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Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely
Martin L Blakely1, Jon E Tyson, Kevin P Lally
1University of Tennessee Health Science Center, Memphis, Tennessee, USA. mblakely@utmem.edu
Insights
Initial surgical drainage for extremely low birth weight infants with necrotizing enterocolitis or intestinal perforation had poor outcomes. Laparotomy showed a trend toward better survival and neurodevelopmental results, suggesting a need for further clinical trials.
Area of Science:
- Neonatal surgery
- Pediatric surgery
- Gastroenterology
Background:
- Extremely low birth weight (ELBW) infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP) require surgical intervention.
- Current treatment options include initial laparotomy or peritoneal drain placement.
- Limited data exist comparing these surgical approaches, particularly regarding long-term outcomes.
Purpose of the Study:
- To form a hypothesis on the comparative effectiveness of initial laparotomy versus peritoneal drain placement for ELBW infants with NEC or IP.
- To gather data for designing a future clinical trial.
- To assess risk-adjusted outcomes up to 18–22 months of corrected age.
Main Methods:
- A prospective, multicenter observational cohort study involving 16 clinical centers.
- Data collection included preoperative and intraoperative diagnoses and identification of infants too ill for laparotomy.
- Outcome measures comprised predischarge death or prolonged parenteral nutrition, and death or neurodevelopmental impairment at 18–22 months' corrected age.
Main Results:
- Severe NEC or IP occurred in 5.2% of 2987 ELBW infants; 80 underwent initial drainage, and 76 underwent initial laparotomy.
- By 18–22 months, 50% of infants had died, and 72% had died or exhibited neurodevelopmental impairment.
- Laparotomy was not performed in 76% of survivors treated initially with drainage.
Conclusions:
- Initial surgical drainage for NEC or IP in ELBW infants is common but associated with poor outcomes.
- Risk-adjusted analysis favored laparotomy, suggesting improved survival and neurodevelopmental outcomes.
- A large, multicenter clinical trial is warranted to definitively evaluate the impact of initial surgical strategy on long-term outcomes.
Objective:
Extremely low birth weight (ELBW; < or =1000 g) infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP) are treated surgically with either initial laparotomy or peritoneal drain placement. The only published data comparing these therapies are from small, retrospective, single-center studies that do not address outcomes beyond nursery discharge. The objective of this study was to conduct a prospective, multicenter, observational study to (1) develop a hypothesis about the relative effect of these 2 therapies on risk-adjusted outcomes through 18 to 22 months in ELBW infants and (2) to obtain data that would be useful in designing and conducting a successful trial of this hypothesis.
Methods:
A prospective, cohort study was conducted at 16 clinical centers within the National Institute of Child Health and Human Development Neonatal Research Network. To assist in risk adjustment, the attending pediatric surgeon recorded the preoperative diagnosis and intraoperative diagnosis and identified infants who were considered to be too ill for laparotomy. Predefined measures of short- and longer-term outcome included (1) either predischarge death or prolonged parenteral nutrition (>85 days) after enrollment and (2) either death or neurodevelopmental impairment on a standardized examination at 18 to 22 months' adjusted age.
Results:
Severe NEC or IP occurred in 156 (5.2%) of 2987 ELBW infants; 80 were treated with initial drainage, and 76 were treated with initial laparotomy. By 18 to 22 months, 78 (50%) had died; 112 (72%) had died or were shown to be impaired. Outcome was worse in the subgroup with NEC. Laparotomy was never performed in 76% (28 of 36) of drain-treated survivors.
Conclusions:
Drainage was commonly used, and outcome was poor. Our findings, particularly the risk-adjusted odds ratio favoring laparotomy for death or impairment, indicate the need for a large, multicenter clinical trial to assess the effect of the initial surgical therapy on outcome at > or =18 months.
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