Document Detail


Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation.
MedLine Citation:
PMID:  16723614     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Perforated necrotizing enterocolitis is a major cause of morbidity and mortality in premature infants, and the optimal treatment is uncertain. We designed this multicenter randomized trial to compare outcomes of primary peritoneal drainage with laparotomy and bowel resection in preterm infants with perforated necrotizing enterocolitis. METHODS: We randomly assigned 117 preterm infants (delivered before 34 weeks of gestation) with birth weights less than 1500 g and perforated necrotizing enterocolitis at 15 pediatric centers to undergo primary peritoneal drainage or laparotomy with bowel resection. Postoperative care was standardized. The primary outcome was survival at 90 days postoperatively. Secondary outcomes included dependence on parenteral nutrition 90 days postoperatively and length of hospital stay. RESULTS: At 90 days postoperatively, 19 of 55 infants assigned to primary peritoneal drainage had died (34.5 percent), as compared with 22 of 62 infants assigned to laparotomy (35.5 percent, P=0.92). The percentages of infants who depended on total parenteral nutrition were 17 of 36 (47.2 percent) in the peritoneal-drainage group and 16 of 40 (40.0 percent) in the laparotomy group (P=0.53). The mean (+/-SD) length of hospitalization for the 76 infants who were alive 90 days after operation was similar in the primary peritoneal-drainage and laparotomy groups (126+/-58 days and 116+/-56 days, respectively; P=0.43). Subgroup analyses stratified according to the presence or absence of radiographic evidence of extensive necrotizing enterocolitis (pneumatosis intestinalis), gestational age of less than 25 weeks, and serum pH less than 7.30 at presentation showed no significant advantage of either treatment in any group. CONCLUSIONS: The type of operation performed for perforated necrotizing enterocolitis does not influence survival or other clinically important early outcomes in preterm infants. (ClinicalTrials.gov number, NCT00252681.).
Authors:
R Lawrence Moss; Reed A Dimmitt; Douglas C Barnhart; Karl G Sylvester; Rebeccah L Brown; David M Powell; Saleem Islam; Jacob C Langer; Thomas T Sato; Mary L Brandt; Hanmin Lee; Martin L Blakely; Eric L Lazar; Ronald B Hirschl; Brian D Kenney; David J Hackam; Daniel Zelterman; Bonnie L Silverman
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  The New England journal of medicine     Volume:  354     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-25     Completed Date:  2006-06-01     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2225-34     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2006 Massachusetts Medical Society.
Affiliation:
Section of Pediatric Surgery, Yale University School of Medicine, New Haven, Conn 06520-8062, USA. larry.moss@yale.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00252681
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MeSH Terms
Descriptor/Qualifier:
Birth Weight
Drainage*
Enterocolitis, Necrotizing / complications,  mortality,  surgery,  therapy*
Female
Humans
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / mortality,  surgery,  therapy*
Infant, Very Low Birth Weight*
Intestinal Perforation / etiology,  mortality,  surgery,  therapy*
Laparotomy*
Male
Parenteral Nutrition, Total
Peritoneum
Proportional Hazards Models
Survival Analysis
Treatment Outcome
Grant Support
ID/Acronym/Agency:
K24 HD 42480/HD/NICHD NIH HHS; R01 HD 38462/HD/NICHD NIH HHS
Comments/Corrections
Comment In:
N Engl J Med. 2006 Aug 24;355(8):847; author reply 847   [PMID:  16937551 ]
N Engl J Med. 2006 May 25;354(21):2275-6   [PMID:  16723619 ]
Nat Clin Pract Gastroenterol Hepatol. 2007 Jan;4(1):18-9   [PMID:  17203083 ]
N Engl J Med. 2006 Aug 24;355(8):846-7; author reply 847   [PMID:  16929002 ]
Erratum In:
N Engl J Med. 2006 Aug 24;355(8):856

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