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/
In an international randomized controlled trial comparing peritoneal drain with laparotomy in extremely low birth weight infants with pneumoperitoneum, there was no survival advantage with drain and most patients required laparotomy.
From the *Department of Paediatric Surgery, †MRC Collaborative Centre of Epidemiology for Child Health, ‡Department of Paediatric Radiology, Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, United Kingdom.
Supported by charitable grants from the Eugenio Litta Foundation, Geneva, Switzerland and the Stanley Thomas Johnson Foundation, Berne, Switzerland.
C. M. R. and S. E. are joint first authors.
C. M. R. was the trial coordinator, collected data, analysed data, and wrote the first draft of the manuscript; S. E. supervised C. M. R., was involved in the trial design, data collection and analysis, and writing of the manuscript; E. M. K. assisted in trial design, recruitment and interpretation of results; A. M. W. provided expert statistical advice, contributed to the trial design, and reviewed the statistical analysis; K. M. contributed to the trial design, and provided expert radiological advice; A. P. was the principal investigator for the trial, conceived the idea of the trial, and was involved in all stages of trial design, management, and writing of the manuscript.
All authors contributed to writing the final manuscript and have seen and approved the final version.
A. P., S. E., and C. M. R. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Reprints: Prof. Agostino Pierro, 30 Guilford St., London, WC1N 1EH UK. E-mail: email@example.com.