New Haven, Conn. -- Two surgical procedures, one invasive and the other much less so, for premature infants with intestinal perforation due to necrotizing enterocolitis (NEC) produce virtually identical results, according to a Yale School of Medicine study published today in the New England Journal of Medicine.

A significant aspect of the study is that it is the first multi-center randomized controlled trial to be completed comparing two operations in children, said the lead author, Larry Moss, M.D., chief of pediatric surgery in the Department of Surgery.

"Surgery is one of the most dramatic and potentially life-altering events in a patient's medical life, yet a remarkable amount of surgical practice is based upon historical tradition rather than scientific evidence," Moss said. "The vast majority of research on surgical conditions involves a single group of surgeons reporting upon their personal experience at one institution."

"This report argues against conventional wisdom that randomized studies cannot be effectively utilized to compare treatments for acutely life-threatening conditions," he said. "It proves that despite the biases against surgical trials, they can be completed with appropriate commitment by surgeons and their institutions."

NEC is a severe inflammatory disease of the intestine afflicting 5,000 to 10,000 premature infants in the United States each year. In its most severe form NEC results in perforation of part of the intestine, which requires emergency surgery that can be life-saving.

For more than 25 years surgeons have used two radically different operations for these babies. The first and more aggressive, laparotomy and bowel resection, involves a large abdominal incision with removal of all affected intestine and creation of a stoma, which means bringing the end of the intestine through the abdomen to drain into a bag. The alternative option, peritoneal drainage, involves making a inch incision in th
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Contact: Jacqueline Weaver
jacqueline.weaver@yale.edu
203-432-8555
Yale University
25-May-2006

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