First trial on life-threatening condition finds two surgical approaches have same results

May 25, 2006

PITTSBURGH - A nationwide clinical trial involving researchers at Children's Hospital of Pittsburgh compared two radically different surgical procedures to treat an often fatal intestinal disorder in premature infants and found nearly identical results.

Results of the study, led by Yale University and conducted at 15 medical centers in the United States and Canada, are published in the May 25, 2006, issue of The New England Journal of Medicine. It is the first multicenter randomized controlled trial in the nation to compare two surgical approaches in children.

The study involved 117 premature infants who experienced perforation of the intestine because of necrotizing entercolitis (NEC). This is a potentially life-threatening condition treated with two thoroughly different surgical procedures, one invasive and one much less so.

For 30 years, surgeons have debated which approach produces better results, according to the study authors, including David J. Hackam, MD, PhD, a pediatric surgeon at Children's and assistant professor of surgery, cell biology and physiology at the University of Pittsburgh School of Medicine and Barbara Gaines, MD, also a pediatric surgeon at Children's and assistant professor of surgery at the University of Pittsburgh School of Medicine.

"Our study found that patient survival and other major outcomes were essentially the same for these two surgical approaches. This ends three decades of speculation and debate over which approach is more effective," Dr. Hackam said. "Now our efforts can be focused on studying which babies are at greatest risk for developing intestinal perforation due to NEC and then developing new therapies for these at-risk patients."

Dr. Hackam's lab at Children's studies the causes of NEC and seeks to find novel therapies for this devastating disease. NEC is a severe inflammatory disease of the intestine that affects as many as 10,000 premature infants in the United States each year. In extreme cases, NEC leads to perforation of the intestine, a condition that can be fatal if not treated with emergency surgery.

The first, more aggressive surgical procedure - laparotomy and bowel resection - involves a large abdominal incision and removal of all affected intestine. Surgeons then create a stoma, bringing the end of the intestine through a hole in the stomach to drain into a bag. The second procedure - peritoneal drainage - involves making a quarter-inch incision in the lower abdomen and placing a small bag, allowing stool and pus to drain from the abdomen without removal of any intestine.
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