Question

• Do preterm infants with necrotizing enterocolitis have improved survival to discharge from NICU when using percutaneous peritoneal drain compared to exploratory laparotomy?

Clinical Bottom Lines

1. There is no difference in mortality rates for infants randomized to peritoneal drainage versus exploratory laparotomy for perforated necrotizing enterocolitis at 90 days after procedure. (RR 1.03, CI 0.63-1.69)
2. There was no difference in TPN-dependence at 90 days post-procedure. (RR 0.85, CI 0.51-1.42)

Summary of Key Evidence

1. 117 patients with BW < 1500 g and GA < 34 weeks with perforated NEC or clinical suspicion of perforated NEC were randomized to primary peritoneal drain or exploratory laparotomy. Patients had standardized critical care pathway pre- and post-operatively.¹
2. Patients excluded if GI anomalies, previous abdominal surgery, or bilateral grade IV hemorrhages.
3. 19 of 55 patients assigned to primary peritoneal drainage died (34.5%) 90 days post-operatively.
4. 22 of 62 patients assigned to exploratory laparotomy died (35.5%) 90 days post-operatively.
5. Statistical modeling accounted for variables of birth weight, sex, absence/presence of pneumatosis, absence/presence of ventilator dependence, and platelet count on survival.
6. Authors used Kaplan-Meier survival curves with log rank test and Cox proportional hazards regression to adjust for variables of birth weight, sex, absence/presence of pneumatosis, absence/presence of ventilator dependence, and platelet count on survival.

Additional Comments

• Of 238 patients eligible for study, only 117 patients were enrolled in study.
• Outcomes for patients not enrolled in study were different than patients enrolled in study.
• Of those not enrolled in study, patients who underwent laparotomy had higher birth weight (p < 0.001), higher GA (p < 0.001) and lower mortality (p = 0.002).
• Study does not address long term outcomes such as neurodevelopmental outcomes and dependence on TPN > 90 days post-operatively.
• Lower power (77%) than original goal (80%) to detect drop of mortality rate from 50% to 25%.
• Patient's initial pH may have larger impact on survival if studied with appropriate power. Pts with pH < 7.30 had RR of 1.42 (95%CI 0.78-2.58), and pts with pH = 7.30 had RR of 0.53 (95% CI 0.20 - 1.36).
  

Citation

1. Moss RL, Dimmitt RA, Barnhart DC, et al. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med 2006;354:2225-34.

CAT Author: Amy Hepper, MD

CAT Appraisers: James Gurney, PhD

Date appraised: September 27, 2006