Two very different surgical procedures produce same results in often fatal intestinal disorder

May 25, 2006

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 ¼ inch incision in the lower abdomen and placing a small drain allowing egress of stool and pus from the abdomen without removing any intestine.

The trial led by Moss included 117 premature infants at 15 leading pediatric academic medical centers from the United States and Canada. When a baby developed perforated NEC at a study site, parents were counseled by the operating surgeons and offered enrollment into the trial. If they agreed, the operation their child received was assigned randomly.

"The study found that patient survival and other major outcomes for the two drastically different operations were virtually identical," he said. "After 30 years of debate over which procedure is best, the first true scientific experiment addressing this question suggests that the method of the surgery may not be the important aspect of treatment."

As a next step, Moss, working with six academic medical centers, is directing collection of clinical and biological information for a database to identify which babies with NEC are at greatest risk of perforation. The team is collaborating with other researchers who are developing promising new therapies that can be tested in this targeted group of patients.

"Since the study compared the most aggressive surgical treatment with the least invasive and found no difference, it appears unlikely that ongoing focus on the details of the operation is likely to improve survival in these patients," he said.

Moss also has developed and tested a set of clinical research reporting guidelines for surgery that revealed there was a lack of evidence for many surgical procedures in children. The tool was then validated on a large sample of several hundred studies. As a result of this work, the Journal of Pediatric Surgery has adopted the guidelines and is using them for all clinical research published in the journal.
-end-
NEJM Vol. xx: pp-pp (May 25, 2006)

Yale University

Related Premature Infants Articles from Brightsurf:

Expanded newborn screening could save premature infants' lives
Expanding routine newborn screening to include a metabolic vulnerability profile could lead to earlier detection of life-threatening complications in babies born preterm, according to a study by UC San Francisco researchers.

New machine learning tool predicts devastating intestinal disease in premature infants
Researchers from Columbia Engineering and the University of Pittsburgh have developed a sensitive and specific early warning system for predicting necrotizing enterocolitis (NEC) in premature infants before the life-threatening intestinal disease occurs.

Hormone adjustment may lead to new ways to prevent and treat lung damage in premature infants
Prematurely born babies often need oxygen therapy to prevent brain damage or death.

Revised criteria lead to more accurate screening for eye disease in premature infants
A multicenter group of 41 hospitals led by researchers at Children's Hospital of Philadelphia (CHOP) has confirmed that an improved method for predicting retinopathy of prematurity (ROP), a leading cause of blindness in children, was able to reduce the number of babies having invasive diagnostic examinations by nearly a third, while raising disease detection up to 100 percent.

Deaf infants' gaze behavior more advanced than that of hearing infants
Deaf infants who have been exposed to American Sign Language are better at following an adult's gaze than their hearing peers, supporting the idea that social-cognitive development is sensitive to different kinds of life experiences.

Compared to sustained inflations for extremely premature infants, standard treatment prevails
Preterm infants must establish regular breathing patterns at delivery. For extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving two sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of bronchopulmonary dysplasia or death at 36 weeks postmenstrual age.

Cancer causes premature ageing
New research shows that cancer causes premature ageing. Researchers studied Leukaemia, and found that it promotes premature ageing in healthy bone marrow cells.

Checklist helps assess early feeding skills in premature infants
Infants born prematurely face challenges in developing the complex, interrelated skills needed for effective feeding.

Researchers design delivery system to treat premature infants with NEC
Researchers at Nationwide Children's Hospital have developed Lactobacillus reuteri biofilm formulations that protect against experimental necrotizing enterocolitis (NEC).

Majority of premature infants still exposed to early antibiotics
Most premature infants, who are at risk for sepsis but who may not have a culture confirmation of infection, continue to receive early antibiotics in the first few days of life, a finding that suggests neonatal antibiotic stewardship efforts are needed to help clinicians identify infants at lowest risk for infection to avoid unnecessary antibiotic exposure.

Read More: Premature Infants News and Premature Infants Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.