their pouches created with no need for a diverting ileostomy. At 30 days postoperatively, wound infections occurred in 5% of patients, small bowel obstruction in 4%, sepsis in 4%, bleeding in 3%, anastomotic separation in 2.5%, and fistula in 1%. Less than 1% of patients had pouch failure. At 5-15 years after surgery, however, all complications (sepsis, fistula, anastomotic stricture, obstruction, pouch failure, and pouchitis) had a tendency to increase. Significant increases were seen in small bowel obstruction (from 16% at 5 years to 23% at 15 years) and pouchitis (from 32% to 52% over that same period). Incontinence increased significantly over time. While 75% of patents reported complete continence at 3 months post operatively, only 32% reported it 15 years later. However, there were significant longterm improvements to baseline. Before surgery, only 60% of patients reported rare incontinence or none at all. By 3 months after surgery, the percentage of that combined group of patients had risen to 80%, and it did not vary significantly during the next 15 years of follow-up. There was no significant change in the number of daytime or nighttime bowel movements from baseline to 15 years. Urgency decreased significantly over that period while pad usage and seepage increased. Nonetheless, patients generally reported high quality of life scores as early as 3 months after the procedure, and these scores stayed high throughout the follow-up period, Dr. Remzi said. Quality of life should be a primary end point in any evaluation of long-term outcomes after this procedure, said Dr. Robin McLeod, a discussant at the meeting. “Although the functional outcomes are not perfect, the quality of life for these patients is very good, and they are happy with the procedure,” said Dr. McLeod, an ACS Fellow with Mount Sinai Hospital, Toronto. According to Dr. Remzi, 97% of patients said they would have the procedure again, and would recommend it to others. ■ ELSEVIER GLOBAL MEDICAL NEWS https://web2.facs.org/timssnet464/acspub/frontpage.cfm?product_class=trauma https://web2.facs.org/timssnet464/acspub/frontpage.cfm?product_class=trauma

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Surgery News - February 2008 Contents IOM Committee Looks Into Safety Of Work Schedules Expertise Can Extend Liver Resectability Report Faults Specialty Hospitals' EDs Meeting Expectations Silver Lining HOD on Health Longer Liver Life?

Surgery News - February 2008

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