Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial.
Drainage
Enterocolitis, Necrotizing
/ mortality
Feasibility Studies
Female
Humans
Infant, Extremely Low Birth Weight
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases
/ mortality
Intestinal Perforation
/ mortality
Laparotomy
Male
Neurodevelopmental Disorders
/ diagnosis
Survival Rate
Treatment Outcome
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 10 2021
01 10 2021
Historique:
entrez:
10
9
2021
pubmed:
11
9
2021
medline:
6
10
2021
Statut:
ppublish
Résumé
The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown. We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches. Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%. There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
Sections du résumé
OBJECTIVE
The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP).
SUMMARY BACKGROUND DATA
The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown.
METHODS
We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches.
RESULTS
Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%.
CONCLUSIONS
There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
Identifiants
pubmed: 34506326
doi: 10.1097/SLA.0000000000005099
pii: 00000658-202110000-00027
pmc: PMC8439547
mid: NIHMS1725071
doi:
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e370-e380Subventions
Organisme : NICHD NIH HHS
ID : UG1 HD068263
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD021373
Pays : United States
Organisme : NCRR NIH HHS
ID : UL1 RR025764
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027856
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD034216
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027880
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD053109
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027851
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD036790
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR003142
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD087226
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD053124
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD053119
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD036790
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002538
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068270
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068244
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027853
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000042
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD087229
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR003167
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000006
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD040689
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD053089
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000093
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000454
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD027871
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027904
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000142
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000041
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068284
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD021385
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD040492
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD021364
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001117
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000077
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068278
Pays : United States
Organisme : NICHD NIH HHS
ID : U24 HD095254
Pays : United States
Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors report no conflict of interests.
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