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Annals of Surgery:
doi: 10.1097/SLA.0b013e318176bf81
Randomized Controlled Trials

Peritoneal Drainage or Laparotomy for Neonatal Bowel Perforation?: A Randomized Controlled Trial

Rees, Clare M. MB, ChB, MRCS*; Eaton, Simon PhD*; Kiely, Edward M. FRCSI, FRCS, FRCPCH(Hon)*; Wade, Angie M. PhD, CStat†; McHugh, Kieran FRCR‡; Pierro, Agostino MD, FRCS(Engl), FRCS(Edin), FAAP(Hon)*

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Abstract

Objective: To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation.

Summary Background Data: Optimal surgical management of ELBW infants with intestinal perforation is unknown.

Methods: An international multicenter randomized controlled trial was performed between 2002 and 2006. Inclusion criteria were birthweight ≤1000 g and pneumoperitoneum on x-ray (necrotizing enterocolitis or isolated perforation). Patients were randomized to peritoneal drain or laparotomy, minimizing differences in weight, gestation, ventilation, inotropes, platelets, country, and on-site surgical facilities. Patients randomized to drain were allowed to have a delayed laparotomy after at least 12 hours of no clinical improvement.

Results: Sixty-nine patients were randomized (35 drain, 34 laparotomy); 1 subsequently withdrew consent. Six-month survival was 18/35 (51.4%) with a drain and 21/33 (63.6%) with laparotomy (P = 0.3; difference 12% 95% CI, −11, 34%). Cox regression analysis showed no significant difference between groups (hazard ratio for primary drain 1.6; P = 0.3; 95% CI, 0.7–3.4). Delayed laparotomy was performed in 26/35 (74%) patients after a median of 2.5 days (range, 0.4–21) and did not improve 6-month survival compared with primary laparotomy (relative risk of mortality 1.4; P = 0.4; 95% CI, 0.6–3.4). Drain was effective as a definitive treatment in only 4/35 (11%) surviving neonates, the rest either had a delayed laparotomy or died.

Conclusions: Seventy-four percent of neonates treated with primary peritoneal drainage required delayed laparotomy. There were no significant differences in outcomes between the 2 randomization groups. Primary peritoneal drainage is ineffective as either a temporising measure or definitive treatment. If a drain is inserted, a timely “rescue” laparotomy should be considered.

Trial registration number ISRCTN18282954; http://isrctn.org/

© 2008 Lippincott Williams & Wilkins, Inc.

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