title: Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial.
abstract: OBJECTIVE
  To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation.
  
  
  BACKGROUND
  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 >or=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/
authors.affiliation: Department of Paediatric Surgery, Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, United Kingdom.
authors.forename: Clare M
authors.initials: CM
authors.lastname: Rees
authors.forename: Simon
authors.initials: S
authors.lastname: Eaton
authors.forename: Edward M
authors.initials: EM
authors.lastname: Kiely
authors.forename: Angie M
authors.initials: AM
authors.lastname: Wade
authors.forename: Kieran
authors.initials: K
authors.lastname: McHugh
authors.forename: Agostino
authors.initials: A
authors.lastname: Pierro
mesh_terms: D004322:Drainage; D005260:Female; D006801:Humans; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000401:mortality* / Q000601:surgery*; D007416:Intestinal Perforation / Q000151:congenital / Q000401:mortality* / Q000601:surgery*; D007813:Laparotomy; D007902:Length of Stay; D008297:Male; D016016:Proportional Hazards Models; D012107:Research Design; D016019:Survival Analysis; D016896:Treatment Outcome